Grenalvon

Package Leaflet: Information for the Patient

Grenalvon, 0.5 mg, hard capsules

Grenalvon, 1 mg, hard capsules

Anagrelide

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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Grenalvon and what is it used for

Grenalvon contains the active substance anagrelide.
Grenalvon is a medicine that 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.
This is why 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 Grenalvon

When not to take Grenalvon

• if you are allergic to anagrelide or any of the other ingredientsof 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 disorders.
• if you have moderate or severe kidney disorders.

Warnings and precautions

Before starting treatment with Grenalvon, talk to your doctor:

• if you have or suspect you have heart disorders.
• if you have or have had prolonged QT interval(visible on an ECG, a record of the electrical activity of the heart) or if you are taking other medicines that can change the heart rhythm, or if you have reduced electrolyte levels, such as potassium, magnesium, or calcium (see "Other medicines and Grenalvon").
• if you have any liver or kidney disorders. When taken with acetylsalicylic acid(a component of many pain and anti-fever medicines, as well as blood clotting preventives, also known as aspirin), there is an increased risk of serious bleeding (see "Other medicines and Grenalvon"). Grenalvon 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 suddenly without consulting your doctor. Stopping the medicine suddenly 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 vision problems in one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, and sudden severe headache with no known cause. Seek medical help immediately.

Children and adolescents

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

Other medicines and Grenalvon

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell 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.
• some types of antibioticsused 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, cilostazol.
• acetylsalicylic acid(also known as aspirin, a component of many pain and anti-fever medicines, as well as blood clotting preventives).
• other medicines used to treat diseases 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 the oral contraceptive and therefore an additional method of contraception (e.g., condom) is recommended. Refer to the patient information leaflet accompanying the oral contraceptive pill. Grenalvon or the mentioned medicines may not work properly if taken at the same time. If in 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 contraception during anagrelide treatment.
Your doctor can provide advice on contraception methods.
Patients who are breastfeeding or plan to breastfeed should inform their doctor. Anagrelide should not be used during breastfeeding. The patient should stop breastfeeding if taking anagrelide.

Driving and using machines

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

Grenalvon contains lactose and sodium

This medicine contains lactose. If you have previously been diagnosed with 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 Grenalvon

Take this medicine always exactly as your doctor has told you. If you are not sure, 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 Grenalvon is 1 mg. The patient takes this dose in the form of a 0.5 mg capsule twice a day for at least one week. After this period, the doctor may increase or decrease the number of capsules taken to establish the most suitable dose for the patient, which will provide the most effective treatment.
Swallow the capsules whole with a glass of water. Do not crush or dissolve the contents of the capsules in liquids. The capsules can be taken 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 stop taking this medicine suddenly without consulting your doctor.
Your doctor will order regular blood tests to check if the medicine is working.

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.
Severeside 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 bloody or tarry stools, significant reduction in blood cell count, 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 urinary retention), 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, irregular, or strong 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 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, 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 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 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, abdominal 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 with symptoms such as nausea, vomiting, itching, yellowing of the skin and eyes, and changes in stool and urine color (hepatitis).
• 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, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Grenalvon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The first two digits indicate the month, and the next four digits indicate the year. The expiry date refers to the last day of the stated month.
Grenalvon, 0.5 mg, hard capsules
Do not store above 30°C. Store in the original package to protect from light and moisture.
Grenalvon, 1 mg, hard capsules
Do not store above 30°C. Store in the original package to protect from moisture.
If your doctor tells you to stop taking the medicine, do not store any 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 Grenalvon contains

The active substance is anagrelide
Grenalvon, 0.5 mg, hard capsules
Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).
Grenalvon, 1 mg, hard capsules
Each capsule contains 1 mg of anagrelide (as anagrelide hydrochloride monohydrate).
Other ingredients are:
Capusle content:lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.
Grenalvon, 0.5 mg, hard capsules
Capusle shell:gelatin, titanium dioxide (E 171).
Grenalvon, 1 mg, hard capsules
Capusle shell:gelatin, titanium dioxide (E 171), iron oxide black (E 172).

What Grenalvon looks like and contents of the pack

Grenalvon 0.5 mg is a hard capsule (size 4) with an opaque white body and cap. The capsule is filled with a white or almost white powder.
Grenalvon 1 mg is a hard capsule (size 4) with a gray body and cap. The capsule is filled with a white or almost white powder.
The capsules are provided 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Croatia, Netherlands, Poland, Romania: Grenalvon

For further information about this medicine, contact the local representative of the marketing authorization holder:

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