Patient Information Leaflet    GBR 726-6729-APIL

Pizotifen 0.5 mg Tablets Pizotifen 1.5 mg Tablets

Pizotifen

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

•    Please keep this leaflet. You may need to read it again.

•    Ifyou have any further questions, askyour doctor or pharmacist.

•    This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Pizotifen 0.5 mg & 1.5 mg Tablets are and what they are used for

2.    Before you take Pizotifen 0.5 mg & 1.5 mg Tablets

3.    How to take Pizotifen 0.5 mg & 1.5 mg Tablets

4.    Possible side effects

5.    How to store Pizotifen 0.5 mg & 1.5 mg Tablets

6.    Further information

1.    WHAT PIZOTIFEN 0.5 MG & 1.5 MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Pizotifen 0.5 mg or 1.5 mg Tablets. The active ingredient is pizotifen hydrogen malate. Pizotifen belongs to a group of medicines called anti-migraines. Pizotifen is used to help block the actions of certain chemicals in the blood such as serotonin, histamine and tryptamine. These chemicals act on the blood vessels in the brain and are involved in causing types of headache, such as migraine.

If Pizotifen 0.5 mg or 1.5 mg Tablets are taken regularly, they can help reduce the number and severity of headaches including the pain of cluster headaches and both common and classical migraine.

Pizotifen can also preventsome migraine attacks starting and helps make other attacks less severe but it should not be taken to relieve an attack once it has started.

2.    BEFORE YOU TAKE PIZOTIFEN 0.5 MG & 1.5 MG TABLETS

Do not take this medicine if:

•    you have ever had an allergic reaction to any of the ingredients of Pizotifen Tablets or any other medicines that you may have taken to treat headaches.

•    Pizotifen is not recommended for children under 7 years of age.

Take special care with this medicine and tell your doctor or pharmacist if:

•    you suffer from kidney problems;

•    you are pregnant, trying to become pregnant or breast-feeding;

•    you have difficulty passing water;

•    you suffer with glaucoma (raised pressure in the eyes);

•    you suffer from epilepsy (fits).

Taking other medicines

Tell your doctor ifyou are taking any other medicines, especially the following:

•    medicines for depression, e.g. monoamine oxidase inhibitors;

•    medicines to treat anxiety or sleep disorders, e.g. tranquillisers and hypnotics;

•    medicines for high blood pressure, e.g. anti-hypertensives;

•    medicines to treat allergic reactions, e.g. anti-histamines;

•    medicines to treat a cold.

It is advisable not to drink alcohol while you are taking this medicine as it may make you sleepy.

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

Pregnancy and breast-feeding

Tell your doctor before you take this medicine ifyou are pregnant, planning to become pregnant or if you are breast-feeding.

Driving and using machines

Some people may feel dizzy or drowsy while they are taking this medicine. If you find that you do get dizzy or drowsy, do not drive or operate machinery.

Important information about some of the ingredients of Pizotifen Tablets.

Tell your doctor before taking this medicine ifyou have been told that you have an intolerance to some sugars as these tablets contain lactose, a type of sugar.

3. HOW TO TAKE PIZOTIFEN 0.5 MG & 1.5 MG TABLETS

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablet should be swallowed with water.

Do not wait for a migraine, before taking this medicine to treat the pain. Take Pizotifen 0.5 mg or 1.5 mg Tablets regularly to prevent a migraine or reduce the severity of the migraine.

The usual doses of Pizotifen 0.5 mg or 1.5 mg Tablets are as follows:

Adults

1.5 mg daily (one 1.5 mg tablet at night or 0.5 mg tablets three times daily). Your doctor may increase the number of tablets you take up to a maximum of 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets) if required. You may have been told to take your tablets daily as a single dose or you may have to take three smaller doses.

Do not take more than 3 mg in a single dose.

Do not exceed the maximum daily dose of 4.5 mg.

Children

For children over 7 years of age, at first this may be 0.5 mg daily. This may be taken at night. The dose can be gradually increased to a maximum dose of 1.5 mg daily (three 0.5 mg tablets). This is usually best given in two or three smaller doses.

The maximum single dose is 1 mg (two 0.5 mg tablets).

DO NOT give your child Pizotifen 1.5 mg Tablets.

Carry on taking your Pizotifen Tablets even when you feel well. Your headaches may come back if you stop taking them. Do not stop taking them suddenly, oryou may experience withdrawal symptoms, such as feeling anxious, shaking, insomnia, feeling sick and blackouts. Talk to your doctor if you want to stop taking your tablets.

If you take more tablets than you should

Ifyou accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department immediately. Take your medicine with you.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pizotifen 0.5 mg & 1.5 mg Tablets can cause side effects, although not everybody gets them. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    Itching or skin rashes;

•    swelling of the face, lips or throat;

•    difficulty in breathing or wheeziness.

These symptoms could indicate you are experiencing an allergic reaction. Stop taking the tablets and go to your doctor immediately.

The most common side effects include:

•    Feeling drowsy (although this may be avoided by taking the tablets at night);

•    Increased appetite with or without increase in weight;

•    Feeling dizzy;

•    Nausea (feeling sick);

•    Dry mouth;

•    Feeling tired.

Uncommon side effects include:

•    Constipation.

If you notice any side effects mentioned above, please tell your doctor or pharmacist.

Other rare side effects may include:

•    Difficulty in sleeping;

•    Feeling depressed, anxious or aggressive;

•    Seeing things (hallucinations);

•    Pins and Needles;

•    Restlessness or excitability (in children);

•    Muscle or joint pains.

Very rarely the following may occur:

•    Fits (seizures).

If any of the side effects becomes severe or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

5.    HOWTO STORE PIZOTIFEN 0.5 MG & 1.5 MG TABLETS

Do not use afterthe expiry date that is stated on the carton or label. Store the tablets in the original package. Do not store above 25“C.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Pizotifen 0.5 mg & 1.5 mg Tablets contain:

The tablets are available in two different strengths containing either 0.5 mg or 1.5 mg of the active substance Pizotifen (as the hydrogen malate).

The other ingredients are lactose, microcrystalline cellulose, maize starch, povidone, magnesium stearate, silicon dioxide, hy d roxyp ro py I m e thyl ce 11 u I os e, polyethylene glycol, talc and titanium dioxide.

What Pizotifen 0.5mg & 1.5 mg Tablets look like and the contents of the pack

Pizotifen 0.5 mg Tablets are white, film-coated, approximately 6mm in diameter, embossed with ‘PZ’ on one side.

Pizotifen 1.5 mg Tablets are white, film-coated, approximately 9mm in diameter, embossed with ‘PZ 1.5' on one side.

They are packed in foil blister packs and are available in cartons of 28,56 or 60 tablets.

Marketing Authorisation Holder and Manufacturer

Waymade PLC trading as Sovereign Medical,

Sovereign House, Miles Gray Road, Basildon,

Essex, SS14 3FR

This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, askyour doctor or pharmacist.

The information in this leaflet applies only to Pizotifen 0.5 mg & 1.5 mg Tablets.

Date of preparation of the leaflet: February 2010