Eletriptan Bluefish 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eletriptán Bluefish 20 mg film-coated tablets EFG

eletriptan

Read the entire leaflet carefully before you start taking this medicine, as 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 must not give it to other people, 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 these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains eletriptan as the active substance. Eletriptán Bluefish belongs to a group of medicines called serotonin receptor agonists. Serotonin is a naturally occurring substance in the brain that helps narrow blood vessels.

Eletriptán Bluefish 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 you may have visual disturbances, numbness, and speech disturbances.

2. What you need to know before taking Eletriptán Bluefish

Do not take Eletriptán Bluefish

• 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 to 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 if it was mild and lasted only a few minutes or hours).
• If you have taken ergotamine or ergot-type medications (including methysergide) within 24 hours before or after taking Eletriptán Bluefish.
• 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 Eletriptán Bluefish if you currently have or have previously had any of these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before taking Eletriptán Bluefish 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.

If you have been informed that you may have an increased risk of heart disease, inform your doctor before taking Eletriptán Bluefish.

Repeated use of migraine medications

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

Taking Eletriptán Bluefish 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 Bluefish together with certain medicines may cause serious adverse effects.

Do not take Eletriptán Bluefish if:

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

Some medicines may affect how Eletriptán Bluefish works, or eletriptan itself 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 josamicin).
• Medicines used to treat HIV/AIDS (for example ritonavir, indinavir, and nelfinavir).

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 the St. John’s wort preparation.

Inform your doctor before starting treatment with Eletriptán Bluefish if you are taking certain medicines (commonly known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors)) for depression and 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.

Taking Eletriptán Bluefish with food and drink

Eletriptán Bluefish may be taken before or after food and drink.

Pregnancy, breastfeeding and fertility

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 should be avoided for 24 hours after taking this medicine.

Driving and using machines

Eletriptán Bluefish, 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 the medicine.

Eletriptán Bluefish contains lactose, orange-yellow (E110) and sodium

Eletriptán Bluefish contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Eletriptán Bluefish contains orange-yellow (E110)

This medicine may cause allergic reactions because it contains “orange-yellow”. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Eletriptán Bluefish contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 20 mg and 40 mg tablet; hence, it is essentially “sodium-free”.

3. How to take Eletriptan Bluefish

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 Bluefish during the headache phase of the migraine attack. Do not take this medicine to prevent a migraine attack.

• The usual starting dose is one 40 mg tablet (two Eletriptan Bluefish 20 mg tablets or one Eletriptan Bluefish 40 mg tablet taken orally per day).
• Swallow the tablet whole with some 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 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.
• Do not take more than 80 mg (four Eletriptan Bluefish 20 mg tablets or two Eletriptan Bluefish 40 mg tablets) within 24 hours.
• If you do not obtain relief with a dose of two 20 mg tablets or one 40 mg tablet, consult your doctor. Your doctor will decide whether your dose should be increased to 80 mg (four 20 mg tablets or two 40 mg tablets) for subsequent attacks.

Elderly patients

Eletriptan Bluefish tablets are not recommended for patients over 65 years of age.

Children and adolescents

Eletriptan Bluefish is not recommended for children and adolescents under 18 years of age.

Renal impairment

This medicine may be used in patients with mild or moderate kidney problems. In these patients, the recommended initial dose is 20 mg (one Eletriptan Bluefish 20 mg tablet), and the total daily dose must not exceed 40 mg (two Eletriptan Bluefish 20 mg tablets or one Eletriptan Bluefish 40 mg tablet). Consult your doctor to determine the appropriate dose for you.

Hepatic impairment

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 Bluefish than you should

If you accidentally take more Eletriptan than you should, contact your doctor immediately or go to the nearest hospital emergency department. Always bring the medicine packaging with you, even if it is empty. Adverse effects of overdose with Eletriptan include high blood pressure and heart problems. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eletriptan Bluefish

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 can 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 (allergy).
• 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: 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 (upset stomach), nausea (a feeling of uneasiness 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, sensation of heat, chills, runny nose, sweating, tingling or abnormal sensation, flushing, pain.

Uncommon: 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 (hyperaesthesia), loss of coordination, reduced or slowed movements, tremor, slurred speech.
• Feeling detached from oneself (depersonalisation), depression, abnormal thinking, feeling agitated, feeling confused, changes in mood (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness or malaise (malaise), difficulty sleeping (insomnia).
• Loss of appetite and weight loss (anorexia), changes in taste, thirst.
• Degeneration of joints (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, problems urinating, excessive urine production, diarrhoea.
• Abnormal vision, eye pain, light sensitivity, dry eyes or watery eyes.
• Ear pain, ringing in the ears (tinnitus).
• Poor circulation (peripheral vascular disorder).

Rare: may affect up to 1 in 1,000 people

• Shock, asthma, hives, skin disorders, swollen tongue.
• Chest or throat infection, enlarged lymph nodes.
• Decreased heart rate.
• Emotional lability (mood changes).
• Degeneration of joints (arthritis), muscle disorder, twitching.
• Constipation, inflammation of the oesophagus, belching.
• Breast pain, heavy or prolonged menstruation.
• Eye infection (conjunctivitis).
• Changes in voice.

Other adverse effects described 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/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 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 Bluefish

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 packaging or container after 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. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eletriptán Bluefish

The active substance is eletriptan (as eletriptan hydrobromide).

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

The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, orange-yellow aluminium lake FCF (E110, colouring agent).

Appearance of Eletriptán Bluefish and contents of the pack

Eletriptán Bluefish 20 mg film-coated tablets are orange, round, convex, smooth on one side and marked with "20" on the other.

Eletriptán Bluefish 20 mg film-coated tablets EFG are supplied in opaque PVC/PCTFE/Aluminium blister packs containing 1, 2, 3, 4, 6, 10 and 18 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer:

Chanelle Medical Unlimited Company
Loughrea,
County Galway
Ireland

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007
28320 Madrid, Branch Office 36
Spain

Date of the most recent revision of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/