Relpax 20 Mg/40 Mg/80 Mg Tablets

Acute treatment of migraine with or without aura in adults and adolescents 18 years and older.

RELPAX tablets should be taken as early as possible after the onset of migraine headache. RELPAX tablets should not be used prophylactically. RELPAX should only be taken during the headache phase of migraine. The tablets should be swallowed whole with water.

Adults (18 to 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 RELPAX may be used 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. Clinical trials have shown that the majority of patients who do not respond to the treatment of an initial attack respond to the treatment of a subsequent attack.

Patients who do not obtain satisfactory efficacy with 40 mg may have the dose increased to 80 mg in a subsequent migraine attack. The maximum total daily dose should not exceed 160 mg.

A 20 mg dose of RELPAX is recommended in patients receiving erythromycin and other specific potent CYP3A4 inhibitors e.g. ketoconazole, itraconazole and clarithromycin. The total daily intake should not exceed 40 mg for these patients.

Elderly (over 65 years of age): Safety and efficacy in patients over 65 have not been systematically evaluated due to the small number of such patients in clinical trials. Blood pressure effects may be more marked in this population than in younger adults (see WARNINGS AND SPECIAL PRECAUTIONS).

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.

Renal impairment: As the blood pressure effects of RELPAX are amplified in renal impairment, doses higher than 40 mg should not be used (see WARNINGS AND SPECIAL PRECAUTIONS).

• Patients with hypersensitivity to eletriptan hydrobromide or to any of the excipients.
• Patients with severe hepatic impairment (Child-Pugh class C [score > 9]).
• Patients with uncontrolled hypertension.
• Patients with confirmed coronary heart disease, including ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia).
• Patients with coronary artery vasospasm, objective or subjective symptoms of ischaemic heart disease or Prinzmetalu2019s angina.
• Patients with peripheral vascular disease.
• Peripheral arterial insufficiency.
• Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
• Administration of ergotamine, or derivatives of ergot within 24 hours before or after treatment with RELPAX (see INTERACTIONS).
• Concomitant administration of other 5-HT 1 receptor agonists.
• RELPAX use with potent CYP3A4 inhibitors e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir), is not recommended as plasma levels may double or triple (see INTERACTIONS).
• RELPAX has not been systematically evaluated for use in patients with heart failure. Use in these patients is not recommended.
• Children and adolescents (less than 18 years), as safety and efficacy have not been demonstrated.

Serotonin syndrome: Co-administration of RELPAX with other medicines having serotonergic activity, such as serotonin-norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs), should be undertaken with caution due to reports of the development of serotonin syndrome in isolated cases of concomitant use of a triptan with other serotonergic medicines (see INTERACTIONS u2013 Interaction with serotonergic active medicine).

RELPAX use with potent CYP3A4 inhibitors e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir), is not recommended as plasma levels may double or triple.

RELPAX should only be used where a clear diagnosis of migraine has been established. RELPAX is not indicated for the management of hemiplegic, ophthalmoplegic or basilar migraine.

RELPAX should not be given for the treatment of u201catypicalu201d headaches i.e. headaches which may be related to a possibly serious condition (stroke, aneurysm rupture) where cerebrovascular vasoconstriction may be harmful.

Cardiovascular evaluation prior to commencement of treatment with RELPAX is recommended for patients in whom cardiovascular disease is likely, or for patients at risk of cardiovascular disease (see CONTRAINDICATIONS).

Within the clinical dose range, slight and transient increases in blood pressure have been seen with RELPAX doses of 60 mg or greater. The effect was more pronounced in renally impaired and elderly subjects.

In a clinical pharmacology study, a single oral dose of 80 mg was administered to normal (n=6) subjects and to subjects with severe (n=5), moderate (n=5) and mild (n=6) degrees of renal impairment. The maximum increase from baseline in subjects with renal impairment ranged from 14 mmHg to 17 mmHg for systolic blood pressure or 14 mmHg to 21 mmHg for diastolic blood pressure and was greater than that observed in the normal subjects (3 u2013 4 mmHg).

Excessive use of any anti-migraine medicine can lead to daily chronic headaches. Overuse of all triptans has been reported primarily in patients with chronic daily headache.

Use in children: Use in children less than 18 years is not recommended as safety and efficacy have not been demonstrated (see CONTRAINDICATIONS).

Effects on ability to drive and use machines: Migraine or treatment with some 5-HT 1 receptor agonists, including RELPAX, may cause dizziness or drowsiness in some patients. Therefore, caution is recommended in patients performing skilled tasks (e.g. driving or operating machinery) during the migraine attack and following administration of RELPAX.

Pregnancy: The safety of RELPAX in pregnant women has not been established.

Lactation: RELPAX is excreted in human breast milk. Women using RELPAX should not breastfeed their infants.

RELPAX has been administered in clinical trials to more than 5 000 patients. The incidence and severity of side effects seen in patients who took two doses of the same strength to treat a single attack were similar to these observed in patients who had taken only one dose. The following side effects (with an incidence u2265 1 % and higher than placebo) were reported in patients treated with therapeutic doses in clinical trials. The following side effects have been reported in patients treated with therapeutic doses. Side effects are categorised by frequency as common (u2265 1/100 and < 1/10), uncommon (u2265 1/1 000 and < 1/100), or rare (u2265 1/10 000 and < 1/1 000).

MedDRA system organ class Frequency Side effect

• Nervous system disorders Common Dizziness, headache, hypertonia, hypoesthesia, myasthenia, paraesthesia, somnolence
• Ear and labyrinth disorders Common Vertigo
• Cardiac disorders Common Palpitation, tachycardia
• Vascular disorders Common Sensation of warmth or flushing
• Respiratory, thoracic and mediastinal disorders Common Pharyngitis, throat tightness
• Gastrointestinal disorders Common Abdominal pain, dry mouth, dyspepsia, nausea
• Skin and subcutaneous tissue disorders Common Sweating
• Musculoskeletal, connective tissue and bone disorders Common Back pain, myalgia
• General disorders and administration site conditions Common Asthenia, chest symptoms (pain, tightness, pressure), chills, pain

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

• MedDRA system organ class Side effect
• Immune system disorders Allergic reaction, some of which may be serious, including angioedema
• Nervous system disorders Syncope
• Vascular Hypertension
• Gastrointestinal disorders Vomiting, ischaemic colitis
• Cardiac disorders Myocardial ischaemia or infarction, coronary arteriospasm
• Skin and subcutaneous tissue disorders Pruritus, rash, urticaria

In cases of overdose, standard supportive measures should be adopted as required. The elimination half-life of RELPAX is about 4 hours, and therefore monitoring of patients and provision of general supportive therapy after overdose with RELPAX 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 RELPAX.