RELPAX Film-coated tablet Ref.[8135] Active ingredients: Eletriptan

Posology

RELPAX 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 during a migraine attack.

RELPAX, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELPAX should only be taken during the headache phase of migraine.

RELPAX tablets should not be used prophylactically.

Adults (18-65 years of age)

The recommended initial dose is 40 mg.

If headache returns within 24 hours: If the migraine headache recurs within 24 hours of an initial response, a second dose of the same strength of RELPAX 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 RELPAX 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 show that patients who do not respond to the treatment of an attack are still likely to respond to the treatment of a subsequent attack.

Patients who do not obtain satisfactory efficacy after an appropriate trial of 40 mg, (e.g. good tolerability and failure to respond in 2 out of 3 attacks), may be effectively treated with 80 mg (2 × 40 mg) in subsequent migraine attacks (see section 5.1). A second dose of 80 mg should not be taken within 24 hours.

The maximum daily dose should not exceed 80 mg (see section 4.8).

Elderly patients

The safety and effectiveness of eletriptan in patients over 65 years of age have not been systematically evaluated due to the small number of such patients in clinical trials. Use of RELPAX in the elderly is therefore not recommended.

Paediatric population

Adolescents (12-17 years of age)

The efficacy of RELPAX in adolescents aged 12 to 17 years has not been established. Current available data are described in section 5.2 but no recommendation on a posology can be made.

Children (6-11 years of age)

The safety and efficacy of RELPAX in children aged 6 to 11 years has not been established. Current available data are described in section 5.2 but no recommendation on a posology can be made.

Patients with hepatic impairment

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

Patients with renal impairment

As the blood pressure effects of RELPAX are amplified in renal impairment (see section 4.4), a 20 mg initial dose, is recommended in patients with mild or moderate renal impairment. The maximum daily dose should not exceed 40 mg. RELPAX is contra-indicated, in patients with severe renal impairment.

Method of administration

The tablets should be swallowed whole with water.

Subjects have received single doses of 120 mg without significant adverse effects. However based on the pharmacology of this class, hypertension or other more serious cardiovascular symptoms could occur on overdose.

In cases of overdose, standard supportive measures should be adopted as required. The elimination half-life of eletriptan is about 4 hours, and therefore monitoring of patients and provision of general supportive therapy after overdose with eletriptan should continue for at least 20 hours or while signs and symptoms persist.

It is unknown what effect haemodialysis or peritoneal dialysis has on the serum concentrations of eletriptan.

3 years.

Opaque PVC/Aclar/Aluminium blister: this medicinal product does not require any special storage conditions.

HDPE bottles: keep the container tightly closed, in order to protect from moisture.

Opaque PVC/Aclar/Aluminium blister packs containing 2, 3, 4, 5, 6, 10, 18, 30 and 100 tablets.

HDPE bottles with child-resistant HDPE/PP closures containing 30 and 100 tablets.

Not all pack sizes may be marketed.

No special requirements.