Anagrelide Bluefish

Package Leaflet: Information for the User

Anagrelide Bluefish, 0.5 mg, hard capsules
Anagrelidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet:

• 1. What is Anagrelide Bluefish and what is it used for
• 2. Important information before taking Anagrelide Bluefish
• 3. How to take Anagrelide Bluefish
• 4. Possible side effects
• 5. How to store Anagrelide Bluefish
• 6. Contents of the pack and other information

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

Anagrelide Bluefish contains the active substance anagrelide. Anagrelide Bluefish is a medicine that affects the development of blood platelets. This medicine reduces the number of blood platelets produced by the bone marrow, which leads to a decrease in the number of blood platelets in the blood to a more normal value. Therefore, it is used to treat patients with essential thrombocythemia. Essential thrombocythemia is a disease that occurs when the bone marrow produces too many blood cells, known as platelets. A high number of platelets in the blood can lead to severe blood circulation and clotting disorders.

2. Important information before taking Anagrelide Bluefish

When not to take Anagrelide Bluefish

• If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause a rash, itching, swelling of the face or lips, and difficulty breathing;
• If you have moderate or severe liver function disorders;
• If you have moderate or severe kidney function disorders.

Warnings and precautions

Before starting treatment with Anagrelide Bluefish, tell your doctor:

• if you have or think you may have heart disease;
• if you have a prolonged QT interval (visible on an ECG, a record of the electrical activity of the heart) from birth or if it occurs in your family members, if you are taking other medicines that can change the ECG or if you have decreased levels of electrolytes such as potassium, magnesium, or calcium (see "Anagrelide Bluefish and other medicines");
• if you have liver or kidney disease.

In case of concomitant administration with acetylsalicylic acid (a substance also known as aspirin, present in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting), there is an increased risk of serious bleeding (see "Anagrelide Bluefish and other medicines"). Anagrelide Bluefish should be taken exactly as prescribed by your doctor. Do not stop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine without consulting your doctor. Stopping the medicine suddenly can increase the risk of a stroke. Symptoms of a stroke may include sudden numbness or weakness of the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or understanding speech, sudden problems with vision in one or both eyes, sudden problems with walking, dizziness, loss of balance or coordination, and sudden severe headache without a known cause. You should seek medical attention immediately.

Children and adolescents

Information on the use of Anagrelide Bluefish in children and adolescents is limited, and therefore caution should be exercised when using this medicine.

Anagrelide Bluefish and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Tell your doctor about taking any of the following medicines:

• Medicines that can change the heart rhythm, such as sotalol, amiodarone;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotics used to treat infections, such as enoxacin;
• Theophylline used to treat severe cases of asthma and breathing problems;
• Medicines used to treat heart diseases, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• Acetylsalicylic acid (a substance also known as aspirin, present in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting);
• Other medicines that affect the number of platelets, such as clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives: the occurrence of severe diarrhea while taking this medicine may reduce the effectiveness of the oral contraceptive, and therefore, it is recommended to use additional methods of contraception (e.g., condoms). You should read the recommendations in the patient leaflet accompanying the oral contraceptives.

The effect of Anagrelide Bluefish or the mentioned medicines may be incorrect if they are taken at the same time. In case of doubts, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, inform your doctor. Pregnant women should not take Anagrelide Bluefish. Women who may become pregnant should use effective contraceptive methods during treatment with Anagrelide Bluefish. Your doctor can provide advice on contraceptive methods. If you are breastfeeding or plan to breastfeed, inform your doctor. You should not take Anagrelide Bluefish while breastfeeding. You should stop breastfeeding if you are taking Anagrelide Bluefish.

Driving and using machines

Some patients taking Anagrelide Bluefish have experienced dizziness. If you experience dizziness, do not drive or operate machinery.

Anagrelide Bluefish contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Anagrelide Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The amount of Anagrelide Bluefish taken by individual patients may vary and depends on the patient's condition. Your doctor will prescribe the appropriate dose for each patient. The usual initial dose of Anagrelide Bluefish is 1 mg. To take this dose, you will take one 0.5 mg capsule twice a day for at least one week. After this time, your doctor may instruct you to increase or decrease the number of capsules taken to determine the most effective dose. Swallow the capsules whole with a glass of water. Do not crush the capsules or dissolve their contents in liquids. You can take the capsules with food, after food, or on an empty stomach. It is best to take the capsules at the same time every day. Do nottake more or fewer capsules than your doctor has prescribed. Do notstop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine without consulting your doctor. Your doctor will instruct you to have regular blood tests to determine if the medicine is effective and if your liver and kidneys are working properly.

