Patient Information Leaflet Sumatriptan 50 mg Tablets Sumatriptan 100 mg Tablets

(sumatriptan succinate)

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, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally.

Do not give it to anyone else. It may harm them, even if their symptoms are the same as yours.

IN THIS LEAFLET:

1.    What Sumatriptan tablets are and what it is used for

2.    Before you take Sumatriptan tablets

3.    How to take Sumatriptan tablets

4.    Possible side effects

5.    Storing Sumatriptan tablets

YOUR MEDICINE

Sumatriptan is available in two strengths containing either 50 mg or 100 mg of the active ingredient sumatriptan (as the succinate). The other ingredients are lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc,colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide (El 71), cochineal red (El 24 — 50 mg tablets only) and triethyl citrate.

The 50 mg film coated tablets are light pink in colour, oblong, biconvex, tablets with a scoreline.

The 100 mg film coated tablets are white in colour, oblong, biconvex tablets.

Sumatriptan 50 mg and 100 mg tablets are available in blister packs of 1,2,3,4,6,12,18 or 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation holder:

Consilient Health Ltd., 5th floor. Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland Manufacturer:

Z.F. Polpharma SA,

ul. Pelplinska 19,83-200 Starogard Gdanski, Poland. Distributor:

Consilient Health (UK) Ltd.,

500 Chiswick High Road, London W4 5RG.

Your medicine comes as a tablet containing sumatriptan. Sumatriptan tablets are 5HTi agonists. Sumatriptan is an antimigraine medicine used to treat migraine attacks. A migraine causes attacks of headache, sometimes with sickness or other symptoms e.g. some people become sensitive to light or noise.

Sumatriptan should not be used where migraine has not been diagnosed.

Do not take this medicine and tell your doctor if:

•    you are allergic to sumatriptan or any other ingredients in this tablet, especially El 24 in the 50 mg tablet, which may cause allergic reactions.

•    you have an intolerance to some sugars as this medicine contains lactose.

•    you have heart problems such as heart disease or angina.

•    you have had a heart attack or stroke in the past.

•    you have severe liver problems.

•    your blood pressure is not controlled or you are being treated for high blood pressure (hypertension).

•    you are already taking medicines containing ergotamine or methysergide (to treat migraine).

•    you are already taking medicine to treat mental illness e.g.an MAOI (monoamine oxidase inhibitor), lithium or an antidepressant.

•    you have stopped MAOI treatment in the last 2 weeks.

•    you are pregnant, or likely to become pregnant, or are breast-feeding.

You must tell your doctor before taking Sumatriptan if:

•    you have liver or kidney problems or,

•    you have hardened arteries or are at risk from blood clots.

•    you are taking anysulphonamides.

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

Driving and using machines

Sumatriptan may make you feel drowsy.

Do not drive or operate machinery if you feel drowsy.

■    Take Sumatriptan as soon as possible after the start of the migraine attack

■    Swallow the tablet whole with a glass of water. Adults

Take one 50 mg tablet.

In some cases,a 100 mg dose may be needed.

If the first dose did help but the headache returned, you can take a second dose after two hours.

Do not take a second dose if the first dose had no effect. The maximum dose is 300 mg of Sumatriptan in 24 hours.

If Sumatriptan has no effect after the first dose, a painkiller such as aspirin or a nonsteroidal antiinflammatory drug (NSAID) e.g. ibuprofen, may be taken instead.

Patients with liver problems should be given a lower dose.

Children (under 18 years):

Sumatriptan should not be given to children.

Elderly patients (over 65 years):

Sumatriptan is not recommended.

If you take too much of your medicine contact your doctor or local hospital immediately. Take the pack and any remaining tablets with you.

Like most medicines,Sumatriptan can sometimes cause side effects. Some patients when they first take Sumatriptan suffer from pain, tingling, warmth, redness, heaviness, pressure or tightness which can affect any part of the body including the throat and chest.

Also patients may feel flushed, dizzy, notice numbness in fingers and toes, or feel weak, but these effects should pass. Other effects include feeling unusually tired or drowsy, a rise in blood pressure and sometimes changes to liver function tests. You may also feel or be sick, but this may not be caused by Sumatriptan.

Other effects include an irregular heart rhythm or chest pain (which may be severe). These effects may be serious, tell your doctor straight away if they happen to you. Rarely patients may suffer from fits but these are more likely in patients prone to fits.

If you suffer from any of the above or any other side effect not mentioned in this leaflet, please tell your pharmacist or doctor.

Keep Sumatriptan tablets out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not take this medicine after the expiry date shown on the carton.

Date of leaflet preparation: April 2006

Sumatriptan 50mg Tablets - PL 24837/0001 Sumatriptan 10Omg Tablets - PL 24837/0002 P0012