Anagrelid aurovitas

Package leaflet: Information for the patient

Anagrelid Aurovitas, 0.5 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 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Anagrelid Aurovitas is and what it is used for

Anagrelid Aurovitas contains the active substance anagrelid. Anagrelid Aurovitas is a medicine that inhibits the production of blood platelets. This medicine reduces the number of platelets produced by the bone marrow, thereby lowering the platelet count in the blood to a more normal level. It is therefore 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 known as platelets. A high number of platelets in the blood may lead to serious circulation and blood clotting disorders.

2. Important information before using Anagrelid Aurovitas

When not to use Anagrelid Aurovitas

• 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, 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 treatment with Anagrelid Aurovitas, discuss with your doctor:

• If you have or suspect you may have a heart problem;
• If you have congenital long QT syndrome or a family history of prolonged QT interval (seen on ECG, the graphical recording of the heart's electrical activity), or if you are taking other medicines that may affect the ECG, or if you have low levels of electrolytes such as potassium, magnesium, or calcium (see section "Anagrelid Aurovitas and other medicines");
• If you have liver or kidney problems.

When Anagrelid Aurovitas is taken together with acetylsalicylic acid (a substance also known as aspirin, present in many medicines used to relieve pain and reduce fever, as well as in medicines preventing blood clotting), there is an increased risk of major bleeding (haemorrhage) (see section "Anagrelid Aurovitas and other medicines").
Anagrelid Aurovitas should be taken exactly as prescribed by your doctor. Do not stop taking this medicine without first consulting your doctor. Do not suddenly discontinue treatment with this medicine without consulting your doctor. Abruptly stopping 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, difficulty speaking or understanding speech; sudden vision problems in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; or sudden severe headache with no known cause. Seek immediate medical help.
Children and adolescents
Information on the use of Anagrelid Aurovitas in children and adolescents is limited.
Caution should be exercised when using this medicine in this patient group.
Anagrelid Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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;
• Certain types of antibiotics used to treat infections, such as enoxacin;
• Theophylline, used to treat severe asthma and breathing problems;
• Medicines used to treat heart conditions, e.g. milrinone, enoximone, amrinone, olprinone, and cilostazol;
• Acetylsalicylic acid (commonly known as aspirin, present in many medicines used to relieve pain and reduce fever, as well as in medicines preventing blood clotting);
• Other medicines used to treat diseases affecting platelet count, e.g. clopidogrel;
• Omeprazole, a medicine used to reduce stomach acid production;
• Oral contraceptives: severe diarrhoea during treatment with this medicine may reduce the effectiveness of the oral contraceptive. Therefore, use of an additional contraceptive method (e.g. condoms) is recommended. Please refer to the instructions provided in the patient leaflet of the contraceptive pill being used.

The effect of Anagrelid Aurovitas or the listed medicines may be altered if taken simultaneously.
If in doubt, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, inform your doctor before using this medicine. Pregnant women should not take Anagrelid Aurovitas. Women who could become pregnant should use effective contraception during treatment with Anagrelid Aurovitas. Your doctor can advise you on suitable contraceptive methods.
Do not use Anagrelid Aurovitas during breastfeeding. If you are taking Anagrelid Aurovitas, you should stop breastfeeding.
Driving and operating machinery
Dizziness has been reported in some patients taking Anagrelid Aurovitas. If you experience dizziness, do not drive or operate machinery.
Anagrelid Aurovitas contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Anagrelid Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to use Anagrelid Aurovitas

