Country: European Union
Language: English
Source: EMA (European Medicines Agency)
varenicline
Pfizer Europe MA EEIG
N07BA03
varenicline
Other nervous system drugs
Tobacco Use Cessation
Champix is indicated for smoking cessation in adults.
Revision: 38
Authorised
2006-09-25
117 B. PACKAGE LEAFLET 118 PACKAGE LEAFLET: INFORMATION FOR THE USER CHAMPIX 0.5 MG FILM-COATED TABLETS CHAMPIX 1 MG FILM-COATED TABLETS varenicline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CHAMPIX is and what it is used for 2. What you need to know before you take CHAMPIX 3. How to take CHAMPIX 4. Possible side effects 5. How to store CHAMPIX 6. Contents of the pack and other information 1. WHAT CHAMPIX IS AND WHAT IT IS USED FOR CHAMPIX contains the active substance varenicline. CHAMPIX is a medicine which is used in adults to help them stop smoking. CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking. CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHAMPIX DO NOT TAKE CHAMPIX - If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking CHAMPIX. There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX. If you are taking CHAMPIX and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family or if you develop suicidal thoughts or behaviours you should stop taking CHAMPIX and contact your doctor immediately for treatment assessment. 119 _The effects of stopping smoking _ The effects of changes in your body resulting from stopping smoking, with or wit Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each film-coated tablet contains 0.5 mg of varenicline (as tartrate). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet of 4 mm x 8 mm White, capsular-shaped, biconvex tablets debossed with “ _Pfizer_ ” on one side and “CHX 0.5” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHAMPIX is indicated for smoking cessation in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1 – 3: 0.5 mg once daily Days 4 – 7: 0.5 mg twice daily Day 8 – End of treatment: 1 mg twice daily The patient should set a date to stop smoking. CHAMPIX dosing should usually start at 1-2 weeks before this date (see section 5.1). Patients should be treated with CHAMPIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1). A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking CHAMPIX for an additional 12 weeks for a total of 24 weeks of treatment (see section 5.1). Patients who are motivated to quit and who did not succeed in stopping smoking during prior CHAMPIX therapy, or who relapsed after treatment, may benefit from another quit attempt with CHAMPIX (see section 5.1). Patients who cannot tolerate adverse reactions of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily. 3 In smoking cessation therapy, risk for relapse to smoking is elevated in the period immedi Read the complete document