Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VARENICLINE TARTRATE
PFIZER (MALAYSIA) SDN. BHD.
VARENICLINE TARTRATE
11 Tablets
R-Pharm Germany GmbH
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CHAMPIX _®_ _ _ Varenicline (0.5 mg, 1.0 mg) PLD TITLE : CHAMPIX PLD DATE : 29 July 2019 COUNTRY : Malaysia REFERENCE DOCUMENT : Champix Malaysia LPD dated 27 Sep 2018. REASON FOR CHANGE : Updated based on BoH recommendation on PRAC recommendation on signals published on 9 th July 2018, the risk of loss of consciousness in Champix : To update the PIL as per BOH comments Pfizer Confidential CHAMPIX _®_ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Varenicline (0.5 mg, 1.0 mg) 1 WHAT IS IN THIS LEAFLET 1. What CHAMPIX is used for 2. How CHAMPIX works 3. Before you use CHAMPIX 4. How to use CHAMPIX 5. While you are using it 6. Side effects 7. Storage and Disposal of CHAMPIX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CHAMPIX IS USED FOR Varenicline is indicated for smoking cessation. HOW CHAMPIX WORKS CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking. Although you are not recommended to smoke after your quit date, CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment. (The quit date is the day in the second week of treatment when you will stop smoking, see section, How to use CHAMPIX.) BEFORE YOU USE CHAMPIX - _When you must not use it _ If you are allergic (hypersensitive) to varenicline tartrate or any of the other ingredients of CHAMPIX. _PREGNANCY AND LACTATION _ It is preferable to avoid the use of CHAMPIX while you are pregnant. Talk to your doctor if you are intending to become pregnant. If you want to start treatment with CHAMPIX, your treatment should be timed so that you have completed the course before becoming pregnant. Animal studies suggest that CHAMPIX may pass into breast milk. You should ask your doctor or pharmacist for advice before taking CHAMPIX. - _Before you start to use it _ There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients takin Belgenin tamamını okuyun
Pfizer confidential Page 1 of 28 LPD Title: CHAMPIX (varenicline tartrate) LPD Date: 27 September 2018 Country: Malaysia Reference Document: CDS Version 21.0 Dated 26 July 2018 (main reference) & UK SPC Dated August 2018 (section 4.2, 4.3, 4.4, loss of consciousness (4.7 & 4.8)5.1 & 6). Reason for change: Updated based on BoH recommendation on PRAC recommendation on signals published on 9 th July 2018, the risk of loss of consciousness in Champix. Sections 4.2 (Posology and method of administration), 5.1 (Pharmacodynamic properties), and 5.2 (Pharmacokinetic properties) of the varenicline CDS are being revised based on pediatric study 1. NAME OF THE MEDICINAL PRODUCT CHAMPIX ® 0.5 mg film-coated tablets. CHAMPIX ® 1 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg of varenicline (as tartrate). Each film-coated tablet contains 1 mg of varenicline (as tartrate). Excipients: For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Film-coated tablet. 0.5 mg film-coated tablets: White, film-coated, capsular-shaped, biconvex tablets debossed with “_Pfizer_” on one side and “CHX 0.5” on the other side. 1 mg film-coated tablets: Light blue, film-coated, capsular-shaped, biconvex tablets debossed with “_Pfizer_” on one side and “CHX 1.0” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Varenicline is indicated for smoking cessation. 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 Pfizer confidential Page 2 of 28 The patient should set a date to stop smoking. Varenicline dosing should usually start 1-2 weeks before this date. Alternatively, a flexible approach to quitting may be adopted: the patient can begin varenicline dosing and then quit smoking between days 8 and 35 of treatment (see Belgenin tamamını okuyun