Thursday, 29 September 2016

Dexamethason-Augensalbe Jenapharm




Dexamethason-Augensalbe Jenapharm may be available in the countries listed below.


Ingredient matches for Dexamethason-Augensalbe Jenapharm



Dexamethasone

Dexamethasone is reported as an ingredient of Dexamethason-Augensalbe Jenapharm in the following countries:


  • Germany

International Drug Name Search

Wednesday, 28 September 2016

Uricont




Uricont may be available in the countries listed below.


Ingredient matches for Uricont



Oxybutynin

Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Uricont in the following countries:


  • Chile

  • Israel

  • Peru

International Drug Name Search

Unitac




Unitac may be available in the countries listed below.


Ingredient matches for Unitac



Ranitidine

Ranitidine is reported as an ingredient of Unitac in the following countries:


  • Bangladesh

International Drug Name Search

Abelcet




In the US, Abelcet (amphotericin b lipid complex systemic) is a member of the drug class polyenes and is used to treat Aspergillosis - Aspergilloma, Aspergillosis - Invasive, Blastomycosis, Candida Infections - Systemic, Coccidioidomycosis, Cryptococcosis, Histoplasmosis and Leishmaniasis.

US matches:

  • Abelcet

UK matches:

  • Abelcet
  • Abelcet (Cephalon (UK) Limited) (SPC)

Ingredient matches for Abelcet



Amphotericin B

Amphotericin B is reported as an ingredient of Abelcet in the following countries:


  • Belgium

  • Poland

  • Sweden

Amphotericin B phospholipid complex (a derivative of Amphotericin B) is reported as an ingredient of Abelcet in the following countries:


  • Argentina

  • Australia

  • Austria

  • Czech Republic

  • Denmark

  • Finland

  • France

  • Germany

  • Greece

  • Hungary

  • Iceland

  • Ireland

  • Italy

  • Luxembourg

  • Netherlands

  • Norway

  • Oman

  • Singapore

  • Slovakia

  • Spain

  • Turkey

  • United Kingdom

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Urinter




Urinter may be available in the countries listed below.


Ingredient matches for Urinter



Pipemidic Acid

Pipemidic Acid is reported as an ingredient of Urinter in the following countries:


  • Indonesia

International Drug Name Search

Ovral




In the US, Ovral is a member of the drug class contraceptives and is used to treat Abnormal Uterine Bleeding, Birth Control, Emergency Contraception, Endometriosis and Gonadotropin Inhibition.

Ingredient matches for Ovral



Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Ovral in the following countries:


  • Ethiopia

  • South Africa

  • United States

Norgestrel

Norgestrel is reported as an ingredient of Ovral in the following countries:


  • Canada

  • Ethiopia

  • South Africa

  • United States

International Drug Name Search

Acridilole




Acridilole may be available in the countries listed below.


Ingredient matches for Acridilole



Carvedilol

Carvedilol is reported as an ingredient of Acridilole in the following countries:


  • Russian Federation

International Drug Name Search

Upsarin plus Vitamin C




Upsarin plus Vitamin C may be available in the countries listed below.


Ingredient matches for Upsarin plus Vitamin C



Aspirin

Acetylsalicylic Acid is reported as an ingredient of Upsarin plus Vitamin C in the following countries:


  • Croatia (Hrvatska)

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Upsarin plus Vitamin C in the following countries:


  • Croatia (Hrvatska)

International Drug Name Search

Bupafen




Bupafen may be available in the countries listed below.


Ingredient matches for Bupafen



Bupivacaine

Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Bupafen in the following countries:


  • New Zealand

Fentanyl

Fentanyl citrate (a derivative of Fentanyl) is reported as an ingredient of Bupafen in the following countries:


  • New Zealand

International Drug Name Search

Unidox Solutab




Unidox Solutab may be available in the countries listed below.


Ingredient matches for Unidox Solutab



Doxycycline

Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Unidox Solutab in the following countries:


  • Georgia

  • Russian Federation

International Drug Name Search

Rizin




Rizin may be available in the countries listed below.


Ingredient matches for Rizin



Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Rizin in the following countries:


  • Bangladesh

International Drug Name Search

Monadox




Monadox may be available in the countries listed below.


Ingredient matches for Monadox



Doxycycline

Doxycycline is reported as an ingredient of Monadox in the following countries:


  • Bangladesh

International Drug Name Search

Ufoxilin




Ufoxilin may be available in the countries listed below.


Ingredient matches for Ufoxilin



Cefaclor

Cefaclor is reported as an ingredient of Ufoxilin in the following countries:


  • Greece

International Drug Name Search

Hiperlipen




Hiperlipen may be available in the countries listed below.


Ingredient matches for Hiperlipen



Ciprofibrate

Ciprofibrate is reported as an ingredient of Hiperlipen in the following countries:


  • Colombia

  • Costa Rica

  • Dominican Republic

  • Ecuador

  • El Salvador

  • Guatemala

  • Honduras

  • Nicaragua

  • Panama

  • Peru

  • Venezuela

International Drug Name Search

Ampicillina + Sulbactam IBI




Ampicillina + Sulbactam IBI may be available in the countries listed below.


Ingredient matches for Ampicillina + Sulbactam IBI



Ampicillin

Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Ampicillina + Sulbactam IBI in the following countries:


  • Italy

Sulbactam

Sulbactam sodium salt (a derivative of Sulbactam) is reported as an ingredient of Ampicillina + Sulbactam IBI in the following countries:


  • Italy

International Drug Name Search

Uvasal




Uvasal may be available in the countries listed below.


Ingredient matches for Uvasal



Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Uvasal in the following countries:


  • Argentina

International Drug Name Search

Catapres Tablets 300mcg





1. Name Of The Medicinal Product



Catapres Tablets 300 micrograms.


2. Qualitative And Quantitative Composition



Each tablet contains 300 micrograms of clonidine hydrochloride.



For excipients see 6.1



3. Pharmaceutical Form



Tablet.



