Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
VARENICLINE AS TARTRATE
PFIZER PHARMACEUTICALS ISRAEL LTD
N07BA03
FILM COATED TABLETS
VARENICLINE AS TARTRATE 0.5 MG
PER OS
Required
PFIZER INC, USA
VARENICLINE
VARENICLINE
Champix is indicated as an aid to smoking cessation treatment adults over 18 years of age.
2022-12-31
Champix, PIL Israel, CC TC 100821 2021-0071770 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only CHAMPIX ® 0.5 MG CHAMPIX ® 1.0 MG FILM-COATED TABLETS VARENICLINE (AS TARTRATE) 0.5 MG, 1.0 MG Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others; it may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is intended for adults over the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? Champix ® is indicated as a medicinal aid to smoking cessation in adults over 18. THERAPEUTIC GROUP: selective partial agonist of nicotinic receptor. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine, listed in section 6. Signs of this could be swelling of the face, tongue, lips, gums, throat or neck, trouble breathing, rash including skin peeling, blisters in your mouth. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH CHAMPIX ® , TELL YOUR DOCTOR IF: • You are pregnant, plan to become pregnant and/or are breastfeeding. • You have or have had impaired function of the heart and/or blood vessels, kidney/urinary system, seizures, or any other medical condition. • You have had depression or other mental health conditions. Tell your doctor about symptoms you had during previous times you tried to quit smoking, with or without Champix ® . • You are sensitive to any food or medicine, tell your doctor before taking the medicine. • There is a change in your mood and be Izlasiet visu dokumentu
Champix 0.5 mg and 1.0 mg, LPD, Israel, CC 020521 2021-0069253 1 FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg CHAMPIX 1.0 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg CHAMPIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base. Each 1mg CHAMPIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base For the full list of excipients, see section 11. PHARMACEUTICAL FORM Film coated tablets 1 INDICATIONS AND USAGE CHAMPIX is indicated as an aid to smoking cessation treatment for adults over 18 years of age. 2 DOSAGE AND ADMINISTRATION 2.1 USUAL DOSAGE FOR ADULTS Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt. The patient should set a date to stop smoking. Begin CHAMPIX dosing one week before this date. Alternatively, the patient can begin CHAMPIX dosing and then quit smoking between days 8 and 35 of treatment. CHAMPIX should be taken orally after eating and with a full glass of water. The recommended dose of CHAMPIX is 1 mg 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 Champix 0.5 mg and 1.0 mg, LPD, Israel, CC 020521 2021-0069253 2 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 is recommended to further increase the likelihood of long-term abstinence. For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with CHAMPIX. Patients should begin CHAMPIX dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continu Izlasiet visu dokumentu