SUMATRIPTAN BLUEFISH 50 mg TABLETS

2. What you need to know before you take Sumatriptan Bluefish

Do not take Sumatriptan Bluefish

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have had heart problems, including heart attacks, angina (chest pain caused by exercise or exertion), Prinzmetal's angina (chest pain at rest), or have had symptoms of heart disease such as shortness of breath or chest pain and if you have had circulatory problems in your hands and feet (peripheral vascular disease)
• if you have had a stroke or transient ischaemic attack (TIA, also known as a "mini-stroke")
• if you have had a type of migraine called basilar or hemiplegic migraine
• if you have severe liver disease
• if you have high blood pressure
• if you are taking ergotamine or ergot-type medicines (for migraine) or other triptans/5-HT1 receptor agonists. These medicines must not be taken at the same time as Sumatriptan Bluefish (see also "Taking other medicines")
• if you are taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan must not be taken until two weeks after stopping MAO inhibitors (see also "Taking other medicines")

Warnings and precautions

Before you start taking Sumatriptan Bluefish, tell your doctor if:

• you are a heavy smoker or use nicotine products (e.g. patches or gum), especially if you are a woman who has been through the menopause or a man over 40 years old. Your doctor will examine you before prescribing Sumatriptan Bluefish
• you have kidney or liver problems. Your doctor may need to adjust your dose
• you have had seizures or fits or have a history of seizures or fits; sumatriptan may cause seizures or fits. Sumatriptan Bluefish may increase the risk of seizures or fits
• you are allergic to certain antibiotics (sulphonamides). You may experience an allergic reaction after taking Sumatriptan Bluefish. Caution is recommended
• the use of triptans with herbal preparations containing St John's Wort (Hypericum perforatum) may cause side effects

Sumatriptan Bluefish should only be used if you have a clear diagnosis of migraine and other causes have been ruled out. Some types of migraine cannot be treated with sumatriptan.

After taking Sumatriptan Bluefish, you may experience pain or pressure in your chest or throat. These effects are usually temporary and may be intense. They can spread to the throat and may be accompanied by a feeling of warmth or heaviness in the face or neck. In rare cases, this can be caused by effects on the heart. If the symptoms do not go away, talk to your doctor.

Overuse of Sumatriptan Bluefish can cause daily chronic headaches or make your headaches worse. If you think this is happening to you, talk to your doctor. It may be necessary to stop treatment with Sumatriptan Bluefish to correct the problem.

Other medicines and Sumatriptan Bluefish

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

An interaction occurs when medicines used at the same time can influence the effects and/or side effects of the other medicine. The comments below may also apply to medicines that you have used in the past or that you will use in the future.

• ergotamine medicines (for migraine) or other triptans. These must not be taken at the same time as Sumatriptan Bluefish (see "Do not take Sumatriptan Bluefish"). After taking ergotamine medicines or other triptans, wait 24 hours before taking Sumatriptan Bluefish. After taking Sumatriptan Bluefish, wait at least 6 hours before taking ergotamine medicines and at least 24 hours before taking other triptans
• MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan Bluefish must not be taken until two weeks after stopping MAO inhibitors
• the use of triptans with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) may cause serotonin syndrome (a combination of symptoms that can include confusion, hallucinations, agitation, sweating, muscle spasms, and tremors). If you experience any of these symptoms, tell your doctor
• there is a risk that concomitant use of sumatriptan and lithium (for mania/depressive disorders) may cause serotonin syndrome

Please note that the medicines mentioned may be known by other names, brands. In this section, only the active substance or therapeutic group of the medicine is mentioned, not the brand name. Always check the packaging and information in the leaflet if you are using the active substance or therapeutic group of that medicine.

Pregnancy and breastfeeding

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

Pregnancy

During pregnancy, sumatriptan should only be taken after consulting your doctor. Sumatriptan should only be used during pregnancy if the possible benefit to the mother outweighs any potential risk to the baby and no other treatment options are available.

Breastfeeding

Sumatriptan passes into breast milk. It is recommended not to breastfeed for 12 hours after using Sumatriptan Bluefish. Do not give your baby breast milk for this period.

Driving and using machines

Dizziness may occur as a result of the migraine or its treatment with Sumatriptan, and this can affect your ability to drive or use machines.

Sumatriptan Bluefish contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 50 mg tablet; this is essentially "sodium-free".

