Anagrelide Accord

Leaflet accompanying the packaging: patient information

Anagrelide Accord, 0.5 mg, hard capsules

Anagrelide Accord, 1 mg, hard capsules

Anagrelidum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Anagrelide Accord contains the active substance anagrelide. Anagrelide Accord is a medicine that inhibits the development of blood platelets. It limits the production of blood platelets by the bone marrow, leading to a reduction in the number of blood platelets in the blood to a more normal value. For this reason, 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 called platelets. An excess of platelets in the blood can lead to severe circulatory and blood clotting disorders.

2. Important information before taking Anagrelide Accord

When not to take Anagrelide Accord

• if the patient is 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 the patient has moderate or severe liver function disorders;
• if the patient has moderate or severe kidney function disorders.

Warnings and precautions

Before starting treatment with Anagrelide Accord, the patient should talk to their doctor:

• in case of heart rhythm disorders;
• if the patient has a congenital or suspected prolongation of the QT interval (visible on an ECG, a record of the heart's electrical activity) or if the patient is taking other medicines that can change the heart rhythm or reduce electrolyte levels, such as potassium, magnesium, or calcium (see "Anagrelide Accord and other medicines");
• if the patient has any liver or kidney disorders.

In case of concomitant administration with acetylsalicylic acid(a component of many painkillers and antipyretics, as well as anti-coagulants, also known as aspirin), the risk of serious bleeding (hemorrhage) increases (see section "Anagrelide Accord and other medicines"). Anagrelide Accord should be taken exactly as prescribed by the doctor. Do not stop taking the medicine without consulting a doctor first. Do not suddenly stop taking this medicine without consulting a doctor. Sudden discontinuation of the medicine may lead to an increased risk of stroke. Stroke symptoms 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 vision problems in one or both eyes, sudden walking problems, dizziness, loss of balance or coordination, and sudden severe headache without a known cause. Medical help should be sought immediately.

Children and adolescents

Experience with the use of Anagrelide Accord in children and adolescents is limited. Caution should be exercised when using this medicine in this patient group.

Anagrelide Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor about the use of any of the following medicines:

• medicines that can change the heart rhythm, such as sotalol, amiodarone;
• fluvoxamine, used to treat depression;
• certain types of antibioticsused to treat infections, such as enoxacin;
• theophylline, used to treat severe asthma and breathing difficulties;
• medicines used to treat heart diseases, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid(also known as aspirin, a component of many painkillers and antipyretics, as well as anti-coagulants);
• other medicines used to treat diseases that affect the number of blood platelets, such as clopidogrel;
• omeprazole, used to reduce the amount of acid produced in the stomach;
• oral contraceptives: if severe diarrhea occurs while taking this medicine, it may reduce the effectiveness of the oral contraceptive and, therefore, an additional contraceptive method (e.g., condom) should be used. The patient should read the recommendations in the patient information leaflet accompanying the oral contraceptive pill.

Anagrelide Accord or the above medicines may not work properly if taken together. In case of doubts, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or plans to become pregnant, they should inform their doctor. Pregnant women should not take Anagrelide Accord. Women who may become pregnant should use effective contraceptive methods during treatment with Anagrelide Accord. The doctor can provide advice on contraceptive methods. Breastfeeding patients or those planning to breastfeed should inform their doctor. Anagrelide Accord should not be used during breastfeeding. The patient should stop breastfeeding if they are taking Anagrelide Accord.

Driving and using machines

Some patients taking Anagrelide Accord have experienced dizziness. If dizziness occurs, the patient should not drive or operate machinery.

Anagrelide Accord contains lactose

This medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Anagrelide Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Anagrelide Accord

Anagrelide Accord should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The amount of Anagrelide Accord taken by individual patients may vary and depends on the patient's condition. The doctor will prescribe the appropriate dose for each patient. The usual initial dose of Anagrelide Accord is 1 mg. The patient takes this dose in the form of a capsule, 0.5 mg twice a day for at least one week. After this period, the doctor may increase or decrease the number of capsules taken to determine the most suitable dose for the patient, which will provide the most effective treatment. The capsules should be swallowed whole, with a glass of water. Do not crush the capsules or dissolve their contents in liquids. The patient can take the capsules with food, after food, or on an empty stomach. It is best to take the capsule(s) at the same time every day. Do nottake more or fewer capsules than prescribed by the doctor. Do not stop taking the medicine without consulting a doctor first. Do not suddenly stop taking this medicine. The doctor will order regular blood tests to determine if the medicine is effective and if the liver and kidneys are working properly.

