ANAGRELIDE AUROVITAS 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

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

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

Anagrelida Aurovitas contains the active substance anagrelide. Anagrelida Aurovitas 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 Aurovitas

Do not take Anagrelida Aurovitas

• If you are allergic to anagrelide or any of the other ingredients of 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 Anagrelida Aurovitas:

• 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 produce abnormal changes in the ECG or if you have low levels of electrolytes, e.g. potassium, magnesium or calcium (see the section "Other medicines and Anagrelida Aurovitas");
• 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 Aurovitas").

While taking anagrelide, you must take the exact dose prescribed by your doctor. Do not stop taking the medicine without talking to your doctor first. Do not stop taking this medicine abruptly without consulting your doctor. Stopping the medicine suddenly can increase the risk of 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 difficulty understanding speech, sudden difficulty seeing with one or both eyes, sudden difficulty walking, dizziness, loss of balance or lack of coordination, and severe and sudden headache without known cause. Please seek immediate medical attention.

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 Aurovitas

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, such as 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 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 lower fever, as well as to prevent blood clotting, also known as aspirin);
• Other medicines to treat diseases 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, Anagrelida Aurovitas or these medicines may not work correctly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If you are pregnant, you should not take anagrelide. Women who may become pregnant must ensure they take effective contraceptive measures while taking anagrelide. Consult your doctor if you need advice on contraceptives.

You cannot 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 Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Anagrelida Aurovitas contains sodium

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

3. How to take Anagrelida Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The initial normal dose of anagrelide is equivalent to 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 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 not take more or fewer capsules than your doctor has recommended. Do not stop taking the medicine without talking to your doctor first. Do not stop taking this medicine abruptly without consulting your doctor.

Your doctor will ask you to have a blood test regularly to check if the medicine is working and if your liver and kidneys are working well.

If you take more Anagrelida Aurovitas 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 Anagrelida Aurovitas package.

If you forget to take Anagrelida Aurovitas

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.

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, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and bluish 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 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, decrease in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 patients

Feeling weak or unwell, 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 sputum, hair loss, itching, skin color changes, 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. 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 spasms of the heart's blood vessels (at rest, especially 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 density area in the lungs, increased creatinine levels in blood tests that may indicate kidney problems.

The following side effects have been reported, but the exact frequency is unknown:

• Potentially life-threatening irregular heartbeat (torsades de pointes);
• Liver inflammation, among the symptoms are nausea, vomiting, itching, yellowing of the skin and eyes, abnormal coloration of stools and urine (hepatitis);
• Lung 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelida Aurovitas

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 carton, blister, or label of the bottle after EXP. The expiry date is the last day of the month stated.

Blister:Store below 30°C.

High-density polyethylene (HDPE) bottle:Store below 30°C. Store in the original packaging to protect from moisture. After the first opening, keep the bottle tightly closed and store in a dry environment.

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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelida Aurovitas

• 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, microcrystalline cellulose (PH 101), sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate.

Capsule shell:gelatin, black iron oxide (E172), titanium dioxide (E171).

Printing ink:shellac, black iron oxide (E172), potassium hydroxide.

Appearance and packaging

Hard gelatin capsule of size "4", with the cap gray opaque and the body white opaque, filled with white-white powder, marked with "1453" on the cap and "0.5 mg" on the body printed with black ink.

OPA/Al/PVC-Al blister:

Package sizes: 84, 90, and 100 capsules.

HDPE bottle:

Round white opaque high-density polyethylene (HDPE) bottle with a screw cap. Each bottle contains silica gel as a desiccant.

Package size: 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

Or

PUREN Pharma GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

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

Germany: Anagrelid PUREN 0.5 mg Hartkapseln

Spain: Anagrelida Aurovitas 0.5 mg hard capsules EFG

France: Anagrelide Arrow 0.5 mg gélule

Italy: Anagrelide Aurobindo

Poland: Anagrelid Aurovitas

Portugal: Anagrelida Aurovitas

Date of last revision of this leaflet:October 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/)