GRISEOFULVIN 500MG TABLETS

Active substance: GRISEOFULVIN

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Griseofulvin
125 mg and 500 mg Tablets
Griseofulvin

82-83/L/e/4

Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again.
iIf you have any further questions, ask your doctor or pharmacist.
iThis medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
iIf any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

If you take more 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
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 missed dose.
If you stop taking
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 product, ask your doctor or
pharmacist.

4. Possible side effects

1. What this medicine is and what it is used for
Griseofulvin tablets contain griseofulvin which is an antifungal antibiotic.
Griseofulvin kills the fungi that cause infections of:
ithe 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. Before you take
Do NOT take Griseofulvin tablets if you:
iare allergic to griseofulvin or to any of the other ingredients (see Section 6)
iare pregnant or intending to become pregnant within 1 month of stopping
treatment
iare planning to father children within 6 months of treatment with these
tablets
ihave severe liver disease
ihave porphyria (a metabolism disorder which causes abdominal pains and
mental disorder)
ihave 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription, and
herbal preparations.
Some medicines may be affected by Griseofulvin or they may affect how well
Griseofulvin will work. Tell your doctor or pharmacist if you are taking:
ioral contraceptives (the pill). You will need an additional method of
contraception, such as condoms while you are taking Griseofulvin and also
during the month after stopping treatment
iphenylbutazone, a medicine used to treat a type of arthritis
iphenobarbitone, a medicine used to control epilepsy (fits)
iciclosporin, a medicine used to suppress the immune system
imedicines that thin the blood (e.g.warfarin)
iany medicines that tend to make you sleepy, such as medication used to
help you sleep or calm you down
imedicines containing alcohol. Griseofulvin may enhance the effect of
alcohol.
Pregnancy and breast-feeding
DO NOT take Griseofulvin if you are pregnant or breast-feeding. Griseofulvin
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.
Ask your doctor for advice before taking any medicine.
Important information for men and women:
iWomen should avoid getting pregnant while taking Griseofulvin tablets and
up to one month after treatment.
iMen should not father children within six months of taking Griseofulvin
tablets.
Driving and using machines
Griseofulvin 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 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.

3. How to take
Always take Griseofulvin tablets exactly as your doctor has told you and always
read the label. Your doctor will decide on the appropriate dose to suit your
condition. Ask your doctor or pharmacist if you are not sure.
hSwallow the tablets whole with a drink of water. Take the tablets immediately
after a meal.
hGriseofulvin 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.

Like all medicines, Griseofulvin tablets 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:
idifficulty breathing or swallowing, swelling of the face, lips, tongue or throat
isevere itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following symptoms:
iyellowing of the skin or eyes, pale faeces and dark urine, unexplained
persistent nausea, stomach problems, loss of appetite or unusual tiredness
ifever, sore throat, mouth ulcers, repeated infections or infections that will not
go away
ibutterfly-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:
ireactions 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
ifeeling confused, dizzy or unsteady
ifeeling tired, drowsy or sleepy
ifeeling of numbness and tingling in hands and feet
igriseofulvin 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:
idiarrhoea and stomach problems
inausea and vomiting
iheadache.
If any of the side effects get troublesome, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store
iKeep out of the reach and sight of children.
iDo not take after the expiry date which is stated on the label and on the
carton. The expiry date refers to the last day of that month.
iDo not store above 25ÂșC. Store in the original container.
iDo not throw it away with your household waste or in water. Return all the
unwanted medicine to the pharmacist. This will help to protect the
environment.

6. Further information
What Griseofulvin Tablets contain
iThe active ingredient is griseofulvin (125 mg or 500 mg).
iThe 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, methylene chloride and isopropyl alcohol.
The tablets do not contain any flavouring or colouring agents.
What Griseofulvin Tablets look like and contents of the pack
iGriseofulvin 125 mg Tablets are off-white film-coated tablets, marked 'GF' on
one side and '125' on reverse.
iGriseofulvin 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, 7 Egham Business
Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton,
North Yorkshire BD23 2RW.
This leaflet was last revised in
[08/2010]


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Doses
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.
Children: follow your doctor's instructions.
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.
iFor toe or finger nails you may need 6 to 12 months treatment.
iFor hair or skin at least 4 weeks treatment is required.
Continued over page

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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