Medicinal Products

ALMOTRIPTAN TEVA 125 mg

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

Coated tablet
box of 12
All forms

Indication

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

Dosage ALMOTRIPTAN TEVA 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 Teva

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 following list shows the adverse effects that occurred in patients during clinical trials.

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), including isolated cases, not known (can not be estimated from available data).

Class organ system

frequent

≥1 / 100 <1/10

Uncommon

≥1 / 1000 <1/100

Very rare

<1 / 10, 000

Frequency

indeterminate

Central nervous system

Dizziness, Sleepiness

Paraesthesia, Headache

convulsions

Immune system

Hypersensitivity reactions (including angioedema)

Anaphylactic reactions

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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