Anagrelid Aurovitas must always be used as prescribed by the doctor. If in doubt,
consult the doctor or pharmacist.
The amount of Anagrelid Aurovitas taken by individual patients may vary and
depends on the patient's condition. The doctor will prescribe the appropriate dose for the patient.
The usual starting dose of Anagrelid Aurovitas is 1 mg. To achieve this dose, the patient
will take one 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 to determine the most suitable dose
that allows effective treatment of the patient.
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 prescribed by the doctor. Do not stop taking
the medicine without first consulting the doctor. Do not suddenly stop taking this medicine on your own.
The doctor will arrange for regular blood tests to monitor whether the medicine is effective
and to ensure that the liver and kidneys are functioning properly.
Taking more Anagrelid Aurovitas than prescribed
If a higher dose of Anagrelid Aurovitas than prescribed is taken or if the medicine is taken by someone else,
contact the doctor or pharmacist immediately. Show the Anagrelid Aurovitas packaging.
Missed dose of Anagrelid Aurovitas
The patient should take the capsules as soon as they remember. The next dose should be taken at the 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 have any worrying symptoms, consult your doctor.
Serious adverse reactions
Not common: heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation), severe 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 shortness of breath, swelling of legs or ankles, and bluish discoloration of lips and skin).
Rare: kidney failure (passing very little urine or complete absence of urine), heart attack.
If any of the above serious adverse reactions occur, contact your doctor immediately.
Very common adverse reactions: may affect more than 1 in 10 people
Headache.
Common adverse reactions: may affect up to 1 in 10 people
Dizziness, fatigue, rapid, irregular or strong heartbeats (palpitations), nausea, diarrhoea, stomach pain, bloating, vomiting, reduced number of red blood cells (anaemia), fluid retention or rash.
Uncommon adverse reactions: may affect up to 1 in 100 people
Feeling of weakness or general malaise, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle pain, joint pain, back pain, reduced or lost sensation or numbness, particularly in the skin, abnormal sensation or tingling, insomnia, depression, disorientation, nervousness, dry mouth, memory impairment, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough and sputum production; hair loss, itching and skin discoloration, impotence, chest pain, reduced platelet count (thrombocytopenia) increasing the risk of bleeding or bruising, fluid accumulation around the lungs, increased liver enzyme activity. Your doctor may order a blood test which may show increased liver enzyme activity.
Rare adverse reactions: may affect up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain and palpitations), enlarged heart, fluid accumulation around the heart, painful spasm of the coronary blood vessels (at rest, usually at night or early morning) (Prinzmetal's angina), movement coordination disturbances, speech difficulties, dry skin, migraine, visual disturbances or double vision, ringing in the ears, 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), development of areas of altered density in the lungs, increased blood 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 disturbances in heart rhythm (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 color (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 adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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: www.smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Anagrelid Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Blister:
Do not store above 30°C.
HDPE bottle:
Do not store above 30°C. Store in the original packaging to protect from moisture. After first opening, keep the bottle tightly closed and store in a dry place.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Anagrelid Aurovitas contains
The active substance is anagrelide. One capsule contains 0.5 mg of anagrelide in the form of anagrelide monohydrochloride monohydrate.
Other ingredients are:
Capsule contents: monohydrate lactose (200M), microcrystalline cellulose (PH 101), sodium croscarmellose, hydroxypropylcellulose and magnesium stearate.
Capsule shell: gelatin, black iron oxide (E 172), and titanium dioxide (E 171).
Printing ink: shellac, black iron oxide (E 172), and potassium hydroxide.

What Anagrelid Aurovitas looks like and contents of the pack
Hard gelatin capsule size 4, with an opaque grey body and white cap, printed in black with '1453' on the cap and '0.5 mg' on the body, filled with white or almost white powder.

Blister pack made of OPA/Aluminium/PVC/Aluminium:
Pack sizes: 84, 90 and 100 hard capsules.
HDPE bottle: The medicinal product is available in a white, opaque, round HDPE bottle with a PP closure. The HDPE bottle contains a desiccant.
Pack size: 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
PUREN Pharma GmbH & Co. KG
Willy-Brandt-Allee 2
81829 Munich
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Anagrelide Arrow 0.5 mg gélule
Germany: Anagrelid PUREN 0.5 mg Hartkapseln
Italy: Anagrelide Aurobindo
Poland: Anagrelid Aurovitas
Portugal: Anagrelida Aurovitas
Spain: Anagrelida Aurovitas 0.5 mg capsulas duras EFG

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. This site also contains links to websites on rare diseases and their treatments.