Leaflet: information for the user

Eletriptán Bluefish 20 mg film-coated tablets EFG

eletriptán

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isEletriptán Bluefishand what it is used for

2. What you need to know before you start takingEletriptán Bluefish

3. How to takeEletriptán Bluefish

4. Possible side effects

5. Storage ofEletriptán Bluefish

6. Contents of the pack and additional information

This medication contains eletriptán as the active ingredient. Eletriptán Bluefish belongs to a group of medications called serotonin receptor agonists. Serotonin is a natural substance found in the brain that helps to constrict blood vessels.

Eletriptán Bluefish can be used for the treatment of migraine headache with or without aura in adults. Before a migraine headache begins, you may experience a phase called aura, during which you may experience visual disturbances, numbness, and language alterations.

Do not take Eletriptán Bluefish

• If you are allergic to eletriptán or to any of the other components of this medication (listed in section 6).
• If you have a severe liver or kidney disease.
• If you have high blood pressure, from moderate to severe, or if you have 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 (although it may have been mild and lasted only a few minutes or hours).
• If you have taken ergotamine or medications of the type of ergotamine (including metisergida) within the 24 hours before or after taking Eletriptán Bluefish.
• If you are taking other medications that end in “triptán” (for example sumatriptán, rizatriptán, naratriptán, zolmitriptán, almotriptán and frovatriptán).

Inform your doctor and do not take Eletriptán Bluefish, if you present any of these circumstances currently or if you have presented them in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eletriptán Bluefish 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 has coronary artery disease.

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

Repeated use of migraine medications

If you repeatedly use Eletriptán Bluefish or any migraine medication for several days or weeks, this may cause long-lasting daily headaches. Inform your doctor if you have experienced this, as you may need to interrupt treatment for a time.

Use of Eletriptán Bluefish with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

The use of Eletriptán Bluefish with some medications may cause severe side effects.

Do not take Eletriptán Bluefish if:

• You have taken ergotamine or medications of the type of ergotamine (including metisergida) within the 24 hours before or after taking Eletriptán Bluefish
• You are taking other medications that end in “triptán” (for example sumatriptán, rizatriptán, naratriptán, zolmitriptán, almotriptán and frovatriptán).

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

• Medications used to treat fungal infections (for example ketoconazol and itraconazol).
• Medications used to treat bacterial infections (for example erythromycin, clarithromycin and josamicin).
• Medications used to treat HIV and AIDS (for example ritonavir, indinavir and nelfinavir).

The preparation based on St. John's Wort (Hypericum perforatum) should not be taken at the same time as this medication. If you are already taking St. John's Wort, consult your doctor before stopping the preparation of St. John's Wort.

Inform your doctor before starting treatment with Eletriptán Bluefish, if you are taking some medications, (commonly known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Selective Serotonin and Noradrenaline Reuptake Inhibitors)), for depression and other mental disorders. These medications may increase the risk of developing serotonin syndrome during combined use with certain migraine medications. See Section 4 “Possible side effects” for more information on the symptoms of serotonin syndrome.

Eletriptán Bluefish with food and drinks

Eletriptán Bluefish can be taken before or after consuming food and drinks.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medication.

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

It is recommended to avoid breastfeeding in the 24 hours following the intake of this medication.

Driving and operating machinery

Eletriptán Bluefish, or the migraine itself, may cause drowsiness. This medication may also cause dizziness. For this reason, you should avoid driving and operating machinery during a migraine attack or after taking the medication.

Eletriptán Bluefish contains lactose, yellow orange (E110) and Sodium

Eletriptán Bluefish contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Eletriptán Bluefish contains yellow orange (E110)

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

Eletriptán Bluefish contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

You can take the medication 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 Eletriptán Bluefish during the headache phase of migraine. Do not take this medication to prevent a migraine attack.