White compressed tablets impressed with the motif



4. Clinical Particulars



4.1 Therapeutic Indications



Catapres is indicated for the treatment of all grades of essential and secondary hypertension.



4.2 Posology And Method Of Administration



Catapres Tablets are for oral administration only.



Adults:



Oral treatment should commence with 50 - 100 micrograms three times daily. This dose should be increased gradually every second or third day until control is achieved. Most patients will be controlled on divided daily doses of 300 -1200 micrograms. However, some patients may require higher doses, e.g. 1800 micrograms or more.



Catapres may be added to an existing antihypertensive regimen where blood pressure control has not been satisfactorily achieved. If side effects with existing therapy are troublesome the concomitant use of Catapres may allow a lower dose of the established regimen to be employed. Patients changing treatment should have their existing therapy reduced gradually whilst Catapres is added to their regimen.



Patients undergoing anaesthesia should continue their Catapres treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances.



No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.



Paediatric Population:



There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years.



4.3 Contraindications



Catapres should not be used in patients with known hypersensitivity to the active ingredient or other components of the product and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree.



In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated.



4.4 Special Warnings And Precautions For Use



Caution should be exercised in patients with Raynaud's disease or other peripheral vascular disease. As with all drugs used in hypertension Catapres should be used with caution in patients with cerebrovascular or coronary insufficiency.



Catapres should also be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, and with polyneuropathy or constipation.



Patients with a known history of depression should be carefully supervised while under long-term treatment with Catapres as there have been occasional reports of further depressive episodes during oral treatment in such patients.



As with other antihypertensive drugs, treatment with Catapres should be monitored particularly carefully in patients with heart failure.



In hypertension caused by phaeochromocytoma no therapeutic effect of Catapres can be expected.



Clonidine, the active ingredient of Catapres, and its metabolites are extensively excreted in the urine. Dosage must be adjusted to the individual antihypertensive response, which can show high variability in patients with renal insufficiency; careful monitoring is required. Since only a minimal amount of clonidine is removed during routine haemodialysis there is no need to give supplemental clonidine following dialysis.



Sudden withdrawal of Catapres, particularly in those patients receiving high doses, may result in rebound hypertension. Cases of agitation, restlessness, palpitations, nervousness, tremor, headache and abdominal symptoms have also been reported. Patients should be instructed not to discontinue therapy without consulting their physician. When discontinuing therapy the physician should reduce the dose gradually. However, if withdrawal symptoms should nevertheless occur, these can usually be treated with reintroduction of clonidine or with alpha and beta adrenoceptor blocking agents.



If Catapres is being given concurrently with a beta-blocker, Catapres should not be discontinued until several days after the withdrawal of the beta-blocker.



Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.



This product contains 72.1 mg of lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.



The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population.



Serious adverse events, including sudden death, have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with clonidine has not been systematically evaluated.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



The reduction in blood pressure induced by clonidine can be further potentiated by concurrent administration of other hypotensive agents. This can be of therapeutic use in the case of other antihypertensive agents such as diuretics, vasodilators, beta-receptor blockers, calcium antagonists and ACE-inhibitors, but the effect of alpha1-blockers is unpredictable.



The antihypertensive effect of clonidine may be reduced or abolished and orthostatic hypotension may be provoked or aggravated by concomitant administration of tricyclic antidepressants or neuroleptics with alpha-receptor blocking properties.



Substances which raise blood pressure or induce a sodium ion (Na+) and water retaining effect such as non-steroidal anti-inflammatory agents can reduce the therapeutic effect of clonidine.



Substances with alpha2-receptor blocking properties, such as mirtazapine, may abolish the alpha2-receptor mediated effects of clonidine in a dose-dependent manner.



Concomitant administration of substances with a negative chronotropic or dromotropic effect such as beta-receptor blockers or digitalis glycosides can cause or potentiate bradycardic rhythm disturbances.



It cannot be ruled out that concomitant administration of a beta-receptor blocker will cause or potentiate peripheral vascular disorders.



Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for antihypertensive treatment have not been established.



The effects of centrally depressant substances or alcohol can be potentiated by clonidine.



4.6 Pregnancy And Lactation



This product should only be used in pregnancy if considered essential by the physician. Careful monitoring of mother and child is recommended.



Clonidine passes the placental barrier and may lower the heart rate of the foetus. Post partum, a transient rise in blood pressure in the new born cannot be excluded.



During pregnancy the oral forms of Catapres should be preferred. Intravenous injection of clonidine should be avoided.



There is no adequate experience regarding the long-term effects of prenatal exposure.



The use of Catapres during lactation is not recommended due to a lack of supporting information.



4.7 Effects On Ability To Drive And Use Machines



This product may cause drowsiness. Patients who are affected should not drive or operate machinery. Sedation due to the drug may be increased by the concomitant use of other central nervous system depressants.



4.8 Undesirable Effects



Most adverse effects are mild and tend to diminish with continued therapy.



Adverse events have been ranked under headings of frequency using the following convention:















Very common

> 1/10

Common

> 1/100, <1/10

Uncommon

>1/1000, <1/100

Rare

>1/10000, <1/1000

Very rare

<1/10000

Not known

Cannot be estimated from the available data





























































































Endocrine disorders:
 

Gynaecomastia

rare

Psychiatric disorders:
 

Confusional state

not known

Delusional perception

uncommon

Depression

common

Hallucination

uncommon

Libido decreased

not known

Nightmare

uncommon

Sleep disorder

common

Nervous system disorders:
 

Dizziness

very common

Headache

common

Paraesthesia

uncommon

Sedation

very common

Eye disorders:
 

Accommodation disorder

not known

Lacrimation decreased

rare

Cardiac disorders:
 

Atrioventricular block

rare

Bradyarrhythmia

not known

Sinus bradycardia

uncommon

Vascular disorders:
 

Orthostatic hypotension

very common

Raynaud's phenomenon

uncommon

Respiratory, thoracic and mediastinal disorders:
 

Nasal dryness

rare

Gastrointestinal disorders:
 

Colonic pseudo-obstruction

rare

Constipation

common

Dry mouth

very common

Nausea

common

Salivary gland pain

common

Vomiting

common

Skin and subcutaneous tissue disorders:
 

Alopecia

rare

Pruritus

uncommon

Rash

uncommon

Urticaria

uncommon

Reproductive system and breast disorders:
 

Erectile dysfunction

common

General disorders and administration site conditions:
 

Fatigue

common

Malaise

uncommon

Investigations:
 

Blood glucose increased

rare


There are occasional reports of fluid retention during initial stages of oral treatment. This is usually transitory and can be corrected by the addition of a diuretic.



