- The active ingredient of Relpax is eletriptan. Each Relpax 20 and 40 mg film coated tablet contains 20 or 40 mg of eletriptan (as hydrobromide).

- Relpax film coated tablets also contain the following non--active ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide (E 171), hypromellose, glycerol triacetate and Sunset Yellow Aluminium Lake (E 110).

 

Relpax belongs to a group of medicines called 5-HT1 receptor agonists. Relpax is indicated for the acute treatment of the headache phase of migraine attacks. Before the start of a migraine headache, you may experience a phase called an "aura", which can involve vision disorders, numbness and speech disorders.

 

Treatment with Relpax requires regular medical checkups.

 

- If you are allergic to eletriptan or any of the other ingredients of Relpax

- If you have any severe liver or kidney disease

- If you have blood pressure or uncontrolled blood pressure

- If you have a heart problem, such as angina pectoris, myocardial infarction, etc.

- If you suffer from peripheral vascular disease

- If you have a history of cerebrovascular accident

- If you are concomitantly taking any other medicines specifically indicated to treat migraine. At least 24 hours should elapse after the administration of these medicines before you can take Relpax. It is also recommended that you do not take any other medicines indicated for the treatment of migraine until at least 24 hours have elapsed after the administration of Relpax (see: "Taking other medications").

 

 

- Relpax should only be used where a clear diagnosis of migraine has been established.

Relpax should not be used in the treatment of other types of headaches different to migraine.

- Relpax should not be given without prior evaluation, to patients in whom heart disease is likely, or to patients at risk of heart disease such as patients with high blood pressure, diabetes, smokers or users of nicotine substitution therapy, those with a family history of heart disease, men over 40 years of age, post-menopausal women.

- Children and adolescents: The safety and efficacy of Relpax in children under 17 years of age have not been completely evaluated. Therefore the use of Relpax is not recommended in this age group.

- Elderly patients (over 65 years of age): Relpax tablets are not recommended for patients over 65 years of age.

 

Pregnancy:

Consult your doctor or pharmacist before taking any medication. The safety and efficacy of Relpax in pregnant women have not been evaluated; therefore, Relpax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

Lactation:

Consult your doctor or pharmacist before taking any medication. Relpax is excreted in human breast milk therefore, caution should be exercised when considering the administration of Relpax to women who are breastfeeding. Infant exposure can be minimized by avoiding breast feeding for 24 hours after treatment.

 

The migraine itself or treatment with Relpax (Eletriptan) may cause drowsiness or dizziness in some patients. Therefore patients should avoid driving or using machines during the migraine attack or after taking the medicine.

 

 

This medication contains the inactive ingredient Sunset Yellow Aluminium Lake (E 110), which may cause allergic reactions, including asthma specially in patients that are allergic to acetylsalicylic acid.

 

Always tell your doctor or pharmacist if you are taking or have recently taken any other medication, including those you have bought yourself without a prescription. Relpax should not be taken concomitantly with the following medications:

- antibiotics such as erythromycin, clarithromycin or josamycin

- antifungals such as ketoconazole or itraconazole

- protease inhibitors such as ritonavir, nelfinavir and indinavir

You should not take Relpax (Eletriptan) either 24 hours before or after taking other medications specifically used to treat migraine.

 

Inform your doctor if you are using herbal preparations containing St John's wort.

 

Strictly follow your doctor's instructions on how and when to take your tablets.

If you do not understand something, or you have any more questions about Relpax film coated tablets, please ask your doctor or pharmacist.

 

Do not take a higher dose than the one that has been prescribed for you.

Relpax tEletriptan) tablets should be taken as early as possible after the onset of migraine headache. However you should not take Relpax during the aura phase or to prevent a migraine attack. You should swallow each tablet whole with a drink of water to make oral administration easier.

 

-Use in adults (18-65 years of age)

The recommended initial dose is 20- to 40 mg.

If the first tablet does not relieve your migraine, you should not take a second tablet for the same attack.

 

If after a first tablet your migraine is relieved and then comes back, you may take a second tablet. However, after taking the first tablet you must wait at least 2 hours before taking the second tablet. If you find that a dose of one 20 or 40 mg tablet does not relieve your migraines, tell your doctor - he or she may decide to increase the dose to 80 mg for future attacks. You should not take more than 80 mg in 24 hours.

 

Most patients who do not respond to the treatment of an attack are still likely to respond to the treatment of a subsequent attack.

 

 

- Use in patients with mild or moderate hepatic impairment

Relpax (Eletriptan) may be administered to patients with mild or moderate hepatic impairment.

No dose adjustment is required in these patients.

 

- Use in patients with mild or moderate renal impairment

Relpax may be administered to patients with mild or moderate renal impairment. However a 20 mg initial dose is recommended in these patients.

The maximum daily dose should not exceed 20 to 40 mg.

 

If you take more Relpax than you should:

If you take more tablets than prescribed, contact your doctor or pharmacist immediately.

 

As with any medicine, Relpax may cause some side effects. These side effects are generally mild to moderate and transient and disappear quickly. The most common side effects are: tiredness or somnolence, muscle weakness, nausea, dyspepsia, dizziness, vertigo, sensation of warmth or flushing, tingling or abnormal sensations, hypoaesthesia, chills, chest pain or tightness, palpitations, tachycardia (increased heart rate), dry mouth, throat tightness, muscle pain, stiffness and headache. Some side effects may be caused by the migraine itself. Excessive use (repeated use over several days) of any anti-migraine medicinal product may lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if this occurs. If you notice any other adverse reaction not mentioned in this leaflet, please tell your doctor or pharmacist.

 

Keep Relpax (Eletriptan) out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not take Relpax after the expiry date shown on the pack.