Relpax

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Relpax, 40 mg, film-coated tablets

Eletriptan

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Relpax and what is it used for
• 2. Important information before taking Relpax
• 3. How to take Relpax
• 4. Possible side effects
• 5. How to store Relpax
• 6. Contents of the packaging and other information

1. What is Relpax and what is it used for

Relpax contains the active substance eletriptan, which reduces the severity of migraine pain.
Relpax is indicated for the treatment of acute migraine attacks with or without aura.
Relpax is also effective in treating:

• symptoms accompanying migraine attacks, such as vomiting, nausea, photophobia, and hypersensitivity to sounds,
• menstrual migraine,
• recurrent migraine headaches.

It has not been shown that Relpax taken during a migraine aura prevents the onset of migraine pain,
so Relpax should only be taken during a migraine headache.
Relpax should not be taken prophylactically.
The tablets should be swallowed whole, with a glass of water.

2. Important information before taking Relpax

When not to take Relpax

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver or kidney impairment;
• in cases of moderate or severe hypertension or uncontrolled mild hypertension;
• if the patient has been diagnosed with coronary artery disease, including ischemic heart disease (angina pectoris, myocardial infarction, or confirmed asymptomatic ischemia);
• if the patient experiences coronary artery vasospasm, objective or subjective symptoms of ischemic heart disease, or Prinzmetal's angina;
• in cases of clinically significant arrhythmias and heart failure;
• if the patient has been diagnosed with peripheral vascular disease;
• in cases of a history of stroke or transient cerebral ischemia;
• in cases of concurrent use of ergotamine, ergotamine derivatives (including methysergide) within 24 hours before or 24 hours after taking eletriptan;
• in cases of concurrent use of other 5-HT receptor agonists.

Warnings and precautions

• in patients with suspected, undiagnosed heart disease. Relpax should not be taken without prior diagnostic examination;
• in patients with risk factors for coronary artery disease, such as hypertension, diabetes, smoking, or nicotine replacement therapy, male sex, age over 40, postmenopausal women, and patients with a family history of ischemic heart disease;
• in patients taking medications for depression and other mental illnesses, known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). These medications may increase the risk of developing serotonin syndrome, whose symptoms are: agitation, disorientation, diarrhea, high temperature and blood pressure, excessive sweating, accelerated heart rate, and increased reaction to stimuli;
• in cases of concurrent use of triptans and herbal medicines containing St. John's Wort (Hypericum perforatum);
• in cases of using medications containing ergotamine (used in peripheral vascular disorders and migraine) or its derivatives (e.g., dihydroergotamine). A 24-hour interval should be maintained between the last dose of these medications and the dose of Relpax.

Relpax should only be taken in cases of clear diagnosis of migraine. Relpax is not indicated for the treatment of migraine with hemiplegia (during the aura, there is a short-term weakness of the muscles of half of the body), ophthalmoplegic migraine (after a migraine attack, there is paralysis of the eye muscles), and basilar migraine (during the aura, there are symptoms in the area of the basilar artery, such as double vision, transient visual disturbances, speech disorders, clumsiness, sensation of numbness/tingling, followed by a brief loss of consciousness, and then severe occipital pain with vomiting).
Atypical headaches should not be treated with Relpax, as they may be headaches caused by serious diseases (stroke, aneurysm rupture), in which cerebral vasoconstriction may be harmful.
Relpax may cause transient symptoms including pressure and pain in the chest, sometimes severe and radiating to the throat (see section 4). Due to the occurrence of similar symptoms in ischemic heart disease, in such cases, Relpax should not be taken until the cause of these pains has been clarified.
After taking therapeutic doses of Relpax (60 mg of eletriptan or more), a transient small increase in blood pressure was observed.
Long-term use of any painkillers may cause an increase in headache severity. In patients who experience frequent or daily headaches despite regular use of painkillers, it should be considered to diagnose medication-overuse headache. If the patient experiences or suspects such a cause of headache, the medication should be discontinued.

Relpax and other medicines

The doctor or pharmacist should be informed about all medications currently or recently taken by the patient, as well as medications that the patient plans to take, especially:

• ketokonazole, itraconazole (used to treat fungal infections);
• ritonavir, indinavir, or nelfinavir (antiviral medications used to treat HIV infections);
• erythromycin, clarithromycin, josamycin (antibiotics used to treat bacterial infections); as these medications should not be taken concurrently with Relpax.

The doctor should be informed about the use of:

• medications for depression and other mental illnesses;
• triptans and herbal medicines containing St. John's Wort;
• medications containing ergotamine or its derivatives (e.g., dihydroergotamine); as in the case of concurrent use of these medications with Relpax, special caution should be exercised.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
The safety of Relpax in pregnant women has not been established. Relpax may be used in pregnant women only in cases of clear necessity (when the expected benefit to the mother outweighs the potential risk to the fetus).
Eletriptan passes into breast milk. Relpax should be used with caution in breastfeeding women. The effect of the medication on the infant can be limited by avoiding breastfeeding for 24 hours after taking the medication.

Driving and operating machinery

Migraine or the use of Relpax may cause drowsiness or dizziness in some patients. Caution should be exercised, and the ability to drive and operate machinery during migraine and while taking Relpax should be individually assessed.

Relpax contains lactose monohydrate, orange yellow S, aluminum lake (E 110), and sodium

Lactose is a type of sugar. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medication.
Orange yellow S, aluminum lake (E 110) may cause allergic reactions.
Relpax contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to take Relpax

This medication should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted.
Relpax should be taken as soon as possible after the onset of a migraine attack, although it also works when taken later.
Relpax taken during a migraine aura does not prevent the onset of migraine pain,
so Relpax should only be taken during a migraine headache.
Relpax should not be taken prophylactically.
The tablets should be swallowed whole, with a glass of water.

