Anagrelide Stada

Package Leaflet: Information for the Patient

Anagrelide Stada, 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 only. 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 Anagrelide Stada and what is it used for
• 2. Important information before taking Anagrelide Stada
• 3. How to take Anagrelide Stada
• 4. Possible side effects
• 5. How to store Anagrelide Stada
• 6. Contents of the pack and other information

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

Anagrelide Stada contains the active substance anagrelide.
Anagrelide is a medicine that inhibits the development of blood platelets. It reduces the production of platelets by the bone marrow, leading to a decrease in the number of platelets to a more normal value.
For this reason, 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 circulatory and blood clotting disorders.

2. Important information before taking Anagrelide Stada

When not to take Anagrelide Stada:

• 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, or difficulty breathing;
• if you have moderate or severe liver function disorders;
• if you have moderate or severe kidney function disorders.

Warnings and precautions

Before starting anagrelide, talk to your doctor:

• if you have or suspect you have heart rhythm disorders;
• if you have a congenital or family history of QT interval prolongation (visible on an ECG, a record of the heart's electrical activity) or if you are taking other medicines that can cause abnormal changes in the ECG, or have decreased electrolyte levels, such as potassium, magnesium, or calcium (see "Anagrelide Stada and other medicines");
• if you have any liver or kidney disorders.

In case of concomitant administration with acetylsalicylic acid (a component of many painkillers and antipyretics, as well as anti-coagulant medications), there is an increased risk of serious bleeding (hemorrhage) (see "Anagrelide Stada and other medicines").
Anagrelide Stada 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. You should seek medical attention immediately.

Children and adolescents

Experience with the use of Anagrelide Stada in children and adolescents is limited.
Therefore, caution should be exercised when using this medicine in this patient group.

Anagrelide Stada and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, 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 asthma and breathing difficulties;
• medicines used to treat heart diseases, such as milrinone, enoximone, amrinone, olprinone, cilostazol;
• acetylsalicylic acid (a component of many painkillers and antipyretics, as well as anti-coagulant medications);
• other medicines used to treat diseases that affect the number of platelets, 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 effectiveness of your oral contraceptive, and you should use an additional method of contraception (e.g., a condom). You should read the instructions in the patient information leaflet that comes with your oral contraceptive.

Anagrelide Stada or these medicines may not work properly if taken at the same time.
In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

Pregnant or breastfeeding women should inform their doctor. Pregnant women should not take anagrelide. Women who may become pregnant should use effective contraception during anagrelide treatment. In case of doubt about contraception, consult your doctor.
Breastfeeding women or those planning to breastfeed should inform their doctor. Anagrelide should not be used during breastfeeding. The patient should stop breastfeeding if taking anagrelide.

Driving and using machines

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

Anagrelide Stada contains lactose and sodium

This medicine contains lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Anagrelide Stada

Anagrelide Stada should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The amount of anagrelide 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 anagrelide is 1 mg. You take this dose in the form of 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 taken to determine the most suitable dose for you, which will provide the most effective treatment.
The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve their contents in liquids. You can take the capsules with food, after food, or on an empty stomach. It is best to take the capsule(s) at the same time every day.
Do nottake more or fewer capsules than your doctor has prescribed. Do notstop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine on your own.
Your doctor will order regular blood tests to determine if the medicine is effective and if your liver and kidneys are working properly.

Taking a higher dose of Anagrelide Stada than prescribed

If you have taken more anagrelide than prescribed or taken the medicine by someone else, tell your doctor or pharmacist immediately. Show them the anagrelide packaging.

Missing a dose of Anagrelide Stada

You should 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 missed dose.

4. Possible side effects

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

Severe side effects

Uncommon (may affect up to 1 in 100 people):

• heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation),
• serious heart rhythm disorders or arrhythmias (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation),
• pancreatitis causing severe abdominal and back pain,
• bleeding vomiting or passing black or tarry stools,
• significant decrease in blood cell count, which can cause weakness,
• bruising,
• bleeding or infections (pancytopenia),
• pulmonary hypertension (symptoms include shortness of breath, swelling of the legs or ankles, possible blue discoloration of the lips and skin).

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

• kidney failure (passing very little urine or urine retention),
• heart attack.

If you experience 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,
• irregular or strong heartbeat (palpitations),
• nausea,
• diarrhea,
• stomach pain,
• bloating,
• vomiting,
• decrease in red blood cell count (anemia),
• fluid retention or rash.

Uncommon(may affect up to 1 in 100 people):

• weakness or malaise,
• high blood pressure,
• irregular heartbeat,
• fainting,
• chills or fever,
• indigestion,
• loss of appetite,
• constipation,
• bruising,
• bleeding,
• swelling,
• weight loss,
• muscle pain,
• joint pain,
• back pain,
• limited sensation or loss of sensation or feeling of numbness, especially in the skin,
• abnormal sensation or feeling of numbness or tingling,
• insomnia,
• depression,
• disorientation,
• nervousness,
• dry mouth,
• memory loss,
• shortness of breath,
• nosebleeds,
• severe lung infection with fever,
• shortness of breath,
• cough,
• expectoration of sputum,
• hair loss,
• itching and skin discoloration,
• impotence,
• chest pain,
• decrease in platelet count, increasing the risk of bleeding or bruising (thrombocytopenia),
• fluid accumulation around the lungs and increased liver enzyme activity. Your doctor may order a blood test that can show increased liver enzyme activity.

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

• gum bleeding,
• 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,
• tinnitus,
• dizziness (especially when standing up 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 with abnormal density,
• increased creatinine levels in blood tests, which can be a sign of kidney function disorder.

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

• potentially life-threatening irregular heart rhythm (torsade de pointes);
• hepatitis, which can cause nausea, vomiting, itching, yellowing of the skin and eyes, and changes in stool and urine color (jaundice);
• pneumonitis (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic alveolitis, including interstitial lung disease, pneumonitis);
• 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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://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 Anagrelide Stada

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the label and carton after: EXP. The first two digits indicate the month, and the last four digits indicate the year.
The expiration date is the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
If your doctor advises you to stop taking the medicine, do not store unused capsules unless your doctor advises you to do so.
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 Anagrelide Stada contains

• The active substance of the medicine is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).
• Other ingredients are: capsule contents:lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate. capsule shell:gelatin, titanium dioxide (E171).

What Anagrelide Stada looks like and contents of the pack

Anagrelide Stada, 0.5 mg, is a hard capsule (size 4) with an opaque white body and cap. The capsule is filled with a white to off-white powder.
The capsules are supplied in child-resistant closure bottles with a desiccant, containing 42 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer/importer:
Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
Netherlands

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Czech Republic
Anagrelid STADA
Denmark
Anagrelide Stada
Spain
Anagrelida STADA 0.5 mg hard capsules
Anagrelida STADA 1 mg hard capsules
Finland
Anagrelide Stada 0.5 mg hard capsules
France
Anagrelide EG 0.5 mg / 1 mg, hard capsules
Croatia
Anagrelid STADA 0.5 mg hard capsules
Hungary
Anagrelide STADA
Netherlands
Anagrelide CF 0.5 mg / 1 mg, hard capsules
Poland
Anagrelide Stada
Sweden
Anagrelide Stada 0.5 mg hard capsules
Slovenia
Anagrelid STADA 0.5 mg hard capsules
Slovakia
Anagrelid STADA
Date of last revision of the leaflet:09/2022