Eletriptan Bluefish 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eletriptán Bluefish 40 mg film-coated tablets EFG

eletriptán

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 side 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 natural substance found 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 visual disturbances, numbness, and speech disturbances may occur.

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 minutes or hours).
• If you have taken ergotamine or ergotamine-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 ever 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 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 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 this occurs, as you may need to stop treatment temporarily.

Taking Eletriptán Bluefish with other medicines

Tell 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 ergotamine-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, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

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

• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
• Medicines used to treat bacterial infections (e.g. erythromycin, clarithromycin, josamycin).
• Medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, 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 it.

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 Noradrenaline Reuptake Inhibitors)) for depression or other mental disorders. These medicines may increase the risk of developing serotonin syndrome when used in combination with certain migraine treatments. See Section 4 “Possible side effects” for more information about symptoms of serotonin syndrome.

Taking Eletriptán Bluefish with food and drink

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

Pregnancy, breast-feeding and fertility

Consult your doctor or pharmacist before taking any medicine.

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

Breast-feeding is recommended to be avoided for 24 hours after taking this medicine.

Driving and using machines

Eletriptán Bluefish, or migraine itself, may make you feel sleepy. This medicine may also cause dizziness. Therefore, you should avoid driving or operating machinery during a migraine attack or after taking this medicine.

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

Eletriptán Bluefish contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor 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 for using this medicine as given by your doctor. 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 Bluefish during the headache phase of migraine. You must 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 per day, taken orally).
• 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 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 (four Eletriptan Bluefish 20 mg tablets or two Eletriptan Bluefish 40 mg tablets) within 24 hours.
• If you do not obtain relief with a 40 mg dose, consult your doctor. He or she will decide whether your dose should be increased to 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 starting 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 about the appropriate dose.

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 take the medicine packaging with you, even if it is empty. Adverse effects of Eletriptan overdose 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 experiences them.

Immediately inform your doctor 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 adverse effects that may occur are:

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 (dyspepsia), nausea (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 sensations, 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 (hyperesthesia), loss of coordination, reduced or slowed movements, tremor, slurred speech.
• Feeling detached from oneself (depersonalization), depression, abnormal thinking, feeling agitated, confusion, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness or lack of wellbeing (malaise), difficulty sleeping (insomnia).
• Loss of appetite and weight loss (anorexia), taste disturbances, thirst.
• Joint degeneration (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, problems urinating, excessive urine output, diarrhea.
• Abnormal vision, eye pain, light sensitivity, dry 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, urticaria, skin disorders, swollen tongue.
• Chest or throat 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 adverse effects described include fainting, high blood pressure, inflammation of the colon, vomiting, vascular and brain accidents, 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 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 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 container or bottle 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 unused medicines and their containers at the SIGRE point located at the pharmacy. If in doubt, 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 Bluefish

The active substance is eletriptan (as eletriptan hydrobromide).

Each Eletriptan 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).

Appearance of Eletriptan Bluefish and contents of the pack

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

Eletriptan 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 some 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

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

Bluefish Pharma S.L.U.,

P.O. Box 36007

2832094 Madrid, Branch Office 36

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 Health Products (AEMPS) http://www.aemps.gob.es/