Eletriptan Aurovitas 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eletriptan Aurovitas 40 mg film-coated tablets EFG

Read the entire 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 could 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.

Leaflet contents

1. What Eletriptan Aurovitas is and what it is used for
2. What you need to know before taking Eletriptan Aurovitas
3. How to take Eletriptan Aurovitas
4. Possible adverse effects
5. How to store Eletriptan 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 heart problems (for example, heart attack, angina, heart failure, or significant abnormalities in heart rhythm (arrhythmia), or 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 lasted only a few minutes or hours).
• If you have taken ergotamine or ergotamine-type medicines (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 using 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 that you may be at increased risk of heart disease; inform your doctor of this before taking eletriptan.

Repeated use of migraine medicines

If you repeatedly use eletriptan or any other medicine to treat migraine 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 of time.

Taking Eletriptán Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 ergotamine-type medicines (including methysergide) within 24 hours before or after taking eletriptan.
• You are taking other medicines ending in “triptan” (for example, sumatriptan, rizatriptan, naratriptán, 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) must 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 noradrenaline 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 or 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 after taking this medicine.

Driving and using machines

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

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

If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine. This medicine may cause allergic reactions because it contains orange-yellow aluminium 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 for use of this medicine as given by your doctor. If in doubt, please 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 early 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 dose of 40 mg does not provide relief from your migraines, consult your doctor – they 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 of age

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 starting dose is 20 mg and the total daily dose must not exceed 40 mg. Your doctor will tell you what dose to take.

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, consult your doctor immediately, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department.

Always carry the medicine packaging with you, even if it is empty. Adverse effects from 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 nearly 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 will experience 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.
• Pain and tightness in the chest, 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, reduced 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 heat, 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 detached from oneself (depersonalization), depression, abnormal thinking, feeling agitated, confusion, 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, urinary problems, excessive urine production, diarrhea.
• 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).
• Degeneration of joints (arthritis), muscle disorder, jerking.
• 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 accidents, inadequate blood supply to the heart, heart attack, spasm of the arteries and heart muscles.

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

Reporting of adverse effects

If you experience any type of 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the blister or carton following EXP. The expiry date refers to 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. Unused medicines and waste materials, including packaging, should be handed over at a pharmacy's SIGRE collection point. If you have any doubts, please ask your pharmacist how to dispose of medicines and packaging 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 40 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 (E-110).

Appearance of the product and contents of the pack

Film-coated tablet.

Orange, round, biconvex, film-coated tablets, engraved with “E” and “L” separated by a score on one side and “40” on the other. The tablet can be divided into equal doses.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 European Economic Area member states under the following names:

Spain: Eletriptán Aurovitas 40 mg film-coated tablets EFG

France: Eletriptan Arrow 40 mg comprimé pelliculé

Italy: Eletriptan Aurobindo

Netherlands: Eletriptan Aurobindo 40 mg, filmomhulde tabletten

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)