MEDOFULVIN Tablet Ref.[28278] Active ingredients: Griseofulvin

Pregnancy – Griseofulvin is teratogenic in animals and some cases of human fetal abnormalities have been reported. There is no evidence of safety of griseofulvin in human pregnancy. Medofulvin is contraindicated in pregnancy or in women intending to have a child within one month after cessation of treatment.

Males should not father children within six months of treatment with Medofulvin.

Severe liver disease or porphyria – Liver function should be monitored during griseofulvin administration because it may cause liver disease to deteriorate.

Systemic Lupus Erythematosus – griseofulvin has been reported to increase the condition.

Medofulvin should not be use prophylactically. Hepatomas in mice and tyroid tumors in rats but not in hamsters have been reported after long term administration of high doses of griseofulvin with food.

Medofulvin 125mg contains lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Cyclosporin, coumarin anticoagulants: Griseofulvin undergoes extensive hepatic metabolism (by cytochrome P450 3A4); thus griseofulvin may decrease the blood level and efficacy of the drugs that are metabolized by cytochrome P450 3A4. Medicines levels should be monitored and if necessary dosages should be adjusted.

Oral contraceptives: Griseofulvin undergoes extensive hepatic metabolism (by cytochrome P450 3A4); thus griseofulvin may decrease the blood level and efficacy of the drugs that are metabolized by cytochrome P450 3A4. Additional contraceptive precaution is necessary during griseofulvin administration and one month after.

Phenylbutazone, sedative and hypnotic drugs (inducing metabolizing enzymes) influence the blood level and efficacy of griseofulvin as a result of concurrent administration.

Phenobarbitone inhibits the absorption of griseofulvin when they are taken concomitantly.

Alcohol - griseofulvin enhances the effect of alcohol.

There is no evidence for safety in pregnancy, thus the use of griseofulvin is not recommended (see section 4.4).

Griseofulvin is teratogenic in mice and rats and some cases of human fetal abnormalities have been reported. In vitro and in vivo, griseofulvin induces aneuploidy (abnormal segregation of chromosomes following cell division) in mammalian cells exposed to the product. Thus, Medofulvin is contraindicated in pregnancy or in women intending to have a child within one month after cessation of treatment.

Males should not father children within six months of treatment with Medofulvin.

The excretion of griseofulvin in human milk is unknown. Use in breast feeding is not recommended.

Patients should be cautioned not to drive or operate machinery when they are affected by drowsiness during the administration of griseofulvin.

The adverse reactions are displayed by frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (adverse reactions from post-marketing experience; frequency cannot be estimated from the available data).

Gastrointestinal disorders

Very common: gastric discomfort, nausea, diarrhoea and vomiting.

Nervous system disorders

Very common: headache.

Not known: drowsiness, confusion, dizziness, peripheral neuropathy and impaired coordination.

Skin and subcutaneous tissue disorders

Uncommon: skin reactions, urticaria, toxic epidermal necrolysis, erythema multiforme and precipitation of Systemic Lupus Syndrome.

Not known: photosensitivity reactions can occur because of an intense natural or artificial exposure to the sunlight.

Investigations

Very rare: significant elevation in LFTs (greater than three times the upper limit of normal).

Not known: leucopenia with neutropenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via national reporting system.

Not applicable.