ANAGRELID 0.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
2. What is Anagrelid Aurovitas and what is it used for
3. Important information before taking Anagrelid Aurovitas
   1. When not to take Anagrelid Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Anagrelid Aurovitas and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Anagrelid Aurovitas contains lactose
   8. Anagrelid Aurovitas contains sodium.
4. How to take Anagrelid Aurovitas
   1. Taking more than the prescribed dose of Anagrelid Aurovitas
   2. Missing a dose of Anagrelid Aurovitas
5. Possible side effects
   1. If you experience any of the above side effects, contact your doctor immediately. Very common side effects: may occur in more than 1 in 10 people
   2. Reporting side effects
6. How to store Anagrelid Aurovitas
7. Contents of the pack and other information
   1. What Anagrelid Aurovitas contains
   2. Other ingredients are:
   3. What Anagrelid Aurovitas looks like and contents of the pack
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 04/2023

Package Leaflet: Information for the Patient

Anagrelid Aurovitas, 0.5 mg, Hard Capsules
Anagrelidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Anagrelid Aurovitas and what is it used for
• 2. Important information before taking Anagrelid Aurovitas
• 3. How to take Anagrelid Aurovitas
• 4. Possible side effects
• 5. How to store Anagrelid Aurovitas
• 6. Contents of the pack and other information

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

Anagrelid Aurovitas contains the active substance anagrelide. Anagrelid Aurovitas is a medicine that
inhibits the development of blood platelets. This medicine reduces the number of platelets produced by the bone marrow, which leads to a decrease in the number of platelets in the blood to a more normal value. Therefore, it is used to treat patients with essential thrombocythemia.
Essential thrombocythemia is a disease that occurs when the bone marrow produces too many blood cells called platelets. A high number of platelets in the blood can lead to severe blood circulation and clotting disorders.

2. Important information before taking Anagrelid Aurovitas

When not to take Anagrelid Aurovitas

• If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause a rash, itching, swelling of the face or lips, and difficulty breathing;
• If you have moderate or severe liver function impairment;
• If you have moderate or severe kidney function impairment.

Warnings and precautions

Before taking Anagrelid Aurovitas, discuss it with your doctor:

• If you have or suspect a heart problem;
• If you have a congenital or family history of QT interval prolongation (visible on an ECG, a graphic record of the heart's electrical activity) or if you are taking other medicines that can change the ECG or if you have low levels of electrolytes such as potassium, magnesium, or calcium (see "Anagrelid Aurovitas and other medicines");
• If you have liver or kidney problems.

When taken with acetylsalicylic acid (a substance also known as aspirin, found in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting), there is an increased risk of severe bleeding (bleeding) (see "Anagrelid Aurovitas and other medicines").
Anagrelid Aurovitas should be taken exactly as prescribed by your doctor. Do not stop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine without consulting your doctor. Stopping the medicine suddenly can increase the risk of a stroke.
Stroke symptoms can include sudden numbness or weakness of the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or understanding speech, sudden vision problems in one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, and sudden severe headache without a known cause. Seek medical help immediately.

Children and adolescents

Information on the use of Anagrelid Aurovitas in children and adolescents is limited.
Caution should be exercised when using this medicine in this patient group.

Anagrelid Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor about taking any of the following medicines:

• medicines that can change the heart rhythm, such as sotalol, amiodarone;
• fluvoxamine used to treat depression;
• certain types of antibiotics used to treat infections, such as enoxacin;
• theophylline used to treat severe cases of asthma and breathing problems;
• medicines used to treat heart conditions, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid (aspirin, found in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting);
• other medicines used to treat conditions that affect platelet count, such as clopidogrel;
• omeprazole, a medicine used to reduce the amount of acid produced in the stomach;
• oral contraceptives: the occurrence of severe diarrhea while taking this medicine may reduce the effectiveness of the oral contraceptive and therefore an additional contraceptive method (e.g., condoms) is recommended. Consult the patient information leaflet for the oral contraceptive.

The effect of Anagrelid Aurovitas or the mentioned medicines may be impaired if taken together.
In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, tell your doctor before taking this medicine. Pregnant women should not take Anagrelid Aurovitas. Women who may become pregnant should use effective contraceptive methods during Anagrelid Aurovitas treatment. Your doctor can advise on contraceptive methods.
Do not take Anagrelid Aurovitas during breastfeeding. If you are taking Anagrelid Aurovitas, stop breastfeeding.

Driving and using machines

Some patients taking Anagrelid Aurovitas have experienced dizziness. If you experience dizziness, do not drive or operate machinery.

Anagrelid Aurovitas contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Anagrelid Aurovitas contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Anagrelid Aurovitas

Always take Anagrelid Aurovitas exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The amount of Anagrelid Aurovitas taken by individual patients may vary and depends on the patient's condition. Your doctor will prescribe the appropriate dose for you.
Usually, the initial dose of Anagrelid Aurovitas is 1 mg. To take this dose, you will take 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 to establish the most suitable dose that will effectively treat you.
Swallow the capsules whole with a glass of water. Do not crush or dissolve the contents of the capsules in liquids. The capsules can be taken with food, after food, or on an empty stomach. It is best to take the capsule(s) at the same time every day.
Do not take more or less capsules than your doctor has prescribed. Do not stop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine.
Your doctor will order regular blood tests to check if the medicine is working and if your liver and kidneys are working properly.

