Anagrelide stada

Package leaflet: Information for the patient

Anagrelide Stada, 0.5 mg, hard capsules
Anagrelidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Anagrelide Stada contains the active substance anagrelide.
Anagrelide is a medicine that inhibits the production of platelets. It reduces platelet formation by
the bone marrow, thereby lowering the platelet count to a more normal level.
For this reason, it is used in the treatment of patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition in which the bone marrow produces too many blood cells
called platelets. A high number of platelets in the blood may lead to serious circulation and blood clotting disorders.

2. Important information before using Anagrelide Stada

When not to take Anagrelide Stada:

• if the patient is allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial or lip swelling, or shortness of breath;
• if the patient has moderate or severe liver function disorders;
• if the patient has moderate or severe kidney function disorders.

Warnings and precautions
Before starting anagrelide, talk to your doctor:

• if the patient has or is suspected of having heart disorders;
• if the patient has congenital or previously diagnosed prolonged QT interval (visible on ECG, the recording of the heart's electrical activity), or if the patient is taking other medicines causing abnormal changes in the ECG, or has low levels of electrolytes, such as potassium, magnesium or calcium (see section "Anagrelide Stada with other medicines");
• if the patient has any liver or kidney disorders.

When administered concomitantly with acetylsalicylic acid (a component of many pain-relieving and antipyretic medicines, as well as those preventing blood clotting), there is an increased risk of serious bleeding (haemorrhage) (see section "Anagrelide Stada with other medicines").
Anagrelide Stada should be taken exactly as prescribed by the doctor. Do not stop taking the medicine without first consulting your doctor. Do not suddenly stop taking this medicine without consulting your doctor. Abrupt discontinuation of the medicine may lead to an increased risk of stroke.
Symptoms of stroke may 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 lack of coordination; and sudden severe headache with no known cause. Seek immediate medical help.

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

• medicines that may affect heart rhythm, e.g. sotalol, amiodarone;
• fluvoxamine, used to treat depression;
• some 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, e.g. milrinone, enoximone, amrinone, olprinone and cilostazol;
• acetylsalicylic acid (a component of many pain-relieving and antipyretic medicines, as well as medicines preventing blood clotting);
• other medicines used in the treatment of disorders affecting platelet count, e.g. clopidogrel;
• omeprazole, used to reduce the amount of acid produced in the stomach;
• oral contraceptives: if severe diarrhoea occurs during treatment with this medicine, it may reduce the effectiveness of the oral contraceptive. Therefore, an additional method of contraception (e.g. condom) is recommended. Please refer to the instructions provided in the patient leaflet included in the oral contraceptive packaging.

Anagrelide Stada or the above-mentioned medicines may not work properly if taken together.
If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
Female patients who are pregnant or planning to become pregnant should inform their doctor. Pregnant women should not take anagrelide. Women who could become pregnant should use effective contraception during treatment with anagrelide. If you have any doubts regarding contraception, consult your doctor.
Female patients who are breastfeeding or planning to breastfeed should inform their doctor. Anagrelide should not be used during breastfeeding. The patient should stop breastfeeding if taking anagrelide.

Driving and operating machinery
Dizziness has been reported in some patients taking anagrelide. If dizziness occurs, do not drive or operate machinery.

Anagrelide Stada contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Anagrelide Stada

Anagrelide Stada should always be taken exactly as prescribed by your doctor. If in doubt,
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.
The usual starting dose of anagrelide is 1 mg. The patient takes this dose as a 0.5 mg capsule twice daily for at least one week. After this period, the doctor may increase or decrease the number of capsules taken in order to determine the most suitable dose for the patient, allowing for the most effective treatment.
The capsules should be swallowed whole with a glass of water. The capsules must not be crushed or their contents dissolved in liquids. The patient may take the capsules with food, after food, or on an empty stomach. It is best to take the capsule(s) at the same time each day.
Do not take more or fewer capsules than prescribed by your doctor. Do not stop taking the medicine without first consulting your doctor. Do not suddenly stop taking this medicine on your own.
Your doctor will arrange for regular blood tests to monitor whether the medicine is working properly and to check that the liver and kidneys are functioning normally.
If you take more Anagrelide Stada than you should
If you take more anagrelide than prescribed or if someone else takes the medicine, contact your doctor or pharmacist immediately. Show the anagrelide packaging.
If you forget to take Anagrelide Stada
Take the missed dose as soon as you remember. Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you experience any worrying symptoms, consult your doctor.
Serious adverse reactions
Not common (may occur in 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 disturbances in heart rate or heart rhythm (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation),
• pancreatitis causing severe abdominal and back pain,
• vomiting blood or passing bloody or tarry stools,
• significant reduction in blood cell count, which may cause weakness,
• bruising,
• bleeding or infections (pancytopenia),
• pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, possible bluish discoloration of lips and skin).

