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PIZOTIFEN 1.5MG TABLETS BP

Active substance(s): PIZOTIFEN MALATE

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CXP092FUA

PATIENT INFORMATION LEAFLET
PIZOTIFEN 0.5 mg & 1.5 mg TABLETS BP
(pizotifen malate)

The name of this medicine is Pizotifen 0.5 mg & 1.5 mg Tablets BP, which will be referred to as
Pizotifen Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or your 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 gets serious, or if you notice any side effects not listed in the leaflet,
please tell your doctor or pharmacist. See section 4.
In this leaflet
1. What Pizotifen Tablets are and what they are used for
2. Before you take Pizotifen Tablets
3. How to take Pizotifen Tablets
4. Possible side effects
5. How to store Pizotifen Tablets
6. Further Information

1. WHAT PIZOTIFEN TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in this product is pizotifen malate, which is used to prevent migraine-type
headaches, including cluster headaches, common and classical migraine. These work by stopping
the effects of naturally occurring substances in the body which cause migraine-type headaches.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any of the following medicines, as
the effect of Pizotifen Tablets may be increased or decreased by other medicines and vice versa.
• sleeping tablets
• sedatives (medicines for anxiety and sleeping problems)
• antihistamines, including cold and hayfever remedies
It may still be alright for you to take Pizotifen Tablets and your doctor will be able to decide what is
suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking your medicine with food and drink
Do not drink alcohol whilst taking this medicine.
Pizotifen Tablets should be swallowed with a glass of water and can be taken with or without food.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant, think you might be pregnant, planning to become
pregnant or breast-feeding unless your doctor has told you to do so.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pizotifen Tablets may make you feel drowsy, dizzy or affect your concentration. Do not drive or
operate machines if you are affected.
Important information about some of the ingredients of Pizotifen Tablets
This product contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE PIZOTIFEN TABLETS
Always take Pizotifen Tablets exactly as your doctor has told you to do so. You should check with
your doctor or pharmacist if you are not sure.

2. BEFORE YOU TAKE PIZOTIFEN TABLETS

Dosage:

Do not take Pizotifen Tablets if you:
• are allergic (hypersensitive) to pizotifen malate, or any of the other ingredients in Pizotifen
Tablets (these are listed in section 6, Further Information)

The usual dosage for Pizotifen Tablets is:

Take special care with Pizotifen Tablets
Before you take Pizotifen Tablets you should tell your doctor if you:
• are pregnant, planning to become pregnant or suspect you are pregnant or breast-feeding
• have glaucoma (raised pressure in your eyes causing visual problems your field of vision will be
limited) – your doctor will tell you if you have this
• have problems in passing urine
• have kidney problems
• have epilepsy
• have an intolerance to some sugars

Adults and elderly patients
The usual starting dose is 1.5 mg daily. This may be taken as one 1.5 mg tablet at night or as
three divided doses of 0.5 mg tablets.
Do not take more than 3 mg (two 1.5 mg tablets or six 0.5 mg tablets) in a single dose.
Do not take more than 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets) in a day.
Children (aged 2 years and over)
The usual dose can be up to 1.5 mg daily. This must be given as two or three smaller doses. Do
not give children more than 1.0 mg in a single dose.
Special populations: Renal and hepatic impairment
Caution is required in patients with renal or hepatic impairment and dosage adjustment

may be necessary
Pizotifen Tablets are not recommended for children under 2 years.

Method of administration
Pizotifen Tablets should be swallowed with a glass of water. Keep taking the tablets until your
doctor tells you to stop.
If you take more Pizotifen Tablets than you should
If you have accidentally taken more than the recommended or prescribed dose, contact your
nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining tablets with you.
The most common signs of overdose are a fall in blood pressure (causing dizziness and lightheadedness), uncontrolled muscle movements, drowsiness, dry mouth, confusion, excitatory states
(particularly in children), nausea (feeling sick), shortness in breath and a blue skin colour, vomiting
(being sick), a forceful and rapid heart-beat, convulsions (particularly in children), coma and
sudden stoppage of breathing
If you forget to take Pizotifen Tablets
If you miss a dose do not worry. Take another as soon as you remember and then go on as
before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pizotifen Tablets
Do not stop taking Pizotifen Tablets even if your headaches stop, as they may come back if you
stop taking the tablets. If you stop taking Pizotifen Tablets suddenly you may experience
withdrawal symptoms. Your doctor will tell you how to reduce and then stop this medicine.
Withdrawal symptoms include anxiety, tremor (shakes), insomnia (difficulty sleeping), anxiety,
nausea (feeling sick) and loss of consciousness.
If you have any further questions about this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pizotifen Tablets can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking these tablets you should contact your
doctor or pharmacist immediately:
Rare (affecting 1 to 10 people in 10,000)
• any allergic reaction such as a rash, sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or throat
• urticaria (hives)
The following side effects have also been reported:
Very common (affecting more than 1 in 10 people):
• increased appetite, weight increase
Common (affecting 1 to 10 people in 100):
• drowsiness or a strong desire to sleep
• fatigue (tiredness)
• dizziness
• nausea (feeling sick)
• dry mouth
Uncommon (affecting 1 to 10 people in 1000)
• constipation

Rare (affecting 1 to 10 people in 10,000)
• Depression
• Restlessness (particularly in children)
• difficutly sleeping (insomnia)
• anxiety
• aggression
• agitation
• hallucinations (seeing, feeling and hearing things that are not there)
• ‘Pins and needles’ or a sensation of tingling and prickling of skin
• Muscle and joint pain
Very rare (affecting less than 1 person in 10,000)
• Seizures (fits)
Unknown:
Hepatic enzyme increased, jaundice, hepatitis
Muscle cramp
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 United Kingdom Yellow Card Scheme
Website: 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 TABLETS
Keep all medicines out of the sight and reach of children.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of
that month.
Do not store these tablets above 30ºC. Store in the original packaging. Keep in the outer carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Pizotifen Tablets contain:
The active ingredient is pizotifen malate. Each Pizotifen tablet contains 0.5 mg or 1.5 mg of
pizotifen as pizotifen malate. The other ingredients are: lactose monohydrate, microcrystalline
cellulose, maize starch, povidone K30, magnesium stearate, silicon dioxide, hypromellose, macrogol
6000, talc and E171
What Pizotifen Tablets look like and the contents of the pack:
Pizotifen Tablets are white, round convex film-coated tablets.
Pizotifen 0.5mg tablets are marked 'P' on one side and plain on the other.
Pizotifen 1.5mg tablets are marked 'PZ' on one side and plain on the other
Your medicine is available in packs of 28, 30, 56, 60, 84, 90, 112 and 120 (not all pack sizes may
be marketed).
Marketing Authorisation Holder
Fannin (UK) Limited, 42-46 Booth Drive, Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Unit 200, Westminster 42, Westminster Industrial Estate, Repton Road,
Measham, Swadlincote, DE12 7DT, U.K.
Kent Pharmaceuticals Limited, Joshna House, Crowbridge Road, Orbital Park, Ashford, Kent, TN24
0GR, U.K.
CXP092FUA
This leaflet was last approved in 10/2014

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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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