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PATIENT INFORMATION LEAFLET

In this leaflet:

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

2.    Before you take Sumatriptan Tablets

3.    How to take Sumatriptan Tablets

4.    Possible side effects

5 Storing Sumatriptan Tablets

The name of your medicine is

Sumatriptan 50mg Tablets Sumatriptan 100mg Tablets

-    Each tablet contains either 50mg or 100mg sumatriptan (as the succinate)

-    The other ingredients are lactose monohydrate, croscarmellose sodium, anhydrous lactose, microcrystalline cellulose, magnesium stearate, mannitol, titanium dioxide E171, talc, triacetin.

| i | Marketing Authorisation Holder

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.

Manufacturer

Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.

Sumatriptan Tablets have been developed for the treatment of migraine. The symptoms of migraine, which are thought to be due to temporary swelling of blood vessels in the head, may include aura (warning sensations of visual distortion such as flashes of light and zigzag lines or waves). Medicines like Sumatriptan Tablets are believed to work by reducing the size of these blood vessels. These medicines are called 5HT1 receptor agonists.

If you are not sure why Sumatriptan Tablets have been prescribed for you ask your doctor.

The following pack sizes are available 2, 3, 6, 7, 12, 14, 18, 21, 24, 28, 30, 50, 100, 250, 500 or 1000

Tablets. (* only the marketed pack sizes will be stated on the printed leaflets)

m 2. BEFORE YOU TAKE SUMATRIPTAN TABLETS

Do not take Sumatriptan Tablets if you:

• are allergic to sumatriptan or any of the other ingredients in Sumatriptan Tablets. You may be allergic if after taking sumatriptan, you suddenly experience feelings of tightness in the throat or chest, swelling of the tongue, lips or eyelids, difficulty in breathing or swallowing, a widespread feeling of warmth, flushing or itching of the skin and/or a rash like ‘hives’, progressing to feeling faint or loss of

consciousness. Should any of these occur, stop taking the sumatriptan tablets and get medical assistance immediately

•    have had a heart attack or suffer from any heart disease

•    have symptoms that might indicate heart disease, such as chest pain or a sensation of pressure or tightness in your chest

•    have high blood pressure, or if your blood pressure is high despite medication

•    have poor blood circulation in your legs that causes cramp-like pain when you walk too far (peripheral vascular disease)

•    have a history of stroke or transient ischaemic attack (TIA, a minor form of stroke that lasts less than 24 hrs).

•    have severe liver problems

•    are taking any medicines for your migraine which contain ergotamine or ergotamine derivatives, such as ergotamine tartrate or any other triptan/5-HT1 receptor agonist, or methysergide maleate. You should stop taking the above at least 24 hours before taking Sumatriptan Tablets. You should also wait at least 6 hours after taking Sumatriptam Tablets before taking an ergotamine-containing product or at least 24 hours before taking a triptan/5_HT1 receptor agonist.

•    are taking any medicines on a doctor’s prescription for the treatment of depression such as lithium, monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) (including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or if you have taken an MAOI in the last 2 weeks

If you think you may have any of these problems contact your doctor before taking sumatriptan.

Before prescribing sumatriptan, your doctor will establish whether your headache is caused by migraine

and not by any other condition.

Take special care with Sumatriptan Tablets:

You should tell your doctor before starting sumatriptan if any of these apply to you:

•    if you know that you have problems with your liver or kidneys;

•    if you have been diagnosed with epilepsy or any other disease that reduces the threshold for epileptic fits;

•    if you know that you are allergic to antibacterial medicines that belong to the group of sulphonamides;

•    if you are being treated for high blood pressure as in a small number of cases sumatriptan has been seen to increase blood pressure;

•    if you experience pain and/or tightness in the chest or throat. These effects are usually short lasting. If they however persist and you are concerned, or they become severe, contact your doctor immediately for advice;

•    if you experience chronic daily headaches. Taking sumatriptan too often may result in developing a chronic headache. In such cases you should contact your doctor as you may have to stop taking sumatriptan;

•    if you are considered to be at risk of developing heart disease (e.g. diabetic or a heavy smoker), and particularly if you are a post-menopausal woman or a man over 40 years with these risk factors, your doctor should check your heart function before prescribing sumatriptan. In very rare cases serious heart conditions have occurred after taking sumatriptan, even if no signs of any heart disease were found. Contact your doctor for advice if you have any concerns.

Taking other medicines:

Certain medicines may influence the effectiveness of sumatriptan, and sumatriptan may influence the effectiveness of other medicines. Contact your doctor if you take:

•    other medicines for migraine, such as ergotamine or similar medicines such as other triptan/5-HT1 receptor agonists,

•    medicines to treat depression (MAO inhibitors, serotonin re-uptake inhibitors, serotonin noradrenaline reuptake inhibitors);

•    medicines to treat manic/depressive (bipolar) disorders, such as lithium.

