Champix (Pfizer)

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Varenicline tartrate 1.71mg equivalent to 1 mg varenicline;  ;  

Fáanlegur frá:

Pfizer New Zealand Limited

Skammtar:

1 mg

Lyfjaform:

Film coated tablet

Samsetning:

Active: Varenicline tartrate 1.71mg equivalent to 1 mg varenicline     Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry blue 03B90547 Opadry clear YS-2-19114-A

Gerð lyfseðils:

Prescription

Ábendingar:

An aid to smoking cessation

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, - 56 tablets - 24 months from date of manufacture stored at or below 30°C

Leyfisdagur:

2021-04-14

Upplýsingar fylgiseðill

CHAMPIX
1
CHAMPIX
_(VAR-REN-EE-CLINE FI-ZER) _
_Varenicline tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Champix. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Champix
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VARENCILINE
PFIZER IS USED FOR
Champix is a medicine to help adults
stop smoking. It can help to reduce
craving and withdrawal symptoms
that may happen while you stop
smoking.
People giving up smoking are often
affected by nicotine withdrawal.
Symptoms of nicotine withdrawal
can include craving for tobacco,
irritability, frustration, feeling angry,
sleep problems, depressed mood,
feeling anxious, difficulty
concentrating, restlessness, decreased
heart rate, increased appetite or
weight gain. Not everybody is
affected by symptoms of nicotine
withdrawal.
Although it is not recommended that
you smoke after your quit date,
Champix will reduce your enjoyment
of cigarettes if you do smoke while
on treatment.
_HOW CHAMPIX WORKS _
Champix contains the active
ingredient varenicline and works by
blocking the effects of nicotine in
your body. There are receptors for
nicotine in the brain. When cigarette
smoke is inhaled, nicotine attaches to
these receptors. This sends a message
to a different part of the brain to
release a chemical called dopamine.
Dopamine gives a feeling of pleasure
which only lasts for a short time. The
body wants to repeat this feeling
reinforcing the need to keep
smoking. It is believed that Champix
works by activating these receptors
and blocking nicotine from attaching
to them. Champix does not contain
nicotine and it is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS

Vara einkenni

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DATA SHEET
1. PRODUCT NAME
CHAMPIX (varenicline, as tartrate) 0.5 mg and 1 mg film-coated
tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg or 1 mg varenicline (as
tartrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
0.5 mg capsular biconvex, white to off-white, film-coated tablet
debossed with "
_Pfizer_
" on one
side and "CHX 0.5" on the other side.
1 mg capsular biconvex, light blue film-coated tablet debossed with "
_Pfizer_
" on one side and
"CHX 1.0" on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CHAMPIX is indicated as an aid to smoking cessation.
4.2 DOSE AND METHOD OF ADMINISTRATION
_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 CHAMPIX is 1 mg twice daily following a 1-week
titration as
follows:
Days 1 – 3:
0.5 mg one 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. CHAMPIX 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
,
Clinical Efficacy and Safety, Flexible Quit Date Study).
Patients who cannot tolerate adverse effects of varenicline may have
the dose lowered
temporarily or permanently.
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 at 1 mg twice daily is recommended to further increase the
likelihood of long-term
abstinence.
A gradual approach to quitting smoking with varenicline should be
considered for patients who
are not able or willing to quit abruptly. Patients should reduce
smoking during the first
12