Griseofulvin 125mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Griseofulvin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

D01BA01

INN (International Name):

Griseofulvin

Dosage:

125mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020500

Patient Information leaflet

FRONT
BACK
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WHAT IS IN THIS LEAFLET
1. WHAT GRISEOFULVIN TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRISEOFULVIN TABLETS
3. HOW TO TAKE GRISEOFULVIN TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE GRISEOFULVIN TABLETS
6. FURTHER INFORMATION 1.
WHAT GRISEOFULVIN TABLETS ARE AND WHAT THEY ARE USED FOR
Griseofulvin Tablets contain griseofulvin which is an antifungal
antibiotic.
Griseofulvin kills the fungi that cause infections of:

the skin, scalp, hair or nails.
It works by helping the newly formed skin, hair and nails to resist
attack by fungi. As the new tissue grows,
the old and infected is cast off. It is important to continue
treatment until all the old infected tissue is gone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRISEOFULVIN TABLETS
DO NOT TAKE GRISEOFULVIN TABLETS

if you are allergic to griseofulvin or to any of the other ingredients
of this medicine (listed in section 6).

if you are pregnant or intending to become pregnant within 1 month of
stopping treatment.

if you are planning to father children within 6 months of treatment
with these tablets.

if you have severe liver disease.

if you have porphyria (a metabolism disorder which causes abdominal
pains and mental disorder).

if you have systemic lupus erythematosus (a disorder which causes the
immune system to attack
the body).
Griseofulvin Tablets must NOT be taken if your skin, hair or nails are
healthy, as a precaution to prevent a
long-past infection returning.
If any of the above apply to you, speak to your doctor or pharmacist.
OTHER MEDICINES AND GRISEOFULVIN TABLETS
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Some medicines may be affected by Griseofulvin Tablets or they may
affect how well Griseofulvin Tablets
will work.
Tell your doctor or pharmacist if you are taking:

oral contraceptives (the pill). You will need an additional method of
contraception, such as condoms
wh

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Griseofulvin 125mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Griseofulvin BP 125.0 mg
Excipient(s) with known effect:
Each tablet contains 0.268 mg propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The treatment of fungal infections of the skin, scalp, hair or nails
where topical
therapy is considered inappropriate or has failed.
When griseofulvin is given orally for systemic treatment of fungal
infections,
it enables newly-formed keratin of the skin, hair and nails to resist
attack by
the fungi. As the new keratin extends, the old infected keratin is
shed.
Griseofulvin is effective against the dermatophytes causing ringworm
(tinea),
including: _Microsporum canis and T. Verrucosum. _
_ _
Griseofulvin is not effective in infections caused by _Candida _
_albicans(monilia), Aspergilli, Malassezia furfur (Pityriasis
versicolor) _and
_Nocardia _species.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Normally 500 to 1000 mg daily, but not less than 10 mg/kg bodyweight
daily.
A single dose daily is often satisfactory, but divided doses may be
more
effective in patients who respond poorly.
_Paediatric population_
Usually 10 mg/kg (5 mg/lb) body weight daily in divided doses.
DURATION OF TREATMENT
This depends upon the thickness of keratin at the site of infection.
For hair or
skin at least four weeks treatment is required, whereas toe or
fingernails may
need six to twelve months treatment. Therapy should be continued for
at least
two weeks after all signs of infection have disappeared.
Method of administration
For oral administration.
Doses should be taken after meals, otherwise absorption is likely to
be
inadequate.
4.3
CONTRAINDICATIONS
Porphyria or severe liver disease. Griseofulvin may cause liver
disease to
deteriorate, and liver function should be monitored in such
conditions.
Systemic Lupus Erythematosus: griseofulvin has been r