PACKAGE LEAFLET: INFORMATION FOR THE USER Terbinafine 250 mg Tablets

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

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

•    If you have further questions, please ask your doctor or pharmacist.

•    This 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.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Terbinafine is and what it is used for

2.    Before you take Terbinafine

3.    How to take Terbinafine

4.    Possible side effects

5.    How to store Terbinafine

6.    Further Information

1. What Terbinafine is and what it is used for

Terbinafine belongs to a group of medicines called antifungals which can be used to treat a range of fungal infections. These medicines work by attacking and killing fungal spores which cause certain types of infection.

Terbinafine is used to treat a range of fungal infections of the skin and nails:

athlete’s foot (tinea pedis)

ringworm of the body (tinea corporis)

ringworm of the groin (tinea cruris)

ringworm of the hand (tinea manuum)

a nail infection called onychomycosis, which causes thickening, roughening or splitting of finger and toe nails.

2. Before you take Terbinafine

Do not take Terbinafine

•    if you are allergic (hypersensitive) to the active substance terbinafine or any of the other

ingredients of this medicine.

•    if you are breast-feeding.

•    if you have severe liver problems.

•    if you have kidney problems.

Take special care with Terbinafine Talk to your doctor:

•    if you have liver or kidney problems.

•    if you have patches of thickened or sore skin (Psoriasis).

•    if you have pale patches of rash (Pityriasis versicolor).

•    if you have illness called lupus erythematosus (autoimmune disease)

Terbinafine may cause liver damage. Stop taking terbinafine immediately and go to your doctor or the nearest hospital if you feel the following signs of liver damage:

Sickness, poor appetite, tiredness, vomiting, pain in upper right part of your belly, yellowing of the skin or eyes (jaundice), dark urine or pale stool.

Children and adolescents

Terbinafine tablets are not recommended for use in children and adolescents.

Taking other medicines

Tell your doctor if you are taking any of the following medicines:

tricyclic antidepressants e.g. amitriptyline, desipramine selective serotonin reuptake inhibitors (SSRIs) e.g. fluvoxamine monoamine oxidase inhibitors (MAOIs) e.g. isocarboxazid

beta-blockers (used for treating, angina, high blood pressure and other heart problems), e.g. atenolol or antiarrhythmic drugs for heart problems (e.g amiodarone, propafenone) oral contraceptives, as breakthrough bleeding or irregular periods may occur rifampicin (antibiotic)

cimetidine (a stomach drug), since it might decrease the effect of terbinafine warfarin (blood thinner)

fluconazole, ketoconazole (drugs for fungal infections) caffeine

ciclosporine (a medicine used to control your body’s immune system in order to preven rejection of transplanted organs)

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription.

Taking Terbinafine with food

Your medicine can be taken with or without food as this does not affect its clinical effect.

Pregnancy and Breast-feeding:

Do not take Terbinafine if you are breast-feeding. Terbinafine is not recommended if you are pregnant or planning to become pregnant. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some people have reported feeling dizzy while they are taking terbinafine tablets. If you feel like this you should not drive or operate machinery.

3. How to take Terbinafine

Always take Terbinafine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a drink of water.

The usual dosage instructions are given below:

Adults (including the elderly):

The usual dose is one 250 mg tablet daily.

The length of your treatment will depend on the infection you have and how severe it is. The likely durations of treatments are given below.

Skin infections:

Athlete’s foot: Ringworm of the Ringworm of the Ringworm of the

	2 to 6 weeks.
body:	2 to 4 weeks.
groin:	2 to 4 weeks.
hand:	2 to 6 weeks.

Nail infections:

Treatment usually lasts between 6 weeks and 3 months.

Some patients with toenail infections may require treatment for 6 months or longer. Children and adolescents:

Terbenafine is not recommended for use in children and adolescents.

Patients with kidney problems

Terbinafine tablets are not recommended for use in patients with kidney problems.

Patients with liver problems

Terbinafine tablets are not recommended for use in patients with liver problems.

If you take more Terbinafine than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause headache, nausea (feeling sick), stomach pain and dizziness. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Terbinafine

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Terbinafine can cause side effects, although not everybody gets them.

