Medicinal Products

ALMOGRAN 12.5 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Almotriptan
laboratory: Almirall SAS

Coated tablet
Box of 12
All forms

Indication

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

Dosage ALMOGRAN 12.5 mg Film-coated tablet Box of 12

The almotriptan tablet should be taken with water as early as possible after the onset of the migraine headache attack, but it is also effective when taken at a later stage.

The almotriptan tablet should not be used for prophylaxis.

The tablets can be taken with or without food.

Adult (from 18 to 65 years old)

The recommended dose is one 12.5 mg tablet of almotriptan.

If migraine symptoms reappear within 24 hours a second tablet may be taken, provided that the interval is at least 2 hours apart.

The effectiveness of a second dose for the treatment of the same crisis when the first dose was not effective was not studied in clinical trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same crisis.

The maximum recommended dose is two tablets per 24 hours.

Child and teenager (under 18 years old)

There are no data on the use of almotriptan in children and adolescents. As a result, its use in this age group is not recommended.

Elderly patient (over 65 years old)

No dose adjustment is required for the elderly patient. The safety and efficacy of almotriptan have not been systematically evaluated in patients over 65 years of age.

Inadequate renal

No dosage adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment should not take more than one 12.5 mg almotriptan tablet per 24 hours.

Hepatic insufficiency

There are no data on the use of almotriptan in patients with hepatic impairment (see also Contraindications and Warnings and Precautions for Use ).

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 also Posology and method of administration Posology and method of administration).

Almogran side effects

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 report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.

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