Anagrelide accord

Package leaflet: Information for the user

Anagrelide Accord, 0.5 mg, hard capsules
Anagrelide Accord, 1 mg, hard capsules
Anagrelidum
Please read all of this leaflet carefully before 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 personally. 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 any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

1. What Anagrelide Accord is and what it is used for
2. What you need to know 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 blood platelets. It reduces the formation of platelets by 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 that occurs when 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 to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest as rash, itching, facial or lip swelling, or shortness of breath;
• if the patient has moderate or severe liver function impairment;
• if the patient has moderate or severe kidney function impairment.

Warnings and precautions
Before starting Anagrelide Accord, speak with your doctor:

• if the patient has or is suspected of having heart disorders;
• if the patient has congenital prolonged QT interval (seen on ECG, the recording of the heart's electrical activity), or if a family member has had prolonged QT interval, or if the patient is taking other medicines that cause 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 disorders.

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

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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Please inform your doctor if the patient is taking any of the following medicines:

• medicines that may affect heart rhythm, e.g. sotalol, amiodarone;
• fluvoxamine, used in the treatment of depression;
• certain types of antibiotics used to treat infections, such as enoxacin;
• theophylline, used in the treatment of severe asthma and breathing difficulties;
• medicines used in the treatment of 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 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. In such cases, an additional method of contraception (e.g. condom) should be used. Please refer to the instructions provided in the patient leaflet included with the oral contraceptive.

Anagrelide Accord or the above-mentioned 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 contraceptive methods during treatment with Anagrelide Accord. Advice regarding contraceptive methods may be obtained from 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 discontinue breastfeeding if taking Anagrelide Accord.

Driving and operating machinery
Dizziness has been reported in some patients taking Anagrelide Accord. If dizziness occurs, the patient should not drive or operate machinery.

Anagrelide Accord contains lactose
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.

3. How to use Anagrelide Accord

Anagrelide Accord must always be used as directed by the physician. If in doubt,
consult a 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,
which will allow 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 each day.
Do not take more capsules than prescribed by the doctor.
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 Anagrelide Accord than prescribed
If a higher dose of Anagrelide Accord than recommended is taken, or if the medicine is taken by someone else,
contact a doctor or pharmacist immediately. Show the medicine packaging.
If a dose of Anagrelide Accord is missed
The patient should take the capsule 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience any worrying symptoms, consult your doctor.
Serious adverse 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, swelling of legs or ankles, possible bluish discoloration of lips and skin).
Rare: kidney failure (passing very little or no urine), heart attack.
If any of the above serious adverse effects occur, contact your doctor immediately.
Very common adverse effects: affecting at least 1 in 10 patients:
headache.
Common adverse effects: may affect less than 1 in 10 patients:
dizziness, fatigue, rapid, irregular or strong heartbeats (palpitations), nausea, diarrhoea, stomach pain, bloating, vomiting, slight decrease in red blood cells (anaemia), fluid retention or rash.
Uncommon adverse effects: may affect less than 1 in 100 patients:
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 or loss of sensation or 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, 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 blood tests which may show increased liver enzyme activity.
Rare adverse effects:
bleeding 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, movement coordination problems, speech difficulties, dry skin, migraine, visual disturbances or double vision, tinnitus, dizziness upon standing (especially from sitting or lying positions), 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), areas of altered density in the lungs, increased creatinine levels in blood tests, which may indicate impaired kidney function.
The following adverse effects have also been reported, although their frequency is unknown:

• potentially life-threatening heart rhythm disorders (torsade de pointes);
• liver inflammation causing nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (jaundice);
• lung inflammation (symptoms include fever, cough, breathing difficulties, wheezing; the disease may lead to lung tissue scarring) (allergic alveolitis, including interstitial lung disease, pneumonitis);
• kidney inflammation (tubulointerstitial nephritis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse 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, Email: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to 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, 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 the medicine, 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 will help protect the environment.

6. Contents of the pack 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), black iron oxide (E172).

What Anagrelide Accord looks like and contents of the pack
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.
The 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.
ul. Taśmowa 7
02-677 Warsaw
Poland

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 European Economic Area countries 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 complete information about this medicine.
The European Medicines Agency will review all new information on the medicine every year, and the summary of product characteristics will be updated accordingly if necessary.