ELETRIPTAN BLUEFISH 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eletriptan Bluefish 20 mg film-coated tablets EFG

eletriptan

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 pack

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

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

This medicine contains eletriptan as the active substance. Eletriptan Bluefish 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 Bluefish can be used to treat migraine headache with or without aura in adults. Before the 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 Bluefish

Do not take Eletriptan Bluefish

• If you are allergic to eletriptan or 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 if you have mild high blood pressure that is not being treated.
• If you have had heart problems (for example, heart attack, angina, heart failure, or significant irregular heart rhythms).
• If you have poor circulation (peripheral vascular disease).
• If you have ever had a stroke (even if it was mild and only lasted a few minutes or hours).
• If you have taken ergotamine or ergotamine-type medicines (including methysergide) within the last 24 hours before or after taking Eletriptan Bluefish.
• If 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 Bluefish if you currently have or have had any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before taking Eletriptan 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 have coronary artery disease.

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

Repeated use of migraine medicines

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

Using Eletriptan Bluefish with other medicines

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

Taking Eletriptan Bluefish with some medicines can cause serious side effects.

Do not take Eletriptan Bluefish if:

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

Some medicines may affect how Eletriptan 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 josamycin).
• Medicines used to treat HIV and AIDS (for example, ritonavir, indinavir, and nelfinavir).

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 Bluefish if you are taking certain medicines (commonly known as SSRIs or SNRIs) for depression and 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.

Taking Eletriptan Bluefish with food and drink

Eletriptan Bluefish can be taken before or after food and drink.

Pregnancy, breastfeeding, 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 have a baby, ask your doctor for advice before taking this medicine.

Breastfeeding is not recommended for 24 hours after taking this medicine.

Driving and using machines

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

Eletriptan Bluefish contains lactose, orange yellow (E110), and sodium

Eletriptan Bluefish contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Eletriptan Bluefish contains orange yellow (E110)

This medicine may cause allergic reactions because it contains "orange yellow". It can trigger asthma, especially in patients allergic to acetylsalicylic acid.

Eletriptan Bluefish contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per 20 mg and 40 mg tablet; this is essentially "sodium-free".

3. How to take Eletriptan Bluefish

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

You can take the medicine at any time after the migraine headache starts, 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. Do not take this medicine to prevent the migraine attack.

• The usual starting dose is one 40 mg tablet (two 20 mg Eletriptan Bluefish tablets or one 40 mg Eletriptan Bluefish tablet per day by mouth).
• Take 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 (four 20 mg Eletriptan Bluefish tablets or two 40 mg Eletriptan Bluefish tablets) in 24 hours.
• If, with a dose of two 20 mg tablets or one 40 mg tablet, you do not get relief, consult your doctor. He will decide whether you should increase the dose to 80 mg (four 20 mg tablets or two 40 mg tablets) in subsequent attacks.

Elderly patients

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

Children and adolescents

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

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 (one 20 mg Eletriptan Bluefish tablet), and the total daily dose should not exceed 40 mg (two 20 mg Eletriptan Bluefish tablets or one 40 mg Eletriptan Bluefish tablet). Consult your doctor about the dose you should 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 liver 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 emergency department of the nearest hospital. Always take the medicine pack with you, even if it is empty. The side effects of an overdose with Eletriptan include high blood pressure and heart problems. You can also call the Toxicology Information Service, phone 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 close to the time for the next dose. Do not take a double dose to make up for forgotten doses.

If you have any other questions about 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 (allergy).
• Chest pain and tightness, which can be severe and affect the throat. These can be symptoms of heart circulation problems (ischemic 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 hyperactivity of the reflexes.

Other side effects that may occur are:

Common: may affect up to 1 in 10 people

• Chest pain or tightness, 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 discomfort, indigestion (upset stomach), 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: 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 (dissociation), depression, abnormal thinking, feeling agitated, feeling confused, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness, or malaise, sleep problems (insomnia).
• Lack 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 teary 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 changes, swollen tongue.
• Chest or throat infection, swollen lymph nodes.
• Slow heart rate.
• Emotional fragility (mood changes).
• Joint degeneration (arthritis), muscle problems, 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 heart blood supply, heart attack, 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, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side 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 carton or bottle 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 a pharmacy for proper disposal. 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 Bluefish

The active substance is eletriptan (as eletriptan hydrobromide).

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

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

Appearance of Eletriptan Bluefish and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Chanelle Medical Unlimited Company

Loughrea,

County Galway

You can obtain 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

Date of last revision of this leaflet: February 2022

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