Occasional reports of abnormal liver function tests and two cases of hepatitis have also been reported.



4.9 Overdose



Symptoms:



Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and respiratory depression including apnoea. Paradoxical hypertension caused by stimulation of peripheral alpha1-receptors may occur. Transient hypertension may be seen if the total dose is over 10 mg.



Treatment:



There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate.



Supportive care may include atropine sulphate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs.



Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Catapres has been shown to have both central and peripheral sites of action. With long-term treatment Catapres reduces the responsiveness of peripheral vessels to vasoconstrictor and vasodilator substances and to sympathetic nerve stimulation. Early in treatment, however, blood pressure reduction is associated with a central reduction of sympathetic outflow and increased vagal tone.



Clinically, there may be reduced venous return and slight bradycardia resulting in reduced cardiac output. Although initially peripheral resistance may be unchanged, it tends to be reduced as treatment continues. There is no interference with myocardial contractility. Studies have shown that cardiovascular reflexes, as shown by the lack of postural hypotension and exercise hypotension, are preserved.



The efficacy of clonidine in the treatment of hypertension has been investigated in five clinical studies in paediatric patients. The efficacy data confirms the properties of clonidine in reduction of systolic and diastolic blood pressure. However, due to limited data and methodological insufficiencies, no definitive conclusion can be drawn on the use of clonidine for hypertensive children.



The efficacy of clonidine has also been investigated in a few clinical studies with paediatric patients with ADHD, Tourette syndrome and stuttering. The efficacy of clonidine in these conditions has not been demonstrated.



There were also two small paediatric studies in migraine, neither of which demonstrated efficacy. In the paediatric studies the most frequent adverse events were drowsiness, dry mouth, headache, dizziness and insomnia. These adverse events might have serious impact on daily functioning in paediatric patients.



Overall, the safety and efficacy of clonidine in children and adolescents have not been established (see section 4.2).



5.2 Pharmacokinetic Properties



The pharmacokinetics of clonidine is dose-proportional in the range of 75-300 micrograms; over this range, dose linearity has not been fully demonstrated. Clonidine, the active ingredient of Catapres, is highly absorbed and undergoes a minor first pass effect. Peak plasma concentrations are reached within 1-3 h after oral administration. Clonidine is rapidly and extensively distributed into tissues and crosses the blood-brain barrier, the placenta barrier and is distributed in to breast milk. The plasma protein binding is 30-40%.



The plasma half-life of clonidine has been found to range between 5.2 h and 24 h. It can be prolonged in patients with severely impaired renal function up to 41 hours.



About 70% of the dose administered is excreted with the urine mainly in form of the unchanged parent drug (40-60% of the dose). The main metabolite p-hydroxy-clonidine is pharmacologically inactive. Approximately 20% of the total amount is excreted with the faeces. There is no definitive data about food or race effects on the pharmacokinetics of clonidine.



The antihypertensive effect is reached at plasma concentrations between about 0.2 and 1.5 ng/ml in patients with normal renal function. A further rise in the plasma levels will not enhance the antihypertensive effect. The hypotensive effect decreases with plasma concentrations above 1.5 ng/ml.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactose monohydrate, fine



Calcium hydrogen phosphate (anhydrous)



Maize starch, dried



Colloidal silica (anhydrous)



Povidone



Starch, soluble



Stearic acid



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



5 years



6.4 Special Precautions For Storage



Do not store above 30°C.



Keep the blisters in the outer carton



6.5 Nature And Contents Of Container



PVC blister packs (foil 20 µm thick, PVC 200 µm thick) of 100 tablets..



6.6 Special Precautions For Disposal And Other Handling



No special requirements



7. Marketing Authorisation Holder



Boehringer Ingelheim Limited



Ellesfield Avenue



Bracknell



Berkshire



RG12 8YS



United Kingdom



8. Marketing Authorisation Number(S)



PL 00015/5041R



9. Date Of First Authorisation/Renewal Of The Authorisation



10/05/2006



10. Date Of Revision Of The Text



June 2011



LEGAL CATEGORY


POM




Zunex




Zunex may be available in the countries listed below.


Ingredient matches for Zunex



Permethrin

Permethrin is reported as an ingredient of Zunex in the following countries:


  • Bangladesh

International Drug Name Search

Pharex Isoniazid




Pharex Isoniazid may be available in the countries listed below.


Ingredient matches for Pharex Isoniazid



Isoniazid

Isoniazid is reported as an ingredient of Pharex Isoniazid in the following countries:


  • Philippines

International Drug Name Search

Antalfebal




Antalfebal may be available in the countries listed below.


Ingredient matches for Antalfebal



Ibuprofen

Ibuprofen is reported as an ingredient of Antalfebal in the following countries:


  • Italy

International Drug Name Search

Burnax




Burnax may be available in the countries listed below.


Ingredient matches for Burnax



Fluconazole

Fluconazole is reported as an ingredient of Burnax in the following countries:


  • Ecuador

International Drug Name Search

Iperton




Iperton may be available in the countries listed below.


Ingredient matches for Iperton



Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Iperton in the following countries:


  • Greece

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Iperton in the following countries:


  • Greece

International Drug Name Search

Unizen




Unizen may be available in the countries listed below.


Ingredient matches for Unizen



Serrapeptase

Serrapeptase is reported as an ingredient of Unizen in the following countries:


  • Hong Kong

  • Myanmar

  • Singapore

International Drug Name Search

Viadrops




Viadrops may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Viadrops



Retinol

Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Viadrops in the following countries:


  • Netherlands

International Drug Name Search

Protanon




Protanon may be available in the countries listed below.


