Anagrelide bluefish

Patient Information Leaflet

Anagrelide Bluefish, 0.5 mg, hard capsules
Anagrelidum
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Anagrelide Bluefish is and what it is used for
2. What you need to know before you take 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 Anagrelide Bluefish is and what it is used for

Anagrelide Bluefish contains the active substance anagrelid. Anagrelide Bluefish is a medicine that affects the production of blood platelets. This medicine reduces the number of platelets produced by the bone marrow, thereby lowering the platelet count in the blood to a more normal level. For this reason, it is used in the treatment of patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition in which the bone marrow produces too many blood cells known as platelets. A high number of platelets in the blood may lead to serious circulation and blood clotting disorders.

2. Important information before using Anagrelide Bluefish

When not to use Anagrelide Bluefish

• If the patient is allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Allergic reaction may manifest as rash, itching, swelling of the face or lips, and difficulty breathing;
• If the patient has moderate or severe liver function impairment;
• If the patient has moderate or severe kidney function impairment.

Warnings and precautions
Before starting treatment with Anagrelide Bluefish, consult a doctor:

• if the patient has or suspects having heart disease;
• if the patient has prolonged QT interval (seen on ECG, the recording of the heart's electrical activity), either from birth or occurring in family members, if the patient is taking other medicines causing ECG changes, or if the patient has low levels of electrolytes such as potassium, magnesium, or calcium (see section "Anagrelide Bluefish with other medicines");
• if the patient has liver or kidney disease.

When administered concomitantly 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 reduce blood clotting), there is an increased risk of serious bleeding (haemorrhage) (see section "Anagrelide Bluefish with other medicines").
Anagrelide Bluefish must be taken exactly as prescribed by the doctor. Do not stop taking the medicine without first consulting your doctor. Do not suddenly stop taking this medicine without consulting your doctor. Abrupt discontinuation of the medicine may lead to an increased risk of stroke.
Symptoms of stroke may include sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; sudden confusion, trouble speaking or difficulty understanding speech; sudden vision problems in one or both eyes; sudden trouble walking, dizziness, loss of balance or lack of coordination; and sudden severe headache with no known cause. Seek immediate medical help.

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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if you are taking any of the following medicines:

• Medicines that may affect heart rhythm, e.g. sotalol, amiodarone;
• Fluvoxamine, used to treat depression;
• Specific types of antibiotics used to treat infections, such as enoxacin;
• Theophylline, used to treat severe asthma and breathing problems;
• Medicines used to treat heart conditions, for example 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 preventing blood clotting);
• Other medicines affecting platelet count, e.g. clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives: severe diarrhoea during treatment with this medicine may reduce the effectiveness of oral contraceptives, therefore additional contraceptive methods (e.g. condoms) are recommended. Please refer to the instructions provided in the patient leaflet included in the packaging of oral contraceptives.

The effect of Anagrelide Bluefish or the listed medicines may be altered if taken simultaneously. If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If the patient is pregnant or planning to become pregnant, she should inform her doctor. Pregnant women should not take Anagrelide Bluefish. Women who could become pregnant should use effective contraception during treatment with Anagrelide Bluefish. Advice regarding contraceptive methods can be provided by a doctor.
Women who are breastfeeding or planning to breastfeed should inform their doctor. Anagrelide Bluefish must not be used during breastfeeding. The patient should stop breastfeeding if taking Anagrelide Bluefish.

Driving and operating machinery
Dizziness has been reported in some patients taking Anagrelide Bluefish. If dizziness occurs, do not drive or operate machinery.

Anagrelide Bluefish contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Anagrelide Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult 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 starting dose of Anagrelide Bluefish is 1 mg. To achieve this dose, the patient will take one 0.5 mg capsule twice daily for at least one week. After this time, the doctor may instruct to increase or decrease the number of capsules taken in order to determine the most effective dose.
The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve their contents in liquids. The capsules may be taken with food, after food, or on an empty stomach. It is best to take the capsules at the same time each day.
Do not take more or fewer capsules than prescribed by your doctor. Do not stop taking this medicine without first consulting your doctor. Do not suddenly stop taking this medicine on your own.
Your doctor will arrange regular blood tests to monitor whether the medicine is working and to check that the liver and kidneys are functioning properly.
Taking more Anagrelide Bluefish than prescribed
If a higher than recommended dose of Anagrelide Bluefish has been taken, or if someone else has taken the medicine, contact a doctor or pharmacist immediately. Show the Anagrelide Bluefish packaging.
Missed dose of Anagrelide Bluefish
If the patient remembers taking a dose late, they should take it as soon as possible. The next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any worrying symptoms, consult your doctor.

