Anagrelide Zentiva

Leaflet accompanying the packaging: patient information

Anagrelide Zentiva, 0.5 mg, hard capsules
Anagrelidum

Read the 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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Anagrelide Zentiva contains the active substance anagrelide.
Anagrelide inhibits the development of blood platelets. It reduces the production of platelets by the bone marrow, which leads to a decrease in the number of 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 Zentiva

When not to take Anagrelide Zentiva:

• 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 anagrelide, you should talk to your doctor:

• if you have or suspect heart rhythm disorders;
• if you have or have had a prolonged QT interval (visible on an ECG, a record of the heart's electrical activity) or if you are taking other medicines that can change the heart rhythm, or if you have low levels of electrolytes such as potassium, magnesium, or calcium (see "Anagrelide Zentiva and other medicines");
• if you have any liver or kidney problems;

When taking anagrelide with acetylsalicylic acid (a component of many painkillers and antipyretics, as well as anti-coagulant medications, also known as aspirin), there is an increased risk of serious bleeding (see "Anagrelide Zentiva and other medicines").
Anagrelide Zentiva should be taken exactly as prescribed by your doctor. Do not stop taking the medicine without consulting your doctor first. Do not stop taking this medicine abruptly without consulting your doctor. Stopping anagrelide abruptly can increase the risk of a stroke.
Symptoms of a stroke can 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 help immediately.

Children and adolescents

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

Anagrelide Zentiva 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 if you are 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 difficulties;
• medicines used to treat heart conditions, 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-coagulant medications);
• other medicines used to treat conditions that affect the number of 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 effectiveness of your oral contraceptive, and you should use an additional method of contraception (e.g., a condom). You should read the instructions in the patient information leaflet that comes with your oral contraceptive pill.

Anagrelide Zentiva or these medicines may not work properly if taken together.
If you are unsure, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, tell your doctor. Women who are pregnant should not take anagrelide. Women who may become pregnant should use effective contraception while taking anagrelide. Your doctor can advise on contraception methods.
Patients who are breastfeeding or plan to breastfeed should inform their doctor. You should not take anagrelide while breastfeeding. You should stop breastfeeding if you take anagrelide.

Driving and using machines

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

Anagrelide Zentiva contains lactose and sodium

This medicine contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Anagrelide Zentiva

Anagrelide Zentiva should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.
The amount of anagrelide taken by individual patients may vary and depends on the patient's condition. Your doctor will prescribe the appropriate dose for each patient.
Usually, the initial dose of Anagrelide Zentiva is 1 mg. You take this dose in the form of 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 taken to determine the most suitable dose for you, 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. You 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 your doctor. Do notstop taking the medicine without consulting your doctor first. Do not stop taking this medicine abruptly without consulting your doctor.
Your doctor will order regular blood tests to determine if the medicine is working and if your liver and kidneys are working properly.

Taking a higher dose of Anagrelide Zentiva than recommended

If you take a higher dose of Anagrelide Zentiva than recommended or take the medicine by another person, tell your doctor or pharmacist immediately. Show them the packaging of Anagrelide Zentiva.

Missing a dose of Anagrelide Zentiva

You should 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 the missed dose.

4. Possible side effects

Like all medicines, Anagrelide Zentiva can cause side effects, although not everybody gets them.
If you experience any worrying symptoms, consult your doctor.
Severeside effects:
Uncommon: 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 • vomiting blood or passing black, tarry stools • significant reduction in blood cells, which can cause weakness • bruising • bleeding or infections (pancytopenia) • pulmonary hypertension (symptoms include shortness of breath, swelling of the feet or ankles, possible blue discoloration of the lips and skin).

Rare: kidney failure (passing very little urine or retaining urine) • heart attack.

If you experience any of the above side effects, contact your doctor immediately.

Very commonside effects (may affect more than 1 in 10 people):
headache.
Commonside effects (may affect up to 1 in 10 people):
dizziness • fatigue • rapid heartbeat • irregular or forceful heartbeat (palpitations) • nausea • diarrhea • stomach pain • bloating • vomiting • mild reduction in red blood cell count (anemia) • fluid retention or rash.
Uncommonside effects (may affect up to 1 in 100 people):
weakness or malaise • high blood pressure • irregular heartbeat • fainting • chills or fever • indigestion • loss of appetite • constipation • bruising • bleeding • swelling

• weight loss • muscle pain • joint pain • back pain • numbness or tingling, especially in the skin, • abnormal sensation or feeling of numbness or tingling and burning• insomnia • depression • disorientation • nervousness • dry mouth • memory loss • shortness of breath • nosebleeds • severe lung infection with fever • shortness of breath • cough • expectoration of sputum • hair loss • itching and skin discoloration
• impotence • chest pain • decreased platelet count, increasing the risk of bleeding or bruising (thrombocytopenia) • fluid accumulation around the lungs and increased liver enzyme activity. Your doctor may order a blood test, which may show increased liver enzyme activity.

Rareside effects (may affect up to 1 in 1,000 people):
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 disturbances or double vision • tinnitus • dizziness (especially when standing up 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.

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

• 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);
• 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 (interstitial 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. You can report side effects directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
You can also report side effects to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Anagrelide Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and label 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 stated month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
If your doctor tells you to stop taking the medicine, do not store unused capsules unless your doctor advises you to do so.
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 Zentiva contains

The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).
Other ingredients are:
Capusle contents:lactose monohydrate, croscarmellose sodium, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.
Capusle shell:gelatin, titanium dioxide (E 171).

What Anagrelide Zentiva looks like and contents of the pack

Anagrelide Zentiva is available in the form of non-transparent, white, hard capsules (size 4).
The capsules are available in bottles containing 42 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Anagrelid Zentiva
France, Netherlands, Poland, Czech Republic, Slovakia, United Kingdom (Northern Ireland): Anagrelide Zentiva

For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:September 2022