Package Insert: Information for the User

Eletriptán Aurovitas 40 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Eletriptán Aurovitas contains eletriptán as the active ingredient. Eletriptán 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. Eletriptán 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 visual disturbances, numbness, and language alterations may occur.

Do not takeEletriptán Aurovitas:

• If you are allergic to eletriptán or 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, moderate, or severe hypertension, or if you have untreated mild hypertension.
• If you have had heart problems (for example, heart attack, angina, heart failure, or significant arrhythmias, 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 ergotamine-type medications (including metisergida) within the 24 hours before or after taking eletriptán.
• If you are taking other medications that end in “triptán” (for example, sumatriptán, rizatriptán, naratriptán, zolmitriptán, almotriptán, and frovatriptán).

Inform your doctor and do not take eletriptán if you are currently experiencing any of these circumstances or if you have experienced them in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take eletriptán 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 a higher risk of developing heart disease, inform your doctor before taking eletriptán.

Repeated use of migraine medications

If you repeatedly use eletriptán 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 Eletriptán Aurovitas with other medications

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

Taking Eletriptán Aurovitas with some medications may cause severe side effects. Do not take Eletriptán Aurovitas if:

• You have taken ergotamine or ergotamine-type medications (including metisergida) within the 24 hours before or after taking eletriptán.
• You are taking other medications that end in “triptán” (for example, sumatriptán, rizatriptán, naratriptán, zolmitriptán, almotriptán, and frovatriptán).

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

• Medications used to treat fungal infections (for example, ketoconazol and itraconazol).
• Medications used to treat bacterial infections (for example, erythromycin, clarithromycin, and josamicin).
• Medications used to treat HIV and AIDS (for example, ritonavir, nelfinavir, and indinavir).

Preparations containing 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 eletriptán 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 migraine medications. See Section 4 “Possible side effects” for more information on the symptoms of serotonin syndrome.

*ISRSs – Selective serotonin reuptake inhibitors.

**IRSNs – Serotonin and noradrenaline reuptake inhibitors.

Taking Eletriptán Aurovitas with food and drinks

Eletriptán 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 for 24 hours after taking this medication.

Driving and operating machinery

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

Eletriptán Aurovitas contains lactose and aluminium lake yellow-orange S (E110)

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 yellow-orange S (E110).

Eletriptán Aurovitas contains sodium

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 eletriptan during the headache phase of the migraine. Do not take this medication to prevent a migraine attack.

• The recommended initial starting dose is one 40 mg tablet.
• Swallow the tablet whole 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 80 mg (two 40 mg eletriptan tablets) in 24 hours.
• If with a 40 mg dose you do not obtain relief from your migraines, consult your doctor - they will decide if you should increase the dose to two 40 mg eletriptan tablets for subsequent attacks.

Use in children and adolescents under 18 years

The use of eletriptan tablets is not recommended in children and adolescents under 18 years.

Older patients

The use of eletriptan tablets is not recommended in patients over 65 years.

Kidney problems

This medication can be used in patients with mild or moderate kidney problems. In these patients, the recommended initial dose is 20 mg, and the total daily dose should not exceed 40 mg. Your doctor will tell you what dose to take.

Liver problems

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 Eletriptan Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor immediately, call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency service of the nearest hospital.

Always carry the medication packaging with you, even if it is empty. The adverse effects of an overdose with eletriptan include high blood pressure and heart problems.

If you forgot to take Eletriptan Aurovitas

If you forgot to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up 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.
• Chest pain and pressure, which can 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 heartbeat, 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 pressure, heart palpitations, increased heart rate.
• Dizziness, spinning sensation (vertigo), headache, numbness, decreased sense of touch or pain.
• Sore throat, sensation of throat pressure, dry mouth.
• Abdominal pain and stomach pain, indigestion (dyspepsia), nausea (sensation 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, sensation of heat, chills, coughing, sweating, tingling or abnormal sensation, redness, pain.

Rare 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, mood changes (euphoria).
• Periods of unresponsiveness (stupor), general feeling of discomfort, illness, or lack of well-being (malaise), difficulty sleeping (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, 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.
• Throat or chest 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).
• Voice changes.

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

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 blister pack or carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Eletriptán Aurovitas

• The active ingredient is eletriptán(as eletriptán hydrobromide).

Each coated tablet contains 40 mg of eletriptán (as hydrobromide).

• The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating:hypromellose 2910 (6cp), triacetin, titanium dioxide (E171), lactose monohydrate, aluminium lake yellow-orange S (E-110).

Appearance of the product and contents of the package

Coated tablet.

Coated tablets, orange in color, round, biconvex, engraved with “E” and “L” separated by a groove on one face and “40” on the other face. The tablet can be divided into equal doses.

Eletriptán Aurovitas coated tablets are available in blisters of 2, 3, 4, 6 and 10 coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

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

Spain:Eletriptán Aurovitas 40 mg coated tablets EFG

France:Eletriptan Arrow 40 mg coated tablet

Italy:Eletriptan Aurobindo

Netherlands:Eletriptan Aurobindo 40 mg, film-coated tablets

Portugal:Eletriptano Aurovitas

Last review date of this leaflet: March 2021

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