RELPAX TABLET 40 MG [SIN11767P]

Product Info

RELPAX TABLET 40 MG

[SIN11767P]

4.1 Therapeutic indication

Acute treatment of migraine with or without aura.

4.2 Posology and method of administration

Eletriptan tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage.

Eletriptan tablets should not be used prophylactically.

The tablets should be swallowed whole with water.

Adults (18–65 years of age)

The recommended initial dose is 40 mg.

If headache returns within 24 hours: If after an initial response migraine headache recurs within 24 hours, an additional dose of the same strength of eletriptan has been shown to be effective in treating the recurrence. If a second dose is required, it should not be taken within 2 hours of the initial dose.

If no response is obtained: If a patient does not achieve a headache response to the first dose of eletriptan within 2 hours, a second dose should not be taken for the same attack, as clinical trials have not adequately established efficacy with the second dose. Clinical trials have shown that the majority of patients who do not respond to the treatment of an attack will respond to the treatment of a subsequent attack.

Patients who do not obtain satisfactory efficacy with 40 mg may be effectively treated with 80 mg in a subsequent migraine attack.

The maximum daily dose should not exceed 160 mg.

Elderly (over 65 years of age)

Safety and efficacy in patients over 65 years of age have not been systematically evaluated due to a small number of such patients in clinical trials. Blood pressure effects may be more marked in this population than in younger adults (see section 4.4 Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adolescents (12–17 years of age)

In a clinical trial in adolescents, a high placebo response rate was observed. The efficacy of eletriptan has not been established in this population, and its use is therefore not recommended in this age group.

Children (6–11 years of age)

The safety and efficacy of eletriptan in children have not been evaluated. Therefore, the use of eletriptan is not recommended in this age group (see section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. As eletriptan has not been studied in patients with severe hepatic impairment, it is contraindicated in these patients.

Renal Impairment

As the blood pressure effects of eletriptan are amplified in renal impairment (see section 4.4 Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), a 20 mg initial dose is recommended in patients with mild or moderate renal impairment. The maximum single dose is 40 mg in these patients. The maximum daily dose should not exceed 80 mg.

4.3 Contraindications

Patients with hypersensitivity to eletriptan hydrobromide or to any of the excipients.

Patients with severe hepatic impairment.

Patients with severe renal impairment.

As with other 5-hydroxytryptamine type 1 (5-HT₁) receptor agonists, the following contra-indications are based on the pharmacodynamic properties of eletriptan:

Patients with uncontrolled hypertension.

Patients with confirmed coronary heart disease, including ischemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischemia).

Patients with coronary artery vasospasm, objective or subjective symptoms of ischemic heart disease or Prinzmetal’s angina.

Patients with significant arrhythmias or heart failure.

Patients with peripheral vascular disease.

Patients with a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA).

Administration of ergotamine, or derivatives of ergotamine (including methysergide) within 24 hours before or after treatment with eletriptan (see section 4.5 Interactions with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant administration of other 5-HT₁ receptor agonists.

Within 48 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, erythromycin, clarithromycin, amprenavir, ritonavir, indinavir, saquinavir, nelfinavir and nefazodone.