Fluconazole 150mg capsules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Fluconazole

Disponible desde:

DE Pharmaceuticals

Código ATC:

J02AC01

Designación común internacional (DCI):

Fluconazole

Dosis:

150mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05020100

Información para el usuario

1
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 I
N THIS LEAFLET
:
1.
What Fluconazole 150mg Capsules are and what they are used for
2.
What you need to know before you take Fluconazole 150mg Capsules
3.
How to take Fluconazole 150mg Capsules
4.
Possible side effects
5.
How to store Fluconazole 150mg Capsules
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE 150MG 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 recurrenc

Ficha técnica

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 in