Relert Tablets

/ Dexcel

RELERT 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. RELERT, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELERT should only be taken during the headache phase of migraine. RELERT 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 the migraine headache recurs within 24 hours of an initial response, a second dose of the same strength 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 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 the majority of 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 40mg, (e.g. good tolerability and failure to respond in 2 out of 3 attacks), may be effectively treated with 80mg in subsequent migraine attacks. The maximum daily dose should not exceed 160mg.
Elderly (over 65 years of age): Safety and efficacy 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 this product in the elderly is therefore not recommended. Blood pressure effects may be more marked in this population than in younger adults.
Adolescents (12-17 years of age): In a clinical trial in adolescents, a high placebo response rate was observed. The efficacy of this product 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 this product has not been established in this population and its use is therefore not recommended in this age group.
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. As this product has not been studied in patients with severe hepatic impairment, it is contraindicated in these patients.
Renal impairment: As the blood pressure effects of this product are amplified in renal impairment, a 20mg initial dose, is recommended in patients with mild or moderate renal impairment. The maximum daily dose should not exceed 40mg. This product is contra-indicated, in patients with severe renal impairment.

Acute treatment of the headache phase of migraine attacks, with or without aura.

Hypersensitivity to eletriptan hydrobromide or to any of the excipients. 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), oronary artery vasospasm (Prinzmetal’s angina), objective or subjective symptoms of ischaemic heart disease. Significant arrhythmias or heart failure. Peripheral vascular disease. History of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Administration of ergotamine, or derivatives of ergotamine (including methysergide), within 24hr before or after treatment with eletriptan. Concomitant administration of other 5-HT1 receptor agonists with eletriptan. Should not be used together with potent CYP3A4 inhibitors, e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, amprenavir, ritonavir, indinavir, saquinavir, nafazodone and nelfinavir.

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.
Serotonin syndrome: Co-administration of eletriptan with other drugs having serotonergic activity, such as Serotonin–norepinephrine reuptake inhibitor (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 drugs (see section 3.5 – Interaction with other medicinal products and other forms of interaction – Interaction with serotonergic active drugs).
RELERT should not be used together with potent CYP3A4 inhibitors eg ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir).
RELERT should only be used where a clear diagnosis of migraine has been established. RELERT is not indicated for the management of hemiplegic, ophthalmoplegic, or basilar migraine.
RELERT should not be given for the treatment of ‘atypical’ headaches, i.e. headaches, that may be related to a possibly serious condition (stroke, aneurysm rupture) where cerebrovascular vasoconstriction may be harmful.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of
5 HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5 HT1 agonists have not been clearly established.
RELERT can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat (see 3.8 ‘Undesirable effects’). 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 cardiac failure: RELERT should not be given without prior cardiovascular evaluation, to patients in whom unrecognised cardiac disease is likely, or to patients at risk of coronary artery disease (CAD) [e.g. 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. Patients in whom CAD is established, should not be given RELERT (see 3.3 Contra-indications).
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 60mg or greater. 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.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5 HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5 HT1 agonists have not been clearly established.

Common: pharyngitis and rhinitis. somnolence, headache, dizziness, tingling or abnormal sensation, hypertonia, hypoaesthesia, and myasthenia. vertigo. palpitation, and tachycardia. flushing. throat tightness. abdominal pain, nausea, dry mouth, and dyspepsia. sweating. back pain, myalgia. feeling hot, asthenia, chest symptoms (pain, tightness, pressure), chills and Pain.
For full details see prescribing information.

RELERT should not be used together with potent CYP3A4 inhibitors eg ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin, and protease inhibitors (ritonavir, indinavir and nelfinavir ). It is recommended that either ergotamine-containing or ergot-type medications (e.g. dihydroergotamine) should not be taken within 24 hours of eletriptan dosing. Conversely, at least 24 hours should elapse after the administration of an ergotamine-containing preparation before eletriptan is given. Co-administration of 5-HT agonists, including eletriptan, with drugs having serotonergic activity, such as SSRIs and SNRIs, may increase the risk of serotonin syndrome. If concomitant treatment with eletriptan and a serotonergic active drug is clinically warranted, caution is advised.
For full details see prescribing information.

Pregnancy: The safety of eletriptan in pregnant women has not been established. There is no evidence of teratogenicity in animal studies. Administration of eletriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: Eletriptan is excreted in human breast milk. Nevertheless, caution should be exercised when considering the administration of RELERT to women who are breast-feeding. Infant exposure can be minimised by avoiding breast-feeding for 24 hours after treatment.
For full details see prescribing information.

Subjects have received single doses of 120mg 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.

Storage: Do not store above 30°C.