Medicinal Products

ALMOTRIPTAN 125 mg

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

Coated tablet
box of 12
All forms

Indication

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

Dosage ALMOTRIPTAN EG 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 (5HT1B / 1D) receptor agonists, almotriptan should not be used in patients with history, symptoms, or signs of ischemic heart disease (myocardial infarction, chest, 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 (5HT1B / 1D) receptor agonists is contraindicated.

Administration of almotriptan is contraindicated in patients with severe hepatic impairment (see also section Posology and method of administration ).

Adverse effects Almotriptan Eg

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 above 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.

Frequencies are defined as follows: very common (³ 1/10), frequent (³ 1/100 - <1/10), infrequent (³ 1/1000 - <1/100), rare (³ 1 / 10000 - <1/1000), very rare (<1/10000), not known (can not be estimated with available data).

Class organ system

frequent

Uncommon

Very rare

indeterminate

Immune system

Hypersensitivity reactions (including angioedema)

Anaphylactic reactions

Central nervous system

Dizziness, Sleepiness

Paraesthesia, Headache

convulsions

Eye disorders

Visual impairment *

Blurry vision*

Auditory and vestibular apparatus

tinnitus

Cardiovascular system

Palpitations.

Vasospasm of the coronary arteries. Myocardial infarction. Tachycardia.

Respiratory system, thorax and mediastinum

Feeling of tight throat.

Digestive system

Nausea

Vomiting

Diarrhea, Dyspepsia, Dryness of the mouth.

Musculoskeletal system, connective tissue

myalgia

Bone pain.

General disorders

Tired

Asthenia

Pain in the chest.

* However, visual disturbances can also occur during the migraine attack itself

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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