Anagrelide Teva 0.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anagrelide Teva 0.5 mg hard capsules EFG

Read the entire leaflet carefully before you start taking 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 for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Anagrelide Teva contains the active substance anagrelide. Anagrelide Teva is a medicine that interferes with platelet development. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in the platelet count in the blood towards 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

Do not take Anagrelide Teva

• if you are allergic to anagrelide or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may present as 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

Talk to your doctor before starting to take Anagrelide Teva:

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

• if you were born with prolonged QT interval or have a family history of prolonged QT interval (seen on ECG, the heart's electrical recording), or if you are taking other medicines that cause abnormal changes in the ECG, or if you have low levels of electrolytes, e.g., potassium, magnesium, or calcium (see section “Taking Anagrelide Teva with other medicines”),

• if you have liver or kidney problems.

When taken together with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting), there is an increased risk of major bleeding (see section “Taking Anagrelide Teva with other medicines”).

While being treated with Anagrelide Teva, you must take the exact dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor first. You should not stop taking this medicine suddenly without consulting your doctor. Abruptly stopping the medicine may increase the risk of stroke.

Signs and symptoms of 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 trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; or sudden severe headache with no known cause. Please consult your doctor immediately.

Children and adolescents

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

Taking Anagrelide Teva with other medicines

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

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

• medicines that may affect heart rhythm, for example, sotalol, amiodarone,
• fluvoxamine, used to treat depression,
• certain types of antibiotics, such as enoxacin, used to treat infections,
• theophylline, used to treat asthma and serious breathing problems,
• medicines used to treat heart conditions such as milrinone, enoximone, amrinone, olprinone, and cilostazol,
• acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• other medicines used to treat conditions affecting blood platelets, 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, the effectiveness of the oral contraceptive may be reduced and it is recommended to use an additional contraceptive method (e.g., condom). Refer to the instructions in the leaflet of the oral contraceptive you are taking.

When used together, either Anagrelide Teva or these medicines may not work properly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

Consult your doctor if you are pregnant or planning to become pregnant. If you are pregnant, you must not take Anagrelide Teva. Women who could become pregnant must ensure they use effective contraception while taking Anagrelide Teva. Consult your doctor if you need advice on contraception.

Consult your doctor if you are breastfeeding or planning to breastfeed. You must not take Anagrelide Teva while breastfeeding. If you are taking Anagrelide Teva, you must stop breastfeeding.

Driving and using machines

Some patients taking Anagrelide Teva have reported dizziness. Do not drive or operate machinery if you feel dizzy.

Anagrelide Teva contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially “sodium-free”.

3. How to take Anagrelide Teva

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The usual starting dose of Anagrelide Teva is 1 mg. This dose is taken as one 0.5 mg capsule twice daily for at least one week. After this period, your doctor may increase or decrease the number of capsules you should take until the dose best suited to your condition is found, ensuring the most effective treatment.

The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dissolve the contents in liquid. You may take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) at the same time each day.

Do not take more or fewer capsules than your doctor has recommended. Do not stop taking the medicine without first informing your doctor. You must not stop taking this medicine suddenly on your own.

Your doctor will arrange for you to have regular blood tests to check whether the medicine is working and to ensure your liver and kidneys are functioning properly.

If you take more Anagrelide Teva than you should

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

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

If you forget to take Anagrelide Teva

Take the missed dose as soon as you remember. Take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible adverse effects

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

Serious adverse effects:

Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious problem with heart rate or heart rhythm (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas causing severe back and abdominal pain (pancreatitis), vomiting blood or dark or bloody stools, severe decrease in blood cell count which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles, and bluish discoloration of lips and skin).

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

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

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

Headache.

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

Dizziness, tiredness, rapid heartbeat, strong or irregular heartbeat (palpitations), feeling sick (nausea), diarrhoea, stomach pain, gas, vomiting, decrease in red blood cell count (anaemia), fluid retention or rash.

Uncommon adverse 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 (oedema), weight loss, muscle pain, joint pain, back pain, loss or reduced sensation or numbness (especially in the skin), tingling or abnormal sensation (pins and needles), insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling short of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough or phlegm, hair loss, skin itching, changes in skin colour, impotence, chest pain, decreased platelet count in the blood which increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or increased liver enzymes. Your doctor may perform blood tests that could indicate elevated liver enzymes.

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

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

The following adverse effects have been reported, although the exact frequency is unknown:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelide Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

If your doctor discontinues treatment, do not keep any leftover capsules unless your doctor instructs you otherwise. Medicines must not be disposed of via wastewater or household waste. Return unused packaging and medicines to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelide Teva

• The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide monohydrochloride monohydrate).
• The other components are:

Capsule contents: lactose monohydrate, croscarmellose sodium, povidone K 29/32, lactose, microcrystalline cellulose and magnesium stearate (see section 2, “Anagrelide Teva contains lactose and sodium”).

Capsule shell: gelatin and titanium dioxide (E171).

Appearance of the product and pack contents

Anagrelide Teva is presented as opaque white hard capsules approximately 14.3 mm in length. The capsules are available in bottles containing 42 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

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

The 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 medicinal product 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 σκληρές καψύλες

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 kapsulės

Latvia Anagrelide Teva 0.5 mg cietas kapsulas

The 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 most recent revision of this leaflet: November 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)