Patient Information Leaflet

Anagrelida Pharmavic 0.5 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine. 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Anagrelida Pharmavic

3. How to take Anagrelida Pharmavic

4. Possible side effects

5. Storage of Anagrelida Pharmavic

6. Contents of the pack and additional information

AnagrelidaPharmaviccontains the active ingredient, anagrelida. Anagrelida is a medication 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 that approaches 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 severe circulation and blood coagulation problems.

Do not take AnagrelidaPharmavic:

• if you are allergic toanagrelida or any of the other componentsof this medication (listed in section 6). Allergic reactions may manifest as rash, itching, facial and lip swelling, or difficulty breathing.
• if you havemoderate or severe liver problems.
• if you havemoderate or severe kidney problems.

Warnings and precautions

Consult your doctor before starting to take anagrelida.

• if you have or think you may have aheart problem.
• if you were born with a prolonged QT interval orhave a family history of a prolonged QT intervalobserved on an ECG, or if you are taking other medications that causeabnormal changes in the ECGor if you havelow levels of electrolytes, such as potassium, magnesium, or calcium (see the section “Other medications andAnagrelidaPharmavic”).
• if you haveliver or kidney problems.

In combination withacetylsalicylic acid(a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting, also known asaspirin), there is a higher risk of major bleeding (bleeding) (see section “Other medications andAnagrelidaPharmavic”).

Children and adolescents

The information on the use ofAnagrelidaPharmavicin children and adolescents is limited, and therefore this medication should be used with caution.

Other medications and AnagrelidaPharmavic

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

Inform your doctor if you are taking any of the following medications:

• Medications that may alter your heart rhythm, such assotalol,amiodarone;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotics, such asenoxacin, used to treat infections;
• Theophylline, used to treat asthma and severe respiratory problems;
• Medications to treat heart conditions such as, for example,milrinone,enoximone,amrinone,olprinone, andcilostazol;
• Acetylsalicylic acid(a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting, also known asaspirin);
• Other medications totreat conditions that affect platelets in the bloodsuch as, for example,clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives:If you experience intense diarrhea while taking this medication, it may reduce the effectiveness of the oral contraceptive, and it is recommended to use an additional contraceptive method (e.g., condom). Consult the instructions that appear in the package insert of the oral contraceptive you are taking.

If used together, eitherAnagrelidaPharmavicor these medications 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 planning to become pregnant. If you are pregnant, do not take anagrelida. Women who may become pregnant should ensure they take effective contraceptive measures while taking anagrelida. Consult your doctor if you need advice on contraceptives.

Consult your doctor if you are breastfeeding or planning to breastfeed. You cannot take anagrelida while breastfeeding. If you are taking anagrelida, you should stop breastfeeding.

Driving and operating machines

Some patients takinganagrelidahave reported symptoms of dizziness. Do not drive or operate machines if you feel dizzy.

AnagrelidaPharmaviccontains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow the administration instructions for anagrelida exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The amount of anagrelida 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 usual initial dose of anagrelida 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 finding the dose that best suits your case and effectively treats the condition.

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) at the same time every day.

Do not take more capsules than your doctor has recommended.

Your doctor will instruct you to undergo regular blood tests to check if the medication is effective and if your liver and kidneys are functioning 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 medication, inform your doctor or pharmacist immediately. You will need to show them the packaging of Anagrelida Pharmavic.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot 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 the missed doses.

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

Severe side effects

Rare: heart failure (symptoms include shortness of breath, chest pain, swelling of the legs due to fluid accumulation)•serious problem with heart rate or rhythm (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation)•inflammation of the pancreas that causes intense back and abdominal pain (pancreatitis)•vomiting with blood or dark or bloody stools•severe decrease in blood cell count that can cause weakness•cardiac arrhythmias•bleeding or infections (pancytopenia)•pulmonary hypertension (symptoms include shortness of breath, leg or ankle swelling, and blue 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 doctorimmediately.

Frequent side effects: can affect more than 1 in 10 patients

Headache.

