Patient leaflet - PIZOTIFEN 0.5 MG TABLETS
hat Pizotifen is and what it is used for
2. What you need to know before you take Pizotifen
3. How to take Pizotifen
4. Possible side effects
5. How to store Pizotifen
6. Contents of the pack and other information
1. what pizotifen is and what it is used for
Pizotifen tablets are available in two different strengths containing either 0.5 mg or 1.5 mg of the active ingredient, pizotifen
Pizotifen tablets are a migraine treatment. They may help to stop the effects of certain naturally occurring substances in your body called “serotonin”, “histamine” and “tryptamine” which are involved in causing some kinds of headache, including migraine.
Pizotifen Tablets have been prescribed for you by your doctor to help your migraine type headaches. If they are taken regularly they can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Pizotifen Tablets can stop some migraine attacks starting and help make other attacks less severe. They will not stop migraine attacks once they have started.
2. what you need to know before you take pizotifen
Do not take Pizotifen and tell your doctor if:
- you think you may be allergic to Pizotifen or any of the other ingredients of Pizotifen tablets. (These are listed in section 6 of this leaflet).
Pizotifen tablets should not be given to children aged under 2.
You should also ask yourself these questions before taking Pizotifen Tablets:
- Do you have glaucoma (raised pressure in your eyes)?
- Do you ever have problems passing urine?
- Do you have kidney problems, especially kidney failure? (The medical term for this is renal failure.)
- Do you have liver problems? Pizotifen has been associated with abnormal results of liver function tests and possibly liver problems in a few patients. You may not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness, tell your doctor straightaway. Your doctor may request blood tests to check and to monitor your liver function and may request that you stop the treatment if your liver problem is serious.
- Do you have epilepsy?
- Are you pregnant?
If the answer to any of these questions is YES, tell your doctor or pharmacist because Pizotifen Tablets might not be the right medicine for you.
Other medicines and Pizotifen
- Remind your doctor if you are taking drugs called alpha- or beta- blockers because Pizotifen tablets may affect the way they work.
- Anything that makes you sleepy may make you even sleepier if you are taking Pizotifen tablets as well. This includes sleeping pills, sedatives and antihistamines such as cold and hayfever medicines. It also includes alcohol. It is best not to drink alcohol while you are taking Pizotifen tablets.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription.
Pizotifen with food, drink and alcohol
AVOID ALCOHOL whilst taking Pizotifen. This is because taking Pizotifen may make you drowsy and less alert than normal, and alcohol will increase these effects.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some people may feel drowsy and/or dizzy while they are taking Pizotifen tablets. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until such problems clear. Make sure you are not affected before you attempt to drive or use any tools or machines.
Pizotifen tablets contain lactose
This medicine contains lactose (a type of sugar). If you have been told that you cannot digest or are intolerant to some sugars, talk to your doctor before taking this medicine.
3. how to take pizotifen
The doctor will decide what dose of Pizotifen Tablets you should take. Always take Pizotifen tablets exactly as your doctor has told you. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor.
With Pizotifen Tablets, you do not wait for a migraine and then treat the pain. You take it regularly to stop your migraines even beginning or to make them less severe.
Adults
- The usual dose is 1.5 mg of pizotifen each day.
This is one 1.5 mg tablet or three 0.5 mg tablets. You may have been told to take your tablets once a day or as three smaller doses.
- Do not take more than 3 mg given as a single dose (two 1.5 mg tablets or six 0.5 mg tablets). Do not take more than 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets) in a day.
Children (aged over 2 years)
- Children can take up to 1.5 mg of pizotifen each day. This is three 0.5 mg tablets. This is usually best given in two or three smaller doses.
- Do not use the 1.5 mg tablets for children. Do not give them more than 1 mg in a single dose. This is two 0.5 mg tablets
Pizotifen Tablets should not be given to children under 2 years of age.
Taking Pizotifen Tablets
- Swallow the tablets whole. Have a drink with them if this helps you to swallow.
- If you take Pizotifen Tablets once a day, take them in the evening a few hours before you go to bed as any drowsiness will help you to sleep.
- If you take your tablets in two or three doses, spread them evenly through the day.
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 forget to take Pizotifen
If you forget to take your tablets, do not worry. If you normally take Pizotifen Tablets several times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not take double doses or take more than your maximum daily dose.
If you normally take one tablet each day take the dose as soon as you remember. Take your next dose as usual. Do not take more than your maximum daily dose.
Tell your doctor if you keep forgetting to take your tablets.
If you take more Pizotifen than you should
All tablets can be risky if you take too many. If you take too many Pizotifen Tablets at once, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.
If you stop taking Pizotifen
Do not change or stop the treatment without first asking your doctor. Your doctor may want you to reduce the dosage gradually before stopping completely. This is to prevent any worsening of your condition and reduce the risk of withdrawal symptoms such as depression, trembling, nausea, anxiety, generally feeling unwell, dizziness, sleep disorder and weight loss.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Pizotifen 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.
- Hepatitis.
Rare: may affect up to 1 in 1,000 people:
Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbance anxiety, tingling or numbness of the hands or feet, muscle and joint pain.
Very rare: may affect up to 1 in 10,000 people:
Convulsions (fits).
Tell your doctor immediately if you have a fit.
Not known: Frequency cannot be estimated from the available data:
If you have signs of yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea, vomiting and tiredness (signs of jaundice). Muscle cramps.
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
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 the Yellow card scheme at: or search for MHRA Yellow Card Google play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store pizotifen
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not use these tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.
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. contents of the pack and other information
What Pizotifen tablets contain
The active ingredient in these tablets is Pizotifen. Each tablet contains either 0.725 mg or 2.175 mg of the ingredient Pizotifen malate, which is equivalent to 0.5 mg and 1.5 mg of Pizotifen. The other ingredients are lactose monohydrate, cellulose microcrystalline, maize starch, povidone K30, magnesium stearate, silicon dioxide, hypromellose, macrogol, talc, titanium dioxide (E171).
What Pizotifen tablets look like and contents of the pack
Pizotifen 0.5 mg tablets are white, round, flat, film-coated tablets, marked MP84 on one side.
Pizotifen 1.5 mg tablets are white, round, flat, film-coated tablets, marked MP85 on one side.
Both strengths of Pizotifen tablets come in blister packs of 28, 30, 56, 60, 84, 90, 112 and 120 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited, 41–43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus
Manufacturer
Edmond Pharma S.R.L.,
Via dei Giovi 131,
Paderno Dugnano, Italy
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 08/2020
GE0046–0047/O/PIL/GE2