Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pizotifen 0.5mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pizotifen malate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Pizotifen 0.5 mg or 1.5 mg Tablets (referred to as Pizotifen in this leaflet). Pizotifen contains the active ingredient pizotifen malate, which 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 is taken regularly, it 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.
What you need to know before you take it
e Pizotifen Do not take Pizotifen
- if you are allergic to Pizotifen or any of the other ingredients of this medicine (listed in section 6) or any other medicines that you may have taken to treat headaches.
- If you are taking monoamine oxidase inhibitors (MAOIs).
- Do not take Pizotifen to stop a migraine once one has started. Warnings and precautions Talk to your doctor or pharmacist before taking Pizotifen if you
- suffer from kidney problems;
- are pregnant, trying to become pregnant or breast-feeding;
- have difficulty passing water;
- suffer with glaucoma (raised pressure in the eyes);
- suffer from epilepsy (fits);
- have an intolerance to lactose. Children Pizotifen is not recommended for children under 2 years of age. Other medicines and Pizotifen Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any medicines obtained without a prescription, and herbal medicines.
This is especially important if you are taking:
- medicines for depression, e.g. monoamine oxidase inhibitors (MAOIs); patients taking MAOIs should not take Pizotifen.
- 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. Pizotifen and alcohol It is advisable not to drink alcohol while you are taking this medicine as it may make you sleepy. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. 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, as impaired alertness may put yourself or others at risk. Pizotifen contains lactose Pizotifen tablets contain lactose. If you have been told that you have an intolerance to some sugars, talk to your doctor before taking Pizotifen.
How to take it
Pizotifen Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor. 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. Do not wait for a migraine before taking this medicine to treat the pain. Take Pizotifen regularly to prevent a migraine or reduce the severity of the migraine. The recommended dose is Adults and the elderly 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 (two 1.5 mg tablets or six 0.5 mg tablets). Do not exceed the maximum daily dose of 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets). Use in children Pizotifen is not recommended for children under 2 years of age. For children over 2 years of age, at first, the dose 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. If you take more Pizotifen 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. Signs of an overdose include drowsiness, dizziness, confusion, fits or excitement (particularly in children), difficulty in breathing or controlling movements, fast heartbeat, low blood pressure, dry mouth, feeling or being sick, blueness of the skin, coma or respiratory paralysis. If you forget to take Pizotifen If you forget to take a dose, just take the next dose at the usual time. 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 a double dose to make up for the forgotten dose. Do not take more than your maximum daily dose. Tell your doctor if you keep forgetting to take your tablets. If you stop taking Pizotifen Carry on taking Pizotifen 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. 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects 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. These rare side effects (may affect up to 1 in 1,000 people) could indicate you are experiencing an allergic reaction. Stop taking the tablets and seek medical attention. Other side effects Very common side effects (may affect more than 1 in 10 people)
- Increased appetite with or without increase in weight Common side effects (may affect up to 1 in 10 people)
- Feeling drowsy (although this may be avoided by taking the tablets at night);
- Feeling dizzy;
- Nausea (feeling sick);
- Dry mouth;
- Feeling tired (fatigue). Uncommon side effects (may affect up to 1 in 100 people)
- Constipation. Rare side effects (may affect up to 1 in 1,000 people)
- Difficulty in sleeping; sleep disorders
- Feeling depressed, anxious or aggressive;
- Seeing things (hallucinations);
- Pins and needles;
- Restlessness or excitability (in children);
- Muscle or joint pains. Very rare side effects (may affect up to 1 in 10,000 people)
- Fits (seizures).
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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Pizotifen Keep out of the sight and reach of children. Do not use this medicine after the expiry date that is stated on the carton or blister after EXP. The expiry date refers to the last day of that month. Do not store above 25oC. Keep in the original package. 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.
Contents of the pack and other information
What Pizotifen contains Each Pizotifen 0.5 mg Tablet contains 0.5 mg of the active ingredient pizotifen (as the malate). Each Pizotifen 1.5 mg Tablet contains 1.5 mg of the active ingredient pizotifen (as the malate). The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, povidone, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, talc and titanium dioxide. What Pizotifen looks like and the contents of the pack Pizotifen 0.5 mg Tablets are white, round, film-coated, approximately 6mm in diameter, embossed with 'PZ' on one side. Pizotifen 1.5 mg Tablets are white, round, 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. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom Manufacturer Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom This leaflet was last revised in July 2024 PL 06464/1002 PL 06464/1003
Pizotifen 0.5 mg Tablets Pizotifen 1.5 mg Tablets
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
Frequently asked questions about Pizotifen 0.5mg Tablets
How do I take Pizotifen 0.5mg Tablets?
Pizotifen 0.5mg Tablets comes as tablet containing 0.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pizotifen 0.5mg Tablets?
