Package Leaflet: Information for the User

RELPAX 40mg Film-Coated Tablets

Eletriptan

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only.Do not pass it on to others even if their symptoms are the same as yours.It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

6. Contents of the pack and additional information

Relpax contains eletriptan as the active ingredient. Relpax belongs to a group of medicines called serotonin receptor agonists. Serotonin is a natural substance found in the brain that helps to constrict blood vessels.

Relpax can be used for the treatment of migraine headache with or without aura in adults. Before a migraine headache begins, you may experience a phase called “aura”, in which you may experience visual disturbances, numbness, and language alterations.

Do not takeRelpax:

• If you are allergic (hypersensitive) to eletriptan or to any of the other components of this medication (listed in section 6).
• If you have a severe liver or kidney disease.
• If you have high blood pressure, moderate or severe, or if you have untreated mild high blood pressure.
• If you have had heart problems [for example, heart attack, angina, heart failure or significant abnormalities in heart rhythm (arrhythmia), transient and sudden narrowing of one of the coronary arteries].
• If you have poor circulation (peripheral vascular disease).
• If you have ever had a stroke (although it may have been mild and lasted only a few minutes or hours).
• If you have taken ergotamine or medications of the ergotamine type (including metisergide) within the 24 hours before or after taking Relpax.
• If you are taking other medications that end in “triptan” (for example, sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Inform your doctor and do not take Relpax, if you have any of these circumstances currently or if you have had them in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Relpax if:

• You have diabetes.
• You smoke or are undergoing nicotine replacement therapy.
• You are a male over 40 years old.
• You are a postmenopausal woman.
• You or a family member has coronary artery disease.
• You have been informed that you may be at increased risk of developing heart disease, inform your doctor before taking Relpax.

Repeated use of migraine medications

If you repeatedly use Relpax or any other migraine medication for several days or weeks, this may cause long-lasting daily headaches. Inform your doctor if you have experienced this, as you may need to interrupt treatment for a time.

Use of Relpax with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Relpax with some medications may cause severe adverse effects. Do not take Relpax if:

• You have taken ergotamine or medications of the ergotamine type (including metisergide) within the 24 hours before or after taking Relpax.
• You are taking other medications that end in “triptan” (for example, sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Some medications may affect how Relpax works, or Relpax itself may reduce the effectiveness of other medications taken at the same time. This includes:

• Medications used to treat fungal infections (for example, ketoconazole and itraconazole).
• Medications used to treat bacterial infections (for example, erythromycin, clarithromycin, and josamycin).
• Medications used to treat HIV and AIDS (for example, ritonavir, nelfinavir, and indinavir).

Preparations based on St. John's Wort (Hypericum perforatum) should not be taken at the same time as this medication. If you are already taking St. John's Wort, consult your doctor before stopping the preparation.

Inform your doctor before starting treatment with eletriptan, if you are taking some medications (commonly known as ISRSs* or IRSNs**) for depression or other mental disorders. These medications may increase the risk of developing serotonin syndrome when used in combination with certain medications for migraine. See Section 4 “Possible adverse effects” for more information on the symptoms of serotonin syndrome.

*ISRSs – Selective serotonin reuptake inhibitors.

**IRSNs – Serotonin and noradrenaline reuptake inhibitors.

Taking Relpax with food and drinks

Relpax can be taken before or after consuming food and drinks.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

It is recommended to avoid breastfeeding in the 24 hours following the intake of this medication.

Driving and operating machinery

Relpax, or the migraine itself, may cause drowsiness. This medication may also cause dizziness. For this reason, you should avoid driving and operating machinery during a migraine attack or after taking the medication.

Relpax contains lactose, aluminium lake of yellow-orange colour (E110) and sodium

Lactose is a type of sugar.This medication contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause allergic reactions because it contains aluminium lake of yellow-orange colour (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

You can take the medication at any time after the onset of migraine headache, but it is best to take it as soon as possible. However, you should only take Relpax during the headache phase of migraine. Do not take this medication to prevent a migraine attack.

• The recommended initial starting dose is 40mg (two Relpax 20mg tablets or one Relpax 40 mg tablet per day orally).
• Take the entire tablet with a little water.
• If the first tablet does not alleviate your migraine, you should not take a second tablet for the same attack.
• If after taking the first tablet your migraine is alleviated but then reappears, you can take a second tablet. However, after taking the first tablet, you should wait at least 2 hours before taking the second tablet.
• You should not take more than 80mg (four Relpax 20 mg tablets or two Relpax 40 mg tablets) in 24 hours.
• If with a dose of 40mg (two Relpax 20mg tablets or one Relpax 40 mg tablet) you do not obtain relief, consult your doctor. He will decide if you should increase the dose to 80mg (four Relpax 20mg tablets or two Relpax 40mg tablets) in successive attacks.

Use in childrenand adolescents under 18 years

Relpax tablets are not recommended for use in children and adolescents under 18 years.

Over 65 years

Relpax tablets are not recommended for use in patients over 65 years.