Serious side effects:
Not common: heart failure (symptoms include breathlessness, chest pain, swelling of the lower limbs due to fluid accumulation), severe disturbances in heart rate or rhythm (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), pancreatitis causing severe abdominal and back pain, vomiting blood or passing bloody or tarry stools, marked decrease in blood cell counts which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and bluish discoloration of lips and skin).

Rare: kidney failure (passing very little or no urine), heart attack.

If any of the above serious side effects occur, contact your doctor immediately.

Very common side effects: may affect more than 1 in 10 people
Headache.

Common side effects: may affect up to 1 in 10 people
Dizziness, fatigue, rapid heartbeat, irregular or forceful heartbeats (palpitations), nausea, diarrhoea, stomach pain, bloating with gas, vomiting, reduced number of red blood cells (anaemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 people
Feeling weak or generally unwell, high blood pressure, irregular heart rhythm, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle pain, joint pain, back pain, reduced sensation or loss of sensation or tingling, particularly in the skin, abnormal sensation or feeling of numbness or pins and needles, insomnia, depression, disorientation, nervousness, dry mouth, memory impairment, breathlessness, nosebleeds, severe lung infection with fever, breathlessness, cough and sputum production; hair loss, itching and skin discoloration, impotence, chest pain, reduced platelet count (thrombocytopenia) increasing the risk of bleeding or bruising, fluid accumulation around the lungs, increased liver enzyme activity. Your doctor may order a blood test which may show increased liver enzyme activity.

Rare side effects: may affect up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina), heart muscle disease (symptoms include fatigue, chest pain and palpitations), enlarged heart, fluid accumulation around the heart, painful spasm of coronary blood vessels (at rest, usually at night or early morning) (Prinzmetal's angina), movement coordination problems, difficulty speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness when standing up (especially from sitting or lying positions), increased need to pass urine at night, pain, flu-like symptoms, drowsiness, blood vessel dilation, inflammation of the large intestine (symptoms include diarrhoea, usually containing blood and mucus, stomach pain, fever), inflammation of the stomach (symptoms include pain, nausea, vomiting), development of areas of altered density in the lungs, increased blood creatinine levels, which may indicate impaired kidney function.

The following side effects have also been reported, but their frequency is unknown:

• Potentially life-threatening heart rhythm disorders (torsade de pointes);
• Liver inflammation presenting with nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine colour (jaundice);
• Lung inflammation (symptoms include fever, cough, difficulty breathing, wheezing; the disease may lead to lung tissue scarring) (allergic alveolitis, including interstitial lung disease, pneumonia);
• Kidney inflammation (tubulointerstitial nephritis).
• Stroke (see section 2).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Anagrelide Bluefish

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, cardboard box or blister pack following the word "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions apply.
If your doctor has advised you to stop taking this medicine, do not keep any unused capsules, unless otherwise advised by your doctor. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 anagrelide (as anagrelide hydrochloride).
• The other ingredients are: Capsule contents: povidone (E 1201), crospovidone (E 1202), lactose, monohydrate lactose, 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 an opaque white lower part and an opaque white cap, measuring 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 closure and a moisture-absorbing agent.
Pack sizes: 42 or 100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Manufacturer/Importer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Anagrelid Bluefish 0.5 mg Hard Capsules
Denmark Anagrelid "Bluefish"
Germany Anagrelid Bluefish 0.5 mg Hard Capsules
Norway Anagrelide Bluefish 0.5 mg hard capsules
Portugal Anagrelida Bluefish 0.5 mg capsules
Spain Anagrelida Bluefish 0.5 mg hard capsules 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