ANAGRELIDE TEVA-RATIOPHARM 0.5 mg HARD CAPSULES

Introduction

Leaflet:information for the patient

Anagrelide Teva-ratiopharm 0.5 mg hard capsules EFG

Read the entire leaflet carefully before starting to take this medicine,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Anagrelide Teva-ratiopharm and what is it used for
2. What you need to know before taking Anagrelide Teva-ratiopharm
3. How to take Anagrelide Teva-ratiopharm
4. Possible side effects
5. Storage of Anagrelide Teva-ratiopharm
6. Package contents and additional information

1. What is Anagrelide Teva-ratiopharm and what is it used for

Anagrelide Teva-ratiopharm contains the active substance anagrelide. Anagrelide Teva-ratiopharm is a medicine that interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, resulting in a reduction in the platelet count in the blood to a more normal level. For this reason, it is used to treat patients with essential thrombocythemia.

Essential thrombocythemia is a condition that occurs when the bone marrow produces an excessive number of blood cells known as platelets. A high number of platelets in the blood can cause serious circulation and blood clotting problems.

2. What you need to know before taking Anagrelide Teva-ratiopharm

Do not take AnagrelideTeva-ratiopharm

• if you are allergic to anagrelide or any of the other components of this medicine (listed in section 6). Allergic reactions can manifest as a rash, itching, swelling of the face and lips, or difficulty breathing,
• if you have moderate or severe liver problems,
• if you have moderate or severe kidney problems.

Warnings and precautions

Consult your doctor before starting to take Anagrelide Teva-ratiopharm:

• if you have or think you may have a heart problem,

• if you were born with a prolonged QT interval or have a family history of prolonged QT interval (observed on the ECG, electrical recording of the heart) or if you are taking other medicines that produce abnormal changes in the ECG or if you have low levels of electrolytes, e.g., potassium, magnesium, or calcium (see the section "Taking Anagrelide Teva-ratiopharm with other medicines"),
• if you have liver or kidney problems.

In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting), there is a greater risk of presenting major bleeding (bleeding) (see section "Taking Anagrelide Teva-ratiopharm with other medicines").

While you are being treated with Anagrelide Teva-ratiopharm, you must take the exact dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor beforehand. You should not stop taking this medicine suddenly without consulting your doctor. Sudden withdrawal of the medicine may increase the risk of stroke.

The signs and symptoms of a stroke can 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 difficulty seeing with one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, and severe headache with no known cause. Please consult your doctor immediately.

Children and adolescents

Information on the use of Anagrelide Teva-ratiopharm in children and adolescents is limited, and therefore, this medicine should be used with caution.

Taking Anagrelide Teva-ratiopharmwithother medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Inform your doctor if you are taking any of the following medicines:

• medicines that can alter the heart rhythm, such as sotalol, amiodarone,
• fluvoxamine, used to treat depression,
• certain types of antibiotics, such as enoxacin, used to treat infections,
• theophylline, used to treat asthma and severe respiratory problems,
• medicines for treating heart conditions, such as milrinone, enoximone, amrinone, olprinone, and cilostazol,
• acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting),
• other medicines for treating conditions that affect 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 effect of the oral contraceptive, and it is recommended to use an additional contraceptive method (e.g., condom). Consult the instructions in the leaflet of the oral contraceptive you are taking.

If used together, Anagrelide Teva-ratiopharm or these medicines may not work correctly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy andbreastfeeding

Consult your doctor if you are pregnant or plan to become pregnant. If you are pregnant, you should not take Anagrelide Teva-ratiopharm. Women who may become pregnant must ensure they use effective contraceptive measures while taking Anagrelide Teva-ratiopharm. Consult your doctor if you need advice on contraceptives.

Consult your doctor if you are breastfeeding or plan to breastfeed. You should not take Anagrelide Teva-ratiopharm while breastfeeding. If you are taking Anagrelide Teva-ratiopharm, you muststop breastfeeding.

Driving and using machines

Some patients taking Anagrelide Teva-ratiopharm have reported symptoms of dizziness. Do notdrive or operate machines if you feel dizzy.

Anagrelide Teva-ratiopharm contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is, essentially, "sodium-free".

3. How to take Anagrelide Teva-ratiopharm

Follow the exact instructions for administering this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The amount of Anagrelide Teva-ratiopharm that different patients can take may vary, as this amount depends on the condition. Your doctor will prescribe the most suitable dose for your case.

