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.
• In case of any doubts, consult a 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 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 limits the production of blood platelets by the bone marrow, which leads to a reduction in the number of blood 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 the patient is allergic to anagrelide or any of the other ingredientsof this medicine (listed in section 6). An allergic reaction is characterized by a rash, itching, swelling of the face or lips, and shortness of breath.
• if the patient has moderate or severe liver disorders.
• if the patient has moderate or severe kidney disorders.

Warnings and precautions

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

• in case of heart disorders.
• if the patient has a prolonged 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 has reduced electrolyte levels, such as potassium, magnesium, or calcium (see "Other medicines and Grenalvon").
• if the patient has any liver or kidney disorders. When given with acetylsalicylic acid(a component of many painkillers and antipyretics, as well as anti-coagulants, also known as aspirin), there is an increased risk of serious bleeding (see "Other medicines and Grenalvon"). The patient should take Grenalvon exactly as prescribed by their doctor. The patient should not stop taking the medicine without consulting their doctor first. The patient should not suddenly stop taking this medicine without consulting their doctor. Suddenly stopping the medicine may increase the risk of a 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 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. The patient should 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 group of patients.

Other medicines and Grenalvon

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 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 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 the patient experiences 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. The patient should read the instructions in the package leaflet of the oral contraceptive pill. Grenalvon or the mentioned medicines may not work properly if taken at the same time. In case of doubts, the patient should consult their doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant or plans to become pregnant, they should inform their doctor.
Pregnant women should not take anagrelide. Women who may become pregnant should use effective contraception during anagrelide treatment.
The 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 they are taking anagrelide.

Driving and using machines

Some patients taking Grenalvon may experience dizziness. If such symptoms occur, the patient should not drive or operate machinery.

Grenalvon contains lactose and sodium

This medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Grenalvon

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The amount of anagrelide taken by individual patients may vary and depends on the patient's condition. The 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 determine the most appropriate dose for the patient, which will provide the most effective treatment.
The capsules should be swallowed whole, with a glass of water. The capsules should not be crushed or their contents dissolved 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 prescribed by the doctor. Do notstop taking the medicine without consulting the doctor first. The patient should not suddenly stop taking this medicine without consulting their doctor.
The doctor will order regular blood tests to determine if the medicine is effective.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any worrying symptoms, they should consult their 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 the patient experiences any of the above side effects, they should immediately contact their doctor.

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 heartbeats (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, decrease in platelet count, which can increase 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.
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, stomach pain, fever), gastritis (symptoms include pain, nausea, vomiting), lung changes (symptoms include cough, shortness of breath), 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 (torsades de pointes).
• hepatitis characterized by nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (hepatitis).
• 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 (tubulointerstitial nephritis).
• stroke (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Grenalvon

The medicine should be stored 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 first two digits indicate the month, and the next four digits indicate the year. The expiry date stated on the label and carton 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 the doctor advises the patient to stop taking the medicine, they should not store any unused capsules unless advised to do so by their 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 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:
Capsule contents:lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.
Grenalvon, 0.5 mg, hard capsules
Capsule shell:gelatin, titanium dioxide (E 171).
Grenalvon, 1 mg, hard capsules
Capsule 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 supplied 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, the patient should contact their local representative of the marketing authorization holder:

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