Use in adults

The recommended initial dose is 40 mg.
If the headache returns within 24 hours:If the migraine headache returns within 24 hours despite the initial effectiveness of the medication, it has been shown that an additional dose of Relpax (the same as the first) may be effective in treating this recurrence. If a second dose is indicated, it should not be taken before 2 hours have elapsed since the first dose.
If the headache does not subside:If the patient does not experience improvement within 2 hours after taking the first dose of Relpax, they should not take a second dose to treat the same attack, as the effectiveness of a second dose has not been confirmed in clinical trials.
Clinical trials have shown that in patients for whom the treatment of one migraine attack was ineffective, it may be effective in the next migraine attack.
In patients for whom a dose of 40 mg was ineffective (in cases of good tolerance and lack of response to treatment in 2 out of 3 attacks), a dose of 80 mg (2 x 40 mg) may be effective during subsequent migraine attacks. The next dose of 80 mg should not be taken before 24 hours have elapsed since the first dose.
The maximum daily dose of Relpax should not exceed 80 mg.

Use in children and adolescents

Relpax is not recommended for use in children and adolescents.

Use in patients with renal impairment

An initial dose of 20 mg is recommended in cases of mild and moderate renal impairment. The maximum daily dose should not exceed 40 mg. Relpax is contraindicated in patients with severe renal impairment.

Use in patients with hepatic impairment

In cases of mild or moderate hepatic impairment, dose modification is not necessary. The use of Relpax in patients with severe hepatic impairment is contraindicated.

Use in elderly patients

Relpax is not recommended for the treatment of patients over 65 years of age.

Use of a higher than recommended dose of Relpax

In case of taking a higher dose of Relpax than recommended, the doctor or the nearest hospital should be informed immediately.
Symptoms of overdose may include hypertension and serious cardiovascular disorders.

4. Possible side effects

Like all medicines, Relpax can cause side effects, although not everybody gets them.
Relpax has been used in clinical trials in over 5,000 patients. The most common side effects are weakness, drowsiness, nausea, and dizziness. The severity of side effects was mostly dose-dependent. In patients receiving therapeutic doses of Relpax in clinical trials, the following side effects were observed:

Common (may affect up to 1 in 10 people):

Pharyngitis and rhinitis, drowsiness, headache, dizziness, paresthesia or sensory disturbances, increased muscle tone, hypoesthesia, muscle weakness, vertigo of labyrinthine origin, palpitations, tachycardia, sudden flushing, pharyngitis, throat tightness, abdominal pain, nausea, dry mouth, dyspepsia, excessive sweating, back pain, muscle pain, feeling of warmth, weakness, chest symptoms (pain, feeling of constriction, feeling of pressure), chills, and pain.

Uncommon (may affect up to 1 in 100 people):

Anorexia, thinking disturbances, agitation, confusion, depersonalization, euphoria, depression, and insomnia, tremor, hyperesthesia, ataxia (incoordination), hypokinesia (prolonged motor activity characterized by slowing and impoverishment of movements), speech disturbances, stupor (torpor), taste disturbances, vision disturbances, eye pain, photophobia, lacrimation disturbances, ear pain, tinnitus, peripheral vascular disease, dyspnea, respiratory disturbances, yawning, diarrhea, glossitis, rash, pruritus, arthralgia, joint degenerative changes, bone pain, pollakiuria, urinary disorders, polyuria, malaise, facial edema, increased thirst, edema, and peripheral edema.

Rare (may affect up to 1 in 1,000 people):

Respiratory tract infection, lymphadenopathy, emotional lability, conjunctivitis, bradycardia, shock, asthma, voice changes, constipation, esophagitis, tongue edema, gastroesophageal reflux, hyperbilirubinemia (increased bilirubin levels in serum), elevated AST activity, skin disorders, urticaria, arthrosis, myopathy, and fasciculations (irregular muscle twitches), chest pain, menorrhagia.
Frequency not known(frequency cannot be estimated from the available data) – side effects observed after the marketing authorization of the medicinal product:
allergic reactions (some of which may be severe, such as angioedema), serotonin syndrome, rare cases of syncope, stroke, hypertension, ischemia, or myocardial infarction, coronary artery vasospasm, rare reports of ischemic colitis, vomiting, pruritus, rash, urticaria.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to store Relpax

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store at a temperature below 30°C. Protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Relpax contains

• The active substance of Relpax is eletriptan in the form of eletriptan hydrobromide. One film-coated tablet of Relpax contains 40 mg of eletriptan.
• The other ingredients of Relpax are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, orange yellow S, aluminum lake (E 110) (see section 2 Relpax contains lactose monohydrate, orange yellow S, aluminum lake (E 110), and sodium).

What Relpax looks like and what the packaging contains

Relpax is a round, convex, orange film-coated tablet with the inscription "REP 40" on one side and "Pfizer" on the other side.
The packaging contains 5 or 6 tablets in PVC/Aclar/Aluminum blisters in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in France, the country of export:

Viatris up
1, rue de Turin
69007 Lyon, France

Manufacturer:

Pfizer Italia S.R.L.
Località Marino del Tronto
63100 Ascoli Piceno, Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in France, the country of export:
34009 301 473 1 3
34009 357 868 5 2
34009 357 869 1 3

Parallel import authorization number: 226/24

Date of leaflet approval: 05.06.2024

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