Fluconazole 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluconazole

Available from:

Bristol Laboratories Ltd

ATC code:

J02AC01

INN (International Name):

Fluconazole

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100; GTIN: 5060013940859

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 MG CAPSULES
FLUCONAZOLE 200 MG 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fluconazole Capsules are and what they are used for
2.
What you need to know before you take Fluconazole Capsules
3.
How to take Fluconazole Capsules
4.
Possible side effects
5.
How to Store Fluconazole Capsules
6.
Contents of the pack and other information
1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Fluconazole 50mg or 200mg Capsules and
the active ingredient is
Fluconazole. Fluconazole is one of a group of medicines called
“antifungals”.
Fluconazole 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 FLUCONAZOLE CAPSULES TO:
•
Stop cryptococcal meningitis fr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 50 mg of fluconazole.
Excipients with known effect: Contains methyl parahydroxybenzoate
(E218) and propyl
parahydroxybenzoate (E216) and 50mg of anhydrous lactose
For the full list of excipients: see section 6.1
3
PHARMACEUTICAL FORM
Capsules for oral administration.
White to off white powder filled in blue/white coloured hard gelatin
capsules of size ‘4’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole 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.
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 sectio