Flucona-Denk 100 capsules hard

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

fluconazole

Sẵn có từ:

Denk Pharma GmbH & Co. KG

Mã ATC:

J02AC01

INN (Tên quốc tế):

fluconazole

Liều dùng:

100mg

Dạng dược phẩm:

capsules hard

Các đơn vị trong gói:

(10/1x10/) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-12-05

Tờ rơi thông tin

_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 TAK-
ING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN-
FORMATION 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 medicines called
“antifungals”. The active substance is fluconazole. Fluco-
na-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 bronchopulmona-
ry 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 Flucona-Denk 100 to:
• stop cryptococcal meningitis from coming back
• stop mucosal thrush from coming bac

Đặc tính sản phẩm

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.
Excipient 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
Fluconazole is indicated in term newborn infants, infants, toddlers,
children