Anagrelide Sandoz

Package Leaflet: Information for the Patient

Anagrelide Sandoz, 0.5 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Anagrelide Sandoz contains the active substance anagrelide. Anagrelide Sandoz is a medicine that reduces the production of platelets in the blood. It works by decreasing the number of platelets produced by the bone marrow, which leads to a decrease in their number in the blood to a more normal value. For this reason, the medicine is used to treat patients with essential thrombocythemia. Essential thrombocythemia is a disease in which the bone marrow produces too many blood cells called platelets. A high number of platelets can cause serious blood circulation and clotting disorders.

2. Important information before taking Anagrelide Sandoz

When not to take Anagrelide Sandoz

• if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, itching, swelling of the face or lips or difficulty breathing.
• if you have moderate or severe liver problems.
• if you have moderate or severe kidney problems.

Warnings and precautions

Before taking Anagrelide Sandoz, discuss with your doctor if:

• you have been diagnosed with heart disease or are suspected of having it;
• you have been diagnosed with a congenital prolongation of the QT interval (visible on an ECG - a record of the electrical activity of the heart) or if such a condition has occurred in your relatives, or if you are taking other medicines that cause changes in the ECG, or if the level of electrolytes (such as potassium, magnesium or calcium) in your blood is low (see "Anagrelide Sandoz and other medicines");
• you have been diagnosed with liver or kidney problems.

When taking Anagrelide Sandoz with acetylsalicylic acid (a substance also known as "aspirin", present in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting), there is an increased risk of serious bleeding (bleeding), see section "Anagrelide Sandoz and other medicines". When taking Anagrelide Sandoz, you should take the dose of the medicine exactly as prescribed by your doctor. Do not stop taking the medicine without first consulting your doctor. Do not suddenly stop taking this medicine without consulting your doctor. Stopping the medicine suddenly may increase the risk of a stroke. Symptoms of a stroke may include sudden numbness or weakness in 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 in such a situation.

Children and adolescents

Due to limited information on the use of Anagrelide Sandoz in children and adolescents, caution is recommended in this group of patients.

Anagrelide Sandoz and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as about medicines you plan to take. Tell your doctor or pharmacist about taking any of the following medicines:

• medicines that can change heart rhythm, such as sotalol, amiodarone;
• fluvoxamine (a medicine used to treat depression);
• certain types of antibiotics, such as enoxacin, used to treat infections;
• theophylline (a medicine used to treat severe asthma and breathing disorders);
• medicines used to treat heart diseases, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid (a substance present in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as "aspirin");
• other medicines used in conditions that affect platelet function, such as clopidogrel;
• omeprazole (a medicine used to reduce stomach acid production);
• oral contraceptives: if during treatment with Anagrelide Sandoz, a patient experiences severe diarrhea, it may be a cause of reduced effectiveness of oral contraceptives. It is recommended to use an additional method of contraception (i.e., condom). Women taking oral contraceptives should read the leaflet accompanying their packaging.

If Anagrelide Sandoz or the mentioned medicines are taken at the same time, they may not work properly. In case of doubts, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, tell your doctor. Anagrelide Sandoz should not be taken during pregnancy. Women of childbearing age should use effective contraception during treatment with Anagrelide Sandoz. If a patient needs advice on contraception, she should consult her doctor. If you are breastfeeding or planning to breastfeed, tell your doctor. Anagrelide Sandoz should not be taken during breastfeeding. Patients taking Anagrelide Sandoz must stop breastfeeding.

Driving and using machines

Some people taking Anagrelide Sandoz have reported dizziness. If you experience dizziness, you should not drive or operate machinery.

Anagrelide Sandoz contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Anagrelide Sandoz

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The dose of Anagrelide Sandoz may vary from patient to patient, depending on the condition. Your doctor will prescribe a dose tailored to your needs. The usual starting dose is 1 mg per day. You can take one 0.5 mg capsule twice a day for at least a week. After this time, your doctor may increase or decrease the number of capsules to determine the best, most effective dose for you. The capsules should be taken orally, swallowed whole, with a glass of water. The capsules should not be crushed or their contents dissolved in liquids. The medicine can be taken with or without food, preferably at the same time every day. Do nottake more or fewer capsules than your doctor has prescribed. Do notstop taking the medicine without first consulting your doctor. Do not suddenly stop taking this medicine on your own. Your doctor will order regular blood tests to check if the medicine is working effectively and if your liver and kidney function is normal.

