Fluconazole 150mg capsules

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Fluconazole

Pieejams no:

PLIVA Pharma Ltd

ATĶ kods:

J02AC01

SNN (starptautisko nepatentēto nosaukumu):

Fluconazole

Deva:

150mg

Zāļu forma:

Oral capsule

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 05020100

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 150MG CAPSULE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further question, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluconazole is and what it is used for
2.
What you need to know before you take Fluconazole
3.
How to take Fluconazole
4.
Possible side- effects
5.
How to store Fluconazole
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called “antifungals”.
The active substance is fluconazole.
_ _
Fluconazole 150mg Capsule is used in adults to treat infections caused
by fungi. The most common cause
of fungal infections is a yeast called_ Candida_.
You might be given this medicine by your doctor to treat genital
thrush, infection of the vagina or penis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE 150MG CAPSULE.
_ _
DO NOT TAKE FLUCONAZOLE

if you
are allergic (hypersensitive) to fluconazole, to other medicines you
have taken to treat
fungal infections or to any of the other ingredients of
this medicine(listed in section 6)
.. The
symptoms may include itching, reddening of the skin or difficulty in
breathing

if you
are taking astemizole, terfenadine (antihistamine medicines for
allergies)

if you
are taking cisapride (used for stomach upsets)

if you
are taking pimozide (used for treating mental illness)

if you
are taking quinidine (used for treating heart arrhythmia)

if you
are taking erythromycin (an antibiotic for treating infections)
WARNINGS AND PRECAUTIONS
Talk to yo

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 150 mg Capsule
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole.
Excipient(s) with known effect
Also contains 50mg lactose and 0.02mg Sunset yellow (E110) per
capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Fluconazole 150 mg Capsules are yellow capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole is indicated for the treatment of the following fungal
infections in adults
(see section 5.1):
•
Acute vaginal candidiasis when local therapy is not appropriate.
•
_Candidal balanitis_ when local therapy is not appropriate.
Therapy may be instituted before the results of the cultures and other
laboratory
studies are known; however, once results become available,
anti-infective therapy
should be adjusted accordingly.
Consideration should be given to official guidance on the appropriate
use of
antifungals.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
Single dose 150 mg.
Special populations
_ _
_Elderly _
Where there is no evidence of renal impairment, normal dose
recommendations
should be adopted.
_ _
_Renal impairment_
Fluconazole is predominantly excreted in the urine as unchanged active
substance. No
adjustments in single dose therapy are necessary.
_Hepatic impairment _
Limited data are available in patients with hepatic impairment,
therefore fluconazole
should be administered with caution to patients with liver dysfunction
(see sections
4.4 and 4.8).
_ _Paediatric population
Safety and efficacy for genital candidiasis indication in paediatric
population has not
been established. Current available data for other paediatric
indications are described
in section 4.8. If treatment is imperative in adolescents (from 12 to
17 years old), the
posology should be the same as adults posology.
Method of administration
The capsules should be swallowed whole and independent of food intake.
4.3
CONTRAINDICATIONS
Hypersensitivit