Flucona-Denk 100

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

fluconazole

Dostępny od:

Denk Pharma GmbH & Co. KG

INN (International Nazwa):

fluconazole

Dawkowanie:

100mg

Forma farmaceutyczna:

capsules

Typ recepty:

Prescription

Ulotka dla pacjenta

_Flucona-Denk 100_
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 INFORMATION 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 section 4.
WHAT IS IN THIS LEAFLET
1. WHAT FLUCONA-DENK 100 IS AND
WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FLUCONA-DENK 100
3. HOW TO TAKE FLUCONA-DENK 100
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FLUCONA-DENK 100
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FLUCONA-DENK 100 IS
AND WHAT IT IS USED FOR
Flucona-Denk 100 is one of a group of medi-
cines called “antifungals”. The active sub-
stance is fluconazole. Flucona-Denk 100 is
used to treat infections caused by fungi and
may also be used to stop you from getting a
candidal infection. The most common cause
of fungal infections is a yeast called _Candida._
ADULTS
You might be given this medicine by your
doctor to treat the following types of fungal
infections:
– Cryptococcal meningitis – a fungal infection
in the brain
– Coccidioidomycosis – a disease of the
bronchopulmonary system
– Infections caused by _Candida_ and found in
the blood stream, body organs (e.g. heart,
lungs) or urinary tract
– Mucosal thrush – infection affecting the
lining of the mouth, throat and denture
sore mouth
– Genital thrush – infection of the vagina or
penis
– Skin infections – e.g. athlete’s foot, ring-
worm, jock itch, nail infection
You might also be given Flucona-Denk 100 to:
– stop cryptococcal meningitis from coming
back
– stop mucosal trush from coming back
�

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flucona-Denk 100
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluconazole
Each hard capsule contains 100 mg fluconazole.
Excipients with known effect: Each hard capsule contains 33.2 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Flucona-Denk 100 hard capsule is buff
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flucona-Denk 100 is indicated in the following fungal infections (see
section 5.1).
Flucona-Denk 100 is indicated in adults for the treatment of:

Cryptococcal meningitis (see section 4.4).

Coccidioidomycosis (see section 4.4).

Invasive candidiasis.

Mucosal candidiasis including oropharyngeal, oesophageal candidiasis,
candiduria and chronic
mucocutaneous candidiasis.

Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical treatment are
insufficient.

Vaginal candidiasis, acute or recurrent, when local therapy is not
appropriate.

_Candidal balanitis _
when local therapy is not appropriate.

Dermatomycosis including
_tinea pedis_
,
_tinea corporis_
,
_tinea cruris_
,
_tinea versicolor _
and dermal
_candida _
infections when systemic therapy is indicated.

_Tinea unguinium (onychomycosis) _
when other agents are not considered appropriate.
Flucona-Denk 100 is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of
recurrence.

Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high
risk of experiencing relapse.

To reduce the incidence of recurrent vaginal candidiasis (4 or more
episodes a year).

Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as patients with
haematological malignancies receiving chemotherapy or patients
receiving Hematopoietic Stem
Cell Transplantation (see section 5.1)).
2
Flucona-Denk 100 is indicated in term newborn infants, infan