3. How to take Sumatriptan Bluefish

Always take Sumatriptan Bluefish exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

Adults

The usual dose is 1 tablet of 50 mg Sumatriptan Bluefish, to be swallowed whole with water (without breaking or chewing).

Some patients may need a dose of 100 mg Sumatriptan Bluefish; follow your doctor's instructions.

Use in children and adolescents

Sumatriptan Bluefish is not recommended for use in children under 18 years.

Elderly

Sumatriptan Bluefish is not recommended for use in the elderly.

Method of administration

• It is best to take Sumatriptan Bluefish as soon as possible after the migraine headache starts, although it can be taken at any time during an attack.

• Do not use Sumatriptan Bluefish to try to prevent an attack.

The tablet should be swallowed whole with water, preferably as soon as possible after the migraine headache starts

Duration of treatment

If your symptoms do not improve after the first dose, do not take a second dose for the same attack. For another attack, Sumatriptan Bluefish can be taken again.

If your symptoms improve but then come back, you can take a second dose after 2 hours, but no sooner. You must wait at least 2 hours between doses.

Do not take more than 300 mg of Sumatriptan Bluefish in a 24-hour period.

The recommended dose should not be exceeded.

If you take more Sumatriptan Bluefish than you should

In case of overdose or accidental intake, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

Side effects such as those listed in "Possible side effects" may occur.

If you forget to take Sumatriptan Bluefish

If you forget to take a dose, do not take a double dose to make up for the forgotten dose.

If you have any other 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.

Side effects are listed in order of frequency.

For very serious side effects: seek medical attention immediately.

The following side effects have been reported, but their frequency is not known.

• Allergic reactions/hypersensitivity, ranging from skin reactions to rare cases of anaphylaxis (a sudden fall in blood pressure, paleness, agitation, rapid heartbeat, cool and moist skin, altered consciousness)
• Angina (chest pain, often caused by exercise), heart attack, or spasm of the blood vessels of the heart, transient ischaemic changes on the ECG. Chest pain or difficulty breathing after taking Sumatriptan Bluefish
• Spasm of the blood vessels of the intestine, which can cause damage to the intestine. You may notice stomach pain or bloody diarrhea

If you experience any of these symptoms after taking Sumatriptan Bluefish, contact your doctor immediately and stop taking this medicine.

Other side effects:

Common (may affect up to 1 in 10 people)

• Dizziness, uncertainty, heat, sensory disturbances
• Transient increases in blood pressure shortly after treatment, flushing
• Shortness of breath
• Nausea, vomiting
• Feeling of heaviness, pain, or pressure in parts of the body, including the throat or chest. Myalgia
• Feeling of pain, feeling of cold or heat
• Feeling of weakness and fatigue

Very rare (may affect up to 1 in 10,000 people)

• Changes in liver function test results

Unknown

• Seizures/fits
• Tremors
• Dystonia
• Visual disturbances, e.g. double vision, flashes, and sometimes permanent loss of vision. Visual disturbances that can occur as a result of the migraine attack
• Decreased heart rate, rapid or irregular heartbeat, palpitations
• Decreased blood flow to the arms and legs with resulting paleness or numbness or blue discoloration of the fingers and toes
• Diarrhea
• Decrease in blood pressure
• Stiff neck
• Joint pain
• Anxiety
• Increased sweating
• If you have had a recent injury or if you have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of the injury or inflammation
• Difficulty swallowing

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. Storing Sumatriptan Bluefish

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use Sumatriptan Bluefish if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sumatriptan Bluefish

The active substance is Sumatriptan.

Each tablet contains 50 mg sumatriptan (as sumatriptan succinate).

The other ingredients are: croscarmellose sodium (E468), polysorbate 80 (E433), calcium hydrogen phosphate (E450), microcrystalline cellulose (E460), sodium hydrogen carbonate (E500), magnesium stearate (E470b).

Appearance and packaging

Tablet.

Sumatriptan Bluefish 50 mg: white, capsule-shaped, biconvex, uncoated tablets, marked with a "C" on one face and "33" on the other.

Blister pack of Polyamide/PVC/Aluminium. Pack sizes: 2, 3, 4, 6, 8, 12, 18, 20, 30, 50, and 100 tablets.

Not all 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

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

Bluefish Pharma, S.L.U.

AP 36007

2832094 Madrid, Sucursal 36

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

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/