ANAGRELIDE STADA 0.5 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Anagrelida Stada 0.5mg 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 Stada and what is it used for
2. What you need to know before you take Anagrelida Stada
3. How to take Anagrelida Stada
4. Possible side effects
5. Storing Anagrelida Stada
6. Contents of the pack and other information

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

Anagrelida Stada 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 Stada

Do not take Anagrelida Stada

• 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 (dyspnea);
• 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 Stada");
• 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), there is a greater risk of major bleeding (bleeding) (see section "Other medicines and Anagrelida Stada").

While you are being treated with anagrelide, you should take the exact dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor first. Do not stop taking this medicine suddenly without consulting your doctor. Stopping the medicine abruptly can increase the risk of a stroke.

The signs and symptoms of a stroke can 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 sudden severe headache with no known cause. Please consult your doctor immediately.

Children and adolescents

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

Other medicines and Anagrelida Stada

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, olprinone, and cilostazol;
• acetylsalicylic acid(a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting);
• 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, it may reduce the effect of the oral contraceptive 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 used together, it may be that either anagrelide or these medicines do 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 take 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 Stadacontains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult 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 Stada

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The normal initial dose of anagrelide is 1 mg. This dose is taken with one 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 most effectively.

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 or fewer capsules than your doctor has recommended. Do notstop taking the medicine without informing your doctor first. You should not stop taking this medicine suddenly without consulting your doctor.

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

If you take more Anagrelida Stada than you should

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

If you forget 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 forgotten doses.

4. Possible side effects

Empty section

Like all medicines, this medicine can cause side effects, although not everybody gets them. If this worries you, consult your doctor.

Serious side effects:

Uncommon(may affect up to 1 in 100 people)

• 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 that causes severe pain in the back and abdomen (pancreatitis)
• vomiting blood or black, tarry stools
• severe decrease in blood cell count that can cause weakness
• bruising
• bleeding or infection (pancytopenia)
• pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles, and bluish discoloration of the lips and skin)

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

• kidney failure (when you urinate very little or not at all)
• heart attack

If you notice any of these side effects, contact your doctor immediately.

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

• headache.

Common(may affect up to 1 in 10 people)

• dizziness
• fatigue
• rapid heartbeat
• strong or irregular heartbeat (palpitations)
• nausea
• diarrhea
• stomach pain
• gas
• vomiting
• decrease in red blood cell count (anemia)
• fluid retention or rash

Uncommon(may affect up to 1 in 100 people)

• feeling of weakness or discomfort
• high blood pressure
• irregular heartbeat
• fainting, chills, or fever
• indigestion
• loss of appetite
• constipation
• bruising
• 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
• nosebleeds
• severe lung infection with fever
• shortness of breath
• cough or phlegm
• hair loss
• itching of the skin
• changes in skin color
• impotence
• chest pain
• decrease in platelet count in the blood that increases the risk of bleeding or bruising (thrombocytopenia)
• fluid accumulation in the lungs or an increase in liver enzymes

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

Rare(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 in the heart
• painful spasm of the blood vessels of the heart (at rest, usually 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
• vasodilation
• inflammation of the large intestine (signs include diarrhea usually accompanied by blood or mucus, stomach pain, fever)
• inflammation of the stomach (signs include pain, nausea, vomiting)
• area of abnormal density in the lungs
• increase in creatinine levels in blood tests, which may indicate kidney problems

The following side effects have been reported, but the exact frequency is unknown(the frequency cannot be estimated from the available data)

• potentially life-threatening irregular heartbeat (torsade de pointes);
• inflammation of the liver, among the symptoms are nausea, vomiting, itching, yellowing of the skin and eyes, abnormal coloration of stools and urine (hepatitis);
• lung inflammation (signs 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anagrelida Stada

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 refers to the last day of the month shown.

Do not store above 30°C

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

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelida Stada

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

The other ingredients are:

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

Capsule shell: gelatin, titanium dioxide (E171).

Appearance of the product and packaging

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.

Not all pack sizes may be marketed.

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

Date of last revision of this leaflet:September 2022

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