Rare (may occur in up to 1 in 1000 people):

• kidney failure (passing very little urine or complete absence of urine),
• heart attack.

If any of these adverse reactions occur, contact your doctor immediately.
Very common (may occur in more than 1 in 10 people):

• headache.

Common (may occur in up to 1 in 10 people):

• dizziness,
• fatigue,
• rapid heartbeat,
• irregular or strong heartbeat (palpitations),
• nausea,
• diarrhoea,
• stomach pain,
• bloating,
• vomiting,
• reduction in red blood cells (anaemia),
• fluid retention or rash.

Not common (may occur in up to 1 in 100 people):

• weakness or general malaise,
• high blood pressure,
• irregular heart rhythm,
• fainting,
• chills or fever,
• indigestion,
• loss of appetite,
• constipation,
• bruising,
• bleeding,
• swelling,
• weight loss,
• muscle pain,
• joint pain,
• back pain,
• reduced sensation or loss of sensation, or tingling sensation, particularly in the skin,
• abnormal sensation or feeling of numbness or tingling,
• insomnia,
• depression,
• disorientation,
• nervousness,
• dry mouth,
• memory impairment,
• shortness of breath,
• nosebleeds,
• severe lung infection with fever,
• difficulty breathing,
• cough,
• coughing up phlegm,
• hair loss,
• itching and skin discoloration,
• impotence,
• chest pain,
• decreased 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 which may show increased liver enzyme activity.

Rare (may occur in up to 1 in 1000 people):

• bleeding gums,
• weight gain,
• severe chest pain (angina),
• heart muscle disease (symptoms include fatigue, chest pain and palpitations),
• enlarged heart,
• fluid accumulation around the heart,
• painful spasm of coronary blood vessels (at rest, usually at night or early morning) (Prinzmetal's angina),
• impaired motor coordination,
• difficulty speaking,
• dry skin,
• migraine,
• visual disturbances or double vision,
• tinnitus,
• dizziness (especially when standing up from sitting or lying position),
• increased need to urinate at night,
• pain,
• flu-like symptoms,
• somnolence,
• blood vessel dilation,
• inflammation of the large intestine (symptoms include diarrhoea, usually containing blood and mucus, stomach pain, fever),
• inflammation of the stomach (symptoms include pain, nausea, vomiting), presence of areas with abnormal density in the lungs,
• increased creatinine levels in blood tests, which may indicate impaired kidney function.

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

• potentially life-threatening irregular heart rhythm ( torsade de pointes );
• liver inflammation presenting with nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and change in stool and urine colour (jaundice);
• lung inflammation (symptoms include fever, cough, difficulty breathing, wheezing; the disease may lead to lung tissue scarring) (allergic alveolitis, including interstitial lung disease, pneumonitis);
• kidney inflammation (tubulointerstitial nephritis);
• stroke (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Anagrelide Stada

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and the cardboard
box after: EXP. The first two digits indicate the month, and the last four digits indicate the year.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
If the doctor advises the patient to discontinue treatment, do not keep any unused capsules
unless advised otherwise by the doctor.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Anagrelide Stada contains

• The active substance is anagrelide. Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride monohydrate).
• The 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 HDPE bottles with child-resistant closures and a desiccant, containing 42 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Anagrelid STADA
Denmark: Anagrelide Stada
Spain: Anagrelida STADA 0.5 mg cápsulas duras EFG
Anagrelida STADA 1 mg cápsulas duras
Finland: Anagrelide Stada 0.5 mg kapseli, kova
France: Anagrelide EG 0.5 mg / 1 mg, gélule
Croatia: Anagrelid STADA 0.5 mg tvrde kapsule
Hungary: Anagrelide STADA
Netherlands: Anagrelide CF 0.5 mg / 1 mg, harde capsules
Poland: Anagrelide Stada
Sweden: Anagrelide Stada 0.5 mg kapsel, hard
Slovenia: Anagrelid STADA 0.5 mg trde kapsule
Slovakia: Anagrelid STADA