Relpax

Package Leaflet: Information for the Patient

Relpax, 40 mg, Film-Coated Tablets

Eletriptan

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, nurse, or pharmacist. 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 pack 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 phonophobia,
• menstrual migraine,
• recurrent migraine headaches.

It has not been shown that Relpax taken during the aura phase of a migraine prevents the subsequent headache,
so Relpax should only be taken during a migraine headache.
Relpax should not be taken prophylactically.

2. Important information before taking Relpax

When not to take Relpax

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney impairment;
• in cases of moderate or severe hypertension or uncontrolled mild hypertension;
• if you have been diagnosed with coronary artery disease, including ischemic heart disease (angina pectoris, myocardial infarction, or confirmed asymptomatic ischemia);
• if you have vasospastic coronary artery disease, objective or subjective symptoms of ischemic heart disease, or Prinzmetal's angina;
• in cases of clinically significant arrhythmias and heart failure;
• if you have 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 after taking eletriptan;
• in cases of concurrent use of other 5-HT1 receptor agonists.

Warnings and precautions

• in patients with probable, undiagnosed coronary artery disease. Relpax should not be taken without prior diagnostic evaluation;
• 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 disorders, 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, tachycardia, 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 when migraine is diagnosed without doubt. Relpax is not indicated for the treatment of migraine with hemiplegia (during the aura phase, there is a transient hemiparesis), ophthalmoplegic migraine (after a migraine attack, there is paresis of the eye muscles), and basilar migraine (during the aura phase, there are symptoms in the area of the basilar artery, such as double vision, transient visual disturbances, speech disorders, ataxia, feeling of numbness/tingling, to which is added a brief loss of consciousness, followed by a severe occipital pain with vomiting).
Do not treat "atypical" headaches 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 tightness and pain in the chest, sometimes severe and radiating to the throat (see section 4). Due to the occurrence of similar symptoms in coronary artery disease, in such cases, Relpax should not be taken until the cause of these pains is 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 pain medication may cause an increase in headache severity. In patients who experience frequent or daily headaches despite regular use of pain medications, consideration should be given to the diagnosis of medication-overuse headache. If the patient has or is suspected to have this type of headache, the medication should be discontinued.

Relpax and other medications

Tell your doctor or pharmacist about all medications you are taking now or have taken recently, as well as medications you plan 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); these medications should not be taken concurrently with Relpax.

Inform your doctor about taking:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
The safety of Relpax in pregnant women has not been established. Relpax may be used in pregnant women only 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 medication.

Driving and using machines

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

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

Lactose is a type of sugar. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medication.
Orange yellow S 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 as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Relpax should be taken as soon as possible after the onset of a migraine attack, although it is effective when taken later.
Relpax taken during the aura phase of a migraine does not prevent the subsequent headache,
so Relpax should only be taken during a migraine headache.
Relpax should not be taken prophylactically.
Tablets should be swallowed whole with 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 the 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, a second dose should not be taken 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 the 40 mg dose 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 80 mg dose 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

The recommended initial dose is 20 mg 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 adjustment 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.

Overdose of Relpax

In case of overdose, immediately inform your doctor or go to the nearest hospital.
Symptoms of overdose may include hypertension and serious cardiovascular disorders.

4. Possible side effects

Like all medications, 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 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, hypoaesthesia, myasthenia, vertigo of labyrinthine origin, palpitations, tachycardia, sudden flushing, pharyngitis, tightness in the throat, abdominal pain, nausea, dry mouth, dyspepsia, excessive sweating, back pain, muscle pain, feeling of warmth, weakness, symptoms from the chest (pain, feeling of compression, feeling of tightness), chills, and pain.

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

Anorexia, thinking disturbances, agitation, confusion, depersonalization, euphoria, depression, and insomnia, tremor, hyperaesthesia, ataxia (lack of coordination), hypokinesia (prolonged motor activity characterized by slowing and impoverishment of movements), speech disorders, stupor (torpor), taste disturbances, vision disturbances, eye pain, photophobia, lacrimation disorders, ear pain, tinnitus, peripheral vascular disease, dyspnea, respiratory disorders, 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 disease, urticaria, arthritis, myopathy, and fasciculations (irregular muscle twitches), chest pain, menorrhagia.
Frequency not known(frequency cannot be estimated from the available data) – adverse reactions observed after the medication was marketed:
allergic reactions (some of which may be severe, such as angioedema), serotonin syndrome, rare cases of syncope, cerebral vasospasm, hypertension, ischemia, or myocardial infarction, coronary artery vasospasm, rare reports of ischemic colitis, vomiting, pruritus, rash, urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Relpax

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton after EXP. The expiration date refers to the last day of the month stated.
Store in a temperature below 30°C. Protect from moisture.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack 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. The colored coating - Opadry Orange OY-LS-23016: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, orange yellow S (E 110) (see section 2 Relpax contains lactose, orange yellow S (E 110), and sodium). The clear coating - Opadry Clear YS-2-19114-A: hypromellose, triacetin.

What Relpax looks like and contents of the pack

Relpax is a round, convex, orange film-coated tablet with "REP 40" embossed on one side and "VLE" on the other.
The pack contains 2, 4, 5, or 6 tablets in PVC/Aclar/Al blisters in a cardboard box.

Marketing authorization holder

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands

Manufacturer:

Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno
Italy
To obtain more detailed information about this medication, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: 22 546 64 00

Date of last revision of the leaflet: