Medicinal Products

ELETRIPTAN BGR 40 mg

Generic drug from Relpax
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Eletriptan
laboratory: Biogaran

Coated tablet
box of 6
All forms

Indication

ELETRIPTAN BGR is indicated in adults for the treatment of the cephalalgic phase of migraine attacks with or without aura.

Dosage ELETRIPTAN BGR 40 mg film-coated tablet box of 6

ELETRIPTAN BGR is indicated in adults for the treatment of the cephalalgic phase of migraine attacks with or without aura.

Against indications

ELETRIPTAN BGR is contraindicated in patients with:

· Hypersensitivity to eletriptan hydrobromide or to any of the excipients listed under Composition ;

· Severe hepatic impairment or severe renal impairment;

· Moderately severe to severe hypertension, or untreated mild hypertension;

· Proven coronary heart disease, including ischemic heart disease (angina pectoris, history of myocardial infarction or confirmed silent ischemia). Patients with coronary artery spasm (Prinzmetal's angina), signs and symptoms of ischemic heart disease;

Significant arrhythmias or heart failure;

· Peripheral vascular disease;

· A history of stroke, or transient ischemic attack (TIA)

• Concomitant administration of ergotamine or ergotamine derivatives (including methysergide) within 24 hours before or after taking eletriptan (see section 4.5).

Concomitant administration of other 5-HT 1 receptor agonists.

Eletriptan Bgr side effects

Summary of the security profile

Eletriptan has been administered in clinical studies in more than 5, 000 patients taking one or two doses of 20, 40 or 80 mg eletriptan.

The most common adverse events observed were: asthenia, drowsiness, nausea and dizziness.

Randomized clinical studies using doses of 20, 40 and 80 mg showed that the incidence of adverse events tended to be dose-dependent.

Table of adverse effects

The following adverse events (≥ 1% incidence and greater than placebo) have been reported in clinical trials in patients treated at therapeutic doses. Adverse reactions are classified by frequency: frequent (≥ 1/100, <1/10) or infrequent (≥ 1/1000, <1/100) or rare (≥ 1/10 000, <1/1000) .

Class Organ System

Frequent

Rare

Rare

Infections and infestations

pharyngitis and rhinitis

respiratory tract infections

Blood and lymphatic system disorders

lymphadenopathy

Metabolism and nutrition disorders

anorexia

Psychiatric disorders

thought disorders, agitation, confusion, depersonalization, euphoria, depression and insomnia

emotional lability

Nervous system disorders

drowsiness, headache, dizziness, tingling or sensory disturbances, hypertonia, hypoesthesia and muscular fatigability

tremors, hyperesthesia, ataxia, hypokinesia, slurred speech, stupor and dysgeusia

Eye disorders

abnormal vision, eye pain, photophobia and lachrymal disorders

conjunctivitis

Affections of the ear and labyrinth

dizziness

ear pain, tinnitus

Heart conditions

palpitation and tachycardia

bradycardia

Vascular disorders

flushing

peripheral vascular disorder

shock

Respiratory, thoracic and mediastinal disorders

feeling of constriction of the throat

dyspnea, breathing difficulties and yawning

Asthma and alterations of the voice

Gastrointestinal disorders

abdominal pain, nausea, dryness of the mouth and dyspepsia

diarrhea and glossitis

constipation, oesophagitis, edema of the tongue and eructation

Hepatobiliary disorders

hyperbilirubinemia and AST increase

Skin and skin tissue disorders

sweat

rash and pruritus

skin disorders and urticaria

Musculoskeletal and systemic disorders

back pain, myalgia

arthralgia, osteoarthritis, and bone pain

arthritis, myopathy, and muscle contractions

Renal and urinary disorders

increased frequency of urination, urinary tract disorder, and polyuria

Disorders of reproductive organs and breast

mastodynia and menorrhagia

General disorders and administration site conditions

feeling of heat, asthenia, chest symptoms (pain, tightness, pressure), chills and pain

malaise, edema of the face, thirst, edema and peripheral edema

Common adverse events reported with eletriptan are typical of those reported with 5-HT 1 agonists.

In the post-marketing experience, the following side effects have been reported:

Immune system disorders:

Allergic reactions, some of which may be serious, including Quincke's edema.

Nervous system disorders:

Serotonin syndrome, rare cases of syncope, cerebrovascular accident.

Vascular disorders:

Hypertension.

Heart conditions:

Ischemia or myocardial infarction, coronary arteriosclerosis.

Gastrointestinal disorders:

As with other 5HT 1B / 1D agonists rare cases of ischemic colitis have been reported. Vomiting.

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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