CHAMPIX 0.5 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

VARENICLINE AS TARTRATE

Διαθέσιμο από:

PFIZER PHARMACEUTICALS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

N07BA03

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

VARENICLINE AS TARTRATE 0.5 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PFIZER INC, USA

Θεραπευτική ομάδα:

VARENICLINE

Θεραπευτική περιοχή:

VARENICLINE

Θεραπευτικές ενδείξεις:

Champix is indicated as an aid to smoking cessation treatment adults over 18 years of age.

Ημερομηνία της άδειας:

2022-12-31

Φύλλο οδηγιών χρήσης

Champix, PIL Israel, CC TC 100821
2021-0071770
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
CHAMPIX
®
0.5 MG
CHAMPIX
®
1.0 MG
FILM-COATED TABLETS
VARENICLINE (AS TARTRATE) 0.5 MG, 1.0 MG
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this medicine’s
ingredients’ and section 6 ‘Further information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others; it may harm them, even if it seems to
you that their medical condition is similar to yours.
This medicine is intended for adults over the age of 18.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Champix
®
is indicated as a medicinal aid to smoking cessation in adults over
18.
THERAPEUTIC GROUP:
selective partial agonist of nicotinic receptor.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in
this medicine, listed in section 6.
Signs of this could be swelling of the face, tongue, lips, gums,
throat or neck, trouble
breathing, rash including skin peeling, blisters in your mouth.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH CHAMPIX
®
, TELL YOUR DOCTOR IF:
•
You are pregnant, plan to become pregnant and/or are breastfeeding.
•
You have or have had impaired function of the heart and/or blood
vessels, kidney/urinary system,
seizures, or any other medical condition.
•
You have had depression or other mental health conditions. Tell your
doctor about symptoms you had
during previous times you tried to quit smoking, with or without
Champix
®
.
•
You are sensitive to any food or medicine, tell your doctor before
taking the medicine.
•
There is a change in your mood and be

Αρχείο Π.Χ.Π.

Champix 0.5 mg and 1.0 mg, LPD, Israel, CC 020521
2021-0069253
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
CHAMPIX 1.0 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mg CHAMPIX tablet contains 0.85 mg of varenicline tartrate
equivalent to 0.5 mg of
varenicline free base.
Each 1mg CHAMPIX tablet contains 1.71 mg of varenicline tartrate
equivalent to 1 mg of varenicline
free base
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Film coated tablets
1
INDICATIONS AND USAGE
CHAMPIX is indicated as an aid to smoking cessation treatment for
adults over 18 years of age.
2
DOSAGE AND ADMINISTRATION
2.1
USUAL DOSAGE FOR ADULTS
Smoking cessation therapies are more likely to succeed for patients
who are motivated to stop smoking
and who are provided additional advice and support. Provide patients
with appropriate educational
materials and counseling to support the quit attempt.
The patient should set a date to stop smoking. Begin CHAMPIX dosing
one week before this date.
Alternatively, the patient can begin CHAMPIX dosing and then quit
smoking between days 8 and 35 of
treatment.
CHAMPIX should be taken orally after eating and with a full glass of
water.
The recommended dose of CHAMPIX 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
Champix 0.5 mg and 1.0 mg, LPD, Israel, CC 020521
2021-0069253
2
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 is
recommended to further increase the likelihood of long-term
abstinence.
For patients who are sure that they are not able or willing to quit
abruptly, consider a gradual approach to
quitting smoking with CHAMPIX. Patients should begin CHAMPIX dosing
and reduce smoking by 50%
from baseline within the first four weeks, by an additional 50% in the
next four weeks, and continu