Taking a higher dose of Anagrelide Accord than recommended

In case of taking a higher dose of Anagrelide Accord than recommended or taking the medicine by another person, the patient should immediately inform their doctor or pharmacist. The patient should show the packaging of the medicine.

Missing a dose of Anagrelide Accord

The patient should take the capsules as soon as they remember. The next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Anagrelide Accord can cause side effects, although not everybody gets them. If the patient experiences any worrying symptoms, they should consult their doctor. Serious side effects: Not very common: heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation), serious heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis causing severe abdominal and back pain, bloody vomiting or black, tarry stools, significant reduction in the number of blood cells, which can cause weakness, bruising, bleeding, or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of the legs or ankles, possible blue discoloration of the lips and skin). Rare: kidney failure (passing very little urine or retaining urine), heart attack.

If any of the above side effects occur, the patient should immediately contact their doctor.

Very common side effects: occurring in at least 1 in 10 patients:

headache. Common side effects:may occur in less than 1 in 10 patients: dizziness, fatigue, rapid, irregular, or strong heartbeats (palpitations), nausea, diarrhea, stomach pain, bloating, vomiting, mild reduction in the number of red blood cells (anemia), fluid retention or rash. Uncommon side effects:may occur in less than 1 in 100 patients: weakness or malaise, high blood pressure, irregular heart rhythm, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling, 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 the number of platelets, increasing the risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs, and increased liver enzyme activity. The doctor may order a blood test, which may show increased liver enzyme activity.

Rare side effects:

gum 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, tinnitus, 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, fever), gastritis (symptoms include pain, nausea, vomiting), lung 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 can cause nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (jaundice);
• lung inflammation (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic alveolitis, including interstitial lung disease, pneumonitis);

kidney inflammation (interstitial nephritis).

• stroke (see section 2)

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 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, more information can be gathered on the safety of the medicine.

5. How to store Anagrelide Accord

Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month. Anagrelide Accord, 0.5 mg, hard capsules: Do not store above 30°C. Store in the original packaging to protect from light and moisture. Anagrelide Accord, 1 mg, hard capsules: Do not store above 30°C. 1 mg capsules: Store in the original packaging to protect from moisture. If the doctor advises the patient to stop taking the medicine, do not store any unused capsules unless advised to do so by the doctor. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Anagrelide Accord contains

Anagrelide Accord, 0.5 mg, hard capsules: The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate). Anagrelide Accord, 1 mg, hard capsules: The active substance is anagrelide. Each capsule contains 1 mg of anagrelide (as anagrelide hydrochloride monohydrate). The other ingredients are: Capsule contents: lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate. Anagrelide Accord, 0.5 mg, hard capsules: Capsule shell: gelatin, titanium dioxide (E171). Anagrelide Accord, 1 mg, hard capsules: Capsule shell: gelatin, titanium dioxide (E171), iron oxide black (E172).

What Anagrelide Accord looks like and contents of the pack

Anagrelide Accord 0.5 mg: white, opaque hard capsule, size 4, containing white or almost white powder. Anagrelide Accord 1 mg: gray hard capsule, size 4, containing white or almost white powder. The capsules are available in bottles containing 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o. ul. Taśmowa 7 02-677 Warsaw Tel: +48 22 577 28 00

Manufacturer

Synthon Hispania, S.L. C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat 08830 Barcelona Spain Synthon BV Microweg 22 6545 CM Nijmegen Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: November 2022

This medicine has been authorized under exceptional circumstances. This means that due to the rare occurrence of the disease, it was not possible to obtain complete information on this medicine. The European Medicines Agency will review all new information on the medicine every year and, if necessary, update the contents of this leaflet.