If the following happens, stop taking tablets and tell you doctor immediately or go to the casualty department at your nearest hospital:

Rare (may affect up to 1 in 1 000 people)

• Itching, nausea, loss of appetite, tiredness, yellowing of the skin or eyes (jaundice), vomiting, belly pain, dark urine, or pale stools. These can be signs of liver failure.

Very rare (may affect up to 1 in 10 000 people)

•    Allergic condition which causes joint pain, skin rashes and fever (called lupus)

•    Blisters/bleeding of the lips, eyes, nose, mouth and genitals (called Stevens-Johnson syndrome and Toxic Epidermal Necrolysis)

•    Swelling of mouth and throat with breathing problems, swelling of hands and feet (angioedema)

•    Reduction in white blood cell count (agranulocytosis, neutropaenia), which increases risk of bacterial infection

•    Reduction in blood platelets (thrombocytopenia), which increases risk of bleeding or bruising

•    Reduction of all cells in blood count (pancytopenia), which makes you tired, bruising easily and prone to infections

•    Skin rash with blisters and fever

•    Erythema multiforme, a skin disease characterised by itchy pink-red blotches starting on your feet and hands

Not known (frequency cannot be estimated from the available data)

•    An allergic reaction (which may consist of swelling of the face, neck, hands, feet, lips, tongue or throat leading to difficulty in breathing or swallowing; skin rash or hives)

•    Photosensitivity (usual skin reaction resulting from exposure to sunlight)

•    Tiredness, pain in abdomen, joints or muscles caused by inflammation of the liver (hepatitis)

•    Fever with rash and swollen mouth, glands, joint and muscle pain (serum sickenss-like reaction)

•    Severe belly and back pain with feeling very unwell which can be symptoms of a state called pancreatitis

•    Obstruction to the normal flow of bile (cholestasis) which may cause jaundice (yellowing of the skin or whites of the eyes)

•    Muscle disorders such as pain, tenderness, weakness or cramps which can progress to a state called rhabdomyolysis (abnormal muscle breakdown which can lead to kidney problems)

•    Vasculitis (inflamed blood vessels which are red, swelled and hurt)

Other possible side effects:

In addition, the following side effects can be caused by terbinafine:

Very common (may affect more than 1 in 10 people)

Rash Hives

Indigestion/heartburn and a feeling of fullness Feeling sick (nausea)

Belly pain Diarrhoea Loss of appetite Joint and muscle pain

Common (may affect up to 1 in 10 people):

• Headache

Uncommon (may affect up to 1 in 100 people):

• Taste disturbances

Rare (may affect up to 1 in 1,000 people):

• Hepatic enzymes increased (which can be seen in blood tests)

Very rare (may affect up to 1 in 10,000 people):

•    Worsening of psoriasis (patches of thickened or sore skin)

•    Tingling or numbness in the hands and feet

•    Less sensitive to pain or touch

•    Dizziness

•    General feeling of being unwell

•    Hair loss

Not known (frequency cannot be estimated from the available data)

•    Anaemia

•    Feeling sad (depression)

•    Anxiety (worry)

•    Smell disturbances

•    Hearing problems

•    Tinnitus (ringing in the ears)

•    Flu symptoms (high fever, tiredness, muscle and joint pain)

•    Fever

•    Losing weight

•    Certain side effects can be seen in blood tests only like certain enzyme increased (creatinine phosphokinase)

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 at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE TERBINAFINE

Keep Terbinafine out of the reach and sight of children.

Store in the original package. Do not transfer to another container. Do not use Terbinafine after the expiry date shown on the outer packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Terbinafine contains

•    The active substance is terbinafine hydrochloride (283.1 mg), equivalent to 250 mg of terbinafine.

•    The other ingredients are microcrystalline cellulose, sodium starch glycollate (Type A), hypromellose, colloidal hydrated silica and magnesium stearate.

What Terbinafine looks like and contents of the pack:

•    Terbinafine Tablets are white to off white, capsule shaped biconvex tablets. Scored on one side and debossed "T” on each side of the score. Plain on the other side of the tablet.

•    The product is available in pack sizes* of 8, 14, 28, 30, 42, 50 and 56 tablets. Not all pack sizes may be marketed.

The Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in May 2014 PL 00289/0442