Common side effects: can affect up to 1 in 10 patients

Dizziness•fatigue•rapid heart rate•strong or irregular heartbeat (palpitations)•nausea (gastrointestinal upset)•diarrhea•stomach pain•gas, vomiting, decrease in red blood cell count (anemia), fluid retention, or rash.

Rare side effects: can affect up to 1 in 100 patients

Feeling weak or unwell•high blood pressure•irregular heartbeat•syncope•chills or fever•indigestion•loss of appetite•constipation•cardinal signs•bleeding•swelling (edema)•weight loss•muscle pain•joint pain•back pain•loss or decrease of sensation or numbness (especially in the skin)•abnormal sensitivity or sensation like tingling and numbness•insomnia•depression•confusion•nervousness•dry mouth•memory loss•feeling of lack of air•nasal bleeding•serious lung infection with fever•shortness of breath•cough or phlegm•hair loss•skin itching•skin color changes•impotence•chest pain•decrease in platelet count in the blood that increases the risk of bleeding or cardinal signs (thrombocytopenia)•fluid accumulation in the lungs or an increase in liver enzymes.

Your doctor may do some blood tests that could indicate an increase in liver enzymes.

Rare side effects: can affect up to 1 in 1,000 patients

Bleeding gums•weight gain•intense chest pain (angina pectoris)•cardiac muscle disease (symptoms include fatigue, chest pain, and palpitations)•enlargement of the heart•fluid accumulation in the heart•spasmodic pain of the coronary arteries (while resting, usually at night or in the early morning) (Prinzmetal's angina)•loss of coordination•difficulty speaking•dry skin•migraine•visual disturbances or double vision•tinnitus•dizziness when standing up (especially when standing up after sitting or lying down)•increased need to urinate at night•pain•“pseudogripal” symptoms•drowsiness•vasodilation•inflammation of the large intestine (symptoms include diarrhea, usually accompanied by blood or mucus•stomach pain•fever)•inflammation of the stomach (symptoms include pain, nausea, vomiting)•abnormal density area in the lungs•increase in creatinine levels in blood tests that may indicate renal problems.

The following side effects have been reported, although the exact frequency of their occurrence is unknown:

• potentially fatal irregular heartbeat (torsade de pointes);
• inflammation of the liver, among the symptoms are nausea, vomiting, itching, yellow discoloration of the skin and eyes, abnormal coloration of the stool and urine (hepatitis);
• pulmonary inflammation (symptoms include fever, cough, difficulty breathing, or wheezing; this causes pulmonary fibrosis) (allergic alveolitis that includes interstitial lung disease and pneumonitis);
• inflammation of the kidneys (tubulointerstitial nephritis).
• stroke (see section 2).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle or box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

If your doctor interrupts treatment, do not store any remaining capsules unless the doctor instructs you otherwise.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications that you do not need at the SIGRE point of the pharmacy.By doing so, you will help protect the environment.

Composition of AnagrelidaPharmavic

The active ingredient is anagrelida. Each capsule contains 0.5 mg of anagrelida (as anagrelida hydrochloride monohydrate).

The other components are:

Capule content: lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capule coating: gelatin, titanium dioxide (E171).

Appearance of the product and contents of the package

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 pale white powder.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

phARMAVIC IBERICA, S.L.

C/ Compositor Lehmberg Ruiz 6, Office 7

29007. Málaga

Spain

Responsible 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 with the following names:

Netherlands:Anagrelide Genthon 0.5 mg, hard capsules

Czech Republic:Anagrelide Vipharm 0.5 mg

Finland:Anagrelid Avansor 0.5 mg capsule, hard

Croatia:Anagrelid Alpha-Medical 0.5 mg hard capsules

Hungary:Anagrelide Vipharm

Poland:Anagrelide Vipharm

Sweden:Anagrelid Avansor 0.5 mg capsule, hard

Slovakia:Anagrelide Vipharm 0.5 mg

Spain:Anagrelida Pharmavic 0.5 mg hard capsules EFG

Last review date of this leaflet: September 2022

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