ELETRIPTAN AUROVITAS 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eletriptan Aurovitas 40 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Eletriptan Aurovitas contains eletriptan as the active substance. Eletriptan belongs to a group of medicines called serotonin receptor agonists. Serotonin is a natural substance found in the brain and helps to narrow blood vessels. Eletriptan can be used to treat migraine headaches with or without aura in adults. Before a migraine headache starts, you may experience a phase called "aura", in which vision disturbances, numbness, and language problems may occur.

2. What you need to know before you take Eletriptan Aurovitas

Do not takeEletriptan Aurovitasif:

• You are allergic to eletriptan or any of the other ingredients of this medicine (listed in section 6).
• You have severe liver or kidney disease.
• You have high blood pressure, moderate or severe, or if you have mild high blood pressure that is not being treated.
• You have had heart problems (for example, heart attack, angina, heart failure, or significant irregular heart rhythms).
• You have poor circulation (peripheral vascular disease).
• You have ever had a stroke (even if it was mild and only lasted a few minutes or hours).
• You have taken ergotamine or ergotamine-type medications (including methysergide) within the last 24 hours before or after taking eletriptan.
• You are taking other medicines that end in "triptan" (for example, sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

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

Warnings and precautions

Consult your doctor or pharmacist before taking eletriptan 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 be at higher risk of heart disease, inform your doctor before taking eletriptan.

Repeated use of migraine medicines

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

Using Eletriptan Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Eletriptan Aurovitas with some medicines can cause serious side effects. Do not take Eletriptan Aurovitas if:

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

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

• 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 AIDS and HIV (for example, 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 noradrenaline reuptake inhibitors.

Taking Eletriptan Aurovitas with food and drinks

Eletriptan can be taken before or after eating and drinking.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

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

Eletriptan Aurovitas contains lactose and yellow orange aluminium lake (E110)

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 aluminium lake (E110).

Eletriptan 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 administration instructions of this medicine given by your doctor. If you are unsure, 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 eletriptan during the headache phase of the migraine. Do not take this medicine to prevent a migraine attack.

• The 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, 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 (two 40 mg eletriptan tablets) in 24 hours.
• If you do not get relief from a 40 mg dose, consult your doctor - they will decide whether to increase the dose to two 40 mg eletriptan tablets in 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.

Elderly patients

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

Kidney problems

This medicine 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 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 Eletriptan Aurovitas than you should

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

Always carry the medicine package with you, even if it is empty. The adverse effects of overdose with eletriptan 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 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.
• Chest pain and tightness, which can be severe and affect the throat. These can be symptoms of heart circulation problems (ischaemic 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 overactive reflexes.

Other side effects that may occur are:

Common 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, feeling of tightness in the throat, dry mouth.
• Abdominal pain and stomach pain, indigestion (stomach upset), 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, tongue inflammation or infection, skin rash, itching.
• Increased sensitivity to touch or pain (hyperaesthesia), 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 malaise, sleep problems (insomnia).
• Loss of appetite and weight loss (anorexia), taste disturbances, thirst.
• Joint degeneration (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, urination 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, 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 to the Spanish Medicines Agency's Pharmacovigilance 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 Eletriptan Aurovitas

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 blister or carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating of the tablet:hypromellose 2910 (6cp), triacetin, titanium dioxide (E171), lactose monohydrate, yellow orange aluminium lake (E110).

Appearance of the product and pack contents

Film-coated tablet.

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Phone: 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Eletriptán Aurovitas 40 mg film-coated tablets EFG

France: Eletriptan Arrow 40 mg film-coated tablet

Italy: Eletriptan Aurobindo

Netherlands: Eletriptan Aurobindo 40 mg film-coated tablets

Portugal: Eletriptano Aurovitas

Date of last revision of this leaflet: March 2021

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