Fluconazole 150mg 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:

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: 5060013940866

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 150 MG CAPSULE
(FLUCONAZOLE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
•
You must talk to doctor if you do not feel better or if you feel worse
after few days.
WHAT IS IN THIS LEAFLET:
1. What Fluconazole Capsule is and what it is used for
2. What you need to know before you take Fluconazole Capsule
3. How to take Fluconazole Capsule
4. Possible side effects
5. How to store Fluconazole Capsule
6. Contents of the pack and other information.
1. WHAT FLUCONAZOLE CAPSULE IS AND WHAT IT IS USED FOR
The name of your medicine is Fluconazole 150mg Capsule.
Fluconazole Capsule is a full course of treatment for thrush.
Only use this product if you have been previously diagnosed by your
doctor as having thrush.
The active substance in Fluconazole Capsule is fluconazole.
Fluconazole belongs to a group of
medicines called azoles and is an antifungal agent which fights the
cause of infections such as
thrush.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE CAPSULE
DO NOT TAKE FLUCONAZOLE CAPSULE IF YOU:
-
Are allergic to fluconazole, to other medicines you have taken to
treat fungal infections or
to any of the other ingredients of Fluconazole Capsule. The symptoms
may include itching,
reddening of the skin or difficulty in breathing
-
Are taking astemizole, terfenadine (antihistamine medicines for
allergies)
-
Are taking cisapride (used for stomach upsets)
-
Are taking pimozide (used for treating mental illness)
-
Are taking quinidine (used for treating heart arrhythmia)
-
Are taking erythromycin (an antibiotic for treating infect

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Blicanz Thrush Relief 150 mg capsule
Fluconazole 150mg capsule
Boots Thrush 150mg Capsule (Fluconazole)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Fluconazole 150mg
Excipients with known effect: Contains methyl parahydroxybenzoate
(E218)
and propyl parahydroxybenzoate (E216) and 150mg of anhydrous lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule for oral administration
White to off white powder filled in Blue/Blue coloured hard gelatin
capsules
of
size ‘1’.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Fluconazole 150mg Capsules are recommended for the treatment of
candidal
vaginitis, acute or recurrent. It should also be used for the
treatment of partners
with associated candidal balanitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
Oral.
Fluconazole 150mg capsules should be swallowed whole
_ _
_IN ADULTS_ aged 16 - 60 years
One capsule should be swallowed whole.
IN CHILDREN - Not recommended in children aged under 16 years.
USE IN ELDERLY - Not recommended in patients aged over 60 years.
_ _
USE IN RENAL IMPAIRMENT- Fluconazole is predominantly excreted in the
urine as
unchanged active substance. No adjustments in single dose therapy are
required.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance, to related azole substance,
or to any of the
excipients listed in section 6.1.
Co-administration 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. Co-administration 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 sections 4.4 and 4.5).
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Tinea capitis _
Fluconazole has been stu