Medicines & treatments centre

PIZOTIFEN WARNINGS

Pizotifen should be used with caution in: patients with glaucoma (raised pressure in your eyes); patients with problems passing urine such as an enlarged prostate gland; patients with kidney problems; patients with liver problems; patients with a history of epilepsy; woman who are pregnant, or might be pregnant.

It should not be used in: patients who are allergic (hypersensitive) to pizotifen or any of the other ingredients, woman who are breast feeding; children under 2 years of age.

Also see list of precautions and interactions.

STORAGE

Do not store above 25°C. Protect from direct light.

PIZOTIFEN USES

What is it used for?

• Pizotifen is used to prevent headaches including migraines or cluster headaches.
• It is a member of a group of drugs called antihistamines or antiserotonin agents.
• In general this drug is used to prevent headaches such as classical migraine, common migraine and cluster headaches (periodic migrainous neuralgia) from starting or to make them less severe.
• Benefits of being on this drug can include stopping headaches from happening or to make them less severe if you do get one.

Listed below are the typical uses of pizotifen:

• Prevention of migraine type headaches, including classical migraine, common migraine and cluster headaches (periodic migrainous neuralgia).

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

How often do I take it?

• Take this medication by mouth usually once a day (or the dose can be split into 3 smaller doses) with water.
• Use this medication regularly in order to get the most benefit from it.
• Remember to use it at the same time each day - unless specifically told not to by your doctor.
• It may take up to few hours before the full benefit of this drug takes effect.
• Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

• Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

• Pizotifen may make you feel drowsy. If you are affected, do not drive or operate machinery. Consult your doctor or pharmacist for more details.

When can I stop?

• It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

PIZOTIFEN SIDE EFFECTS

• Increased appetite which may lead to weight gain
• Drowsiness,
• Sleepiness
• Dizziness
• Dry mouth
• Feeling sick
• Tiredness

If any of these persist or you consider them severe then inform your doctor or pharmacist.

Tell your doctor immediately if you develop any of the following symptoms: vision changes; confusion; stomach pain; swelling; mood changes; sexual function problems.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the UK you may report side-effects to the MHRA

PIZOTIFEN PRECAUTIONS

Before taking pizotifen, tell your doctor or pharmacist if you are allergic to it; or to other antiserotonin agents; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of: allergies (hypersensitive) to pizotifen or any of the other ingredients.

Before using this medication tell your doctor or pharmacist your medical history, especially any of the following: glaucoma (raised pressure in your eyes); problems passing urine such as an enlarged prostate gland; kidney problems; liver problems; history of epilepsy; woman who are pregnant, or might be pregnant or who are breastfeeding.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

• You are advised not to drink alcohol with pizotifen.

The elderly: clinical work with pizotifen has not shown elderly patients to require different dosages from younger patients; however caution is advised with elderly patients with liver and kidney problems.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

The safety of Pizotifen has not been established during pregnancy. Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Pizotifen is not safe to take if you are breastfeeding, as it passes into the breast-milk.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

PIZOTIFEN INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: none known

If you are currently using any such medicine, tell your doctor or pharmacist before starting Pizotifen.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

• Medicines to help you sleep or relax (e.g. nitrazepam, diazepam or amobarbital sodium)
• Antihistamines (including common cold preparations)
• Medicines to lower blood pressure (e.g. guanethidine)
• Medicines to treat depression, patients taking monoamine oxidase inhibitors (MAOIs)

This information does not contain all possible interactions. Therefore, before using Pizotifen, tell your doctor or pharmacist of all the products you use.

PIZOTIFEN OVERDOSE

Taking too much Pizotifen may cause the following: drowsiness; dizziness; confusion; fits or excitement (particularly in children); difficulty in breathing or controlling movements; fast heart beat; low blood pressure; dry mouth; feeling or being sick; blueness of the skin; coma; respiratory paralysis.

People who have taken too much Pizotifen, should contact your nearest hospital casualty department or tell your doctor immediately.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of Pizotifen or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on 0845 4647.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.