Medicinal Products

ALMOTRIPTAN MYLAN 125 mg

Generic drug of Almogran
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Almotriptan
laboratory: Mylan

Coated tablet
box of 12
All forms

Indication

Treatment of the cephalalgic phase of the migraine attack with or without aura.

Dosage ALMOTRIPTAN MYLAN 125 mg film-coated tablet box of 12

Treatment of the cephalalgic phase of the migraine attack with or without aura.

Against indications

Hypersensitivity to almotriptan or to any of the excipients listed under section Composition .

As with other 5-hydroxytryptamine (5HT 1B / 1D ) agonists, almotriptan should not be used in patients with history, symptoms, or signs of ischemic heart disease (myocardial infarction, angina breast, documented silent ischemia, Prinzmetal's angina) or with severe hypertension or benign or moderate uncontrolled hypertension.

Almotriptan should not be used in patients with a history of stroke or transient ischemic attack (TIA) or in patients with peripheral vascular disease.

Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine receptor agonists (5HT 1B / 1D ) is contraindicated.

Administration of almotriptan is contraindicated in patients with severe hepatic impairment (see section 4.2 ).

Adverse effects Almotriptan Mylan

Almotriptan has been evaluated in more than 2700 patients in clinical trials up to one year. The most common adverse reactions at the therapeutic dose were: dizziness, drowsiness, nausea, vomiting and fatigue. None of these adverse events occurred at a frequency greater than 1.5%.

The list below shows the adverse effects that have occurred in patients during clinical trials or after marketing.

These adverse effects are presented by organ system and decreasing order of frequency.

The frequencies are defined as follows: very frequent (≥1 / 10), frequent (≥1 / 100 - <1/10), infrequent (≥1 / 1000 - <1/100), rare (≥1 / 10000 - <1/1000), very rare (<1/10000), not known (can not be estimated with available data).

Central nervous system

Frequent: dizziness, drowsiness.

Uncommon: paresthesia, headache.

Undetermined: convulsions.

Auditory and vestibular apparatus

Uncommon: tinnitus.

Cardiovascular system

Uncommon: palpitations.

Very rare: vasospasm of the coronary arteries, myocardial infarction, tachycardia.

Respiratory system, thorax and mediastinum

Uncommon: feeling of tight throat.

Digestive system

Common: nausea, vomiting.

Uncommon: diarrhea, dyspepsia, dry mouth.

Musculoskeletal system, connective tissue

Uncommon: myalgia, bone pain.

General disorders

Frequent: tiredness

Uncommon: asthenia, pain in the chest.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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