Renal insufficiency

This medication can be used in patients with mild or moderate kidney problems. In these patients, the initial recommended dose is 20mg (one Relpax 20mg tablet) and the total daily dose should not exceed 40mg (two Relpax 20mg tablets or one Relpax 40 mg tablet).

Liver insufficiency

This medication can be used in patients with mild or moderate liver problems. No dose adjustments are required for mild or moderate liver insufficiency.

If you take more Relpax than you should

If you accidentally take more Relpax than you should, contact your doctor immediately or go to the nearest hospital emergency room. Always carry the medication packaging with you, even if it is empty. The adverse effects of Relpax overdose include high blood pressure and heart problems.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Relpax

If you forgot to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediatelyif you experience any of the following symptoms after taking the medicine.

• Abnormal breathing sounds, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially affecting the entire body), as this may be a sign of an allergic reaction (hypersensitivity).
• Chest pain and tightness, which may be intense and affect the throat. These may be symptoms of heart circulation problems (ischemic cardiopathy).
• Symptoms and signs of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeats, increased body temperature, rapid changes in blood pressure, and hyperactivity of reflexes.

Other side effects that may occur are:

Frequent side effects:

(may affect up to 1 in 10 people)

• Chest pain or tightness, heart palpitations, increased heart rate.
• Dizziness, spinning sensation (vertigo), headache, numbness, decreased sense of touch or pain.
• Sore throat, sensation of throat tightness, dry mouth.
• Abdominal pain and stomach pain, indigestion (gastrointestinal disorder), nausea (feeling of unease and discomfort in the stomach or abdomen that prompts vomiting).
• Muscle stiffness (increased muscle tone), muscle weakness, back pain, muscle pain.
• General feeling of weakness, feeling of heat, chills, coughing, sweating, tingling or abnormal sensation, redness, pain.

Infrequent side effects:

(may affect up to 1 in 100 people))

• Difficulty breathing, yawning.
• Swelling of the face or hands and feet, inflammation or infection of the tongue, skin rash, itching.
• Increased sensitivity to touch or pain (hyperesthesia), loss of coordination, reduced or slowed movements, tremors, slurred speech.
• Feeling disconnected from oneself (derealization), depression, abnormal thinking, feeling agitated, feeling confused, changes in mood (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness, or lack of well-being (malaise), insomnia.
• Loss of appetite and weight loss (anorexia), alterations in taste, thirst.
• Joint degeneration (arthritis), bone pain, joint pain.
• Increased need to urinate, urinary problems, excessive urine production, diarrhea.
• Abnormal vision, eye pain, light intolerance, dry eyes or watery eyes.
• Ear pain, tinnitus (ringing in the ears).
• Poor circulation (peripheral vascular disorder).

Rare side effects:

(may affect up to 1 in 1,000 people))

• Shock, asthma, urticaria, skin alterations, swollen tongue.
• Chest or throat infection, enlarged lymph nodes.
• Decreased heart rate.
• Emotional fragility (mood changes).
• Joint degeneration (arthritis), muscle alteration, twitching.
• Constipation, esophageal inflammation, belching.
• Breast pain, heavy or prolonged menstruation.
• Eye infection (conjunctivitis).
• Changes in voice.

Other side effects reported include fainting, high blood pressure, inflammation of the large intestine, vomiting,vascular and cerebral accidents, inadequate heart blood flow, heart attack, spasm of the arteries and heart muscles.

Your doctor may make regular blood tests to examine increased liver enzymes or any blood problems.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

PVC/Aclar/Aluminum Blister Packs: No special storage conditions are required.

HDPE Bottles: Store in the original packaging. Keep the packaging perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Relpax 40 mg film-coated tablets

The active ingredient is eletriptan (as eletriptan hydrobromide).

Each Relpax 40 mg film-coated tablet contains 40 mg of eletriptan (in the form of hydrobromide).

The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, titanium dioxide (E-171), hypromellose, glycerol triacetate, and aluminium lake of yellow-orange FCF (E-110) (see section 2).

Appearance of the product and content of the container

Relpax tablets are orange, round, film-coated tablets.

Relpax 40 mg film-coated tablets are marked with “VLE” on one face and “REP 40” on the other.

Relpax is presented in opaque PVC/Aclar/Aluminium blisters containing 2, 3, 4, 5, 6, 10, 18, 30, and 100 tablets or in HDPE bottles with a HDPE/PP child-resistant closure containing 30 and 100 tablets.

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Healthcare, S.L.

General Aranaz Street, 86,3rd floor

28027 Madrid

Spain

Responsible manufacturer

Pfizer Italia S.r.l.,

Marino del Tronto

63100 Ascoli Piceno

Italy

Local Representative

Viatris Pharmaceuticals, S.L.U.

General Aranaz Street, 86

28027 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Relert 20 mg and 40 mg film-coated tablets: Belgium, Finland, Luxembourg, Portugal, Spain, United Kingdom.

Relpax 20 mg and 40 mg film-coated tablets: Austria, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Spain, Sweden, Netherlands, United Kingdom.

Last review date of this leaflet: January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/