Serotonin antagonists.

Pizotifen

Sanomigran Tablets: 0.5mg, ivory s-c tablet marked SMG; 1.5 mg, ivory s-c tablet marked SMG 1.5. Sanomigran Elixir: sucrose-free elixir.

Coated tablets.

Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headaches (periodic migrainous neuralgia). It is not effective in relieving migraine attacks once in progress.

Usually 1.5mg 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 4.5mg daily. Up to 3mg may be given as a single dose.

Up to 1.5mg daily, usually as a divided dose, although up to 1mg has been given as a single dose at night.

Known hypersensitivity to pizotifen or any of the excipients (see section 6.1. List of excipients).

Sanomigran should not be given to children under 2 years of age

Although the anticholinergic activity of Sanomigran 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 with caution in patients with a history of epilepsy.

Sanomigran coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-glactose malabsorption should not take Sanomigran

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

Sanomigran antagonises the hypotensive effect of adrenergic neurone blockers

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), including isolated reports.

Immune system disorders:

Rare: Hypersensitivity reactions, face oedema, urticaria and rash

Metabolism and nutrition disorders:

Very common: Appetite stimulating effect and increase in body weight

Psychiatric disorders:

Rare: Depression, CNS stimulation (e.g. aggression, agitation), hallucination, insomnia, anxiety

Nervous system disorders:

Common: Drowsiness (including somnolence) dizziness

Rare: Paraesthesia

Very rare: Seizures

Gastrointestinal disorders:

Common: Nausea, dry mouth

Uncommon: Constipation

Musculoskeletal and connective tissue disorders:

Rare: Myalgia, arthralgia

General disorders and administration site conditions:

Common: Fatigue

Acute withdrawal reactions have been reported following abrupt cessation of Sanomigran therefore gradual withdrawal is recommended. Withdrawal symptoms include anxiety, tremors, insomnia, nausea and loss of consciousness.

Novartis

(POM)

23 June 2009