Relpax

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Relpax, 40 mg, film-coated tablets
Eletriptanum
Please read the entire leaflet carefully before using this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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-associated migraine,
• recurrent migraine headaches.

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

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, previous myocardial infarction, or confirmed asymptomatic ischemia);
• if the patient has coronary artery spasm, 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 cases of previous stroke or transient ischemic attack (TIA) in the patient's history;
• when concomitantly taking ergotamine, ergotamine derivatives (including methysergide) within 24 hours before or 24 hours after taking eletriptan;
• when concomitantly taking other 5-HT receptor agonists.

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 medications may increase the risk of serotonin syndrome, which may present with symptoms such as agitation, confusion, diarrhea, high body temperature and blood pressure, excessive sweating, tachycardia, and increased sensitivity to stimuli;
• when concomitantly using triptans and 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 medications 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 hemiparesis occurs),
ophthalmoplegic migraine (after a migraine attack, paralysis of the eye-moving muscles appears), or
basilar 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, sensation of numbness/tingling,
accompanied by transient loss of consciousness, followed by severe pain in the occipital region 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 therapeutic doses of Relpax (60 mg eletriptan or higher) (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.
A transient, slight increase in arterial blood pressure has been observed after administration of therapeutic doses of Relpax (60 mg eletriptan or higher).
Long-term use of any analgesic medications 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 medication should be discontinued.

Relpax and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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);
  as these medicines should not be taken simultaneously with Relpax.

Inform your doctor if you are taking:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a 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 of the drug on the infant can be minimized 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 or operate machinery should be individually assessed during a migraine attack and while using Relpax.

Relpax contains monohydrate lactose, 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, the patient 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, meaning the medicine is considered "sodium-free".

3. How to use Relpax

This medicine should always be used exactly as directed 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 a migraine aura does not prevent the occurrence of migraine headache; therefore, Relpax should only be taken during a 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 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 subside: 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 proved ineffective (in cases of good tolerability 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
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 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. Use of Relpax is contraindicated in patients with severe hepatic impairment.

Use in elderly patients
Relpax is not recommended for the treatment of elderly 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 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 will experience them.
Relpax has been used in clinical trials involving over 5000 patients. The most common adverse reactions are weakness, drowsiness, nausea, and dizziness. The intensity of adverse reactions was generally dose-dependent. In patients receiving therapeutic doses of the medicine in clinical trials, the following adverse reactions were observed:
Common (may occur in up to 1 in 10 people):
Pharyngitis and nasopharyngitis, drowsiness, headache, dizziness, tingling or sensory disturbances, increased muscle tension, hypoesthesia, muscle fatigue, 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 up to 1 in 100 people):
Loss of appetite, thinking disturbances, restlessness, confusion, depersonalization, euphoria, depression and insomnia, tremor, hyperesthesia, ataxia (lack of voluntary coordination of muscle movements), hypokinesia (prolonged motor activity including slowness and poverty of movements), speech disorders, stupor, taste disturbances, visual disturbances, eye pain, photophobia, disturbances of tear secretion, ear pain, tinnitus, peripheral vascular disease, dyspnea, breathing disorders, yawning, diarrhea, glossitis, rash, pruritus, joint pain, degenerative joint changes, bone pain, pollakiuria, urinary tract disorders, polyuria, malaise, facial swelling, increased thirst, edema and peripheral edema.
Rare (may occur in up to 1 in 1,000 people):
Respiratory tract infection, lymphadenopathy, emotional lability, conjunctivitis, tetany, shock, asthma, voice alteration, constipation, esophagitis, tongue swelling, belching with regurgitation of food, hyperbilirubinemia (increased bilirubin concentration in plasma), elevated AspAT activity, skin disorders, urticaria, arthritis, myopathy and fasciculations (irregular muscle twitching), breast tenderness, 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, 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 adverse reactions 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 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 as eletriptan hydrobromide. Each 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 film-coated tablet with the imprint "REP 40" on one side and "Pfizer" on the other side.

The pack contains 5 or 6 tablets in PVC/Aclar/Aluminium blisters, packed in a cardboard carton.

For further 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:

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

Repackaged in:

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

Marketing Authorisation numbers in France, the country of export:
34009 301 473 1 3
34009 357 868 5 2
34009 357 869 1 3

Parallel import authorisation number: 226/24