Package Insert:Information for the Patient

Anagrelida Stada 0.5mg Hard EFG Capsules

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only,and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

Anagrelida Stada contains 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 platelet count in the blood that approaches a more normal level. For this reason, it is used to treat patients with essential thrombocytosis.

Essential thrombocytosis 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 Anagrelida Stada

• if you areallergic to anagrelida or any of the other componentsof this medication (listed in section6). Allergic reactions may manifest as rash, itching, facial and lip swelling, or difficulty breathing (dyspnea);
• if you have moderate or severeliver problems;
• if you have moderate or severekidney 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 or havefamily history of prolonged QT interval(observed on ECG, heart electrical recording) or if you are taking other medications that produceabnormal changes in ECGor if you havelow levels of electrolytes, e.g., potassium, magnesium, or calcium (see the section “Other medications and Anagrelida Stada”);
• if you haveliver or kidney problems.

In combination withaspirin(a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting), there is a greater risk of presenting major bleeding (hemorrhage) (see section “Other medications and Anagrelida Stada”).

While taking anagrelida, you must take the exact dose prescribed by your doctor. Do not stop taking the medication without informing your doctor first. Do not stop taking this medication suddenly without consulting your doctor. Sudden withdrawal of the medication may increase the risk of stroke.

The 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 coordination, and severe and sudden headache without known cause. Please consult your doctor immediately.

Children and adolescents

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

Other medicationsand Anagrelida Stada

Inform your doctor or pharmacistif 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, e.g.:sotalol,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;
• aspirin(a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting);
• other medications totreat conditions that affect platelets in the blood such 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, either anagrelidaor 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 plan to become pregnant. If you are pregnant, do not take anagrelida. Women with the possibility of becoming 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 plan to breastfeed. You cannot take anagrelida while breastfeeding. If you are taking anagrelida, you should stop breastfeeding.

Driving and operating machines

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

Anagrelida Stadacontains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 to find 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 with an empty stomach. It is recommended to take the capsule(s) at the same time every day.

Do not take more or fewer capsules than your doctor has recommended. Do not stop taking the medication without first informing your doctor. Do not stop taking this medication abruptly on your own.

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 Stada than you should

If you take more anagrelida than you should or if someone else has taken this medication, inform your doctor or pharmacist immediately. Show them the packaging of anagrelida.

If you forgot to take Anagrelida Stada

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.

Empty section

Like all medications, this medication may cause adverse effects, although not all people may experience them. If you are concerned about this aspect, consult your doctor.

Severe adverse effects:

Rare(may affect up to 1 in 100 people)

• Heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation)
• Severe problem with heart rate or rhythm (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation)
• Pancreatitis (inflammation of the pancreas causing intense back and abdominal pain)
• Vomiting with blood or dark or bloody stools
• Severe decrease in blood cell count that may cause weakness
• Cardenials
• Bleeding or infections (pancytopenia)
• Pulmonary hypertension (symptoms include shortness of breath, leg or ankle swelling, and blue discoloration of lips and skin)

Rare(may affect up to 1 in 1,000 people)

• Renal insufficiency (when little or no urine is produced)
• Heart attack

If you observe anyof these adverse effects, contact your doctorimmediately.

Very common(may affect more than 1 in 10people)

• Headache.

Frequent(may affect up to 1 in 10people)

• Dizziness.
• Fatigue.
• Fast heart rate.
• Strong or irregular heartbeat (palpitations).
• Nausea (ganas de vomitar).
• Diarrhea.
• Abdominal pain.
• Gas.
• Vomiting.
• Decrease in red blood cell count (anemia).
• Fluid retention or rash.

Poco frequent(may affect up to 1 in 100people)

• Feeling of weakness or discomfort.
• Hypertension.
• Irregular heartbeat.
• Fainting, chills, or fever.
• Indigestion.
• Loss of appetite.
• Constipation.
• Cardenials.
• Bleeding.
• Swelling (edema).
• Weight loss.
• Muscle pain.
• Joint pain.
• Back pain, loss or decrease of sensation or feeling of numbness (especially in the skin).
• Abnormal sensation or feeling of tingling and numbness.
• Insomnia.
• Depression.
• Confusion.
• Anxiety.
• Dry mouth.
• Memory loss.
• Feeling of lack of air.
• Nasal bleeding.
• Severe lung infection with fever.
• Shortness of breath.
• Cough or phlegm.
• Hair loss.
• Itching skin.
• Changes in skin color.
• Impotence.
• Chest pain.
• Decrease in platelet count in the blood that increases the risk of bleeding or cardenials (thrombocytopenia).
• Fluid accumulation in the lungs or increase in liver enzymes.

The doctor may perform blood tests that may indicate an increase in liver enzymes.

Raros(may affect up to 1 in 1,000people)

• Swollen 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.
• Painful spasms of the coronary arteries (in rest, usually at night or early in the morning) (Prinzmetal's angina).
• Coordination loss.
• Difficulty speaking.
• Dry skin.
• Migraine.
• Visual disturbances or double vision.
• Tinnitus.
• Dizziness when standing (especiallywhen standing up after sitting or lying down).
• Increased need to urinate at night.
• Pain.
• Pseudogripal symptoms.
• Somnolence.
• Dilation of blood vessels.
• Intestinal inflammation (symptoms include diarrhea, usually with blood or mucus, abdominal pain, fever).
• Stomach inflammation (symptoms include pain, nausea, vomiting).
• Abnormal density area in the lungs.
• Increased levels of creatinine in blood tests that may indicate renal problems.

The following adverse effects have been reported, although the exact frequency is unknown(the frequencycannot be estimated from the available data)

• Potentially fatal irregular heartbeat (torsade de pointes);
• Liver inflammation, symptoms include nausea, vomiting, itching, yellow discoloration of skin and eyes, abnormal color of stools and urine (hepatitis);
• Lung inflammation (symptoms include fever, cough, difficulty breathing or wheezing; this causes pulmonary fibrosis) (allergic alveolitis including interstitial lung disease and pneumonitis);
• Kidney inflammation (tubulointerstitial nephritis).
• Stroke (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, evenif it ispossibleadverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 above 86°F (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 trash.Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Anagrelida Stada

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

The other components are:

Content of the capsules:lactose monohydrate, croscarmelose sodium, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capsule 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) opaque white. The capsules contain white or almost white powder.

The capsules are presented in bottles with child-resistant closures and desiccant, containing 42 or 100 hard capsules.

Only some package sizes may be marketed.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2022

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