Varenicline Pfizer 0.5 mg and 1 mg tablets

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline;  ;  ; Varenicline tartrate 1.71mg equivalent to 1 mg varenicline

Dostupno od:

Pfizer New Zealand Limited

INN (International ime):

Varenicline tartrate 0.85 mg (=0.5 mg varenicline)

Doziranje:

0.5 mg and 1 mg

Farmaceutski oblik:

Combination

Sastav:

Active: Varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline     Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry clear YS-2-19114-A Opadry white YS-1-18202 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

Jedinice u paketu:

Blister pack, 11 x 0.5 mg + 14 x 1 mg tablets, 25 tablets

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Pfizer Pharmaceuticals LLC

Terapijske indikacije:

An aid to smoking cessation

Proizvod sažetak:

Package - Contents - Shelf Life: Combination pack, 11 x 0.5 mg + 14 x 1 mg tablets - 25 tablets - 24 months from date of manufacture stored at or below 30°C - Combination pack, 11 x 0.5 mg + 42 x 1 mg tablets - 53 tablets - 24 months from date of manufacture stored at or below 30°C

Datum autorizacije:

2006-01-23

Uputa o lijeku

VARENICLINE PFIZER
1
VARENICLINE PFIZER
_(VAR-REN-EE-CLINE FI-ZER) _
_Varenicline tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Varenicline Pfizer. 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 Varenicline
Pfizer 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
Varenicline Pfizer 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,
Varenicline Pfizer will reduce your
enjoyment of cigarettes if you do
smoke while on treatment.
_HOW VARENICLINE PFIZER _
_WORKS _
Varenicline Pfizer 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
Varenicline Pfizer works by
activating these receptors and
blocking nicotine from attaching to
them. Varenicline Pfizer does no

Svojstava lijeka

Version: pfdvaret10620
Supersedes: pfdvaret11018
Page 1 of 28
DATA SHEET
1. PRODUCT NAME
VARENICLINE PFIZER (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
VARENICLINE PFIZER 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 VARENICLINE PFIZER 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. VARENICLINE PFIZER
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 VARENICLINE PFIZER 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 PFIZER 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