Fluconazole 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluconazole

Available from:

Sun Pharma UK Ltd

ATC code:

J02AC01

INN (International Name):

Fluconazole

Dosage:

150mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100; GTIN: 5015525060830

Patient Information leaflet

V023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCONAZOLE 150 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, pharmacist or nurse.
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
Fluconazole Capsules are one of a group of medicines called
“antifungals”. The active substance is
fluconazole.
Fluconazole Capsules are 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 from coming back
-
stop mucosal thrush from coming back
-
reduce recurrence of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 150 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 150 mg.
Excipients with known effect:
Each capsule also contains 115.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Blue/blue hard gelatin, self locked capsules of size '1' imprinted
with
'RANBAXY' in black edible ink on both cap and body containing white to
off-white powder.
4.1
THERAPEUTIC INDICATIONS
Fluconazole Capsules are indicated in the following fungal infections
(see
section 5.1):
Fluconazole Capsules are 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 Capsules are 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