Ingredient matches for Protanon



Allylestrenol

Allylestrenol is reported as an ingredient of Protanon in the following countries:


  • Taiwan

International Drug Name Search

Acido Alendronico Bifosal




Acido Alendronico Bifosal may be available in the countries listed below.


Ingredient matches for Acido Alendronico Bifosal



Alendronic Acid

Alendronic Acid is reported as an ingredient of Acido Alendronico Bifosal in the following countries:


  • Portugal

International Drug Name Search

Masaquin




Masaquin may be available in the countries listed below.


Ingredient matches for Masaquin



Chloroquine

Chloroquine phosphate (a derivative of Chloroquine) is reported as an ingredient of Masaquin in the following countries:


  • Myanmar

International Drug Name Search

Uniloc




Uniloc may be available in the countries listed below.


Ingredient matches for Uniloc



Atenolol

Atenolol is reported as an ingredient of Uniloc in the following countries:


  • Denmark

  • Norway

International Drug Name Search

Unicil




Unicil may be available in the countries listed below.


Ingredient matches for Unicil



Benzylpenicillin

Benzylpenicillin benzathine (a derivative of Benzylpenicillin) is reported as an ingredient of Unicil in the following countries:


  • Mexico

Benzylpenicillin sodium (a derivative of Benzylpenicillin) is reported as an ingredient of Unicil in the following countries:


  • Colombia

  • Mexico

International Drug Name Search

Uniof




Uniof may be available in the countries listed below.


Ingredient matches for Uniof



Indometacin

Indometacin is reported as an ingredient of Uniof in the following countries:


  • Peru

International Drug Name Search

Omeprazolo Pensa




Omeprazolo Pensa may be available in the countries listed below.


Ingredient matches for Omeprazolo Pensa



Omeprazole

Omeprazole is reported as an ingredient of Omeprazolo Pensa in the following countries:


  • Italy

International Drug Name Search

Uniplus




Uniplus may be available in the countries listed below.


Ingredient matches for Uniplus



Nitazoxanide

Nitazoxanide is reported as an ingredient of Uniplus in the following countries:


  • Dominican Republic

International Drug Name Search

Uni Masdil




Uni Masdil may be available in the countries listed below.


Ingredient matches for Uni Masdil



Diltiazem

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Uni Masdil in the following countries:


  • Spain

International Drug Name Search

Grexa




Grexa may be available in the countries listed below.


Ingredient matches for Grexa



Glimepiride

Glimepiride is reported as an ingredient of Grexa in the following countries:


  • Peru

International Drug Name Search

Unidie Fournier




Unidie Fournier may be available in the countries listed below.


Ingredient matches for Unidie Fournier



Cefonicid

Cefonicid disodium salt (a derivative of Cefonicid) is reported as an ingredient of Unidie Fournier in the following countries:


  • Spain

International Drug Name Search

Futraful E




Futraful E may be available in the countries listed below.


Ingredient matches for Futraful E



Tegafur

Tegafur is reported as an ingredient of Futraful E in the following countries:


  • Japan

International Drug Name Search

Unilexin




Unilexin may be available in the countries listed below.


Ingredient matches for Unilexin



Cefalexin

Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Unilexin in the following countries:


  • Bahrain

  • Iraq

  • Jordan

  • Libya

  • Qatar

  • Saudi Arabia

  • Sudan

  • United Arab Emirates

  • Yemen

International Drug Name Search

Unipril




Unipril may be available in the countries listed below.


Ingredient matches for Unipril



Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Unipril in the following countries:


  • Colombia

Ramipril

Ramipril is reported as an ingredient of Unipril in the following countries:


  • Italy

International Drug Name Search

Unifungin




Unifungin may be available in the countries listed below.


Ingredient matches for Unifungin



Econazole

Econazole is reported as an ingredient of Unifungin in the following countries:


  • Greece

International Drug Name Search

Nicotine Transdermal System Step 3




Drug Facts

Active ingredient


 Nicotine, 7 mg delivered over 24 hours



Purpose


Stop smoking aid



Uses


reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.



Warnings


If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.



Do not use


  • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products


Ask a doctor before use if you have


  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

  • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.

  • an allergy to adhesive tape or have skin problems, because you are more likely to get rashes.


Ask a doctor or pharmacist before use if you are


  • using a non-nicotine stop smoking drug

  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted


When using this product


  • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.

  • if you have vivid dreams or other sleep disturbances remove this patch at bedtime


Stop use and ask a doctor if


  • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash

  • irregular heartbeat or palpitations occur

  • you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat


Keep out of reach of children and pets


Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.



Directions


  • If you are under 18 years of age, ask a doctor before use

  • before using this product, read the enclosed self-help guide for complete directions and other information

  • stop smoking completely when you begin using the patch

  • if you smoke more than 10 cigarettes per day, use the following schedule below:

 


  • if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop

  • apply one new patch every 24 hours on skin that is dry, clean and hairless 

  • remove backing from patch and immediately press onto skin. Hold for 10 seconds.

  • wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

  • the used patch should be removed and a new one applied to a different skin site at the same time each day

  • if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning

  • do not wear more than one patch at a time

  • do not cut patch in half or into smaller pieces

  • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours

  • to avoid possible burns, remove patch  before  undergoing any MRI (magnetic resonance imaging) procedures

  • stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.


Other information


● store at 20-25°C (68-77°F)


USER'S GUIDE




USER’S GUIDE


Nicotine Transdermal System


STOP SMOKING AID PATCH


HABITROL TAKE CONTROL SUPPORT PROGRAM® (with logo)


Your guide to help you successfully quit smoking


Table of Contents


I: Thinking About Quitting


Why the HABITROL Take Control® Support Program Leads to Success ….... 3

Working Towards Success: The Stages of Change ........................................... 5

Which Way Now? ............................................................................................ 8

Why I Want to Stop Smoking ........................................................................... 8

Health Benefits of Quitting ...............................................................................


