VARENAPIX 1 mg varenicline (as tartrate) tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

varenicline tartrate, Quantity: 1.71 mg (Equivalent: varenicline, Qty 1 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; titanium dioxide; hypromellose; triacetin; calcium hydrogen phosphate; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

Product summary:

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

Authorization status:

Registered

Authorization date:

2022-11-17

Patient Information leaflet

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

Summary of Product characteristics

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