Fluconazole 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluconazole

Available from:

Phoenix Healthcare Distribution 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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
Fluconazole 150mg
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 150 mg Capsules are and
what they are used for
2. What you need to know before you take
Fluconazole 150 mg Capsules
3. How to take Fluconazole 150 mg Capsules
4. Possible side effects
5. How to store Fluconazole 150 mg Capsules
6. Contents of the pack and other information 1. WHAT FLUCONAZOLE 150 MG
CAPSULES ARE AND WHAT THEY
ARE USED FOR
Fluconazole belongs to a group of medicines called
“antifungals”. The active substance is fluconazole.
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 infection 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 150 mg Capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole.
Excipients with known effect:
Also contains Lactose Monohydrate and Sunset Yellow E110.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
Fluconazole 150 mg Capsules are yellow capsules_._
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole 150mg capsule is indicated for the treatment of candidal
vaginitis,
acute or recurrent. It should also be used for treatment of partners
with
associated candidal balanitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Fluconazole is administered orally.
ADULTS (16 TO 60 YEARS):
One capsule should be swallowed whole.
CHILDREN (UNDER 16 YEARS):
Paediatric use is not recommended.
ELDERLY:
Not recommended in patients over 60 years.
RENAL IMPAIRMENT:
There is no separate dosage schedule in patients with renal impairment
for single dose
therapy.
4.3
CONTRAINDICATIONS
Fluconazole should not be used in patients with known hypersensitivity
to the drug,
any of the inert ingredients listed in section 6.1 or to related azole
compounds.
Coadministration of terfenadine is contraindicated in patients
receiving fluconazole at
multiple doses of 400mg per day or higher based upon results of a
multiple dose
interaction study. Coadministration of other medicinal products known
to prolong the
QT interval and which are metabolised via the cytochrome P450 (CYP)
3A4 such as
cisapride, astemizole, pimozide, quinidine and erythromycin are
contraindicated in
patients receiving fluconazole (see section 4.4 and 4.5).
Fluconazole should not be used in patients with porphyria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Renal system
Fluconazole should be administered with caution to patients with renal
dysfunction
(see section 4.2).
Adrenal insufficiency
Ketoconazole is known to cause adrenal insufficiency, and this could
also, although
rarely seen, be applicable to fluconazole.
Adrenal