The initial normal dose of Anagrelide Teva-ratiopharm is 1 mg. This dose is taken with one 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 you should take until they find the dose that best suits your case and treats the condition most effectively.

The capsules should be swallowed whole with a glass of water. Do notcrush the capsules or dissolve the contents in a liquid. You can take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) always at the same time.

Do nottake more or fewer capsules than your doctor has recommended. Do notstop taking the medicine without informing your doctor beforehand. You should not stop taking this medicine suddenly on your own.

Your doctor will indicate that you undergo regular blood tests to check if the medicine is effective and if your liver and kidneys are working well.

If you take more Anagrelide Teva-ratiopharm than you should

If you take more Anagrelide Teva-ratiopharm than you should or if someone else has taken this medicine, inform your doctor or pharmacist immediately. You should show them the Anagrelide Teva-ratiopharm packaging.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take AnagrelideTeva-ratiopharm

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 forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you are concerned about this, consult your doctor.

Serious side effects:

Uncommon: Heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious heart rhythm problems (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis (inflammation of the pancreas that causes severe back and abdominal pain), vomiting blood or black, tarry stools, severe decrease in blood cell count that can cause weakness, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and bluish discoloration of the lips and skin).

Rare: Kidney failure (when little or no urine is produced), heart attack.

If you notice any of these side effects, contact your doctor immediately.

Very common side effects: may affect more than 1 in 10 patients

Headache.

Common side effects: may affect up to 1 in 10 patients

Dizziness, fatigue, rapid heartbeat, strong or irregular heartbeat (palpitations), nausea, diarrhea, stomach pain, gas, vomiting, decrease in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 patients

Feeling of weakness or discomfort, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (edema), weight loss, muscle pain, joint pain, back pain, loss or decrease in sensation or feeling like numbness (especially in the skin), sensitivity or abnormal sensation like tingling and numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling of shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, or sputum, hair loss, itching, skin color changes, impotence, chest pain, decrease in platelet count in the blood that increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or an increase in liver enzymes. Your doctor may perform blood tests that may indicate an increase in liver enzymes.

Rare side effects: may affect up to 1 in 1,000 patients

Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the heart, painful spasm of the heart's blood vessels (while resting, usually at night or early in the morning) (Prinzmetal's angina), loss of coordination, difficulty speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness when standing up (especially when standing up after sitting or lying down), increased need to urinate at night, pain, "flu-like" symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine (symptoms include diarrhea accompanied by blood or mucus, stomach pain, fever), stomach inflammation (symptoms include pain, nausea, vomiting), abnormal density area in the lungs, increased creatinine levels in blood tests that may indicate kidney problems.

The following side effects have been reported, although the exact frequency with which they occur is unknown:

• potentially life-threatening irregular heartbeat (Torsade de pointes),
• liver inflammation, among the symptoms are nausea, vomiting, itching, yellowing of the skin and eyes, abnormal coloration of stools and urine (hepatitis),
• lung inflammation (symptoms include fever, cough, difficulty breathing or wheezing; this causes lung scarring) (allergic alveolitis, including interstitial lung disease and pneumonitis),
• kidney inflammation (tubulointerstitial nephritis),
• stroke (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Anagrelide Teva-ratiopharm

Keepthis medicineout of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging and on the bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C

Store in the original packaging to protect it from light and moisture.

If your doctor interrupts treatment, do not keep leftover capsules unless the doctor tells you to. Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of AnagrelideTeva-ratiopharm

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

The other components are:

Capsule content: lactose monohydrate, sodium croscarmellose, povidone K 29/32, lactose, microcrystalline cellulose, and magnesium stearate (see section 2, "Anagrelide Teva-ratiopharm contains lactose and sodium").

Capsule shell: gelatin and titanium dioxide (E171).

Appearance of the product and package contents

Anagrelide Teva-ratiopharm is presented in the form of hard, opaque white capsules with an approximate length of 14.3 mm. The capsules are presented in bottles of 42 and 100 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Synthon Hispania, S.L.

C/ Castelló, nº1, Pol. Las Salinas,

08830 Sant Boi de Llobregat, Barcelona (Spain)

or

Synthon B.V.

Microweg 22

6545CM Nijmegen

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Anagrelid AbZ 0.5 mg Hartkapseln

Spain Anagrelida Teva-ratiopharm 0.5 mg hard capsules EFG

United Kingdom Anagrelide 0.5 mg hard capsules

Date of the last revision of thisleaflet:July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)