Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Griseofulvin 500 mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Griseofulvin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 it
e 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:
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oral contraceptives (the pill). You will need an additional method of contraception, such as condoms while you are taking Griseofulvin Tablets and also during the month after stopping treatment phenylbutazone, a medicine used to treat a type of arthritis phenobarbitone, a medicine used to control epilepsy (fits) ciclosporin, a medicine used to suppress the immune system medicines that thin the blood (e.g.warfarin) any medicines that tend to make you sleepy, such as medication used to help you sleep or calm you down medicines containing alcohol. Griseofulvin Tablets may enhance the effect of alcohol.
Pregnancy and breast-feeding DO NOT take Griseofulvin Tablets if you are pregnant or breast-feeding. Griseofulvin Tablets may cause birth defects and it may affect breast-fed babies. If you become pregnant while taking Griseofulvin Tablets, stop taking them immediately and contact your doctor. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Important information for men and women:
- Women should avoid getting pregnant while taking Griseofulvin Tablets and up to one month after treatment.
- Men should not father children within six months of taking Griseofulvin Tablets. Driving and using machines Griseofulvin Tablets may cause tiredness or drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert. Protecting your skin Griseofulvin Tablets may make your skin more sensitive to sunlight. Avoid direct sunlight and artificial UV light. When outside, wear protective clothing, hat and sunglasses, and use a sunblock that is at least SPF15 while taking Griseofulvin Tablets. Griseofulvin Tablets contains propylene glycol This medicine contains 0.268 mg propylene glycol in each 125 mg tablet and 1.55 mg propylene glycol in each 500 mg tablet. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'. 3.
How to take it
Griseofulvin Tablets
Always take this medicine exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Check with your doctor or pharmacist if you are not sure.
- Swallow the tablets whole with a drink of water. Take the tablets immediately after a meal.
- Griseofulvin may increase the effect of alcohol. Drinking alcohol with these tablets may cause fast heartbeat, flushing, increased sweating, or redness of the face. If you have this reaction or feel that the alcohol is affecting you more than usual, do not drink alcoholic drinks. The recommended dose is Adults: the usual dose is 500 mg to 1000 mg once daily. Your doctor may ask you to take a smaller dose several times a day. Use in children: follow your doctor's instructions. 82-83/L/x/2
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Keep taking the tablets for at least two weeks after all signs of infection have disappeared. You may need to take Griseofulvin every day for many weeks or months while new skin, hair or nails grow. This depends upon the thickness of keratin (hair, nails) at the site of infection.
- For toe or fingernails you may need 6 to 12 months treatment.
- For hair or skin at least 4 weeks treatment is required. If you take more Griseofulvin Tablets than you should 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the container and any remaining tablets with you so that people can see what you have taken. 3. Do this even if you feel well. If you forget to take Griseofulvin Tablets If you forget to take a dose, take it after food as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not use a double dose to make up for a forgotten dose. If you stop taking Griseofulvin Tablets Do not stop just because the infection seems to have cleared; the medicine may not have killed all the fungus. If you stop too soon, the infection may come back. Keep taking the tablets until the prescribed course is finished. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:
- difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised lumps. Seek immediate medical attention if you have any of the following symptoms:
- yellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness
- fever, sore throat, mouth ulcers, repeated infections or infections that will not go away
- butterfly-shaped skin rash over the nose and cheeks made worse by exposure to the sun. Tiredness and joint pains. Tell your doctor if you get any of the following side effects:
- reactions to the sun. Your skin may become red, painful and swollen – do not sunbathe, use a sun bed, or expose your skin to artificial UV light
- feeling confused, dizzy or unsteady
- feeling tired, drowsy or sleepy
- feeling of numbness and tingling in hands and feet
- griseofulvin may upset normal sperm production. Men wishing to father children within six months of treatment should discuss the possible side effects with their doctor. The following side effects usually settle without changing the dose:
- diarrhoea and stomach problems
- nausea and vomiting 82-83/L/x/2
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headache.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5. 6.
How to store it
Griseofulvin Tablets Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month. Do not store above 25oC. Store in the original container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Griseofulvin Tablets contains
- The active substance is griseofulvin. Each tablet contains either 125 mg or 500 mg griseofulvin.
