Anagrelide vipharm

Package leaflet: Information for the patient

Anagrelide Vipharm, 0.5 mg, hard capsules
Anagrelide Vipharm, 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, as you may need to read it again.
• If you have any further questions, please 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 or pharmacist. See section 4.

Contents of the leaflet

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

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

Anagrelide Vipharm contains the active substance anagrelide.
Anagrelide inhibits the development of blood platelets. It reduces platelet production in the bone marrow, leading to a decrease in platelet count to a more normal level. For this reason, it is used in the treatment of patients with essential thrombocythemia.
Essential thrombocythemia 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 Vipharm

When not to use Anagrelide Vipharm:

• 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, swelling of the face or lips, 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 anagrelide, speak with your doctor:

• if the patient has or is suspected of having heart disorders;
• if the patient has congenital or family history of prolonged QT interval (seen on ECG, the electrical recording of the heart's 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 “Other medicines and Anagrelide Vipharm”);
• 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 Vipharm and other medicines”).

Anagrelide Vipharm should be taken exactly as prescribed by the doctor. Do not stop taking the medicine without first consulting your doctor. Do not suddenly discontinue 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 coordination; and sudden severe headache with no known cause. Seek immediate medical help.

Children and adolescents
Experience with the use of Anagrelide Vipharm in children and adolescents is limited. Caution is advised when using.

Anagrelide Vipharm and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans 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 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 diseases, e.g. milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid (also known as aspirin, a component of many pain-relieving, antipyretic, and blood clot-preventing medicines);
• 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 instructions provided in the patient leaflet included in the oral contraceptive packaging.

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

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

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 Vipharm contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Anagrelide Vipharm

This medicine should always be used exactly as your doctor has told you. If you are not sure,
please consult your doctor or pharmacist.
The amount of anagrelide required by individual patients may vary and depends on the patient's
condition. Your doctor will prescribe the appropriate dose for each patient.
The usual starting dose of anagrelide is 1 mg. This is taken as one 0.5 mg capsule twice daily for
at least one week. After this period, your doctor may increase or decrease the number of
capsules taken in order 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 capsules may be taken 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 your doctor has prescribed. Do not stop taking
this 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 and
to ensure that your liver and kidneys are functioning properly.
Taking more Anagrelide Vipharm than prescribed
If you take more anagrelide than prescribed, or if someone else takes this medicine, contact your
doctor or pharmacist immediately. Show the packaging of the medicine containing anagrelide.
Missing a dose of Anagrelide Vipharm
If you forget to take a dose, take the capsule 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 will get 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 cells, 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 side effects occur, contact your doctor immediately.

Very common side effects (may affect more than 1 in 10 people):
headache.

Common side effects (may affect up to 1 in 10 people):
dizziness • fatigue, • rapid, irregular or forceful heartbeats (palpitations), • nausea, • diarrhoea, • stomach pain, • bloating, • vomiting, • mild reduction in red blood cells (anaemia), • fluid retention or rash.

Uncommon side effects (may affect up to 1 in 100 people):
weakness or feeling unwell, • 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 lost sensation or feeling of numbness, particularly in the skin, • abnormal sensation or feeling of numbness or tingling, • 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 (may affect up to 1 in 1,000 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 the heart's blood vessels (occurring at rest, usually at night or early morning) (Prinzmetal's angina), • movement coordination disorders, • speech difficulties, • dry skin, • migraine, • visual disturbances or double vision, • tinnitus, • dizziness (especially when standing up 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), • lung areas with altered density, • increased creatinine levels in blood tests, which may indicate impaired kidney function.

The following adverse reactions have also been reported, but their frequency is unknown:

• potentially life-threatening heart rhythm disorders (torsade de pointes);
• liver inflammation presenting with 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, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the marketing authorization holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Anagrelide Vipharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following: EXP.
The expiry date refers to the last day of the stated month.
Anagrelide Vipharm, 0.5 mg, hard capsules
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Anagrelide Vipharm, 1 mg, hard capsules
Do not store above 30°C.
Store in the original packaging to protect from moisture.
If the doctor advises the patient to discontinue treatment with this medicine, 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 package and other information

What Anagrelide Vipharm contains
Anagrelide Vipharm, 0.5 mg, hard capsules

• The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).

Anagrelide Vipharm, 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 Vipharm, 0.5 mg, hard capsules
Capsule shell: gelatin, titanium dioxide (E 171)
Anagrelide Vipharm, 1 mg, hard capsules
Capsule shell: gelatin, titanium dioxide (E 171), iron oxide black (E 172)

What Anagrelide Vipharm looks like and contents of the pack
Anagrelide Vipharm 0.5 mg is in the form of hard capsules (size 4, 14.3 x 5.3 mm) with an opaque white body and cap. Each capsule is filled with a white or almost white powder.
Anagrelide Vipharm 1 mg is in the form of hard capsules (size 4, 14.3 x 5.3 mm) with a grey body and cap. Each capsule is filled with a white or almost white powder.
Capsules are supplied in bottles containing 42 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturers/Importers
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 for marketing in the European Economic Area countries under the following names:
Netherlands: Anagrelide Genthon 0.5 mg / 1 mg, hard capsules
Czech Republic: Anagrelide Vipharm
Spain: Anagrelida Pharmavic 0.5 mg hard capsules EFG
Finland: Anagrelid Avansor 0.5 mg capsules, hard
Croatia: Anagrelid Alpha-Medical 0.5 mg hard capsules
Hungary: Anagrelide Vipharm
Poland: Anagrelide Vipharm
Slovakia: Anagrelide Vipharm 0.5 mg
Sweden: Anagrelid Avansor 0.5 mg capsule, hard