Almotriptan

Patients with severe renal impairment should take no more than one 12.5 mg tablet in a 24 hour period.

Caution is recommended in administration of almotriptan in patients with mild to moderate hepatic disease.

As with other 5-HT1 agonists, the potential risk of a serotoninergic syndrome due to a pharmacodynamic interaction in case of concomitant treatment with MAOIs cannot be ruled out.

There have been reports describing patients with symptoms compatible with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans.

For almotriptan, very limited data on pregnant patients are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing almotriptan to pregnant women.

There are no data regarding excretion of almotriptan in human milk. Studies in rats have shown that almotriptan and/or its metabolites are excreted in milk.

Caution should therefore be exercised when prescribing during lactation. Infant exposure may be minimised by avoiding breast feeding for 24 hours after treatment.

There are no studies on the effect of almotriptan on the ability to drive or operate machinery. However, since somnolence may occur during a migraine attack and has been reported as a side effect of treatment with almotriptan, caution is recommended in patients performing skilled tasks.

Almotriptan was evaluated in over 2700 patients for up to one year in clinical trials. The most common adverse reactions at the therapeutic dose were dizziness, somnolence, nausea, vomiting and fatigue. None of the adverse reactions had an incidence superior to 1.5%.

The following adverse reactions have been evaluated in clinical studies and/or reported in post-marketing experience. They have been listed by System Organ Class (SOC) and in descending order of frequency. Frequencies are defined as: very common (>1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Immune system disorders

Not known: Hypersensitivity reactions (including angioedema), Anaphylactic reactions

Nervous system disorders

Common: Dizziness, Somnolence

Uncommon: Paraesthesia, Headache

Not known: Seizures

Eye disorders

Not known: Visual impairment*, Vision blurred*

Ear and labyrinth disorders

Uncommon: Tinnitus

Cardiac disorders

Uncommon: Palpitations

Very rare: Coronary vasospasm, Myocardial infarction, Tachycardia

Respiratory, thoracic and mediastinal disorders

Uncommon: Throat tightness

Gastrointestinal Disorders

Common: Nausea, Vomiting

Uncommon: Diarrhoea, Dyspepsia, Dry mouth

Not known: Intestinal ischemia

Musculoskeletal, connective tissue and bone disorders

Uncommon: Myalgia, Bone pain

General Disorders

Common: Fatigue

Uncommon: Chest pain, Asthenia

* However visual disorders may also occur during a migraine attack itself.