Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Relpax
40 mg, coated tablets
Eletriptan
Please read this 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.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Relpax is and what it is used for
Important information before taking Relpax
How to take Relpax
Possible side effects
How to store Relpax
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 migraines,
recurrent migraine headaches.

It has not been demonstrated that Relpax, when administered during a migraine aura, 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 ingredients of this medicine (listed in section 6);
if the patient has severe hepatic or renal insufficiency;
in case 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 case of previous stroke or transient ischemic attack (TIA) in medical history;
when concurrently taking ergotamine, ergotamine derivatives (including methysergide) within 24 hours before or 24 hours after taking eletriptan;
when concurrently 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 drugs may increase the risk of serotonin syndrome, the symptoms of which include: agitation, confusion, diarrhea, high body temperature and blood pressure, excessive sweating, increased heart rate, and heightened response to stimuli;
when taking tryptans 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 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 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.
Relpax may cause transient symptoms including pressure and pain in the chest, sometimes intense and
radiating to the throat (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 of eletriptan or higher), a transient, slight
increase in blood pressure has been observed.
Prolonged use of any pain-relieving medication may lead to worsening of headache. In patients
experiencing frequent or daily headaches despite regular use of pain medications, consider the
diagnosis of medication-overuse headache. 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 currently taken 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);
as these medicines should not be taken simultaneously with Relpax.

Inform your doctor if you are taking:

medications for depression and other psychiatric disorders;
tryptans 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 concurrently with Relpax.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 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 is advised, and the ability to drive or operate machinery should be individually assessed during a migraine attack and while taking Relpax.

Relpax contains lactose monohydrate, Orange Yellow S FCF, aluminium lake (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.
Orange Yellow S FCF, aluminium lake (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 a doctor or pharmacist.
Relpax should be taken as soon as possible after the onset of a migraine attack, although it is also effective when 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 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 should 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 treatment of the same attack, as clinical studies have not confirmed the effectiveness of a second dose.
Clinical studies have shown that in patients in whom treatment of one migraine attack was ineffective, treatment may prove effective during a subsequent migraine attack.
In patients in whom the 40 mg dose was ineffective (in cases of good tolerability 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 80 mg dose should not be taken earlier than 24 hours after the first dose.
The maximum daily dose of Relpax should 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 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 use in 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, a doctor should be notified immediately or the nearest hospital should be contacted.
Symptoms of overdose may include hypertension and serious cardiovascular adverse effects.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Relpax has been used in clinical trials involving more than 5,000 patients. The most common adverse reactions were weakness, drowsiness, nausea, and dizziness. The intensity of adverse reactions was generally dose-dependent. The following adverse reactions were observed in patients receiving therapeutic doses during clinical trials:

Common (may occur in up to 1 in 10 people):
Pharyngitis, nasopharyngitis, drowsiness, headache, dizziness, paraesthesia or sensory disturbances, increased muscle tension, hypoaesthesia, myalgia, vertigo, palpitations, tachycardia, flushing, pharyngitis, throat tightness, abdominal pain, nausea, dry mouth, dyspepsia, excessive sweating, back pain, muscle pain, feeling of warmth, fatigue, chest symptoms (pain, tightness, pressure), chills, and pain.

Uncommon (may occur in up to 1 in 100 people):
Loss of appetite, thinking disturbances, excitation, confusion, depersonalization, euphoria, depression, insomnia, tremor, hyperaesthesia, ataxia (lack of coordination of movements), hypokinesia (prolonged motor activity including slowing and reduction of movements), speech disorders, stupor, taste disturbances, visual disturbances, eye pain, photophobia, lacrimation disorders, ear pain, tinnitus, peripheral vascular disease, dyspnoea, breathing difficulties, 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 occur in up to 1 in 1,000 people):
Respiratory tract infection, lymphadenopathy, emotional lability, conjunctivitis, rare seizures, 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 twitches), 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 also 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, phone: +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 this 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 required. Such measures will help protect the environment.

6. Package contents and other information

What the medicine Relpax contains

The active substance is eletriptan in the form of eletriptan hydrobromide. One coated tablet of Relpax contains 40 mg of eletriptan.
Other components of the medicine are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, orange-yellow S FCF, aluminium lake (E 110). (See section 2. Relpax contains lactose monohydrate, orange-yellow S FCF, aluminium lake (E 110), and sodium.)

What Relpax looks like and contents of the pack
Relpax is a round, convex, orange coated tablet, embossed with "REP 40" on one side and "Pfizer" on the other side.
The pack contains 2 tablets or 6 tablets in PVC/Aclar/Aluminium blisters, in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Austria, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle Aan Den Ijssel
The Netherlands
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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Austria, country of export: 1-24155
Parallel Import Authorisation Number: 189/24