Relpax

Patient Information Leaflet

Warning! Keep this leaflet! The packaging label is in a foreign language.
Relpax
40 mg, coated tablets
Eletriptanum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Relpax is and what it is 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 pack and other information

1. What Relpax is and what it is used for

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

• symptoms associated with migraine attacks, such as vomiting, nausea, photophobia, and phonophobia,
• menstrually-related migraine,
• recurrent migraine headaches.

It has not been shown that Relpax, when administered during the migraine aura phase, prevents the onset of headache.
Therefore, Relpax should be taken only during a migraine headache attack.

2. Important information before using Relpax

When not to use Relpax

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

Warnings and precautions

• in patients with suspected but undiagnosed heart disease. Relpax should not be used without prior diagnostic evaluation;
• in patients with risk factors for coronary artery disease, such as: hypertension, diabetes, cigarette smoking or nicotine replacement therapy, male gender, age over 40 years, postmenopausal women, and patients with a family history of ischemic heart disease;
• in patients taking medications for depression and other psychiatric disorders known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). These drugs may increase the risk of serotonin syndrome, which may manifest as agitation, confusion, diarrhea, high body temperature and blood pressure, excessive sweating, tachycardia, and increased responsiveness to stimuli;
• when taking triptans together with herbal medicines containing St. John's wort (Hypericum perforatum);
• when using medications containing ergotamine (used, among others, in peripheral vascular disorders and migraine) or its derivatives (e.g. dihydroergotamine). A 24-hour interval must be maintained between the last dose of these drugs and administration of Relpax.

Relpax should only be used when migraine has been clearly diagnosed. Relpax is not indicated for the treatment of hemiplegic migraine (during aura, transient weakness of muscles on one side of the body occurs), ophthalmoplegic migraine (after a migraine attack, paralysis of the eye-moving muscles appears), or basilar migraine (during aura, symptoms related to the territory supplied by the basilar artery of the brain occur, such as diplopia, transient visual disturbances, speech disturbances, ataxia, tingling/numbness, accompanied by transient loss of consciousness, followed by severe occipital pain with vomiting).

"Atypical" headaches should not be treated with Relpax, as they may be caused by serious conditions (e.g. stroke, aneurysm rupture), in which cerebral vasoconstriction could be harmful.

Transient symptoms including chest tightness and pain, sometimes severe and radiating to the throat, may occur after taking Relpax (see section 4). Because similar symptoms may occur in ischemic heart disease, Relpax should not be taken until the cause of such pain has been clarified.

After administration of therapeutic doses of Relpax (60 mg eletriptan or higher), a transient, slight increase in blood pressure has been observed.

Prolonged use of any analgesic drugs may lead to worsening of headache. In patients experiencing frequent or daily headaches despite regular use of pain medications, medication-overuse headache should be considered. If this condition is present or suspected, the drug should be discontinued.

Relpax and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take, especially:

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

Inform your doctor if you are taking:

• medications for depression and other psychiatric disorders;
• triptans or herbal medicines containing St. John's wort;
• medications containing ergotamine or its derivatives (e.g. dihydroergotamine); as special caution is required when these drugs are used concomitantly with Relpax.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The safety of Relpax in pregnant women has not been established. Relpax may be used during pregnancy only if clearly necessary (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 on the infant can be minimized by avoiding breastfeeding for 24 hours after taking the medicine.

Driving and operating machinery

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

Relpax contains lactose monohydrate, sunset yellow FCF, aluminium lake of sunset yellow (E 110), and sodium

Lactose is a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Sunset yellow FCF, aluminium lake of sunset yellow (E 110) may cause allergic reactions.

Relpax contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Relpax

This medicine should always be used as directed by a physician. If in doubt, consult your doctor or pharmacist.
Relpax should be taken as soon as possible after the onset of a migraine attack, although it is also effective if taken later.
Relpax taken during the migraine aura phase does not prevent the occurrence of migraine headache; therefore, Relpax should be taken only during migraine headache.
Relpax must not be used prophylactically.
Tablets should be swallowed whole with water.

