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PIZOTIFEN 1.5 MG TABLETS

Active substance(s): PIZOTIFEN HYDROGEN MALATE

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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.
• 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 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 prevent some 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 if you 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.

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, or you 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
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.

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

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.

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

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.

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 if you 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:

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. HOW TO STORE PIZOTIFEN 0.5 MG & 1.5 MG 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 25ºC.
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,
hydroxypropylmethylcellulose, 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, ask your 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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