Taking more than the prescribed dose of Anagrelid Aurovitas

If you take more Anagrelid Aurovitas than prescribed or if someone else takes your medicine, contact your doctor or pharmacist immediately. Show them the Anagrelid Aurovitas packaging.

Missing a dose of Anagrelid 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 a forgotten dose.

4. Possible side effects

Like all medicines, Anagrelid Aurovitas can cause side effects, although not everybody gets them.
If you experience any worrying symptoms, consult your doctor.
Severe side effects
Uncommon: heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation), severe heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis causing severe abdominal and back pain, bloody vomiting, or passing bloody or tarry stools, significant decrease in blood cell count, which can cause weakness, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of the legs or ankles, and blue discoloration of the lips and skin).
Rare: kidney failure (passing very little urine or urine retention), heart attack.

If you experience any of the above side effects, contact your doctor immediately. Very common side effects: may occur in more than 1 in 10 people

Headache.
Common side effects: may occur in up to 1 in 10 people
Dizziness, fatigue, rapid, irregular, or strong heartbeat (palpitations), nausea, diarrhea, stomach pain, bloating, vomiting, decreased red blood cell count (anemia), fluid retention, or rash.
Uncommon side effects: may occur in up to 1 in 100 people
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, limited sensation or loss of sensation, or tingling, especially in the skin, abnormal sensation or feeling of tingling or numbness, insomnia, depression, disorientation, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, and expectoration of sputum; hair loss, itching, and skin discoloration, impotence, chest pain, decreased platelet count (thrombocytopenia) increasing the risk of bleeding or bruising, fluid accumulation around the lungs, increased liver enzyme activity. Your doctor may order a blood test that can show increased liver enzyme activity.
Rare side effects: may occur in up to 1 in 1,000 people
Bleeding from the gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation around the heart, painful coronary artery spasm (at rest, usually at night or early in the morning) (Prinzmetal's angina) coordination disorders, speech difficulties, dry skin, migraine, vision disorders or double vision, ringing in the ears, dizziness when standing up (especially from a sitting or lying position), increased need to urinate at night, pain, flu-like symptoms, drowsiness, vasodilation, colitis (symptoms include diarrhea, usually containing blood and mucus, stomach pain, fever), gastritis (symptoms include pain, nausea, vomiting), lung tissue density changes, increased creatinine levels in blood tests, which may indicate kidney function impairment.
Side effects with unknown frequency:

• Potentially life-threatening heart rhythm disorders (torsade de pointes);
• Hepatitis with symptoms of nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (jaundice);
• Pneumonia (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic pneumonia, including interstitial lung disease, pneumonia);
• Kidney inflammation (tubulointerstitial nephritis);
• Stroke (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: www.smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Anagrelid Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Blister:
Do not store above 30°C.
HDPE bottle:
Do not store above 30°C. Store in the original packaging to protect from moisture. After first opening, close the bottle tightly and store in a dry place.
Medicines should not be disposed of via wastewater or household waste. 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

What Anagrelid Aurovitas contains

The active substance of Anagrelid Aurovitas is anagrelide. One capsule contains 0.5 mg of anagrelide in the form of anagrelide hydrochloride monohydrate.

Other ingredients are:

Capsule contents: lactose monohydrate (200M), microcrystalline cellulose (PH 101), sodium croscarmellose, hydroxypropyl cellulose, and magnesium stearate.
Capsule shell: gelatin, iron oxide black (E 172), and titanium dioxide (E 171).
Ink: shellac, iron oxide black (E 172), and potassium hydroxide.

What Anagrelid Aurovitas looks like and contents of the pack

Hard gelatin capsule, size 4, with a non-transparent gray body and a white cap, with black printing '1453' on the cap and '0.5 mg' on the body, filled with a white or off-white powder.
Blister pack with OPA/Aluminum/PVC/Aluminum:
Pack sizes:84, 90, and 100 hard capsules.
HDPE bottle: The medicinal product is available in a white, non-transparent, round HDPE bottle with a PP closure. The HDPE bottle contains a desiccant.
Pack sizes:100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
PUREN Pharma GmbH & Co. KG
Willy-Brandt-Allee 2
81829 Munich
Germany

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

France:
Anagrelide Arrow 0.5 mg gelule
Germany:
Anagrelid PUREN 0.5 mg Hartkapseln
Italy:
Anagrelide Aurobindo
Poland:
Anagrelid Aurovitas
Portugal:
Anagrelida Aurovitas
Spain:
Anagrelida Aurovitas 0.5 mg capsulas duras EFG

Date of last revision of the leaflet: 04/2023

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu. There are also links to websites about rare diseases and their treatment.