Terbinafine 250mg Tablets

Document: leaflet MAH GENERIC_PL 00289-0441 change

TEVA UK Ref: 231-30-62077-W LEA TERBINAFINE 250mg TAB TUK Version: 1 17 March 2015

REG0068810 Version 2.4 Approved Page 1 of 2

PAGE 1: FRONT FACE (INSIDE OF REEL)

TERBINAFINE 250 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 any further questions, 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,

INTHIS 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

OWHAT TERBINAFINE IS AND WHAT IT IS USED FOR

• Terbinafine belongs to a group of medicines called antifungals, 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 ofthe body (Tinea corporis)

• ringworm ofthe groin (Tinea cruris)

• a nail infection called onychomycosis, which causes thickening, roughening or splitting of the nails,

BEFORE YOU TAKE TERBINAFINE

Do NOT take Terbinafine if you:

• are allergic (hypersensitive) to terbinafine or any ofthe other ingredients of this medicine • are breast-feeding.

Take special care with Terbinafine

Talk to your doctor before you start to take this

medicine if you:

• have liver or kidney problems • suffer from psoriasis (patches of thickened or sore skin)

• suffer from lupus erythematosus (auto-immune disease which causes joint pain, skin rashes and fever). Taking other medicines

Talk to your doctor if you are taking any of the following:

• tricyclic antidepressants e.g. amitriptyline, desipramine

• selective serotonin reuptake inhibitors (SSRIs) e.g. fluvoxamine

• monoamine oxidase inhibitors (MAOIs) e.g. isoca rboxazid

• oral contraceptives, as breakthrough bleeding or irregular periods may occur • rifampicin or cimetidine, as the dosage of Terbinafine may need altering • beta blockers to treat high blood pressure or angina (chest pain)

• anti-arrhythmics (e.g, propafenone, amiodarone) for heart problems

• ciclosporin, a medicine used to control your body's immune system in order to prevent rejection of transplanted organs

• medicines used to treat fungal infections (e.g. fluconazole, ketoconazole)

• medicines used to treat cough (e.g. dextromethorphan)

• caffeine.

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

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 for advice before taking any medicine.

Driving and using machines

Some people have reported feeling dizzy or giddy

while they are taking Terbinafine, If you feel

like this you should not drive or operate machinery,

0 HOW TO TAKE TERBINAFINE

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

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

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 duration of treatments for specific infections are given below,

• Skin infections:

Athlete's foot: 2 to 6 weeks,

Ringworm of the body: 4 weeks.

Ringworm of the groin: 2 to 4 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.

Kidney problems:

Use of Terbinafine tablets is not recommended in patients with kidney problems (please see section 2 'Take special care with Terbinafine')

Liver problems:

Use of Terbinafine tablets is not recommended in patients with chronic or active liver disease, Children:

Terbinafine is not recommended for use in children,

If you take more Terbinafine than you should

If you (or someone else) swallow a lot ofthe tablets all together, or ifyou think a child has swallowed any ofthe tablets, contact your nearest hospital casualty department or you r 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.

Top of page cut-off to middle of registration mark: 21 mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)

62077-W

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,

If you stop taking Terbinafine

Do not stop taking your medicine without talking to

your doctor first even if you feel better.

If you have any further questions on the use of this product, askyour doctor or pharmacist,

POSSIBLE SIDE EFFECTS

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

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

• an allergic reaction (which may consist of swelling of the face, lips, neck, throat leading to severe difficulty in breathing; skin rash or hives)

• blisters/bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome)

• a severe blistering rash in which the surface layers of the skin may peel off to leave large areas of raw skin over the body,

These are very serious but rare side effects, You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you experience the following, as your doctor may decide it is necessary to stop your treatment:

• photosensitivity (usually a skin reaction resulting from exposure to sunlight)

• liver problems including jaundice (yellowing of the skin and the whites of the eyes)

• symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation)

• severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation)

• unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)

• weakness, unusual bleeding, bruising, abnormal pale skin, unusual tiredness, or weakness or breathlessness on exertion or frequent infections (this may be a sign of blood disorders).

These side effects may occur with certain frequencies, which are defined as follows:

Very common: affects more than 1 user in 10, Common: affects 1 to 10 users in 100,

Uncommon: affects 1 to 10 users in 1,000,

Rare: affects 1 to 10 users in 10,000,

Very rare: affects less than 1 user in 10,000

The side effects listed below have also been reported

Very common

Decreased appetite, headache, stomach problems such as loss of appetite, ache, indigestion/heartburn, feeling bloated or sick, diarrhoea, feeling sick, feeling of fullness, abdominal pain, joint or muscle pain (these may occur as part of a hypersensitivity reaction usually together with allergic skin reactions), Uncommon

Taste loss and taste disturbance, this usually disappears when you stop taking the medicine. However, a very small number of people, have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight.

Rare

Pins-and-needles, numbness or tingling, reduced sense of touch or sensation (hypoaesthesia), dizziness, a general feeling of being unwell, tiredness,

Very rare

Decrease in the number of some blood cells, You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual, Depression and anxiety, psoriasis like skin eruptions orworsening of any psoriasis, hair loss,,

The following have also been reported (Frequency not known)

Signs of blood disorders, symptoms you may feel are like weakness, unusual bleeding, bruising or frequent infections, Disorders of sense of smell, impaired hearing, hissing and/or ringing in the ears, inflammation of pancreas, flu like symptoms, increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test), weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist, 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, m h ra .gov. u k/ye I lowca rd By reporting side effects you can help provide more information on the safety of this medicine,

HOW TO STORE TERBINAFINE

Keep 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 that is stated on the outer packaging. The expiry date refers to the last day of that 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,

FURTHER INFORMATION

What Terbinafine tablets contain:

• The active ingredient is terbinafine hydrochloride, equivalent to 250 mg of terbinafine,

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

What Terbinafine tablets look like and contents of the pack:

• Terbinafine Tablets are white to off white, capsule shaped biconvex tablets, scored on one side and engraved "T" on each side of the score, and 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.

Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne, BN22 9AG,

This leaflet was last revised: February 2015 PL 00289/0441

This is a representation of an electronic record that was signed electronically and this

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V 1.3.2 mockup-pil-uk-pl-00289-0441-terbinafine-250mg-tablets

Approvals

Signed by	Meaning of Signature	Server Date
Aran Ramachandran	Regulatory Affairs Approval	22-Apr-2015 02:51:25 PM

REG0068810 Version 2.4 Approved Page 2 of 2