Relpax

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Relpax
40 mg, film-coated tablets
Eletriptanum
Please read this leaflet carefully before taking 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. It may harm someone else, even if their symptoms are the same.
• 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 of the leaflet

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.

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 components 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 history of stroke or transient ischemic attack (TIA);
• when taking ergotamine, ergotamine derivatives (including methysergide) within 24 hours before or 24 hours after taking eletriptan;
• when taking other 5-HT1 receptor agonists simultaneously.

Warnings and precautions

• in patients with probable, 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, the symptoms of which include: agitation, confusion, diarrhea, high body temperature and blood pressure, excessive sweating, tachycardia, and increased response 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 should be maintained between the last dose of these medications and the dose of Relpax.

Relpax should only be taken when migraine has been clearly diagnosed. Relpax is not indicated for the treatment of hemiplegic migraine (during aura, transient hemiparesis occurs), ophthalmoplegic migraine (after a migraine attack, paralysis of the eye muscles appears), or basilar-type migraine (during aura, symptoms occur in the territory supplied by the basilar artery of the brain, 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 pressure and pain in the chest, sometimes intense 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 symptoms has been clarified.

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

Prolonged use of any pain-relieving medicines 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 such a cause of headache is present or suspected, the medicine should be discontinued.

Relpax and other medicines

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

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

Inform your doctor if you are taking:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

The safety of Relpax during pregnancy 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 the use of Relpax may cause drowsiness or dizziness in some patients. Caution is advised, 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 monohydrate is a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they 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 take Relpax

This medicine should always be taken according to the instructions given by your doctor. 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 remains effective even if taken later.
Relpax taken during the migraine aura phase does not prevent the occurrence of migraine headache; therefore, Relpax should only be taken during a migraine headache.
Relpax must not be taken 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 initial effective treatment, 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 improve: 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 treating 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 prove effective during the next migraine attack.
In patients in whom the 40 mg dose proved ineffective (in cases of good tolerance and lack of response to treatment in 2 out of 3 attacks), an 80 mg dose (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 daily dose of Relpax must not exceed 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 must 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 your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include arterial hypertension and serious cardiovascular disturbances.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Relpax has been used in clinical trials involving over 5000 patients. The most common adverse reactions are fatigue, drowsiness, nausea, and dizziness. The intensity of adverse reactions was generally dose-dependent. In patients receiving therapeutic doses in clinical trials, the following adverse reactions were observed:

Common (may occur in no more than 1 in 10 people):
Pharyngitis, nasopharyngitis, drowsiness, headache, dizziness, tingling or sensory disturbances, increased muscle tension, hypoesthesia, myasthenia, vestibular dizziness, palpitations, tachycardia, sudden facial 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 occur in no more than 1 in 100 people):
Loss of appetite, thinking disturbances, restlessness, confusion, depersonalization, euphoria, depression, and insomnia, tremor, hyperesthesia, ataxia (lack of coordination of movements), hypokinesia (prolonged motor activity including slowness and reduction of movements), speech disorders, stupor, taste disturbances, visual disturbances, eye pain, photophobia, disturbances in tear secretion, ear pain, tinnitus, peripheral vascular disorder, dyspnea, breathing difficulties, yawning, diarrhea, glossitis, rash, pruritus, joint pain, degenerative joint changes, bone pain, pollakiuria, urinary disorders, polyuria, malaise, facial swelling, increased thirst, edema, and peripheral edema.

Rare (may occur in no more than 1 in 1,000 people):
Respiratory tract infection, lymph node enlargement, emotional lability, conjunctivitis, rare seizures, shock, asthma, voice changes, constipation, esophagitis, tongue swelling, regurgitation with food content, hyperbilirubinemia (increased bilirubin concentration in plasma), elevated AspAT activity, skin disorders, urticaria, arthritis, myopathy, and fasciculations (irregular muscle twitches), breast tenderness, heavy menstruation.

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, ischemia or myocardial infarction, coronary artery spasm, rare reports of ischemic 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 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 to provide more information on the safety of the medicine.

5. How to store the medicine Relpax

Keep this medicine out of 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. Such measures 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,
orange yellow S, aluminium lake (E 110) (see section 2: Relpax contains lactose monohydrate,
orange yellow S, 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 tablets in a PVC/Aclar/Aluminium blister pack, in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in France, country of export: 34009 357 869 1 3
357 869-1

Parallel Import Licence Number: 88/25