Diflucan 200 mg hard capsules

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Fluconazole

제공처:

Pfizer Healthcare Ireland

ATC 코드:

J02AC; J02AC01

INN (국제 이름):

Fluconazole

복용량:

200 milligram(s)

약제 형태:

Capsule, hard

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Triazole derivatives; fluconazole

승인 상태:

Marketed

승인 날짜:

1989-08-22

환자 정보 전단

Page 1 of 9
2023-0089584
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUCAN
® 50 MG HARD CAPSULES
DIFLUCAN
® 200 MG HARD CAPSULES
fluconazole
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Diflucan is and what it is used for
2.
What you need to know before you take Diflucan
3.
How to take Diflucan
4.
Possible side effects
5.
How to store Diflucan
6.
Contents of the pack and other information
1.
WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan is one of a group of medicines called “antifungals”. The
active substance is
fluconazole.
Diflucan 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 Diflucan to:
-
stop cryptococcal meningitis from coming back
-
stop mucosal thrush from coming back
-
reduce recurrence of vaginal thrush
-
stop you from getting an inf

제품 특성 요약

Health Products Regulatory Authority
26 March 2024
CRN00F50Z
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan 200 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 200 mg
Excipient(s) with known effects: each hard capsule also contains
198.82 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
The 200 mg hard gelatin capsule has a white body and a purple cap
overprinted with “Pfizer” and the code “FLU‑200” with
black ink. The capsule size is no. 0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diflucan is indicated in the following fungal infections (see section
5.1).
Diflucan 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.
Diflucan 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 chemot