Consumer medicine information

1. Why am I using Varenicline Sandoz?

Varenicline Sandoz contains the active ingredient varenicline (as citrate). Varenicline Sandoz is used to help adults stop smoking.
For more information, see Section 1. Why am I using Varenicline Sandoz? in the full CMI.

2. What should I know before I use Varenicline Sandoz?

Do not use if you have ever had an allergic reaction to varenicline citrate 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 Varenicline Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Varenicline Sandoz and affect how it works. Furthermore, the effects of changes in your body resulting from stopping smoking, with or without varenicline, 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.

4. How do I use Varenicline Sandoz?

Your doctor will decide with you on how to use Varenicline Sandoz to quit smoking. There are 3 ways to quit smoking with Varenicline Sandoz.
To take Varenicline Sandoz, you start with the white 0.5 mg tablet and then increase the dose up to the light blue 1 mg tablet. More instructions can be found in Section 4. How do I use Varenicline Sandoz? in the full CMI.

5. What should I know while using Varenicline Sandoz?

6. Are there any side effects?

Common side effects of Varenicline Sandoz include: stomach or bowel problems (e.g. nausea), dry mouth, toothache, headache, dizziness, sleep problems, signs and symptoms of a cold, change in appetite, weight gain, changes in taste, muscle or joint pain. Other serious side effects have also been reported: convulsions, vision problems or pain in eyes, blood in stools or vomit, stomach pain, excessive thirst, dry mouth and skin, passing large amounts of urine, changes in behaviour, thinking or mood, severe skin issues, allergic reactions, heart related issues.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Varenicline (as citrate).

2 Qualitative and Quantitative Composition

Each Varenicline Sandoz 0.5 mg film-coated tablet contains 0.5 mg varenicline (as citrate).
Each Varenicline Sandoz 1 mg film-coated tablet contains 1 mg varenicline (as citrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Film-coated tablets.
Varenicline Sandoz is supplied for oral administration in two strengths:
0.5 mg, white, capsule shaped film-coated tablet debossed with "0.5" on one side and plain on the other side.
1 mg, light blue, capsule shaped film-coated tablet, debossed with "1.0" on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

No cases of overdose were reported in pre-marketing clinical trials.
In case of overdose, standard supportive measures should be instituted as required.
Varenicline has been shown to be dialysed in patients with end stage renal disease (see Section 5.2 Pharmacokinetic Properties); however, there is no experience in dialysis following overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Varenicline had no genotoxic effects, with or without metabolic activation, based on the following assays: Ames bacterial mutation assay; mammalian CHO/HGPRT assay; and tests for cytogenic aberrations in vivo in rat bone marrow and in vitro in human lymphocytes.
Carcinogenicity. Carcinogenicity studies were performed in mice and rats at respective oral doses of varenicline up to 20 mg/kg/day and 15 mg/kg/day for 2 years, with respective systemic drug exposure (C_max) up to 130 and 50 times the human plasma C_max at the maximal recommended dose of 1 mg twice daily. There was no evidence of carcinogenicity in mice or female rats. Male rats showed increased incidences of hibernoma (a rare tumour of brown fat) at systemic exposures of 25 times the human C_max (incidence 1/65 rats) and 50 times the human C_max (incidence 2/65 rats); the no-effect exposure was 10 times the human C_max. The clinical relevance of this finding has not been established.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSVARCIT.gif Varenicline citrate is a off-white/beige to light orange powder. It is freely soluble in water.
Chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-H][3]benzazepine citrate.
Molecular weight: 403.4 g/mol.
Molecular formula: C₁₉H₂₁N₃O₇.
CAS number. CAS Registry No: 536696-70-5.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VARSANST.gif