During concomitant use of sumatriptan and herbal preparations containing St. John’s Wort (Hypericum perforatum) side effects may become more common

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

Sumatriptan Tablets should not be taken if you are pregnant, likely to become pregnant or if you are breast-feeding, unless advised to do so by your doctor. Breastfeeding should be avoided for 12 hours after a dose and during this time any breast milk expressed should be discarded.

Driving and using machines:

Sumatriptan Tablets may cause drowsiness. If you are affected do not drive or operate machinery.

Sugar intolerance

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE SUMATRIPTAN TABLETS

Always take Sumatriptan Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

ONE tablet should be taken at the first sign of a migraine attack, although it will still be effective if taken at a later stage. If this tablet does not make your migraine better do not take any more tablets for this attack because it is unlikely that a second dose will work. Sumatriptan Tablets can be used for your next attack.

If, after your first dose, your migraine goes away but then returns, you may take another tablet, provided it is at least two hours since you took the first tablet.

DO NOT TAKE MORE THAN 300 mg of Sumatriptan in any 24-hour period. Swallow each tablet whole with water. Do not chew or crush them.

Sumatriptan Tablets should not be used in children under 18 years of age, as the safety and effectiveness of this medicine in children has not been established.

There is little experience of Sumatriptan Tablets in those over 65 years of age so it is not usually prescribed for this age group.

If you have the impression that the effect of Sumatriptan Tablets is too strong or too weak, talk to your doctor or pharmacist.

How quickly will the treatment start to work?

It takes Sumatriptan Tablets about 30 minutes to start working. If the tablets do not ease your migraine, then you may take your usual ‘pain killers’, provided they do not contain ergotamine or its derivatives. Wait at least six hours after taking a Sumatriptan tablet before taking any medicines containing ergotamine or its derivatives.

If you take more Sumatriptan Tablets than you should:

It is important to keep to the dose on the label or follow the instructions above. Taking more than this could make you ill. If an overdose is taken, DO NOT DELAY, ask your doctor what to do or contact your nearest accident and emergency department.

m 4. POSSIBLE SIDE EFFECTS

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

Stop taking Sumatriptan Tablets and seek medical advice immediately if you notice any of the

following serious side effects:

•    Sudden wheeziness, fluttering or tightness in the chest, swelling of eyelids, face or lips, skin rash - red spots or hives (skin lumps), which may be signs of an allergic reaction

•    Heart attack (myocardial infarction)

•    Severe suffocating pain radiating from the chest down the left arm (angina)

•    Pain in the centre of the chest caused by a narrowing of the blood vessels that supply the heart (coronary artery spasm)

•    There have rare reports describing patients with serotonin syndrome: Symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common side effects (occurs in less than 1 in 10 users):

•    Tingling, dizziness, and drowsiness (IMPORTANT if you are driving or working a machine)

•    Sensory disturbances including pins and needles’ / tingling (paraesthesia), and reduced sense of touch (hypoaesthesia)

•    Short lasting increases in blood pressure soon after taking the medicine

•    Flushing (redness of the face lasting a few minutes),

•    Dyspnoea (difficulty breathing)

•    Feeling sick (nausea) or being sick (vomiting) - when not part of migraine attack

•    Sensations of heaviness (usually short-term and may be intense and can affect any part of the body including the chest and throat)

•    Muscle pain (myalgia)

•    Pain, sensations of heat or cold, pressure or tightness (these events are usually short-term and may be intense and can affect any part of the body including the chest and throat);

•    Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and short-term).

Very rare side effects (occurs in less than 1 in 10,000 users):

•    If you have a blood test to check how your liver is working and have taken Sumatriptan tablets, tell your doctor as it may affect the results.

The following side effects, frequency is not known:

•    Fits (usually in people with a history of epilepsy)

•    Shaking, tremors or uncontrolled movements

•    Visual disturbances including uncontrolled eye movements (nystagmus), blind spot (scotoma), flickering, double vision and reduced vision. There have been cases where permanent vision defects have occurred

•    Slowing or quickening in the speed of your heart beat, palpitations (feeling of fast heart beat), changes in heart rhythm

•    Lowering of blood pressure that can lead to feeling of faintness especially on standing up

•    Raynaud's phenomenon (a painful condition causing the fingers or toes to turn white, then blue and red)

•    Inflammation of the colon (part of the intestine), which may present as lower left-sided abdominal pain and/or bloody diarrhoea

•    Diarrhoea

•    Stiffness in the neck

•    Joint pain (arthralgia)

•    Generalised fear / worry (anxiety)

•    Excessive sweating (hyperhidrosis)

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. STORING SUMATRIPTAN TABLETS

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions. Do not use after the expiry date stated on the label.

This leaflet was last revised on March 2013

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