II: Getting Started: Your Personal Quit Plan


Setting Your Quit Date ..................................................................................... 10


Understanding Nicotine Addiction ................................................................... 10


Smoking and Your Body ................................................................................. 10

Smoking and Your Mind ................................................................................. 11

Knowing Your Triggers ................................................................................... 12


Taming Your Triggers ...................................................................................... 12


Reducing the Urge to Smoke ........................................................................... 12


Building Your Supporting Cast ....................................................................... 14


Countdown to Quit Day: 10 Steps to Success ................................................. 15


Rewarding Yourself ....................................................................................... 16


If You Slip ..................................................................................................... 16


III: The Patch


Important Information About this Nicotine Transdermal System ................... 18


How the Patch Works .................................................................................... 19


How to Use the Patch .................................................................................... 20


IV: Weight Control Guide .......................................................................... 27


V: You Are on Your Way ......................................................................... 29


VI: Your Daily Success Calendar ............................................................. 30


VII: HABITROL Take Control® Support Program Resources ............. 34




















Congratulations! You’ve joined millions of others who have made the important and rewarding decision to quit smoking. A large percentage of smokers have already successfully quit. You can too. You’ve already taken the first smart step by choosing the patch and the HABITROL Take Control® Support Program. The program includes the use of nicotine replacement therapy and behavioral support, a combination that can significantly increase your chances of quitting.


The patch helps smokers quit smoking by reducing nicotine withdrawal symptoms. Many patch users will be able to stop smoking for at least a few days, but many will start smoking again. Most smokers usually have to try to quit several times before they completely stop.


Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you.


First, there is the 3-step nicotine patch that delivers controlled amounts of nicotine to help reduce your withdrawal cravings for nicotine. The patch utilizes nicotine replacement therapy, and through the use of step-down dosing, gradually reduces the amount of nicotine in your system.


Second, the HABITROL Take Control® Support Program, developed by behavioral change and smoking cessation experts, recognizes that quitting smoking is a personal journey that occurs in six stages, known as the “Stages of Change.”


The HABITROL Take Control® Support Program offers the following support elements to help you quit:



 

1. This guide will teach you how to move through the quit process by helping you to identify your reasons for quitting, manage urges to smoke, recover from slips and control your weight.

 



2. An optional compact disc* gives you more information about the patch and the six “Stages of Change.” It provides guidance about what to do at each stage to increase your chances of quitting for good, as well as, relaxation techniques to help you become and remain smoke-free. It also includes a full track of soothing instrumental music.

 



3. 1-888-HABITROL — our toll-free telephone support center, staffed by smoking cessation professionals, will offer you friendly support and information. Call Monday through Friday between 9 a.m. and 8 p.m. ET. You can use this resource to help you get ready to quit, manage urges, cope with withdrawal symptoms, recover from slips and deal with smoking spouses and friends.


*If you need a cassette tape instead of the compact disc, please call 1-888-HABITROL.






Working Towards Success


— The Stages of Change


Quitting smoking is a process that begins long before your quit day. Researchers have determined that smokers go through the following six “Stages of Change” while on the road to becoming smoke-free.




Pre-Contemplation Stage:


If you are in this stage, you don’t have any intention to quit smoking in the near future (i.e., within the next 6 months). You feel that the benefits you receive from smoking outweigh the costs and risks of smoking. This is called the Pre-Contemplation Stage. If you are in this stage right now, you are not ready to use the patch.





Contemplation Stage:


After a period of time, often years, you may begin to realize that you are “hooked,” and that smoking is affecting your health and the health of those around you. You begin to think about the benefits of quitting, but you know that quitting will be difficult. You are seriously considering quitting smoking sometime within the next six months, but you are ambivalent. This is called the Contemplation Stage. In this stage, you may read articles on ways to quit or on the health effects of smoking, while you would have ignored this information in the Pre-Contemplation Stage. You begin to imagine your life without cigarettes. You also begin to experiment with making changes. For example, you may be trying to delay your first cigarette of the day, smoke only half of some cigarettes, or not smoke in your house or car. If you are in this stage right now, you are still not ready to use the patch.




Preparation Stage:


When you’ve made the decision to quit within the next month, and you have experimented with making changes, you’ve entered the Preparation Stage. Most people who have purchased the patch for the first time are in this stage. Preparation is a good name for this stage because thorough preparation greatly improves your chances of success. Just “winging it” or relying on willpower alone is not enough. You need a game plan that includes setting a quit date and committing to at least one person that you will make this change. Using this guide, as well as talking to the professionals at 1-888-HABITROL, will help you become fully prepared for your quit day and beyond.




Action Stage:


On the day that you quit smoking, you are in the Action Stage. It’s time to set your plan in motion. You will probably experience cravings for nicotine and urges to have a cigarette throughout the day, but through preparation, you have developed multiple strategies for dealing with your “triggers,” withdrawal symptoms and those cravings or urges to smoke. It’s important to start using the patch on the morning of your quit-day to help reduce urges to smoke and other withdrawal symptoms, such as irritability and difficulty concentrating.




Maintenance and Termination Stages:


If you are able to remain smoke-free for 6 months, you enter the Maintenance Stage. You like your new life, but still have occasional urges. Watch out for overconfidence. Thinking you can smoke “just one cigarette” should be a blinking neon warning sign. For most people, that one cigarette leads to two, then three, then full-time smoking again. Constantly remind yourself of the benefits you now enjoy as a nonsmoker. Have a plan ready to help you manage unexpected situations that may cause you stress and challenge your resolve to remain smoke-free. Most successful quitters will have occasional urges for many years.


Only about 1 in 5 quitters reach the Termination Stage, in which they have absolutely no temptation to smoke, and are 100% confident that they will never smoke again.


Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you.


the next 6 months). You feel that the benefits you receive from smoking outweigh the costs and risks of smoking. This is called the Pre-Contemplation Stage. If you are in this stage right now, you are not ready to use the patch.


the next 6 months). You feel that the benefits you receive from smoking outweigh the costs and risks of smoking. This is called the Pre-Contemplation Stage. If you are in this stage right now, you are not ready to use the patch.




