Flucona-Denk 150

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluconazole

Available from:

Denk Pharma GmbH & Co. KG

INN (International Name):

fluconazole

Dosage:

150mg

Pharmaceutical form:

capsules

Prescription type:

Prescription

Patient Information leaflet

_Flucona-Denk 150_
Hard capsule – oral use
Antimycotic
Active substance: fluconazole
PACKAGE LEAFLET:
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFOR-
MATION FOR YOU.
– Keep this leaflet. You may need to
read it again.
– If you have any further questions,
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 sec-
tion 4.
WHAT IS IN THIS LEAFLET
1.WHAT FLUCONA-DENK 150 IS AND
WHAT IT IS USED FOR
2.WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FLUCONA-DENK 150
3.HOW TO TAKE FLUCONA-DENK 150
4.POSSIBLE SIDE EFFECTS
5.HOW TO STORE FLUCONA-DENK 150
6.CONTENTS OF THE PACK AND OTHER INFOR-
MATION
1.
WHAT FLUCONA-DENK 150 IS
AND WHAT IT IS USED FOR
Flucona-Denk 150 is one of a group of
medicines called “antifungals”. The
active substance is fluconazole. Flucona-
Denk 150 is used in adults to treat infec-
tions caused by fungi. The most com-
mon 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
FLUCONA-DENK 150
DO NOT TAKE FLUCONA-DENK 150 IF YOU
– are allergic to fluconazole, other medi-
cines you have taken to treat fungal
infections, sunset yellow or 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
– 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 treating
heart arrhythmia)
– are taking erythromycin (an antibiotic
for treating infections)
WA

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flucona-Denk 150
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluconazole
Each hard capsule contains 150 mg fluconazole.
Excipients with known effect: Each hard capsule contains sunset yellow
and 50.0 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Flucona-Denk 150 hard capsule is yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flucona-Denk 150 is indicated in 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 these 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).
2
_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
Hyperse