Anagrelide Pharmavíc 0.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anagrelide Pharmavic 0.5 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 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 Pharmavic is and what it is used for
2. What you need to know before taking Anagrelide Pharmavic
3. How to take Anagrelide Pharmavic
4. Possible side effects
5. How to store Anagrelide Pharmavic
6. Contents of the pack and other information

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

Anagrelide Pharmavic contains the active substance anagrelide. Anagrelide 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 use Anagrelide Pharmavic

Do not take Anagrelide Pharmavic:

• 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

Consult your doctor before starting to take anagrelide.

• 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 (observed 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 “Other medicines and Anagrelide Pharmavic”).
• if you have liver or kidney problems.

When used in combination with 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), there is an increased risk of major bleeding (haemorrhage) (see section “Other medicines and Anagrelide Pharmavic”).

Children and adolescents

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

Other medicines and Anagrelide Pharmavic

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 your heart rhythm, e.g., 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 present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin);
• 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 leaflet of the oral contraceptive you are taking.

If used together, either Anagrelide Pharmavic 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. Women of childbearing potential should ensure they use effective contraception while taking anagrelide. Consult your doctor for advice on contraception.

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

Driving and using machines

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

Anagrelide Pharmavic contains lactose and sodium

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

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

3. How to take Anagrelide Pharmavic

Follow exactly the dosing instructions for anagrelide as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The usual starting dose of anagrelide 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 the dose best suited to your condition and providing the most effective treatment is reached.

The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve the 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 capsules than your doctor has recommended.

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 Pharmavic than you should

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

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 missed dose.

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, consult your doctor.

Serious adverse effects

Uncommon: heart failure (symptoms 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 pain in the back and abdomen (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 (symptoms 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 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 • flatulence, 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 sensation of numbness (especially in the skin) • sensitivity or abnormal sensation such as tingling and 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 • itching of the skin • 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 carry out blood tests which could indicate increased 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 (symptoms include fatigue, chest pain, and palpitations) • enlargement of the heart • fluid accumulation around the heart • painful spasm of blood vessels in the heart (usually occurring at rest, typically 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 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 (symptoms include diarrhoea usually accompanied by blood or mucus • stomach pain • fever) • inflammation of the stomach (symptoms 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);
• Inflammation of the liver, symptoms of which include nausea, vomiting, itching, yellowing of the skin and eyes, and abnormal stool or urine colour (hepatitis);
• Lung inflammation (symptoms include fever, cough, difficulty breathing, or wheezing; this leads to lung scarring) (allergic alveolitis including interstitial lung disease and pneumonitis);
• Inflammation of the kidneys (tubulointerstitial nephritis).
• Stroke (see section 2).

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 Pharmavic

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

Do not use this medicine after the expiry date stated on the label of the bottle or carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original container 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. This helps protect the environment.

6. Package contents and other information

Composition of AnagrelidaPharmavic

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, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171).

Appearance of the medicinal product and contents of the container

Anagrelide 0.5 mg is presented as hard capsules (size 4) with white, opaque cap and body. The capsule contains a white to off-white powder.

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

phARMAVIC IBERICA, S.L.
C/ Compositor Lehmberg Ruiz 6, Oficina 7
29006 Málaga
Spain

Manufacturer:

Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

or

Synthon BV
Microweg 22,
6545 CM Nijmegen
The Netherlands

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

Netherlands: Anagrelide Genthon 0.5 mg, harde capsules
Czech Republic: Anagrelide Vipharm 0.5 mg
Finland: Anagrelid Avansor 0.5 mg kapseli, kova
Croatia: Anagrelid Alpha-Medical 0.5 mg tvrde kapsule
Hungary: Anagrelide Vipharm
Poland: Anagrelide Vipharm
Sweden: Anagrelid Avansor 0.5 mg kapsel, hard
Slovakia: Anagrelide Vipharm 0.5 mg
Spain: Anagrelida Pharmavic 0.5 mg hard capsules EFG

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

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also provided.