Fluconazole 150mg capsules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Fluconazole

Disponível em:

Kent Pharma (UK) Ltd

Código ATC:

J02AC01

DCI (Denominação Comum Internacional):

Fluconazole

Dosagem:

150mg

Forma farmacêutica:

Oral capsule

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05020100; GTIN: 5015201007869

Folheto informativo - Bula

20000XXXX
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCONAZOLE 150 MG CAPSULE
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.
• ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE. • IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. • YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU
FEEL WORSE AFTER 7 DAYS. WHAT IS IN THIS LEAFLET:
1. What Fluconazole 150 mg Capsule is and what it is used for
2. What you need to know before you take Fluconazole 150 mg Capsule
3. How to take Fluconazole 150 mg Capsule
4. Possible side effects
5. How to store Fluconazole 150 mg Capsule
6. Contents of the pack and other information WHAT FLUCONAZOLE 150 MG CAPSULE IS AND WHAT IT IS USED FOR
Fluconazole 150 mg 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 is Fluconazole. It belongs to a
group of medicines called azoles and is an antifungal
agent. It fights the cause of infections such as thrush.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE 150 MG CAPSULE
DO NOT TAKE FLUCONAZOLE 150 MG CAPSULE IF YOU:
• are allergic (hypersensitive) to fluconazole, or another
drug from the same group of antifungal drugs (i.e.
imidazoles), or any of the other ingredients of
Fluconazole 150 mg Capsule (See section 6, Contents
of the pack and other information)
• are taking another drug called terfenadine or
astemizole (antihistamines), cisapride (a drug used to
treat acid reflux, indigestion or decreased gastric
motility), pimozide (a psychiatric medicine), quinidine
(for heart disease) or erythromycin (an antibiotic for
treating infections)
• suffer from porphyria
WARNINGS AND PRECAUTIONS
Before taking Fluconazole 150 mg Capsule, you should
see your doctor if you:
• are unsure about

Características técnicas

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