Anagrelide accord

Package leaflet: Information for the patient

Anagrelide Accord, 0.5 mg, hard capsules
Anagrelide Accord, 1 mg, hard capsules
Anagrelidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

Anagrelide Accord contains the active substance anagrelide.
Anagrelide Accord is a medicine that inhibits the production of platelets. It reduces platelet formation
in the bone marrow, thereby lowering the platelet count in the blood 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. An excess of platelets in the blood may lead to serious circulatory and blood clotting disorders.

2. Important information before using Anagrelide Accord

When not to use Anagrelide Accord

• if the patient is allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest as rash, itching, facial or lip swelling, and 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 treatment with Anagrelide Accord, speak to your doctor:

• if the patient has or is suspected of having heart problems;
• if the patient has congenital or family history of prolonged QT interval (visible on ECG, the recording of the heart's electrical activity), or if the patient is taking other medicines causing ECG changes, or has low electrolyte levels, such as potassium, magnesium, or calcium (see section "Anagrelide Accord and other medicines");
• if the patient has any liver or kidney problems.

Concomitant administration with acetylsalicylic acid (a component of many pain-relieving and antipyretic medicines, as well as those preventing blood clotting, also known as aspirin) increases the risk of serious bleeding (haemorrhage) (see section "Anagrelide Accord and other medicines").

Anagrelide Accord must be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor. Do not suddenly discontinue this medicine without consulting your doctor. Abrupt discontinuation of the medicine may increase the 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, trouble 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 with no known cause. Seek immediate medical help.

Children and adolescents
Experience with the use of Anagrelide Accord in children and adolescents is limited. Caution should be exercised when using this medicine in this patient group.

Anagrelide Accord and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Tell 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;
• 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 conditions, for example milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid (also known as aspirin, a component of many pain-relieving and antipyretic medicines, as well as those preventing blood clotting);
• other medicines used in the treatment of diseases affecting platelet count, e.g. clopidogrel;
• omeprazole, used to reduce stomach acid production;
• oral contraceptives: if severe diarrhoea occurs while taking this medicine, it may reduce the effectiveness of the oral contraceptive, and therefore use of an additional contraceptive method (e.g. condom) is recommended. Please refer to the patient leaflet included in the oral contraceptive packaging for further guidance.

Anagrelide Accord or the above medicines may not work properly if taken at the same time.
If in doubt, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or planning to become pregnant, she should inform her doctor. Women who are pregnant should not take Anagrelide Accord. Women of childbearing potential should use effective contraception during treatment with Anagrelide Accord. Advice on contraceptive methods can be provided by a doctor.

Patients who are breastfeeding or planning to breastfeed should inform their doctor. Anagrelide Accord must not be used during breastfeeding. The patient should stop breastfeeding if taking Anagrelide Accord.

Driving and using machines
Dizziness has been reported in some patients taking Anagrelide Accord. If dizziness occurs, do not drive or operate machinery.

Anagrelide Accord contains lactose
This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Anagrelide Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Anagrelide Accord

Anagrelide Accord must always be taken exactly as directed by the physician. If in doubt,
consult the doctor or pharmacist.
The amount of Anagrelide Accord taken by individual patients may vary and depends on
the patient's condition. The physician will prescribe the appropriate dose for each patient.
The usual starting dose of Anagrelide Accord is 1 mg. The patient takes this dose, in the form of
a 0.5 mg capsule twice daily, for at least one week. After this period, the physician may
increase or decrease the number of capsules taken to determine the most suitable dose for the patient,
allowing 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. The patient may take the capsules with food, after a meal, or
on an empty stomach. It is best to take the capsule(s) at the same time every day.
Do not take more or fewer capsules than prescribed by the doctor. Do not stop
taking the medication without first consulting the doctor. Do not suddenly stop taking this medication on your own.
The physician will order regular blood tests to monitor whether the medication is
effective and to ensure that the liver and kidneys are functioning properly.
Taking more than the recommended dose of Anagrelide Accord
If a higher dose of Anagrelide Accord than recommended is taken, or if the medication is taken by someone else,
contact the doctor or pharmacist immediately. Show the medication packaging.
Missed dose of Anagrelide Accord
The patient should take the missed capsule(s) as soon as they 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.

Serious side effects:
Not common: heart failure (symptoms include breathlessness, 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 counts which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (symptoms include breathlessness, leg or ankle swelling, possible bluish discoloration of lips and skin).

Rare: kidney failure (passing very little or no urine), heart attack.
If any of the above serious side effects occur, contact your doctor immediately.

Very common side effects: occurring in at least 1 in 10 patients:
headache.

Common side effects: may occur in less than 1 in 10 patients:
dizziness, fatigue, rapid, irregular or strong heartbeats (palpitations), nausea, diarrhoea, stomach pain, bloating, vomiting, slight reduction in red blood cells (anaemia), fluid retention or rash.

Uncommon side effects: may occur in less than 1 in 100 patients:
weakness or feeling unwell, 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, reduced sensation or loss of sensation or feeling of numbness, particularly in the skin, abnormal sensation or tingling or pins and needles, insomnia, depression, disorientation, nervousness, dry mouth, memory impairment, breathlessness, nosebleeds, severe lung infection with fever, breathlessness, cough and sputum production, hair loss, itching and skin discoloration, impotence, chest pain, reduced 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 side effects:
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 the heart's blood vessels (at rest, usually at night or early morning) (Prinzmetal’s angina), movement coordination problems, difficulty speaking, dry skin, migraine, visual disturbances or double vision, tinnitus, dizziness upon standing (especially from sitting or lying positions), increased need to pass urine 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), areas of altered density in the lungs, increased blood creatinine levels which may indicate impaired kidney function.

The following side effects have also been reported, but their frequency is unknown:

• potentially life-threatening heart rhythm disorders (torsade de pointes);
• hepatitis, manifesting as nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes 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, pneumonia);
• kidney inflammation (tubulointerstitial nephritis);
• stroke (see section 2).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Anagrelide Accord

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack 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.
Anagrelide Accord, 0.5 mg, hard capsules:
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Anagrelide Accord, 1 mg, hard capsules:
Do not store above 30°C.
1 mg capsules: Store in the original packaging to protect from moisture.
If the doctor advises the patient to discontinue treatment, any unused capsules should not be kept unless otherwise advised by the doctor.
Medicines must 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 packaging and other information

What Anagrelide Accord contains
Anagrelide Accord, 0.5 mg, hard capsules:
The active substance is anagrelide.
Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).
Anagrelide Accord, 1 mg, hard capsules:
The active substance is anagrelide.
Each capsule contains 1 mg of anagrelide (as anagrelide hydrochloride monohydrate).
Other ingredients are:
Capsule contents: lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.
Anagrelide Accord, 0.5 mg, hard capsules:
Capsule shell: gelatin, titanium dioxide (E171).
Anagrelide Accord, 1 mg, hard capsules:
Capsule shell: gelatin, titanium dioxide (E171), iron oxide black (E172).

What Anagrelide Accord looks like and contents of the packaging
Anagrelide Accord 0.5 mg: white, opaque hard capsule size 4 containing white or almost white powder.
Anagrelide Accord 1 mg: grey hard capsule size 4 containing white or almost white powder.
Capsules are available in bottles containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

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

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

This medicine has been authorised under exceptional circumstances.
This means that because the disease is rare, it has not been possible to obtain full information on this medicine.
The European Medicines Agency will review all new information on the medicine each year, and the text of this leaflet will be updated if necessary.