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Pizotifen oral

Updated 2 Feb 2023 | Pizotifen


Oral formulations containing pizotifen

Drugs List

  • pizotifen 1.5mg tablets
  • pizotifen 500microgram tablets
  • Therapeutic Indications


    Classical migraine: prophylaxis
    Cluster headache: prophylaxis
    Common migraine: prophylaxis
    Vascular headache: prophylaxis



    Usual dose: 1.5mg daily as a single dose taken at night or in three divided doses. Titrate according to individual response.
    Maximum dose: 4.5mg daily. The maximum single dose to be taken is 3mg.

    The following alternative dosing schedule may be suitable:
    Initial dose: 500micrograms at night. Gradually increase according to response.


    Pizotifen is available as a sugar-free oral solution for children, with the 500micrograms mg tablets as an alternative.
    The 1.5mg tablets are not recommended.

    Children aged 2 to 18 years
    Initial dose: 500micrograms at night. Gradually increase according to response.
    Maximum dose: 1.5mg daily, usually given in three divided doses. Maximum single dose 1 mg at night.


    Children under 2 years

    Precautions and Warnings

    Children aged 2 to 5 years
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of seizures
    History of urinary retention
    Lactose intolerance
    Narrow angle glaucoma
    Renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Not all available brands/formulations are licensed for use in children
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Not effective in relieving migraine attacks once in progress
    Avoid abrupt withdrawal
    Discontinue if symptoms of hepatic disease occur
    Advise patient that the effects of alcohol may be potentiated

    Pregnancy and Lactation


    Use pizotifen with caution in pregnancy.

    Use with caution. Limited data available. The manufacturer advises that use should be avoided unless the potential benefit outweighs the risk.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use pizotifen with caution in breastfeeding.

    Pizotifen is found in breast milk. The levels of pizotifen in breast milk is not thought likely to affect the infant though its safety has not established.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    CNS stimulation
    Dry mouth
    Facial oedema
    Hypersensitivity reactions
    Increased appetite
    Increases in hepatic enzymes
    Muscle cramps
    Weight gain
    Withdrawal symptoms


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2014

    Reference Sources

    Summary of Product Characteristics: Sanomigran 1.5mg tablets. Novartis Pharmaceuticals UK Ltd. Revised March 2012.

    Summary of Product Characteristics: Sanomigran 0.5mg tablets. Novartis Pharmaceuticals UK Ltd. Revised March 2012.

    Summary of Product Characteristics: Sanomigran Elixir. Novartis Pharmaceuticals UK Ltd. Revised January 2014.

    NICE Evidence Services Available at: Last accessed: 14 September 2017

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