Anagrelide Teva-Ratiopharm 0.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anagrelide Teva-ratiopharm 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, since it may 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.

Leaflet contents

1. What Anagrelide Teva-ratiopharm is and what it is 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. How to store Anagrelide Teva-ratiopharm
6. Contents of the pack and other information

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

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

Do not take Anagrelide Teva-ratiopharm

• 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-ratiopharm:

• if you have or think you might 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 electrical recording of the heart), 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-ratiopharm 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-ratiopharm with other medicines”).

While 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 first. You should not stop taking this medicine suddenly without consulting your doctor. Abrupt discontinuation of the medicine may increase the risk of stroke.

Signs and 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 difficulty seeing with one or both eyes; sudden difficulty walking, dizziness, loss of balance, or lack of coordination; and sudden 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-ratiopharm 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 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 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 diarrhoea while taking this medicine, the effectiveness of the oral contraceptive may be reduced and you are advised to use an additional contraceptive method (e.g., condom). Refer to the instructions in the patient leaflet of the oral contraceptive you are taking.

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

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

Anagrelide Teva-ratiopharm 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; therefore, it is essentially “sodium-free”.

3. How to take Anagrelide Teva-ratiopharm

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

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

The usual starting dose of Anagrelide Teva-ratiopharm 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 need to take until finding the dose best suited to your condition and that treats the disorder most effectively.

The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dissolve their contents in a 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 informing your doctor first. You should not stop taking this medicine suddenly on your own.

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

If you take more Anagrelide Teva-ratiopharm than you should

If you take more Anagrelide Teva-ratiopharm than prescribed, or if someone else has taken this medicine, inform your doctor or pharmacist immediately. You must 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 at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Anagrelide Teva-ratiopharm

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 forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you are concerned about this, please 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 experience any of these adverse effects, contact your doctor immediately.

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

Headache.

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

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

Uncommon adverse effects: may affect up to 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 (oedema), weight loss, muscle pain, joint pain, back pain, loss or reduced sensation or numbness (especially in the skin), sensitivity or abnormal sensation such as tingling or numbness, 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 people

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 heart's blood vessels (occurring at rest, usually 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, "flu-like" 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), abnormal density area 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 Medicines: 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-ratiopharm

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

Do not use this medicine after the expiry date stated on the 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.

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

If your doctor discontinues treatment, do not keep any leftover capsules unless otherwise instructed by your doctor. Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelide Teva-ratiopharm

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

The other components are:

Capsule contents: 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).

Nature of the product and contents of the container

Anagrelide Teva-ratiopharm is presented as white, opaque hard capsules approximately 14.3 mm in length. The capsules are available in bottles containing 42 or 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, 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

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Anagrelid AbZ 0.5 mg Hard Capsules
Spain Anagrelida Teva-ratiopharm 0.5 mg hard capsules EFG
United Kingdom Anagrelide 0.5 mg hard capsules

Date of the most recent review of this leaflet: July 2022

Detailed and up-to-date 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/)

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82522/P_82522.html

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