Eletriptan Aurovitas 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eletriptán Aurovitas 20 mg film-coated tablets EFG

Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Eletriptán Aurovitas is and what it is used for
2. What you need to know before taking Eletriptán Aurovitas
3. How to take Eletriptán Aurovitas
4. Possible side effects
5. How to store Eletriptán Aurovitas
6. Contents of the pack and other information

1. What Eletriptán Aurovitas is and what it is used for

Eletriptán Aurovitas contains eletriptán as the active substance. Eletriptán belongs to a group of medicines known as serotonin receptor agonists. Serotonin is a natural substance found in the brain that helps narrow blood vessels. Eletriptán can be used for the treatment of migraine headache with or without aura in adults. Before the migraine headache begins, you may experience a phase called "aura," during which visual disturbances, numbness, and speech disturbances may occur.

2. What you need to know before taking Eletriptán Aurovitas

Do not take Eletriptán Aurovitas:

• If you are allergic to eletriptan or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver or kidney disease.
• If you have moderate or severe high blood pressure, or 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 (even a mild one that lasted only minutes or hours).
• If you have taken ergotamine or ergot-type medications (including methysergide) within 24 hours before or after taking eletriptan.
• If you are taking other medicines ending in “triptan” (for example, sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Inform your doctor and do not take eletriptan if you currently have or have ever had any of these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before taking eletriptan if:

• You have diabetes.
• You smoke or are undergoing nicotine replacement therapy.
• You are a man over 40 years of age.
• You are a postmenopausal woman.
• You or a family member has coronary artery disease.
• You have been told you may be at increased risk of heart disease; inform your doctor about this before taking eletriptan.

Repeated use of migraine medications

If you repeatedly use eletriptan or any other migraine treatment over several days or weeks, this may cause long-lasting daily headaches. Inform your doctor if this occurs, as you may need to stop treatment for a period.

Taking Eletriptán Aurovitas with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Taking Eletriptán Aurovitas together with certain medicines may cause serious adverse effects. Do not take Eletriptán Aurovitas if:

• You have taken ergotamine or ergot-type medications (including methysergide) within 24 hours before or after taking eletriptan.
• You are taking other medicines ending in “triptan” (for example, sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Some medicines may affect how eletriptan works, or eletriptan itself may reduce the effectiveness of other medicines taken at the same time. These include:

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

The herbal preparation 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 it.

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

*SSRIs – Selective Serotonin Reuptake Inhibitors.
**SNRIs – Serotonin and Norepinephrine Reuptake Inhibitors.

Taking Eletriptán Aurovitas with food and drink

Eletriptan may be taken before or after food and drink.

Pregnancy and breastfeeding

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

Breastfeeding is not recommended for 24 hours following administration of this medicine.

Driving and using machines

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

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

If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine. This medicine may cause allergic-type reactions because it contains orange-yellow aluminum lake S (E110).

Eletriptán Aurovitas contains sodium

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

3. How to take Eletriptan Aurovitas

Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.

Adults

You may take the medicine 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 migraine. You must not take this medicine to prevent a migraine attack.

• The usual recommended starting dose is one 40 mg tablet.
• Swallow the tablet whole with a little water.
• If the first tablet does not relieve your migraine, you must not take a second tablet for the same attack.
• If, after taking the first tablet, your migraine improves but then returns later, you may take a second tablet. However, you must wait at least 2 hours after taking the first tablet before taking the second tablet.
• You must not take more than 80 mg (two eletriptan 40 mg tablets) within 24 hours.
• If a 40 mg dose does not provide relief from your migraines, consult your doctor – he or she will decide whether your dose should be increased to two eletriptan 40 mg 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 of age.

Elderly patients

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

Kidney problems

This medicine may 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 must not exceed 40 mg. Your doctor will advise you on the appropriate dose.

Liver problems

This medicine may be used in patients with mild or moderate liver problems. Dose adjustments are not required for mild or moderate hepatic impairment.

If you take more Eletriptan Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor immediately, call the Toxicology Information Service at 91 562 04 20, indicating the medicine and amount taken, or go to the nearest hospital emergency department.

Always keep the medicine packaging with you, even if it is empty. Adverse effects of eletriptan overdose include high blood pressure and heart problems.

If you forget to take Eletriptan Aurovitas

If you forget 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if 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 these may be signs of a hypersensitivity reaction.
• Chest pain and tightness, which may be severe and affect the throat. These may be symptoms of problems with blood circulation in the heart (ischaemic heart disease).
• Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, and overactive reflexes.

Other possible adverse effects include:

Frequent adverse 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, sensation of tightness in the throat, dry mouth.
• Abdominal and stomach pain, indigestion (dyspepsia), nausea (a feeling of uneasiness and discomfort in the stomach or abdomen that may lead to vomiting).
• Muscle stiffness (increased muscle tone), muscle weakness, back pain, muscle pain.
• General feeling of weakness, sensation of warmth, chills, runny nose, sweating, tingling or abnormal sensation, flushing, pain.

Uncommon adverse 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 unlike oneself (depersonalization), depression, abnormal thinking, feeling agitated, feeling confused, changes in mood (euphoria).
• Periods of unresponsiveness (stupor), general feeling of discomfort, illness or malaise, sleep problems (insomnia).
• Loss of appetite and weight loss (anorexia), taste disturbances, thirst.
• Degeneration of joints (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, problems urinating, excessive urine output, diarrhoea.
• Abnormal vision, eye pain, light sensitivity, dry or watery eyes.
• Ear pain, ringing in the ears (tinnitus).
• Poor circulation (peripheral vascular disorder).

Rare adverse effects (may affect up to 1 in 1,000 people)

• Shock, asthma, urticaria, skin disorders, swollen tongue.
• Throat or chest infection, enlarged lymph nodes.
• Decreased heart rate.
• Emotional lability (mood changes).
• Joint degeneration (arthritis), muscle disorder, twitching.
• Constipation, inflammation of the oesophagus, belching.
• Breast pain, heavy or prolonged menstruation.
• Eye infection (conjunctivitis).
• Voice changes.

Other reported adverse effects include fainting, high blood pressure, inflammation of the large intestine, vomiting, vascular and brain events, inadequate blood supply to the heart, heart attack, spasm of the arteries and heart muscles.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eletriptan Aurovitas

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

Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eletriptan Aurovitas

• The active substance is eletriptan (as eletriptan hydrobromide).

Each film-coated tablet contains 20 mg of eletriptan (as hydrobromide).

• The other components are:

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

Tablet coating: hypromellose 2910 (6 cP), triacetin, titanium dioxide (E171), lactose monohydrate, orange-yellow aluminium lake S (E110).

Appearance of the product and contents of the pack

Film-coated tablet.

Orange, round, biconvex, film-coated tablets, engraved with "EL" on one side and "20" on the other.

Eletriptan Aurovitas film-coated tablets are available in blisters containing 2, 3, 4, 6 and 10 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Eletriptán Aurovitas 20 mg film-coated tablets EFG

France: Eletriptan Arrow 20 mg comprimé pelliculé

Italy: Eletriptan Aurobindo

Portugal: Eletriptano Aurovitas

Date of the most recent review of this leaflet: March 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)