Use in adults
The recommended initial dose is 40 mg.
If headache recurs within 24 hours: If migraine headache recurs within 24 hours despite an initially effective response, clinical studies have 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 must not be taken earlier than 2 hours after the first dose.
If headache does not resolve: If the patient does not experience improvement within 2 hours after taking the first dose of Relpax, a second dose should not be taken for treatment of the same attack, as clinical studies have not confirmed the efficacy of a second dose in such cases.
Clinical studies have shown that in patients in whom treatment of one migraine attack was ineffective, treatment may be effective in a subsequent migraine attack.
In patients for whom the 40 mg dose was ineffective (in cases of good tolerability and lack of response in 2 out of 3 attacks), a dose of 80 mg (2 x 40 mg) may be effective during subsequent migraine attacks. The next 80 mg dose must not be taken earlier than 24 hours after the first dose.
The maximum recommended daily dose of Relpax is 80 mg.

Use in children and adolescents
The use of Relpax is not recommended in children and adolescents.

Use in patients with renal impairment
An initial dose of 20 mg is recommended in patients with mild to 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
Dose adjustment is not necessary in cases of mild or moderate hepatic impairment. The use of Relpax is contraindicated in patients with severe hepatic impairment.

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
If a higher than recommended dose of Relpax is taken, contact a physician immediately or go to the nearest hospital.
Symptoms of overdose may include hypertension and serious cardiovascular events.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will experience them.
Relpax has been used in clinical trials in over 5000 patients. The most common adverse reactions are weakness, drowsiness, nausea and dizziness. The severity of adverse reactions was generally dose-dependent. In patients receiving therapeutic doses in clinical trials, the following adverse reactions were observed:
Common (may affect up to 1 in 10 people):
Pharyngitis and nasopharyngitis, drowsiness, headache, dizziness, tingling or sensory disturbances, increased muscle tension, hypoaesthesia, myasthenia, 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, tightness, pressure), chills and pain.
Uncommon (may affect up to 1 in 100 people):
Anorexia, thinking disturbances, restlessness, confusion, depersonalization, euphoria, depression and insomnia, tremor, hyperaesthesia, ataxia (lack of coordination of movements), hypokinesia (prolonged motor activity including slowing down and impoverishment of movements), speech disorders, stupor, taste disturbances, visual disturbances, eye pain, photophobia, lacrimation disorders, ear pain, tinnitus, peripheral vascular disease, dyspnoea, breathing disorders, yawning, diarrhoea, glossitis, rash, pruritus, joint pain, degenerative joint changes, bone pain, pollakiuria, urinary disorders, polyuria, malaise, facial swelling, increased thirst, oedema and peripheral oedema.
Rare (may affect up to 1 in 1,000 people):
Respiratory tract infection, lymph node enlargement, emotional lability, conjunctivitis, bradycardia, shock, asthma, voice changes, constipation, oesophagitis, tongue oedema, regurgitation with food content, hyperbilirubinaemia (increased bilirubin concentration in plasma), elevated AspAT activity, skin disease, urticaria, arthritis, myopathy and fasciculations (irregular muscle twitching), breast pain, menorrhagia.
Frequency not known (frequency cannot be estimated from the available data) – adverse reactions observed after marketing authorization:
allergic reactions (some of which may be severe, such as angioedema), serotonin syndrome, rare cases of fainting, stroke, hypertension, ischaemia or myocardial infarction, coronary artery spasm, rare reports of ischaemic colitis, vomiting, pruritus, rash, urticaria.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 adverse reactions helps provide more information on the safety of the medicine.

5. How to store Relpax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 30°C. Protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Relpax contains

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

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

What Relpax looks like and contents of the pack

Relpax is a round, convex, orange-coated tablet, with the imprint "REP 40" on one side and "VLE" on the other side.

The pack contains 5 or 6 tablets in PVC/Aclar/Aluminium blisters.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation numbers in France, the country of export: 34009 357 868 5 2
34009 357 869 1 3

Parallel Import Authorisation number: 50/23