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Terbinafine 250mg Tablets

Document: leaflet MAH GENERIC_PL 15764-0017 change

170 mm

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TERBINAFINE 250 MG TABLETS

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

• Ifyou have further questions, pleaseaskyourdoctororyourpharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


220 mm


In this leaflet:

1.    What Terbinafine Tablets are and what they are used for

2.    Before you take Terbinafine Tablets

3.    How to take Terbinafine Tablets

4.    Possible side effects

5.    Storing Terbinafine Tablets

6.    Further Information

1.    WHAT TERBINAFINE TABLETS ARE AND WHAT THEY ARE USED FOR

Terbinafine Tablets act by attacking and killing fungus which causes infection. Your doctor has prescribed the medicine for you to treat fungal infections of the skin and nails or for the treatment of ringworm.

2.    BEFORE YOU TAKE TERBINAFINE

Do not take Terbinafine Tablets if:

•    you are hypersensitive to terbinafine or any of the other ingredients (listed in Section 6)

•    you suffer from severe liver problems

•    you suffer from severe kidney problems

Tell your doctor if:

•    you have psoriasis

•    you have liver problems or you have had a history of liver disease

•    you have kidney problems.

•    you are pregnant or breastfeeding

Pregnancy and Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

The use of Terbinafine during pregnancy is not recommended.

The use of Terbinafine whilst breastfeeding is not recommended.

Taking Terbinafine Tablets with other medicines

Tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines including those obtained without a prescription. Some medicines can interfere with terbinafine, in particular, tell your doctor if you are taking any of the following medicines:

•    rifampicin, used to treat tuberculosis

•    cimetidine, used to treat indigestion or stomach ulcers

•    oral contraceptives

•    antidepressants

•    beta blockers, used to treat high blood pressure.

If you go into hospital or to the dentist for treatment, make sure the doctor or dentist knows you are taking Terbinafine Tablets.

3. HOW TO TAKE TERBINAFINE TABLETS

Your doctor will decide the right dose for you and how long you will need to take this medicine. Follow your doctor's instructions. Check the pharmacy label and ask your doctor or pharmacist if you're not sure.

Dose for adults including the elderly:

•    The usual dose is one 250 mg tablet per day. The dose may be lower if you suffer from kidney problems.

•    For skin infections treatment lasts for between 2 and 6 weeks, depending on the site and severity of the infection. For nail infections the treatment may be between 6 and 12 weeks. For toenail infections the treatment may be up to 6 months.

•    Take your tablet with a glass of water.

•    Take the tablets for as long as directed by your doctor. It is important that you complete the course of treatment.

Terbinafine Tablets are not recommended for use in children.

Continued overleaf

If you forget to take a tablet:

Take another as soon as you remember or wait until the next dose is due then continue as before. Do not take a double dose to make up for forgotten individual doses

Ifyou take more Terbinafine Tablets than you should:

Contact your doctor immediately or go to your nearest Accident and Emergency department. Take this leaflet, the container and any remaining tablets, so that the medical staff know exactly what you have taken.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Terbinafine Tablets can cause side effects in some people.

Ifyou notice any of the following rare side effects stop taking the tablets and tell your doctor immediately:

•    severe allergic reactions which may cause prolonged rash, swelling of the face, lips or tongue, difficulty in breathing

•    severe skin reactions including sensitivity to the sun, swelling, blistering or wheals

•    yellowing of the skin or eyes, feeling sick for a long time, vomiting, stomach pain, tiredness, dark urine or pale stools (these may indicate a liver problem)

•    feeling tired and unwell, high temperature or sore throat or become prone to more infections (these may indicate changes in your blood).

Common side effects (reported in less than 1 in 10 people):

•    headache

•    poor appetite, feeling sick, indigestion, mild stomach pains or a feeling of fullness, diarrhoea

•    itchy skin rash or swelling.

Uncommon side effects (reported in less than 1 in 100 people):

•    loss of taste or taste disturbance which usually resolves after Terbinafine treatment is stopped.

Rare side effects (reported in less than 1 in 1000 people):

•    dizziness, tiredness, tingling and numbness

•    muscles and joint pain (which may occur as part of an allergic reaction along with skin rashes).

Very rare side effects (reported in less than 1 in 10,000 people):

•    depression and anxiety

•    loss of hair

•    worsening of psoriasis symptoms

•    blood tests may show a decrease in platelets or white blood cells.

If you notice these or any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.    STORING TERBINAFINE TABLETS

Keep out of the reach and sight of children Keep the blister in the outer carton.

Do not use after the expiry date stated on the carton. Unused tablets should be taken back to the pharmacist for safe disposal.

6.    FURTHER INFORMATION

What is in this medicine:

Each tablet contains 250 mg of the active ingredient terbinafine as terbinafine hydrochloride.

The other ingredients are magnesium stearate, silica colloidal anhydrous, croscarmellose sodium, hypromellose and microcrystalline cellulose.

What this medicine looks like and contents of the pack:

Terbinafine Tablets are white, round, flat tablets, scored on both sides, marked "T" above and "1" below the score on one side.

They are supplied in blister packs of 14 and 28 tablets.

Marketing Authorisation Holder:

Strandhaven Limited T/ASomex Pharma, High Road, Seven Kings, Ilford, Essex, IG3 8BS, UK

Manufacturer:

Somex Pharma, High Road, Ilford, Essex IG3 8RA, UK

Leaflet last approved: August 2008

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PENC658/C