PIZOTIFEN Film-coated tablet Ref.[9288] Active ingredients:

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 (eg prostate hypertrophy). Dosage adjustment may be necessary in patients with kidney insufficiency.

Seizures as adverse effects have been observed more frequently in patients with epilepsy. Pizotifen should be used with 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.

The following drugs may exhibit drug interactions with pizotifen upon concomitant administration.

Anticipated drug interactions to be considered

Pizotifen is extensively metabolized in the liver, primarily by Nglucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation cannot be excluded.

Central nervous system agents

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen.

Pizotifen antagonises the hypotensive effect of adrenergic neurone blockers.

Women of childbearing potential

There is no data for recommendations in women of child-bearing potential.

Pregnancy

As clinical data with pizotifen in pregnancy are very limited it should only be administered during pregnancy if the expected benefits outweigh the potential risks.

Breast-feeding

Although the concentrations of pizotifen measured in the milk of treated mothers are not likely to affect the infant, its use in nursing mothers is not recommended.

Fertility

There were no fertility effects in a rat study with pizotifen hydrogen maleate.

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.

The most common side-effects are appetite stimulating effect, increase 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), unknown (frequency cannot be estimated from available data).

Nervous system disorders

Common: Drowsiness (including somnolence), dizziness.

Rare: Paraesthesia.

Very rare: Seizures.

Gastrointestinal disorders

Common: Dry mouth, nausea.

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

Metabolism and nutrition disorders

Very common: Appetite stimulating effect and increase in body weight.

General disorders and administration site conditions

Common: Fatigue.

Immune system disorders

Rare: Hypersensitivity reactions, face oedema.

Psychiatric disorders

Rare: Depression, CNS stimulation (e.g. aggression, agitation), anxiety, hallucination, insomnia, rare cases of sleep disorders.

^*1 These adverse events were reported in patients treated with pizotifen based on post-marketing spontaneous reports.

In children CNS stimulation may occur.

Withdrawal symptoms

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 may 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.

None known.