Diflukonazol

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluconazole

Available from:

Replek Farm Ltd

INN (International Name):

fluconazole

Dosage:

150mg

Pharmaceutical form:

capsules

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUKONAZOL
(fluconazole)
100MG, 150 MG CAPSULES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
-
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Diflukonazol capsules are and what they are used for
2. Before you take Diflukonazol
3. How to take Diflukonazol
4. Possible side effects
5. How to store Diflukonazol
6. Further information
1. WHAT DIFLUKONAZOL CAPSULES ARE AND WHAT THEY ARE USED FOR
Diflukonazol is one of a group of medicines called “antifungals”.
The active substance is
fluconazole.
Diflukonazol 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, ringworm, jock itch, nail
infection.
You might also be given Diflukonazol to:
- Stop cryptococcal meningitis from coming back.
- Stop mucosal thrush from coming back.
- Reduce recurrence of vaginal thrush.
- Stop you from getting an infection caused by _Candida _(if your
immune system is weak
and not working properly).
CHILDREN AND ADOLESCENTS (0 TO 17 YEARS

Summary of Product characteristics

- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
DIFLUKONAZOL
fluconazole
100 MG, 150 MG CAPSULES
ATC J02A C01
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg, 150 mg fluconazole, excipients.
*For full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Capsule
DIFLUKONAZOL 100 mg, 150 mg capsules are uniform, white, hard,
gelatinous
capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole 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.
- 2 -
• 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.
Fluconazole 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)).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children, and
adolescents aged from