Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
varenicline tartrate, Quantity: 1.71 mg (Equivalent: varenicline, Qty 1 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; titanium dioxide; hypromellose; triacetin; calcium hydrogen phosphate; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate
Oral
56 tablets
(S4) Prescription Only Medicine
Varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.
Visual Identification: Blue, modified capsule-shaped, biconvex, film coated tablet engraved "APO" on one side, "VAR" over "1" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2022-11-17
VARENAPIX 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING VARENAPIX? 2. WHAT SHOULD I KNOW BEFORE I USE VARENAPIX? 3. WHAT IF I AM TAKING OTHER MEDICINES? 4. HOW DO I USE VARENAPIX? 5. WHAT SHOULD I KNOW WHILE USING VARENAPIX? 6. ARE THERE ANY SIDE EFFECTS? VARENAPIX The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. VARENAPIX contains the active ingredient varenicline tartrate. VARENAPIX is used to help adults stop smoking. For more information, see Section 1. Why am I using VARENAPIX? in the full CMI. Do not use if you have ever had an allergic reaction to varenicline tartrate or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use VARENAPIX? in the full CMI. Some medicines may interfere with VARENAPIX and affect how it works. Furthermore, the effects of changes in your body resulting from stopping smoking, with or without VARENAPIX, may alter the way some medicines work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. Your doctor will decide with you on how to use VARENAPIX to quit smoking. There are 3 ways to quit smoking with VARENAPIX. To take VARENAPIX, you start with the white 0.5 mg tablet and then increase the dose up to the blue 1 mg tablet. More instructions can be found in Section 4. How do I use VARENAPIX? in the full CMI. THINGS YOU SHOULD DO • Make sure you try to stop smoking on your quit date. If you slip up and smoke, try again. • Stop taking VARENAPIX and call your doctor straight away if you or those around you notice changes in behaviour, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions. • Call your doctor straight away if you have existing heart or blood vessel problems and notice an Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – VARENAPIX (VARENICLINE TARTRATE) TABLETS 1 NAME OF THE MEDICINE Varenicline tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg film coated tablet contains 0.855 mg varenicline tartrate, equivalent to 0.5 mg varenicline. Each 1 mg film coated tablet contains 1.71 mg varenicline tartrate, equivalent to 1 mg varenicline. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 1 MG TABLETS Blue coloured, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “1” on the other side. 0.5 MG TABLETS White coloured, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “0.5” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Varenicline is indicated as an aid to smoking cessation in adults over the age of 18 years. 4.2 DOSE AND METHOD OF ADMINISTRATION VARENAPIX film coated tablets are intended for oral administration. DOSAGE USE IN ADULTS Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support. The recommended dose of varenicline 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 The patient should set a date to stop smoking. Varenicline dosing should start 1 – 2 weeks before this date. Alternatively, a flexible approach to quitting smoking may be adopted. Patients can begin varenicline dosing and then quit smoking between days 8 and 35 of treatment (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS, FLEXIBLE QUIT DATE STUDY). 2 Patients should be treated with varenicline for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline at 1 mg twice daily is recommended to further increase th Read the complete document