- The other ingredients are: sodium laurilsulfate, povidone, maize starch, potato starch, microcrystalline cellulose, magnesium stearate and purified water. The film coating contains: hypromellose, ethylcellulose, acetylated monoglyceride, polysorbate 80, propylene glycol (E 1520), methylene chloride and isopropyl alcohol. (See end of Section 2 for further information on propylene glycol). The tablets do not contain any flavouring or colouring agents. What Griseofulvin Tablets look like and contents of the pack
- Griseofulvin 125 mg Tablets are off-white film-coated tablets, marked 'GF' on one side and '125' on reverse.
- Griseofulvin 500 mg Tablets are off-white film-coated tablets, marked 'GF' on one side and '500' on reverse. They are available in containers of 100 tablets. Marketing Authorisation Holder Chemidex Pharma Ltd., trading as Essential Generics, 8a Crabtree Road, Egham, Surrey, TW20 8RN, UK. Manufacturer Lelypharma B.V., Zuiveringweg 42, 8243 PZ Lelystad, the Netherlands. This leaflet was last revised in 07/2024
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Frequently asked questions about Griseofulvin 500 mg Tablets
How do I take Griseofulvin 500 mg Tablets?
Griseofulvin 500 mg Tablets comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Griseofulvin 500 mg Tablets?
The active substance in Griseofulvin 500 mg Tablets is griseofulvin.
Are there equivalent medicines to Griseofulvin 500 mg Tablets?
Medicines with the same active substance, strength and form include: Griseofulvin 500mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Griseofulvin 500 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Griseofulvin 500 mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: griseofulvin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 reported to exacerbate the condition.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
There is no evidence of the safety of Griseofulvin in human pregnancy. Griseofulvin is teratogenic in animals and some case reports of human foetal abnormalities have been observed. Therefore, Griseofulvin should not be used in pregnancy, or in women intending to become pregnant within one month following cessation of treatment.
Males should not father children within six months of treatment with Griseofulvin.
Long term administration of high doses of griseofulvin with food has been reported to induce hepatomas in mice and thyroid tumours in rats but not hamsters. The clinical significance of these findings in man is not known. In view of these data, Griseofulvin tablets should not be used prophylactically.
4.4. Special warnings and precautions for use
None.
4.5. Interaction with other medicinal products and other forms of interaction
Griseofulvin may decrease the blood level and hence efficacy of certain drugs, which are metabolised by cytochrome P450 3A4. These include oral contraceptives, coumarin anticoagulants and ciclosporin. Appropriate monitoring should be undertaken and dosage should be adjusted as necessary. Additional contraceptive precautions should be taken during griseofulvin treatment and for a month after stopping griseofulvin.
Absorption of griseofulvin is inhibited when phenobarbitone is taken concurrently. The blood level, and hence efficacy, of griseofulvin may also be impaired as the result of concurrent administration of substances such as phenylbutazone and sedative and hypnotic drugs which induce metabolising enzymes.
Patients should be warned that an enhancement of the effects of alcohol by griseofulvin has been reported.
Excipients
This medicine contains 1.55 mg propylene glycol in each tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no evidence of its safety in human pregnancy (see contraindications). Griseofulvin has been shown to be teratogenic in mice and rats following administration to pregnant animals. Some casereports suggest that it produces human foetal abnormalities.
As Griseofulvin is capable of inducing aneuploidy (abnormal segregation of chromosomes following cell division) in mammalian cells exposed to the compound in vitro and in vivo, women should be warned that they should not take the drug during pregnancy or become pregnant within one month following cessation of treatment.
Additionally, males should not father children within six months of treatment.
Breast-feeding
It is not known if griseofulvin is excreted in human milk. Safety in children of mothers who are breastfeeding has not been established.
4.7. Effects on ability to drive and use machines
In those rare cases where individuals are affected by drowsiness while taking griseofulvin, they should not drive vehicles or operate machinery.
4.8. Undesirable effects
Diarrhoea, nausea and vomiting are common adverse events.
Headache and gastric discomfort sometimes occur, but usually disappear as treatment continues. On rare occasions urticarial reactions, skin rashes and precipitation of Systemic Lupus Erythematosus have been reported.
Toxic epidermal necrolysis and erythema multiforme have been reported.
Significant elevations in LFTs (greater than three times the upper limit of normal) have been reported very rarely.
There have been reports of central nervous system effects e.g. confusion, dizziness, impaired coordination and peripheral neuropathy.
Leucopenia with neutropenia has been reported.
Photosensitivity reactions can occur on exposure to intense natural or artificial sunlight.
Drowsiness has been reported.
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Treatment is unlikely to be required in cases of acute overdosage.
💬 Ask about this leaflet
Ask anything about Griseofulvin 500 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.