Why I Want to Stop Smoking


Knowing that there are benefits to quitting is essential to your success. Writing down the reasons you want to quit on a card and keeping it with you to review can help you resist a temptation to smoke. Check off the reasons below that apply to you.




□ I want control back — I’m almost always thinking about or smoking a cigarette. I feel like the cigarette is controlling me.


□ I want to improve my chances of living a longer, healthier life.


□ I want to spend my cigarette money on other things — maybe a vacation.


□ I want more time for myself. Instead of taking those smoke breaks outside, I could be doing so many other things.


□ I want to look and smell better by getting rid of that lingering odor of smoke.


□ I want to set a healthier example for my children and grandchildren.




Write other reasons you have for quitting in the space below:


________________________________________________________


________________________________________________________


________________________________________________________


________________________________________________________


________________________________________________________


________________________________________________________


After completing this list, refer to it every day to reinforce your commitment to becoming a nonsmoker.




Health Benefits of Quitting


Most of us recognize the risks of smoking, such as cancer, heart disease and emphysema, but may not be aware of the many immediate and long-term benefits of quitting.


Immediate benefits in the first days and months may include:


• Breathing may get easier


• Food tastes better


• Sense of smell improves


• Walking and exercise may become easier








Now that you are motivated and committed, the next step is to choose a quit date within the next 2–3 weeks to stop smoking. Decide whether it will be easier to quit on a workday when your smoking may already be restricted, or on the weekend when you are more relaxed. You may want to consider quitting at the beginning of the week, on a Sunday or Monday. It’s best to choose a date when:


• Your stress level is low


• You’ll be confronted with a minimum of smoking triggers


• You will not be in a social situation with other smokers, especially those that include alcohol


Enter your quit date on Day 1 of your Daily Success Calendar, located in the back of this guide.




Understanding Nicotine Addiction


Dependence on cigarettes is a twofold problem: the physical side of addiction to nicotine and the psychological side. Preparing to deal with both in advance will help make quitting easier and more comfortable.




Smoking and your body


As you know, smoking cigarettes is addictive. Nicotine, the addictive agent, reaches your brain in just seconds after each puff. Your brain and body get used to functioning with a certain level of nicotine. Within a few hours of your last cigarette, your nicotine level drops dramatically, resulting in withdrawal symptoms for most smokers.


Common withdrawal symptoms include intense cravings for nicotine, irritability, anxiety, depression, restlessness, difficulty concentrating, difficulty sleeping and increased appetite. Physical withdrawal symptoms usually peak within 24 to 72 hours after quitting, then decline over the next several weeks. Some smokers, however, may experience withdrawal symptoms for several months.


Staying on this patch for the full eight weeks can reduce the withdrawal symptoms you experience.




Smoking and your mind


The physical need for nicotine isn’t the only reason you may find it difficult to quit smoking. You can also be psychologically dependent.


Over time you’ve created strong associations or “triggers” to light up a cigarette. Sometimes you smoke for comfort: “Smoking helps me relax,” or “I don’t feel as angry when I smoke.” Sometimes it seems to make a social situation more enjoyable: “I like to smoke when I’m out having coffee with a friend or when drinking at a party.” At other times, you smoke out of habit: “I light up as soon as I get in the car,” “I smoke when I’m taking a break at work” or “Because I am so used to smoking, I feel uncomfortable without a cigarette in my hand.”





Knowing your “triggers”


Listed to the right are some of the common situations or activities that “trigger” smoking in many people and some suggestions on how to change your habits in order to reduce your urge to smoke.




Taming Your Triggers


Here are some other common “triggers.” Check off the ones that apply to you and write down how you will cope in the spaces below. Also, record other personal “triggers” and the things you plan to do instead.




Reducing the Urge to Smoke


Urges to smoke only last for a few seconds to a few minutes. Believe it or not, the urge to smoke will pass whether you smoke or not. When an urge strikes, try the following:




 

1. The “Three-Second Breathing” Exercise. Nothing relaxes you more quickly than taking a deep breath. Inhale deeply through pursed lips. Hold your breath for 3 seconds. Then slowly exhale through your mouth.






 

2. Switch your focus. Deliberately switch your attention from having a cigarette onto something else, like reading or stretching.

 

3. Use mental imagery to transform the urge into something manageable. For example, imagine the urge to smoke is like feeling thirsty. Then imagine reaching for a glass of cool ice water. Feel the coolness in your throat. Your entire body feels relief. You are calm and the urge has disappeared.
























My Trigger


(In the past, I smoked ...)

My Solution


(Now, I will ...)
To concentrate

_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


_________________________________


To relax 
To give myself a lift 
Because I was angry 
Because I was bored 

Because I felt stressed


_________________________________________


_________________________________________


 


Remember when you first tried a cigarette? Remember how awful it tasted? Remember your initial dizziness? Nausea? The point is, it took some time for you to learn how to smoke. Now you can learn not to smoke. That takes time too. Sticking with the HABITROL program can help. Call 1-888-HABITROL. We can help you develop customized solutions to your personal triggers.




Building Your Supporting Cast
















Quitting isn’t easy. Sometimes you can feel all alone. This is where friends and family, both smokers and nonsmokers, can help. Take your friends and family through your quit plan. Once they understand why you are changing some of your old habits, they’ll be in a better position to understand and support you.


Tell your smoking friends of your desire to quit (truth is, many of them may have that same desire). You might be pleasantly surprised how supportive they can be. If your smoking friends express an interest in quitting, give them our number, 1-888-HABITROL, and we’ll help get them started. You might even choose to quit at the same time so that you can work as a team supporting one another.


It’s hard for people who have never smoked to understand what you’re going through, both emotionally and physically. Be patient with them. Explain that you might be a little (or very) irritable for a while.