What to do if you take more Anagrelide Bluefish than you should

If you have taken more Anagrelide Bluefish than you should or if someone else has taken your medicine, contact your doctor or pharmacist immediately. Show them the package of Anagrelide Bluefish.

What to do if you forget to take Anagrelide 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 a forgotten dose.

4. Possible side effects

Like all medicines, Anagrelide Bluefish can cause side effects, although not everybody gets them. If you experience any worrying symptoms, consult your doctor. Severe side effects:Not very common: heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation), severe heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis causing severe abdominal and back pain, bloody vomiting, or passing bloody or black stools, significant decrease in blood cells, which can cause weakness, bruising, bleeding, or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of the legs or ankles, and blue discoloration of the lips and skin). Rare: kidney failure (passing very little urine or urine retention), heart attack. If you experience any of the above side effects, contact your doctor immediately. Very common side effects: may occur in more than 1 in 10 people

If you experience any of the above side effects, tell your doctor or pharmacist.

Headache. Common side effects: may occur in up to 1 in 10 peopleDizziness, fatigue, rapid heartbeat, irregular or strong heartbeat (palpitations), nausea, diarrhea, stomach pain, bloating with gas, vomiting, decrease in red blood cells (anemia), fluid retention or rash. Uncommon side effects: may occur in up to 1 in 100 peopleFeeling weak or unwell, 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, limited sensation or loss of sensation or feeling of numbness, especially in the skin, abnormal sensation or feeling of numbness or tingling, insomnia, depression, disorientation, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, and expectoration of sputum; hair loss, itching, and skin discoloration, impotence, chest pain, decrease in platelets (thrombocytopenia) increasing the risk of bleeding or bruising, fluid accumulation around the lungs, increased liver enzyme activity. Your doctor may instruct you to have a blood test, which may show increased liver enzyme activity. Rare side effects: may occur in up to 1 in 1,000 peopleGum bleeding, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation around the heart, painful coronary artery spasm (at rest, usually at night or early in the morning) (Prinzmetal's angina), coordination disorders, speech difficulties, dry skin, migraine, vision disorders or double vision, ringing in the ears, dizziness when standing up (especially from a sitting or lying position), increased need to urinate at night, pain, flu-like symptoms, drowsiness, vasodilation, colitis (symptoms include diarrhea, usually containing blood and mucus, stomach pain, and fever), gastritis (symptoms include pain, nausea, vomiting), lung tissue changes, increased creatinine levels in blood tests, which may indicate kidney function disorders. Side effects with unknown frequency:

• Potentially life-threatening heart rhythm disorders (torsade de pointes);
• Hepatitis, which may cause nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (jaundice);
• Pneumonitis (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic pneumonitis, including interstitial lung disease, pneumonitis);
• Nephritis (tubulointerstitial nephritis).
• Stroke (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anagrelide Bluefish

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the bottle, carton, or blister after "EXP". The expiry date refers to the last day of the month stated. There are no special precautions for storage. If your doctor instructs you to stop taking the medicine, do not leave any unused capsules unless your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. 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

What Anagrelide Bluefish contains

• The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride).
• The other ingredients are: Capsule contents: 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.

What Anagrelide Bluefish looks like and contents of the pack

Anagrelide Bluefish is available as hard, gelatin capsules with a white, opaque lower part and a white, opaque upper part, 14.3 mm in length and 5.2 mm in width, filled with a white or almost white, granular powder. The hard capsules of Anagrelide Bluefish are packed in high-density polyethylene (HDPE) bottles with a child-resistant polypropylene (PP) closure and a desiccant. Pack sizes: 42 or 100 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Bluefish Pharmaceuticals AB P.O. Box 49013 100 28 Stockholm Sweden

Manufacturer/Importer

Bluefish Pharmaceuticals AB Gävlegatan 22 113 30 Stockholm Sweden

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

Austria Anagrelid Bluefish 0.5 mg Hartkapseln Denmark Anagrelid "Bluefish" Germany Anagrelid Bluefish 0.5 mg Hartkapseln Norway Anagrelide Bluefish 0.5 mg hard capsules Portugal Anagrelida Bluefish 0.5 mg cápsulas Spain Anagrelida Bluefish 0.5 mg cápsulas duras EFG Sweden Anagrelide Bluefish 0.5 mg hårda kapslar United Kingdom (Northern Ireland) Anagrelide 0.5 mg hard capsules Iceland Anagrelide Bluefish 0,5 mg hörð hylki Poland Anagrelide Bluefish Date of last revision of the leaflet:December 2022