The active substance in Pizotifen 0.5mg Tablets is pizotifen malate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pizotifen 0.5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pizotifen 0.5mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: pizotifen malate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia).
The International Classification of Headache Disorders 2nd edition (ICHD-II) are standard classifications of headache used by health professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache.
It is not effective in relieving migraine attacks once in progress.
4.2. Posology and method of administration
Dose:
Adults:
Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children and adolescents from 2 years of age:
Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
The elderly:
Clinical work with pizotifen has not shown that elderly patients require different dosages from younger patients.
Special populations:
Renal and hepatic impairment
Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2).
Method of Administration
For oral use.
4.3. Contraindications
Hypersensitivity to pizotifen or to any of the excipients (see section 6.1. List of excipients).
4.4. Special warnings and precautions for use
Hepatic injury has been reported, ranging from transaminase elevations to severe hepatitis. Pizotifen treatment should be discontinued if there is any clinical evidence of hepatic dysfunction during treatment and until the cause of the liver abnormality is determined.
Although the anticholinergic activity of pizotifen is relatively weak, caution is required in the presence of closed angle glaucoma and in patients with a predisposition to urinary retention. Dosage adjustment may be necessary in patients with kidney insufficiency.
Pizotifen should be used in caution in patients with a history of epilepsy.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Withdrawal symptoms like depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease have been reported following abrupt cessation of pizotifen, therefore gradual withdrawal is recommended.
4.5. Interaction with other medicinal products and other forms of interaction
The effect of alcohol may be enhanced. Pizotifen may increase and prolong drowsiness that occurs as an adverse effect of commonly used tranquillizers, hypnotics, antihistamines (including certain common cold preparations) and antidepressants. Pizotifen should not be used in patients receiving monoamine oxidase inhibitors (MAOIs). The hypotensive effect of adrenergic neurone blockers (antihypertensives) are antagonised by pizotifen.
Anticipated drug interactions to be considered
Pizotifen is extensively metabolized in the liver, primarily by N-glucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation can not be excluded.
4.6. Fertility, pregnancy and lactation
Pregnancy
Clinical data with pizotifen in pregnancy are very limited and should therefore only be prescribed or administered under compelling circumstances.
Breast-feeding
Although the concentration of pizotifen measured in the milk of treated mothers are not likely to affect breast-fed infants, its use in nursing mothers is not recommended.
Fertility
There were no fertility effects in a rat study with pizotifen hydrogen maleate.
4.7. Effects on ability to drive and use machines
Pizotifen may cause drowsiness, somnolence, dizziness and other CNS effects. Therefore, caution should be exercised when driving or using machines.
Patients being treated with pizotifen and presenting with drowsiness (including somnolence and fatigue) must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk.
4.8. Undesirable effects
The most common side-effects are appetite stimulating effects, increases in body weight and drowsiness (including somnolence and fatigue).
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1000, < 1/100); rare (≥1/10,000, < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Immune system disorders:
Rare: Hypersensitivity reactions, face oedema
Metabolism and nutrition disorders:
Very common: Appetite stimulating effect and increase in body weight.
Psychiatric disorders:
Rare: Depression, CNS stimulation (e.g. aggression, agitation, restlessness and excitability), hallucination, insomnia, anxiety.
Nervous system disorders:
Common: Drowsiness (including somnolence), dizziness.
Rare: Paraesthesia.
Very rare: Seizures.
Gastrointestinal disorders:
Common: Nausea, dry mouth.
Uncommon: Constipation.
Hepatobiliary disorders:
Unknown: Hepatic enzyme increased, jaundice, hepatitis*1
Skin and subcutaneous tissue disorders:
Rare: Urticaria, rash
Musculoskeletal and connective tissue disorders:
Rare: Myalgia, arthralgia.
Unknown: Muscle cramps*1
General disorders and administration site conditions:
Common: Fatigue.
*1 These adverse events were reported in patients treated with pizotifen based on post-marketing spontaneous reports.
Acute withdrawal reactions have been reported following abrupt cessation of Pizotifen therefore gradual withdrawal is recommended (see section 4.4 Special warnings and precautions for use). Withdrawal symptoms include depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Drowsiness, dizziness, pyrexia, hypotension, dryness of the mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, convulsions (particularly in children), coma and respiratory paralysis.
Treatment
Administration of activated charcoal is recommended; in case of very recent uptake, gastric lavage may be considered. Severe hypotension must be corrected (CAVE: adrenaline may produce paradoxical effects). If necessary, symptomatic treatment including monitoring of the cardiovascular and respiratory systems. Excitatory states or convulsions may be treated with short acting benzodiazepines.
💬 Ask about this leaflet
Ask anything about Pizotifen 0.5mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.