PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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

In this leaflet:

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

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

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

4.    Possible side effects

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

6.    Further information

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

The name of your medicine is Pizotifen 0.5mg or 1.5mg 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 0.5mg or 1.5mg 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 prevent some migraine attacks starting and helps make other attacks less severe.

Pizotifen does not help to relieve a migraine attack once it has started

2.    BEFORE YOU TAKE PIZOTIFEN 0.5MG & 1.5MG 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

•    you are pregnant, or if you are breast feeding an infant Pizotifen must not be given to children under the age of 2 years

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, or have suffered, from epilepsy

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Pizotifen Tablets contain lactose, a type of sugar.

Taking other medicines

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

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

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

•    medicines to treat a cold

•    medicines called alpha- or beta- blockers

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 if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant or if you are breast-feeding.

Driving and using machines

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

3.    HOW TO TAKE PIZOTIFEN 0.5MG & 1.5MG 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 0.5mg or 1.5mg Tablets regularly to prevent a migraine or reduce the severity of the migraine.

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

Adults

1.5mg daily (one 1.5mg tablet at night or 0.5mg tablets three times daily). Your doctor may increase the number of tablets you take up to a maximum of 4.5mg (three 1.5mg tablets or nine 0.5mg 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 3mg in a single dose.

Do not exceed the maximum daily dose of 4.5mg.

Children

For children over 2 years of age, at first this may be 0.5mg daily. This may be taken at night. The dose can be gradually increased to a maximum dose of 1.5mg daily (three 0.5mg tablets).

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

DO NOT give your child Pizotifen 1.5mg Tablets.

If you take more tablets than you should

If you 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

Pizotifen 0.5mg & 1.5mg Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

Some side effects can be serious. Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

• Symptoms of allergy such as a rash, itching or hives on the skin or swelling of the face.

The side effects listed below have also been reported:

More than 1 in 10 people have experienced:

Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight.

If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods.

Your doctor can give you advice about diet as some kinds of foods are known to trigger migraine.

Up to 1 in 10 people have experienced:

Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you can take the tablets in the evening. The effect of making you drowsy will help you to sleep.

You are less likely to feel drowsy after a few weeks, as you get used to the tablets.

Up to 1 in 100 people have experienced:

Constipation.

Up to 1 in 1,000 people have experienced:

Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or joint pain.

Very rarely (less than 1 in 10,000) people have experienced:

Seizures (fits). Tell your doctor immediately if you have a fit.

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 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 PIZOTIFEN 0.5MG & 1.5MG TABLETS

Do not use after the expiry date that is stated on the carton or label.

Store the tablets in the original package. Do not store above 30°C

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Pizotifen 0.5mg & 1.5mg Tablets contain:

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

The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, povidone, magnesium stearate, silicon dioxide, hydroxypropylmethylcellulose, polyethylene glycol, talc and titanium dioxide.

What Pizotifen 0.5mg & 1.5mg Tablets look like and the contents of the pack Pizotifen 0.5mg Tablets are white, film coated, embossed with 'P' on one side.

Pizotifen 1.5mg Tablets are white, film coated, embossed with 'PZ' on one side.

They are packed in foil blister packs and are available in cartons of 28.

Marketing Authorisation Holder and Manufacturer

Edmond Pharma S.r.l. Strada Statale dei Giovi 131 20037 Paderno Dugnano (Mi) Italy Distributor

Genesis Pharmaceuticals Limited, 84 Pembroke Road, London, W8 6NX, United Kingdom

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

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

Date of preparation of the leaflet: March 2016

EP0001-0002/O/PIL/G1

Cod. 1800