ANAGRELIDE BLUEFISH 0.5 mg HARD CAPSULES

In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is a greater risk of presenting major bleeding (bleeding) (see section "Taking Anagrelida Bluefish with other medicines").

While you are being treated with Anagrelida Bluefish, you must take the exact dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor first. You should not stop taking this medicine suddenly without consulting your doctor. The abrupt withdrawal of the medicine may increase the risk of stroke.

The signs and symptoms of a stroke may include sudden numbness or weakness in the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or difficulty understanding speech, sudden difficulty seeing with one or both eyes, sudden difficulty walking, dizziness, loss of balance or lack of coordination, and severe and sudden headache without known cause. Please consult your doctor immediately.

Children and adolescents

Information on the use of Anagrelida Bluefish in children and adolescents is limited, and therefore, this medicine should be used with caution.

Other medicines and Anagrelida Bluefish

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

Tell your doctor if you are taking any of the following medicines:

• medicines that can alter heart rhythm, such as sotalol, amiodarone
• fluvoxamine, used to treat depression
• certain types of antibiotics, such as enoxacin, used to treat infections
• theophylline, used to treat asthma and severe respiratory problems
• medicines to treat heart conditions, such as milrinone, enoximone, amrinone, olprinone, and cilostazol
• acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin)
• other medicines to treat conditions that affect platelets in the blood, such as clopidogrel
• omeprazole, used to reduce the amount of acid produced in the stomach
• oral contraceptives: if you experience severe diarrhea while taking this medicine, it may reduce the effect of the oral contraceptive and it is recommended to use an additional contraceptive method (e.g. condom). Consult the instructions that appear in the package leaflet of the oral contraceptive you are taking.

If they are used together, either Anagrelida Bluefish or these medicines may not work properly. Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or plan to become pregnant, consult your doctor. If you are pregnant, you should not take Anagrelida Bluefish. Women who may become pregnant must ensure they take effective contraceptive measures while taking Anagrelida Bluefish. Consult your doctor if you need advice on contraceptives.

Consult your doctor if you are breastfeeding or plan to breastfeed. You cannot take Anagrelida Bluefish while breastfeeding. If you are taking Anagrelida Bluefish, you should stop breastfeeding.

Driving and using machines

Some patients who were taking Anagrelida Bluefish have reported symptoms of dizziness. Do not drive or operate machinery if you feel dizzy.

AnagrelidaBluefishcontains lactose

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

AnagrelidaBluefishcontains sodium

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

3. How to take Anagrelida Bluefish

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

The amount of Anagrelida Bluefish that patients can take may vary, as this amount depends on the condition. Your doctor will prescribe the most convenient dose for your case.

The initial normal dose of Anagrelida Bluefish is 1 mg. This dose is taken with a 0.5 mg capsule twice a day for at least one week. After this period, your doctor may increase or decrease the number of capsules you should take until they find the dose that best suits your case and treats the condition most effectively.

The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve the contents in a liquid. You can take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) always at the same time.

Do not takemore or fewer capsules than your doctor has recommended. Do notstop taking the medicine without informing your doctor first. You should not stop taking this medicine suddenly on your own.

Your doctor will indicate that you undergo regular blood tests to check if the medicine is working and if your liver and kidneys are working well.

If you take more Anagrelida Bluefish than you should

If you take more Anagrelida Bluefish than you should or if someone else has taken this medicine, inform your doctor or pharmacist immediately. You should show them the Anagrelida Bluefish package.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Anagrelida Bluefish

Take the capsules as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Uncommon: Heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious heart rhythm problems (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis (inflammation of the pancreas that causes severe back and abdominal pain), vomiting blood or black, tarry stools, severe decrease in blood cell count that can cause weakness, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and bluish discoloration of the lips and skin).

Rare: Kidney failure (when little or no urine is produced), heart attack.

If you notice any of these side effects, contact your doctorimmediately.

Very common side effects: may affect more than 1 in 10 patients

Headache.

Common side effects: may affect up to 1 in 10 patients

Dizziness, fatigue, rapid heartbeat, strong or irregular heartbeat (palpitations), nausea, diarrhea, stomach pain, gas, vomiting, decrease in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 patients

Feeling of weakness or discomfort, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (edema), weight loss, muscle pain, joint pain, back pain, loss or decrease in sensation or feeling like numbness (especially in the skin), sensitivity or abnormal sensation like tingling and numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling of shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, phlegm, hair loss, itching of the skin, changes in skin color, impotence, chest pain, decrease in platelet count in the blood that increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or an increase in liver enzymes. Your doctor may perform blood tests that may indicate an increase in liver enzymes.

Rare side effects: may affect up to 1 in 1,000 patients

Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the heart, painful spasm of the heart's blood vessels (usually at rest, normally at night or early in the morning) (Prinzmetal's angina), loss of coordination, difficulty speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness when standing up (especially when standing up after sitting or lying down), increased need to urinate at night, pain, "flu-like" symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine (symptoms include diarrhea accompanied by blood or mucus, stomach pain, fever), inflammation of the stomach (symptoms include: pain, nausea, vomiting), abnormal density area in the lungs, increase in creatinine levels in blood tests that may indicate kidney problems.

The following side effects have been reported, although the exact frequency with which they occur is unknown:

• potentially life-threatening irregular heartbeat (torsades de pointes);
• liver inflammation, among the symptoms are nausea, vomiting, itching, yellowing of the skin and eyes, abnormal coloration of feces and urine (hepatitis);
• lung inflammation (symptoms include fever, cough, difficulty breathing or wheezing; this causes lung scarring) (allergic alveolitis that includes interstitial lung disease and pneumonitis);
• kidney inflammation (tubulointerstitial nephritis);
• stroke (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelida 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 label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

If your doctor stops the treatment, do not keep the remaining capsules unless the doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

CompositionofAnagrelidaBluefish

The active substance is anagrelida. Each capsule contains 0.5 mg of anagrelida (as anagrelida hydrochloride).

The other ingredients are:

Contents of the capsule: povidone (E 1201), crospovidone (E 1202), lactose, lactose monohydrate, microcrystalline cellulose (E 460), and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, and water

Appearance of the product and contents of the pack

Anagrelida Bluefish is presented in the form of hard gelatin capsules, white, opaque, with a white to off-white granular powder inside. Its approximate length is 14.3 mm and the width is 5.2 mm.

Anagrelida Bluefish 0.5 mg hard capsules EFG are presented in HDPE bottles with a child-resistant closure made of polypropylene that contains a desiccant.

Package size: 42 or 100 capsules.

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:

Bluefish Pharmaceuticals AB;

Gävlegatan 22

113 30 Stockholm;

Sweden

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

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Anagrelid Bluefish 0.5 mg Hartkapseln

Austria Anagrelid Bluefish 0.5 mg Hartkapseln

Denmark Anagrelid "Bluefish"

Spain Anagrelida Bluefish 0.5 mg hard capsules EFG

Norway Anagrelide Bluefish 0.5 mg hard capsules

Iceland Anagrelide Bluefish 0.5 mg hard capsules

Poland Anagrelide Bluefish 0.5 mg hard capsules

Portugal Anagrelida Bluefish 0.5 mg capsules

United Kingdom (Northern Ireland) Anagrelide 0.5 mg hard capsules

Sweden Anagrelide Bluefish 0.5 mg hard capsules

Date of the last revision of this leaflet:April 2023

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