• The usual starting dose is a 40 mg tablet(two tablets of Eletriptán Bluefish 20 mg or one tablet of Eletriptán Bluefish 40 mg per day orally).
• Take the entire tablet with a little water.
• If the first tablet does not alleviate your migraine, you should not take a second tablet for the same attack.
• If after taking the first tablet your migraine is alleviated but then reappears, you can take a second tablet. However, after taking the first tablet, you should wait at least 2 hours before taking the second tablet.
• You should not take more than 80 mg(four tablets of Eletriptán Bluefish 20 mg or two tablets of Eletriptán Bluefish 40 mg)in 24 hours.
• If with a dose of two tablets of 20 mg or one of 40 mg you do not obtain relief, consult your doctor. He will decide if you should increase the dose to 80 mg (four tablets of 20 mg or two tablets of 40 mg) in successive attacks.

Older patients

Eletriptán Bluefish tablets are not recommended for patients over 65 years old.

Children and adolescents

Eletriptán Bluefish is not recommended for children and adolescents under 18 years old.

Renal insufficiency

This medication can be used in patients with mild or moderate kidney problems. In these patients, the recommended initial dose is 20 mg (one tablet ofEletriptán Bluefish 20 mg), and the total daily dose should not exceed 40mg (two tablets ofEletriptán Bluefish 20 mg or one tablet of Eletriptán Bluefish 40 mg). Consult your doctor about what dose you should take.

Liver insufficiency

This medication can be used in patients with mild or moderate liver problems. No dose adjustments are required for mild or moderate liver insufficiency.

If you take more Eletriptán Bluefish than you should

If you accidentally take more Eletriptán than you should, contact your doctor immediately or go to the nearest hospital emergency room. Always carry the medication packaging with you, even if it is empty. The adverse effects of an overdose of Eletriptán include high blood pressure and heart problems. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Eletriptán Bluefish

If you forgot 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 the missed doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Inform your doctor immediatelyif you experience any of the following symptoms after taking the medication.

• Abnormal breathing sounds, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially affecting the entire body), as this may be a sign of an allergic reaction (hypersensitivity).
• Chest pain and pressure, which can be intense and affect the throat. These may be symptoms of heart blood circulation problems (ischemic cardiopathy).
• Symptoms and signs of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, and hyperactivity of reflexes.

Other side effects that may occur are:

Frequent: may affect up to 1 in 10 people

• Chest pain or pressure, heart palpitations, increased heart rate.
• Dizziness, spinning sensation (vertigo), headache, numbness, decreased sense of touch or pain.
• Sore throat, sensation of throat pressure, dry mouth.
• Abdominal pain and stomach pain, indigestion (gastrointestinal disorder), nausea (sensation of unease and discomfort in the stomach or abdomen that prompts vomiting).
• Muscle stiffness (increased muscle tone), muscle weakness, back pain, muscle pain.
• General feeling of weakness, sensation of heat, chills, coughing, sweating, tingling or abnormal sensation, redness, pain.

Rare: 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, tremors, slurred speech.
• Feeling disconnected from oneself (derealization), depression, abnormal thinking, feeling agitated, feeling confused, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness, or lack of well-being (malaise), insomnia.
• Loss of appetite and weight loss (anorexia), altered taste, thirst.
• Joint degeneration (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, urinary 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: may affect up to 1 in 1,000 people

• Shock, asthma, urticaria, skin alterations, swollen tongue.
• Chest or throat infection, enlarged lymph nodes.
• Decreased heart rate.
• Emotional fragility (mood changes).
• Joint degeneration (arthritis), muscle alteration, twitching.
• Constipation, esophageal inflammation, belching.
• Breast pain, heavy or prolonged menstruation.
• Eye infection (conjunctivitis).
• Voice changes.

Other side effects described include dizziness, high blood pressure, inflammation of the large intestine, vomiting, vascular and cerebral accidents, inadequate heart blood circulation, heart attack, heart muscle spasms.

Your doctor may make regular blood tests to examine liver enzyme increases or any blood problems.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date, which appears on the packaging or container after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Eletriptán Bluefish

The active ingredient is eletriptan (as eletriptan hydrobromide).

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

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

Appearance of Eletriptán Bluefish and content of the container

The film-coated Eletriptán Bluefish 20 mg tablets are orange, round, convex, smooth on one face and marked with “20” on the other.

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

Only some container sizes may be commercially available.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder :

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Responsible person for manufacturing :

Chanelle Medical Unlimited Company

Loughrea,

County Galway

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

Last review date of this leaflet: February 2022

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/