ANAGRELIDE PHARMAVIC 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Anagrelida Pharmavic 0.5 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Anagrelida Pharmavic contains the active substance anagrelide. Anagrelide is a medicine that interferes with the production 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 too many of the blood cells known as platelets. A high number of platelets in the blood can cause serious problems with blood circulation and clotting.

2. What you need to know before you take Anagrelida Pharmavic

Do not take Anagrelida Pharmavic:

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

• 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 cause abnormal changes in the ECGor if you have low levels of electrolytes, e.g. potassium, magnesium or calcium (see the section "Other medicines and Anagrelida Pharmavic").
• 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, also known as aspirin), there is a greater risk of major bleeding (bleeding) (see section "Other medicines and Anagrelida Pharmavic").

Children and adolescents

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

Other medicines and Anagrelida Pharmavic

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

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

• Medicines that can alter 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 severe respiratory problems;
• Medicines for treating heart conditions, such as milrinone, enoximone, amrinone, olprinoneand cilostazol;
• Acetylsalicylic acid(a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin);
• 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, the effect of the oral contraceptive may be reduced and it is recommended to use an additional contraceptive method (e.g. condom). Consult the instructions in the package leaflet of the oral contraceptive you are taking.

If they are used together, either Anagrelida 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 plan to become pregnant. If you are pregnant, you should not take anagrelide. Women who may become pregnant should ensure they use effective contraceptive measures while taking anagrelide. 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 anagrelide while breastfeeding. If you are taking anagrelide, you should stop breastfeeding.

Driving and using machines

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

Anagrelida Pharmavic contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them 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 Anagrelida Pharmavic

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

The amount of anagrelide that can be taken by different patients 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 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 in the most effective way.

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

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

If you take more Anagrelida Pharmavic than you should

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

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 Pharmavic

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 everybody 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 • cardiolipin • bleeding or infection (pancytopenia) • pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles and blue discoloration of the lips and skin).

Rare: renal 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, decreased 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 • hypertension • irregular heartbeat • fainting • chills or fever • indigestion • loss of appetite • constipation • cardiolipin • 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 • nosebleed • severe lung infection with fever • shortness of breath • cough or phlegm • hair loss • itching of the skin • changes in skin color • impotence • chest pain • decreased platelet count in the blood that increases the risk of bleeding or cardiolipin (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 (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) • inflammation of the stomach (symptoms include pain, nausea, vomiting) • abnormal 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);
• Hepatitis (inflammation of the liver, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, abnormal color of stools and urine);
• Pulmonary 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).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelida Pharmavic

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

Do not use this medicine after the expiry date which is stated on the label of the bottle or carton after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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

If your doctor stops the treatment, do not keep the remaining capsules unless the doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy's SIGRE point. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelida Pharmavic

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

The other ingredients are:

Contents of the capsule: lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171).

Appearance and packaging

Anagrelida 0.5 mg is presented in the form of hard capsules (size 4) with a white and opaque cap and body. The capsule contains a white to off-white powder.

The capsules are presented in bottles of 42 and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

phARMAVIC IBERICA, S.L.

C/ Compositor Lehmberg Ruiz 6, Oficina 7

1. 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

Netherlands

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

Netherlands: Anagrelide Genthon 0.5 mg, hard 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 cápsulas duras EFG

Date of last revision of this leaflet: September 2022

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.