RELPAX 40 mg FILM-COATED TABLETS

1. What is Relpax and what is it used for

Relpax contains eletriptan as the active substance. Relpax belongs to a group of medicines called serotonin receptor agonists. Serotonin is a naturally occurring substance found in the brain, which helps to narrow blood vessels.

Relpax can be used for the treatment of migraine with or without aura in adults. Before the migraine attack starts, you may experience a phase called "aura", in which vision disturbances, numbness, and language disturbances may occur.

2. What you need to know before you take Relpax

Do not takeRelpax:

• If you are allergic (hypersensitive) to eletriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver or kidney disease.
• If you have high blood pressure, moderate or severe, or if you have mild untreated high blood pressure.
• If you have had heart problems [e.g., heart attack, angina, heart failure, or significant cardiac rhythm disturbances (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 (even if it was mild and only lasted a few minutes or hours).
• If you have taken ergotamine or ergotamine-type medications (including methysergide) within 24 hours before or after taking Relpax.
• If you are taking other medicines that end in "triptan" (e.g., sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Tell your doctor and do not take Relpax if you currently have or have had any of these conditions.

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 have coronary artery disease.
• You have been informed that you may have an increased risk of heart disease, inform your doctor before taking Relpax.

Repeated Use of Migraine Medicines

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

Use of Relpax with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Taking Relpax with some medicines may cause serious side effects. Do not take Relpax if:

• You have taken ergotamine or ergotamine-type medications (including methysergide) within 24 hours before or after taking Relpax.
• You are taking other medicines that end in "triptan" (e.g., sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

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

• Medicines used to treat fungal infections (e.g., ketoconazole and itraconazole).
• Medicines used to treat bacterial infections (e.g., erythromycin, clarithromycin, and josamycin).
• Medicines used to treat AIDS and HIV (e.g., ritonavir, nelfinavir, and indinavir).

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

Tell your doctor before starting treatment with eletriptan if you are taking some medicines (commonly known as SSRIs* or SNRIs**) for depression or other mental disorders. These medicines may increase the risk of developing serotonin syndrome during combined use with certain migraine medicines. See Section 4 "Possible side effects" for more information on serotonin syndrome symptoms.

*SSRIs – Selective serotonin reuptake inhibitors.

**SNRIs – Serotonin and norepinephrine reuptake inhibitors.

Taking Relpax with Food and Drinks

Relpax can be taken before or after food and drinks.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

It is recommended to avoid breastfeeding for 24 hours after taking this medicine.

Driving and Using Machines

Relpax, or the migraine itself, may cause drowsiness. This medicine may also cause a feeling of dizziness. For this reason, you should avoid driving and using machines during the migraine attack or after taking the medicine.

Relpax contains Lactose, Yellow-Orange Aluminum Lake (E110), and Sodium

Lactose is a type of sugar. This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause allergic reactions because it contains Yellow-Orange Aluminum Lake (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to Take Relpax

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

Adults

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

• The recommended starting dose is 40 mg (two 20 mg Relpax tablets or one 40 mg Relpax tablet per day by mouth).
• Take the tablet whole with a little water.
• If the first tablet does not relieve your migraine, do not take a second tablet for the same attack.
• If after taking the first tablet your migraine is relieved but then returns, you can take a second tablet. However, after taking the first tablet, you must wait at least 2 hours before taking the second tablet.
• Do not take more than 80 mg (four 20 mg Relpax tablets or two 40 mg Relpax tablets) in 24 hours.
• If with a dose of 40 mg (two 20 mg Relpax tablets or one 40 mg Relpax tablet) you do not get relief, consult your doctor. He will decide if you should increase the dose to 80 mg (four 20 mg Relpax tablets or two 40 mg Relpax tablets) in subsequent attacks.

Use in Children and Adolescents Under 18 Years

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

Elderly Over 65 Years

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

Renal Impairment

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

Hepatic Impairment

This medicine can be used in patients with mild or moderate liver problems. No dose adjustments are required for mild or moderate hepatic impairment.

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 emergency department of the nearest hospital. Always take the medicine package with you, even if it is empty. The adverse effects of overdose with Relpax include high blood pressure and heart problems.

Consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the medicine package and leaflet to the healthcare professional.

If You Forget to Take Relpax

If you forget to take a dose, take it as soon as you remember, unless it is close to the time for the next dose. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially affecting the whole body), as this may be a sign of hypersensitivity (allergy).
• Chest pain and tightness, which can be severe and affect the throat. These can be symptoms of heart circulation problems (ischemic heart disease).
• Signs and symptoms of serotonin syndrome, which can include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, and hyperactivity of the reflexes.

Other side effects that may occur are:

Common Side Effects:

(may affect up to 1 in 10 people)

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

Uncommon 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, tremor, slurred speech.
• Feeling of detachment from reality (depersonalization), depression, abnormal thinking, feeling agitated, feeling confused, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness, or unease (malaise), sleep problems (insomnia).
• Lack of appetite and weight loss (anorexia), taste disturbances, thirst.
• Joint degeneration (arthrosis), bone pain, joint pain.
• Increased need to urinate, urination problems, excessive urine production, diarrhea.
• Abnormal vision, eye pain, sensitivity to light, dry eyes or teary eyes.
• Ear pain, ringing in the ears (tinnitus).
• Poor circulation (peripheral vascular disorder).

Rare Side Effects:

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

• Shock, asthma, hives, skin changes, swollen tongue.
• Chest or throat infection, swollen lymph nodes.
• Decreased heart rate.
• Emotional fragility (mood changes).
• Joint degeneration (arthritis), muscle disorder, twitching.
• Constipation, esophagus inflammation, belching.
• Breast pain, heavy or prolonged menstrual bleeding.
• Eye infection (conjunctivitis).
• Voice changes.

Other side effects reported include fainting, high blood pressure, large intestine inflammation, vomiting, blood vessel and brain accidents, inadequate blood flow to the heart, heart attack, artery and heart muscle spasms.

Your doctor may perform regular blood tests to check for increased liver enzymes or any blood problems.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Relpax

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

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

HDPE Bottles: Store in the original package. Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages and unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Relpax 40 mg Film-Coated Tablets

The active substance is eletriptan (as eletriptan hydrobromide).

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

The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, titanium dioxide (E-171), hypromellose, glycerol triacetate, and Yellow-Orange Aluminum Lake (E110) (see section 2).

Appearance of the Product and Pack Contents

Relpax tablets are orange and round film-coated tablets.

Relpax 40 mg film-coated tablets are engraved with "VLE" on one side and "REP 40" on the other.

Relpax is available in opaque PVC/Aclar/Aluminum blister packs containing 2, 3, 4, 5, 6, 10, 18, 30, and 100 tablets, or in HDPE bottles with a child-resistant HDPE/PP cap containing 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare, S.L.

Calle General Aranaz, 86, 3rd floor

28027 Madrid

Spain

Manufacturer

Pfizer Italia S.r.l.,

Località Marino del Tronto

63100 Ascoli Piceno

Italy

Local Representative

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 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.

Date of Last Revision of this Leaflet: January 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/