Countdown to Quit Day — 10 Steps to Success


1. Tape a list of your reasons for quitting on the mirror. Go over them daily.


2. Tell one or two friends and your family. Ask for the specific help that you think you will need from each of them.


3. Use the HABITROL Take Control® Support Program.


4. Know your “triggers” and practice your coping strategies.


5. Change your routines (for example, sit in a different chair, not your smoking chair).


6. Plan how you will spend all the money you save from not smoking.


7. Freshen your environment. On the day before your quit date, clean your clothes, car and any rooms where you spend a lot of time.


8. Throw away any remaining cigarettes, ashtrays and lighters the night before your quit day.


9. Have plenty of low-calorie snacks available.


10. Use the patch as directed.


You should not smoke or use any other product containing nicotine while wearing the patch, since doing so will temporarily increase the level of nicotine in your blood. Furthermore, smoking even one cigarette reduces your chances of becoming smoke free.




Rewarding Yourself


Many people get this far and forget to reward themselves. We know that we are more likely to keep going if we get rewarded. So, in the space below, write ways that you can reward yourself at least once a day.



———————————————


———————————————


———————————————


———————————————


———————————————


———————————————


———————————————





If You Slip




Imagine that you go out with friends and end up having a cigarette. In other words, you “slipped.” This is not a relapse back to smoking. Don’t let this mistake make you feel like a failure or like giving up. Get back on track immediately. Don’t smoke another cigarette. Figure out why you had the slip and how, in the future, you will deal with the people, places or feelings that led to smoking. Do whatever works for you. The point is that slips, like mistakes, can be great learning experiences. If you slip and need help, give us a call at 1-888-HABITROL. We’ll be happy to help you find ways to cope — without a cigarette.


If you resume smoking


If you do return to your regular smoking habit, take some time to examine what went wrong. Did you quit without being prepared? Did you have and use the support of friends and family? If you are ready to try again, we can help you evaluate and revise your personal quit plan: call us at 1-888-HABITROL.


The patch helps smokers quit smoking by reducing nicotine withdrawal symptoms. Many patch users will be able to stop smoking for at least a few days, but many will start smoking again. Most smokers usually have to try to quit several times before they completely stop.


Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you.


And, if for some reason you are not ready to try again right now, keep these materials until you are ready. Before you set your quit date, call us to help you prepare for a successful quit.


A quick tip -- If you bought a pack of cigarettes to “just have one,” run the rest under cold water and then throw them out! Every single one! Don’t allow yourself to think that you can keep cigarettes stashed away and still resist them. Remember, the only reason to keep cigarettes around is to smoke them!












































This product is only for those who want to stop smoking. The patch helps smokers quit by reducing nicotine withdrawal symptoms. Almost half of those who use this product will be able to stop smoking for at least a few days, but many will start smoking again. Most smokers will require several attempts before they stop smoking completely. Your own chances of quitting depend on how strongly you are addicted to nicotine, how motivated you are to quit, and how closely you follow a quit program, such as this one. If you find that you cannot stop smoking, or if you start smoking again after using the patch, talk with your doctor, who can help you find a program that may work better for you.



Do not use the patch if you continue to smoke, chew tobacco or use snuff, nicotine gum, nicotine nasal spray, nicotine inhaler or any other nicotine-containing product.




Ask your doctor before use if you:


• Have heart disease or an irregular heartbeat, or if you had a recent heart attack. Nicotine can increase your heart rate.


• Have high blood pressure not controlled with medication. Nicotine can increase blood pressure.


• Are allergic to any adhesives or patch ingredients or have skin problems, because you are more likely to get rashes.


• Are using a non-nicotine stop smoking drug.


• Take prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.


Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

How the Patch Works


The patch is a nicotine transdermal system skin patch containing nicotine, the addictive agent in tobacco products. When you wear a patch, it gradually releases nicotine into your bloodstream through the skin. By replacing some of the nicotine to which your body has become accustomed from smoking, the patch helps reduce the nicotine withdrawal symptoms many people normally feel when they stop smoking. By offering three patches with different nicotine dose levels, this patch uses a step-down dosing system that allows you to gradually reduce your nicotine level by changing the patch you wear (moving to a lower dose) over an eight-week period. Nicotine replacement therapy can reduce nicotine withdrawal symptoms such as irritability, anxiety, restlessness, headaches, difficulty sleeping and concentrating, increased appetite, and craving for nicotine. By helping to reduce your physical nicotine withdrawal symptoms, the patch helps you to concentrate on the psychological aspects of quitting and to change your habits that “trigger” your nicotine cravings.


This patch program takes 8 weeks to complete, at the end of which you should stop using the patch. It is important that you keep using the patch until you have completed the entire program, and continue to use the HABITROL Take Control® Support Program when you need it.



It is important that you are firmly committed to giving up smoking.


Warnings:



• Have heart disease or an irregular heartbeat, or if you had a recent heart attack. Nicotine can increase


your heart rate.


• Have high blood pressure not controlled with medication. Nicotine can increase blood pressure.


• Are allergic to any adhesives or patch ingredients or have skin problems, because you are more likely


to get rashes.


• Are using a non-nicotine stop smoking drug.


• Take prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.




Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away.





How the Patch Works


The patch is a nicotine transdermal system skin patch containing nicotine, the addictive agent in tobacco products. When you wear a patch, it gradually releases nicotine into your bloodstream through the skin. By replacing some of the nicotine to which your body has become accustomed from smoking, the patch helps reduce the nicotine withdrawal symptoms many people normally feel when they stop smoking. By offering three patches with different nicotine dose levels, this patch uses a step-down dosing system that allows you to gradually reduce your nicotine level by changing the patch you wear (moving to a lower dose) over an eight-week period. Nicotine replacement therapy can reduce nicotine withdrawal symptoms such as irritability, anxiety, restlessness, headaches, difficulty sleeping and concentrating, increased appetite, and craving for nicotine. By helping to reduce your physical nicotine withdrawal symptoms, the patch helps you to concentrate on the psychological aspects of quitting and to change your habits that “trigger” your nicotine cravings.


