Medicinal Products

ELETRIPTAN MYLAN 40 mg

Generic drug from Relpax
Therapeutic Class: Neurology-Psychiatry
Active ingredients: [ElÊtriptan, 4525]
laboratory: Mylan

Filmstrip
box of 6
All forms

Indication

Treatment of the acute phase of the migraine attack in adults, with or without aura.

Dosage ELETRIPTAN MYLAN 40 mg tablet film boast 6

Treatment of the acute phase of the migraine attack in adults, with or without aura.

Against indications

ELETRIPTAN MYLAN is contraindicated in patients:

Being hypersensitive to the active substance or to any of the excipients listed under Composition ;

With severe hepatic insufficiency or severe renal insufficiency;

With high blood pressure moderately severe in "sèvÞre, or patients with unhealthy high blood pressure untreated;

With an acute coronary heart disease, including ischemic heart disease (angina pectoris, anterior myocardial infarction or confirmed silent ischemia), signs and symptoms of ischemic heart disease or Prinzmetal's angina;

With significant arrhythmias or heart failure;

With peripheral vascular disease;

Presenting with a history of stroke, or transient ischemic events (TIA);

Concomitant administration of ergotamine or ergotamine derivatives (including mesothrysinide) within 24 hours of taking or taking estréstriptan (see section 4.5 Interactions with other medicinal products and other forms of interaction ) ;

Concomitant administration of other 5-HT 1 receptor agonists .

Eletriptan Mylan side effects

Summary of the safety profile

Estriptan has been administered in clinical trials in more than 5, 000 patients taking one or two doses of 20, 40 or 80 mg of estriptan.

The most common undesirable effects observed were: asthenia, drowsiness, nausea and vertigo.

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

Undesirable effects are listed below by organ system class and frequency.

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

Class of organs

Undesirable effects

Infections and infestations

FrÚquent

pharyngitis and rhinitis

Rare

respiratory tract infections

Hematological and lymphatic system disorders

Rare

lymphadÚnopathie

Metabolism and nutrition disorders

Not very frequent

anorexia

Psychiatric disorders

Not very frequent

thought disorders, agitation, confusion, de-personalization, euphoria, depression, insomnia

Rare

emotional readiness

Nervous System Affections

FrÚquents

drowsiness, headache, dizziness, tingling or sensitivity disorders, hypertonia, hypoesthesia, muscular fatigability

Not very frequent

tremors, hyperesthesia, ataxia, hypokinesia, disturbance of the speech, stupor, dysgeusia

Eye disorders

Not very frequent

abnormal vision, eye pain, photophobia, lachrymal disorders

Rare

conjunctivitis

Affections of the ear and labyrinth

FrÚquents

dizziness

Not very frequent

ear pain, tinnitus

Heart conditions

FrÚquents

palpitation, tachycardia

Rare

bradycardia

Vascular disorders

FrÚquents

vasomotor flush

Not very frequent

peripheral vascular disorder

Rare

shock

Respiratory, thoracic and mediastinal disorders

FrÚquents

feeling of constriction of the throat

Not very frequent

dyspnea, respiratory disorders, sicknesses

Rare

asthma, alterations of the voice

Gastrointestinal disorders

FrÚquents

abdominal pain, nausea, dry mouth, dyspepsia

Not very frequent

diarrhea, glossitis

Rare

constipation, oesophagitis, edema of the tongue, Úructation

Hospital diseases

Rare

bilirubinemia and increase in AST

Skin and skin tissue disorders

FrÚquents

sweat

Not very frequent

rash, pruritus

Rare

skin disorders, urticaria

Musculoskeletal and systemic disorders

FrÚquents

back pain, myalgia

Not very frequent

arthralgia, osteoarthritis, bone pain

Rare

arthritis, myopathy, muscle contractions

Renal and urinary disorders

Not very frequent

increased frequency of urination, urinary tract disorder, polyuria

Disorders of reproductive organs and breast

Rare

mastodynia, menorrhagia

General disorders and administration site abnormalities

FrÚquents

feeling of heat, asthenia, thoracic symptoms (pain, oppression, pressure), chills and pain

Not very frequent

malaise, facial oedze, thirst, oedîmes and peripheral oedîmes

The common adverse events reported under estriptan are typical of those reported with the administration of 5-HT 1 agonists.

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

Immune system disorders

Allergic reactions, some of which may be serious, including angioedema.

Nervous System Affections

Serotonin syndrome, rare cases of syncope, cerebrovascular accident.

Vascular disorders

Hypertension.

Heart conditions

Myocardial ischemia or infarction, coronary artery disease.

Gastrointestinal disorders

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

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Health professionals declare any undesirable effects suspected via the national system of declaration: 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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