RELPAX

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.

g. 1). A second dose of 80 mg should not be taken within 24 hours. 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. 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. 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. 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.

Summary of the safety profile RELPAX has been administered in clinical trials to over 5000 subjects, taking one or two doses of RELPAX 20 or 40 or 80 mg. The most common adverse reactions noted were asthenia, somnolence, nausea and dizziness.

In randomised clinical studies using doses of 20, 40 and 80 mg, a trend for a dose-dependency of the incidence of adverse events has been shown. Tabulated list of adverse reactions The following adverse reactions (with an incidence ≥1% and higher than placebo) were reported in patients treated with therapeutic doses in clinical trials.

Events are categorized by frequency as common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), or rare (≥1/10,000 to <1/1,000). System Organ Class Common Uncommon Rare Infections and infestations: pharyngitis, and rhinitis respiratory tract infection Blood and the lymphadenopathy lymphatic system disorders: Metabolism and nutrition disorders: anorexia Psychiatric disorders: thinking abnormal, agitation, confusion, depersonalisation, euphoria, depression, and insomnia emotional lability Nervous system disorders: somnolence, headache, dizziness, tingling or abnormal sensation, hypertonia, hypoaesthesia, and myasthenia tremor, hyperaesthesia, ataxia, hypokinesia, speech disorder, stupor, and taste perversion Eye disorders: abnormal vision, eye pain, photophobia, and lacrimation disorder conjunctivitis Ear and labyrinth disorders: vertigo ear pain, tinnitus Cardiac disorders: palpitation, and tachycardia bradycardia Vascular disorders: flushing peripheral vascular disorder shock Respiratory, thoracic and mediastinal disorders: throat tightness dyspnea, respiratory disorder and yawning asthma and voice alteration Gastrointestinal disorders: abdominal pain, nausea, dry mouth, and dyspepsia diarrhoea, and glossitis constipation, oesophagitis, tongue oedema and eructation Hepato-biliary disorders: hyperbilirubinaemia, and increased AST Skin and subcutaneous tissue disorders: sweating rash and pruritis skin disorder and urticaria Musculoskeletal, connective tissue and bone disorders: back pain, myalgia arthralgia, arthrosis and bone pain arthritis, myopathy and twitching Renal and urinary disorders: increased urinary frequency, urinary tract disorder and polyuria Reproductive system and breast disorders: breast pain and menorrhagia General disorders and administration site feeling hot, asthenia, chest malaise, face oedema, thirst, oedema and conditions: symptoms (pain, tightness, pressure), chills and pain peripheral oedema The common adverse events seen with eletriptan are typical of adverse events reported with 5-HT1 agonists as a class.

In 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 disorders: serotonin syndrome, rare cases of syncope, cerebrovascular accident Vascular disorders: hypertension Cardiac disorders: myocardial ischaemia or infarction, arteriospasm coronary Gastrointestinal disorders: as with some other 5HT 1B/1D agonists, rare reports of ischaemic colitis have been received, vomiting.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product also contains sunset yellow which may cause allergic reactions.

, ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir). 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.

e. headaches, which may be related to a possibly serious condition (stroke, aneurysm rupture) where cerebrovascular vasoconstriction may be harmful. 8). Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out.

, patients with hypertension, diabetes, smokers or users of nicotine substitution therapy, men over 40 years of age, post-menopausal women and those with a strong family history of CAD]. Cardiac evaluations may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred, in patients without underlying cardiovascular disease when 5-HT1 agonists have been administered.

3). 5-HT1 receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischaemia or infarction, have been reported with 5-HT1 receptor agonists. Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St.

John’s wort (Hypericum perforatum). Within the clinical dose range, slight and transient increases in blood pressure have been seen with eletriptan doses of 60 mg or greater. However, these increases have not been associated with clinical sequelae in the clinical trial programme.

The effect was much more pronounced in renally impaired and elderly subjects. In renally impaired subjects, the range of mean maximum increases in systolic blood pressure was 14 -17mmHg (normal 3mmHg) and for diastolic blood pressure was 14 - 21mmHg (normal 4mmHg).

In elderly subjects, the mean maximum increase in systolic blood pressure was 23mmHg compared with 13mmHg in young adults (placebo 8mmHg). Post-marketing reports of increases in blood pressure have also been received for patients taking 20 and 40 mg doses of eletriptan, and in non-renally impaired and non-elderly patients.

Medication overuse headache (MOH) Prolonged use of any painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Serotonin syndrome Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs).

These reactions can be severe. 5).

1. • severe hepatic or severe renal impairment. • moderately severe or severe hypertension, or untreated mild hypertension. • confirmed coronary heart disease, including ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia), coronary artery vasospasm, objective or subjective symptoms of ischaemic heart disease or Prinzmetal’s angina.

• significant arrhythmias or heart failure. • peripheral vascular disease. • a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). 5). • Concomitant administration of other 5-HT1 receptor agonists with eletriptan.