Taking a higher dose of Anagrelide Sandoz than recommended

If you have taken more Anagrelide Sandoz than you should, or if someone else has taken your medicine, contact your doctor or pharmacist immediately. Show them the medicine package.

Missing a dose of Anagrelide Sandoz

If you miss a dose, take the capsule as soon as possible, and then take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Anagrelide Sandoz can cause side effects, although not everybody gets them. Severe side effects
Uncommon: heart failure (with symptoms such as shortness of breath, chest pain, swelling of the legs due to fluid accumulation), severe heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis (which causes severe abdominal and back pain), vomiting blood, blood in the stool or black stools, significant decrease in blood cell count (which can cause weakness, bruising, bleeding, or infections [pancytopenia]), pulmonary hypertension (with symptoms such as shortness of breath, swelling of the legs or ankles, or cyanosis of the lips and skin).
Rare: kidney failure (the patient does not urinate or urinates a small amount), heart attack.

If you experience any of these side effects, contact your doctor immediately. Very common side effects: may occur in more than 1 in 10 people

Headache. Common side effects: may occur in less than 1 in 10 people
Dizziness, fatigue, rapid heartbeat, irregular or strong heartbeat (palpitations), nausea, diarrhea, stomach pain, gas, vomiting, decreased red blood cell count (anemia), fluid retention or rash. Uncommon side effects: may occur in less than 1 in 100 people
Feeling weak or unwell, 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, weakness or numbness or sensations such as tingling (especially of the skin), abnormal sensations, such as tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, or phlegm in the throat; hair loss, itching or skin discoloration, impotence, chest pain, decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the space around the lungs or increased liver enzyme activity (to control their activity, your doctor may order blood tests). Rare side effects: may occur in less than 1 in 1000 people
Bleeding from the gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (with symptoms such as fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the space around the heart, painful constriction of blood vessels in the heart (at rest, usually at night or early in the morning [Prinzmetal's angina]), lack of coordination, speech disorders, dry skin, migraine, vision disorders or double vision, ringing in the ears, dizziness when standing up (from a sitting or lying position), increased need to urinate at night, pain, flu-like symptoms, drowsiness, vasodilation, colitis (with symptoms such as diarrhea, usually with blood and mucus, stomach pain, fever), gastritis (with symptoms such as pain, nausea, vomiting), appearance of areas in the lungs with decreased density, increased creatinine levels in the blood, which may indicate kidney problems. Side effects with unknown frequency

• Potentially life-threatening, irregular heartbeat (heart rhythm disorders of the type torsade de pointes);
• Hepatitis (symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, discoloration of stool and urine);
• Pneumonitis (symptoms may include fever, cough, difficulty breathing, wheezing); which can cause scarring of the lungs (allergic pneumonitis, including interstitial lung disease);
• 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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 Sandoz

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Store in the original package to protect from moisture. After opening the bottle, use the medicine within 100 days. Store the bottle tightly closed, in a dry place, to protect from moisture. 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 Sandoz contains

The active substance is anagrelide. One capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate). The other ingredients are: povidone (K30); anhydrous lactose; lactose monohydrate; microcrystalline cellulose; crospovidone (type A) and magnesium stearate. Capsule shell: gelatin and titanium dioxide (E 171).

What Anagrelide Sandoz looks like and contents of the pack

Anagrelide Sandoz is a white, hard gelatin capsule (size 4; 14.4 mm), containing a white or almost white powder. The bottle with a desiccant contains 100 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Noucor Health, S.A. Avda. Camí Reial, 51-57, Palau-Solità i Plegamans,
08184 Barcelona, Spain
Galenicum Health S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona, Spain
SAG Manufacturing, S.L.U.
Carretera A-1, Km 36
San Agustín del Guadalix
28750 Madrid, Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland)

contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz logo
Date of last revision of the leaflet:10/2023
The reference medicine containing anagrelide was authorized under the "exceptional circumstances" authorization procedure. This means that due to the rare occurrence of the disease, it was not possible to obtain full information about this medicine. The European Medicines Agency will review any new information once a year and, if necessary, this patient leaflet will be updated.