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Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DIFLUCAN
®
CAPSULES
Fluconazole (50 mg, 100 mg, 150 mg)
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DIFLUCAN
®
CAPSULES
Fluconazole (50 mg, 100 mg, 150 mg)
1
WHAT IS IN THIS LEAFLET
1.
What DIFLUCAN is used for
2.
How DIFLUCAN works
3.
Before you use DIFLUCAN
4.
How to use DIFLUCAN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
DIFLUCAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT DIFLUCAN IS USED FOR
DIFLUCAN is used to treat infections
caused by fungi and may also be used
to prevent you from getting fungal
infections.
You might be given this medicine by
your doctor to treat the following types
of fungal infections:
-
cryptococcal meningitis (fungal
infection in the brain);
-
infections caused by _Candida_ in the
bloodstream, body organs (e.g.,
heart, lungs) or urinary tract;
-
mucosal thrush (infection affecting
the lining of the mouth, throat and
dentures);
-
genital thrush (infection of the
vagina or penis);
-
skin infections (e.g., Athlete’s foot,
ringworm, jock itch).
You might also be given DIFLUCAN
to prevent recurrence of:
-
fungal infection in the brain
-
mucosal thrush;
-
vaginal thrush;
-
infection caused by _Candida_ (if your
immune system is weak and not
working properly).
HOW DIFLUCAN WORKS
DIFLUCAN belongs to a group of
medicines called “antifungals”. The
active substance is fluconazole. It
works by inhibiting the growth of fungi
that cause infection.
BEFORE YOU USE DIFLUCAN
-
_When you must not use it_
Do not take DIFLUCAN if you
-
are allergic (hypersensitive) to
fluconazole or to other medicines
you have taken to treat fungal
infections or to any of the other
ingredients of DIFLUCAN;
-
are taking astemizole, terfenadine
(antihistamine medicines for
allergies);
-
are taking cisapride (used for
stomach upsets);
-
are taking pimozide (used for
treating mental illness);
-
are taking quinidine (used for
tre
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产品特点
1
DIFLUCAN
Fluconazole
1.
NAME OF THE MEDICINAL PRODUCT
DIFLUCAN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN contains as its active ingredient fluconazole 50 mg, 100 mg
and 150 mg as
capsules, and as 2 mg/ml in a saline solution for intravenous
infusion.
Fluconazole is a bis-triazole, having the following chemical name:
2-(2, 4-difluorophenyl)-
1, 3-bis (1H, 2, 4-triazol-1-yl)-2-propanol. It has a molecular weight
of 306.3.
3.
PHARMACEUTICAL FORM
_Capsule (manufactured by France)_
Fluconazole capsule 50 mg is a turquoise and white, opaque No 4
capsules over-printed with
the Pfizer logo and 'FLU 50' and containing white powder.
Fluconazole capsule 100 mg is a white and blue, opaque No 2 capsules
over-printed with the
Pfizer logo and the code FLU-100 and containing a white powder.
Fluconazole capsule 150 mg is a turquoise, opaque No 1 capsules
over-printed with the Pfizer
logo and 'FLU 150' and containing white powder.
_Capsule (manufactured by Australia)_
Fluconazole capsule 50 mg is a blue and white, opaque No 4 capsules
over-printed with the
Pfizer logo and 'FLU 50' and containing white powder.
Fluconazole capsule 150 mg is a blue, opaque No 1 capsules
over-printed with the Pfizer
logo and 'FLU 150' and containing white powder.
_Solution for intravenous infusion_
Fluconazole solution for intravenous infusion is a clear, colourless
solution conforming to
parenteral standards, in clear, neutral glass vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy may be instituted before the results of the cultures and other
laboratory studies are
known; however, once these results become available, anti-infective
therapy should be
adjusted accordingly.
1.
Cryptococcosis, including cryptococcal meningitis and infections of
other sites (e.g.,
pulmonary, cutaneous). Normal hosts and patients with AIDS, organ
transplants or other
causes of immunosuppression may be treated. Fluconazole can be used as
maintenance
therapy to prevent relapse of cryptococcal disease in patients with
AIDS.
2
2.
Systemic candidia
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