Anagrelide Vipharm

Package Leaflet: Information for the Patient

Anagrelide Vipharm, 0.5 mg, Hard Capsules

Anagrelide Vipharm, 1 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 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, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

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

Anagrelide Vipharm 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 to a more normal value. For this reason, it is used in the treatment of 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 Vipharm

When not to take Anagrelide Vipharm:

• 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 you have 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 decreased electrolyte levels, such as potassium, magnesium, or calcium (see "Other medicines and Anagrelide Vipharm");
• if you have 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 Vipharm and other medicines"). Anagrelide Vipharm 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. Sudden discontinuation of the medicine may lead to an increased risk of 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 vision problems in one or both eyes, sudden difficulty 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 the use of Anagrelide Vipharm in children and adolescents is limited. Caution should be exercised when using.

Anagrelide Vipharm 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. Inform your 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 antibiotics used to treat infections, such as enoxacin;
• theophylline, used to treat severe cases of 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 platelets, 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 the oral contraceptive, and you should use an additional method of contraception (e.g., a condom). You should read the recommendations in the patient information leaflet that comes with the oral contraceptive pill.

Anagrelide Vipharm or the above medicines may not work properly if taken at the same time. In case of doubt, 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. Women who may become pregnant should use effective contraceptive methods during anagrelide treatment. Your doctor can provide advice on contraceptive methods. If you are breastfeeding or plan to breastfeed, inform your doctor. You should not take anagrelide during 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 Vipharm contains lactose

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

3. How to take Anagrelide Vipharm

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult 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. The usual initial dose of anagrelide 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 establish 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 suddenly stop taking this medicine without consulting your doctor. Your doctor will order regular blood tests to determine if the medicine is effective and if your liver and kidneys are working properly.

Taking a higher dose of Anagrelide Vipharm than prescribed

If you have taken more anagrelide than prescribed or taken the medicine by another person, inform your doctor or pharmacist immediately. Show them the package with the medicine containing anagrelide.

Missing a dose of Anagrelide Vipharm

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, this medicine can cause side effects, although not everybody gets them. If you experience any worrying symptoms, consult your doctor. Serious side effects: Uncommon: 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 passing bloody or tarry stools, significant reduction in blood cell count, which can cause weakness, bruising, or bleeding, thrombocytopenia, 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 urine retention), heart attack. If you experience any of the above side effects, 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, irregular, or strong heartbeats (palpitations),

• nausea, diarrhea, stomach pain, bloating, vomiting, mild reduction in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects (may affect up to 1 in 100 people): 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, 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, decreased platelet count, which can increase 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 can show increased liver enzyme activity.

Rare side 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 disorders 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 can be a sign of kidney function disorder.

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);
• pneumonia (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic pneumonia, including interstitial lung disease, pneumonia);
• kidney inflammation (tubulointerstitial nephritis);
• stroke (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. 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, you can help provide more information on the safety of this medicine.

5. How to store Anagrelide Vipharm

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month. Anagrelide Vipharm, 0.5 mg, hard capsules Do not store above 30°C. Store in the original package to protect from light and moisture. Anagrelide Vipharm, 1 mg, hard capsules Do not store above 30°C. Store in the original package to protect from moisture. If your doctor advises you to stop taking the medicine, do not store unused capsules unless your doctor advises 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 Vipharm contains

Anagrelide Vipharm, 0.5 mg, hard capsules

• The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).

Anagrelide Vipharm, 1 mg, hard capsules

• The active substance is anagrelide. Each capsule contains 1 mg of anagrelide (as anagrelide hydrochloride monohydrate).
• Other ingredients are: Capsule contents:lactose monohydrate, croscarmellose sodium, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Anagrelide Vipharm, 0.5 mg, hard capsules Capsule shell:gelatin, titanium dioxide (E 171) Anagrelide Vipharm, 1 mg, hard capsules Capsule shell:gelatin, titanium dioxide (E 171), iron oxide black (E 172)

What Anagrelide Vipharm looks like and contents of the pack

Anagrelide Vipharm 0.5 mg is a hard capsule (size 4, 14.3 x 5.3 mm) with an opaque white body and cap. Each capsule is filled with a white or almost white powder. Anagrelide Vipharm 1 mg is a hard capsule (size 4, 14.3 x 5.3 mm) with a gray body and cap. Each capsule is filled with a white or almost white powder. The capsules are supplied in bottles containing 42 or 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturers

Marketing authorization holder Vipharm S.A. ul. A. i F. Radziwiłłów 9 05-850 Ożarów Mazowiecki Manufacturers/Importers 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:

Netherlands Anagrelide Genthon 0.5 mg / 1 mg, hard capsules Czech Republic Anagrelide Vipharm Spain Anagrelida Pharmavic 0.5 mg hard capsules EFG Finland Anagrelid Avansor 0.5 mg capsules, hard Croatia Anagrelid Alpha-Medical 0.5 mg hard capsules Hungary Anagrelide Vipharm Poland Anagrelide Vipharm Slovakia Anagrelide Vipharm 0.5 mg Sweden Anagrelid Avansor 0.5 mg hard capsule

Date of last revision of the leaflet: 19.04.2024