Fluconazole 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluconazole

Available from:

Wockhardt 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: 5012727905976

Patient Information leaflet

PRODUCT NAME
DIMMENSION
NO OF COLOR
FONT USED
VERSION
LANGUAGE
SOFTWARE
ARTWORK LEGEND
FLUCONAZOLE 50MG,150MG & 200MG CAPSULES-S/L-ENG PIL
148 X 410 MM
V1- 29-7-19
ENGLISH
ADOBE ILLUSTRATOR( CREATIVE CLOUD)
01- BLACK
01- ARIAL -9PT
(FONTS USED IN LEGEND : ARIAL TYPE SIZE :10POINTS)

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