This patch program takes 8 weeks to complete, at the end of which you should stop using the patch. It is important that you keep using the patch until you have completed the entire program, and continue to use the HABITROL Take Control® Support Program when you need it.





Why wearing a nicotine patch isn’t as bad as smoking?


By placing a nicotine patch on your skin, you are NOT inhaling the harmful tars, toxins and chemicals found in cigarettes. These are the most dangerous parts of the cigarette.


And, because you’re not smoking while wearing the patch, there’s no second-hand smoke or odors to affect your family and friends.





How to Use the Patch


It is important that you are firmly committed to giving up smoking.


Warnings:


• If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.


• Do not use if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products.


• Ask a doctor before use if you have heart disease, have had a recent heart attack, or have an irregular heartbeat. Nicotine can increase your heart rate.


• Ask a doctor before use if you have high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• Ask a doctor before use if you have an allergy to adhesive tape or have skin problems because you are more likely to get rashes with patch use.


• Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug.


• Ask a doctor or pharmacist before use if you are taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.


• When using this product, do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.


• When using this product, if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning.


• Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash.


• Stop use and ask a doctor if irregular heartbeat or palpitations occur.


• Stop use and ask a doctor if you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat.


• Keep unused and used patches out of the reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. Do not wear more than one patch at a time.


• Do not cut the patch in half or into smaller pieces.


• Do not leave the patch on for more than 24 hours because it may irritate your skin and it loses strength after 24 hours.


• To avoid possible burns, remove patch before undergoing any MRI (Magnetic Resonance Imaging) procedures.


• Stop using the patch at the end of 8 weeks. The patch has been tested in 3 month studies and long





See chart on following page.



First, it is important that you are well prepared to give up smoking. If you are under 18 years of age, ask a doctor before use.
































If you smoke 10 or less cigarettes per day:




• Do not use Step 1 Patch (21 mg/ day). Begin with Step 2 Patch (14mg/day) for 6 weeks, use Step 3 Patch (7mg/day) for 2 weeks and then stop.


• Steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chance of quitting successfully.


• Stop at the end of eight weeks.




Lowering your patch dosage over 8 weeks will help you overcome your physical cravings for nicotine. You should talk to your doctor if, after you complete 8 weeks of patch use, you feel you need to continue therapy.



How to apply the Nicotine Transdermal System Patch




 



1. Choose a clean, dry, non hairy area of skin on your upper body or the outer part of your arm. Do not put a patch on skin that is very oily, burned, broken out, cut or irritated in any way. Immediately before applying the patch, wash your hands and the skin area with plain soap and water and dry completely. Avoid using any soap, lotion, hand cream, tanning lotion or oil, bath oil or insect repellent that contains aloe, lanolin or glycerin as a moisturizer. These products can leave a moisturizing film on your skin, which can interfere with the adherence of the patch.


2. Do not remove the patch from its sealed, protective pouch until you are ready to use it. Carefully cut open the child-resistant pouch along the dotted line, as indicated. If the new patch is cut, throw it away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.





3. A shiny protective liner covers the sticky side of the patch where it contacts the skin. The liner has a precut slit to help you remove it from the patch. With the silver side facing you, pull the liner away from the patch, starting at the precut slit. Hold the patch at the edge (touch the sticky side as little as possible) and pull off the other piece of the protective liner. Throw this liner away.


4. Immediately apply the sticky side of the patch to your skin. Press the patch firmly against your skin with the palm of your hand for about 10 seconds. Make sure it sticks well to your skin, especially around the edges.


5. When you have finished applying or removing the patch, wash your hands with water only. Nicotine on your hands could get into your eyes and nose and could cause stinging, redness or irritation.


6. After 24 hours, remove the patch you have been wearing.


If you remove and apply the patch at about the same time each day, it will help you to remember when to put on a new patch. Choose a different place on your skin to apply the next patch and repeat steps 1 through 5. Do not reapply a patch to a previously used skin site for at least 1 week. Do not leave the patch on for more than 24 hours, because it may irritate your skin and loses strength after 24 hours. Do not wear more than one patch at the same time, and do not cut a patch in half or into smaller pieces to wear.




If you have trouble sleeping


You should wear the patch 24 hours a day. This may help overcome your morning cravings for nicotine. However, if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new patch the following morning. The patch should be applied at approximately the same time each day.




If your patch comes off


If your patch falls off, put on a new one. Then remove this new patch at your regular time to keep your schedule the same. When applying the patch, be sure to press it firmly onto your skin with the palm of your hand for about 10 seconds, making sure that the patch sticks well, especially around the edges.



If your patch gets wet




Water will not harm or affect the patch you are wearing. You can take a bath or a shower, or you can swim while you are wearing the patch.



Disposing of the patch


Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. Keep all used patches out of reach of children and pets.





Storage instructions


Keep the patch in its protective pouch until you are ready to use it. Store your patches between 20-25°C (68-77°F), because the patch is sensitive to heat. The inside of your car, for example, can reach much higher temperatures in the summer. Keep all unused patches out of the reach of children and pets.




If your skin reacts to the patch




When you first put on a patch, mild itching, burning, or tingling at the patch application site is normal and should go away within an hour. After you remove a patch, the skin under the patch might be somewhat red. Your skin should not stay red for more than a day. If you have a skin rash or redness caused by the patch that does not go away after 4 days, or your skin swells, call your doctor. Do not put on a new patch; you may be allergic to one of the components of the patch.




Other side effects you may experience




While wearing a nicotine replacement patch, you may experience one or more of the following side effects: nausea, dizziness, dry mouth, diarrhea, nervousness or restlessness, headache, vivid dreams or other sleep disturbances, and irritability.


If you experience any of the following side effects, immediately remove the patch and call your doctor:




• Severe skin irritation or discoloration


• Irregular heartbeats or palpitations


• Severe chest pain or tightening


• Symptoms of nicotine overdose, such as pallor (extreme paleness), cold sweat, nausea, abnormal salivation, vomiting, abdominal pain or severe headache, disturbed hearing or vision, diz