ANAGRELIDE TEVA 0.5 mg HARD CAPSULES

Introduction

Leaflet: information for the patient

Anagrelida Teva 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, ask 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 Anagrelida Teva and what is it used for
2. What you need to know before taking Anagrelida Teva
3. How to take Anagrelida Teva
4. Possible side effects
5. Storage of Anagrelida Teva
6. Contents of the pack and further information

1. What is Anagrelida Teva and what is it used for

Anagrelida Teva contains the active substance anagrelide. Anagrelida Teva is a medicine that interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which leads to 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 Anagrelida Teva

Do not take Anagrelida Teva

• 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 Anagrelida Teva:

• 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 in 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 Anagrelida Teva 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 major bleeding (bleeding). See section "Taking Anagrelida Teva with other medicines".

While you are being treated with Anagrelida Teva, you should take the exact dose prescribed by your doctor. Do not stop taking the medicine without consulting your doctor first. You should not stop taking this medicine suddenly without consulting your doctor. Sudden withdrawal of the medicine can 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 and sudden headache without known cause. Please consult your doctor immediately.

Children and adolescents

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

Taking Anagrelida Teva with other medicines

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

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

• medicines that can alter 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, either Anagrelida Teva or these medicines may not work correctly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

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

Consult your doctor if you are breastfeeding or plan to breastfeed your child. You should not take Anagrelida Teva while breastfeeding. If you are taking Anagrelida Teva, you should stopbreastfeeding.

Driving and using machines

Some patients who were taking Anagrelida Teva have reported symptoms of dizziness. Do notdrive or operate machines if you feel dizzy.

Anagrelida Teva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with 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 Anagrelida Teva

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

The amount of Anagrelida Teva 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 Anagrelida Teva is 1 mg. This dose is taken with 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 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 dilute 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 consulting your doctor first. 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 Anagrelida Teva than you should

If you take more Anagrelida Teva than you should or if another person has taken this medicine, inform your doctor or pharmacist immediately. You should show them the Anagrelida Teva 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 Anagrelida Teva

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 or bloody 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 weak or unwell, 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, 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 could 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 (usually at rest, normally 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, increase in 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, yellowish discoloration of the skin and eyes, abnormal discoloration of feces and urine (hepatitis),
• lung inflammation (symptoms include fever, cough, difficulty breathing or wheezing; this causes lung scarring) (allergic alveolitis that includes interstitial lung disease and pneumonitis),
• kidney inflammation (tubulointerstitial nephritis).
• stroke (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelida Teva

Keep this medicine out of the 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.

Keep in the original packaging to protect 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 pharmacy's SIGRE point. 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. Contents of the pack and further information

Composition of Anagrelida Teva

• 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, "Anagrelida Teva contains lactose and sodium").

Capsule shell: gelatin and titanium dioxide (E171).

Appearance of the product and packaging contents

Anagrelida Teva 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 B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Local representative:

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

or

Actavis Italy S.p.A.

Via Pasteur 10

Nerviano

20014 Milan

Italy

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

Austria Anagrelid ratiopharm 0.5 mg Kapseln

Czech Republic Anagrelide Teva

Denmark Anagrelid Teva

Greece Anagrelide/Teva 0.5 mg σκληρ? καψ?κια

Spain Anagrelida Teva 0.5 mg hard capsules EFG

Finland Anagrelide ratiopharm 0.5 mg kapseli, kova

France Anagrelide Teva 0.5 mg gélule

Italy Anagrelide Teva

Lithuania Anagrelide Teva 0.5 mg kietosios kapsules

Latvia Anagrelide Teva 0.5 mg cietas kapsulas

Netherlands Anagrelide Teva 0.5 mg, harde capsules

Portugal Anagrelida Teva

Romania ANAGRELIDA TEVA 0.5 mg capsule

Slovenia Anagrelid Teva 0.5 mg trde kapsule

Date of the last revision of this leaflet: November 2022

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