ANAGRELIDE 0.5 MG Hard capsules

Зміст інструкції

1. Anagrelide Aurobindo 0.5 mg hard capsules
   1. What is Anagrelide Aurobindo and what it is used for
   2. What you need to know before taking Anagrelide Aurobindo
   3. How to take Anagrelide Aurobindo
   4. Possible side effects
   5. How to store Anagrelide Aurobindo
   6. Package Contents and Other Information

Anagrelide Aurobindo 0.5 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Anagrelide Aurobindo contains the active substance anagrelide. Anagrelide Aurobindo is a medicine
that interferes with the development of platelets. It reduces the number of platelets produced by the bone
marrow, resulting in a decrease in the number of platelets in the blood to a level closer to normal
values. For this reason, it is used for the treatment of patients with essential thrombocythemia.
Essential thrombocythemia is a disorder that occurs when the bone marrow produces excessive amounts of blood cells called platelets. The presence of a high number of platelets in the
blood can cause serious circulation and coagulation problems.

2. What you need to know before taking Anagrelide Aurobindo

Do not take Anagrelide Aurobindo

• if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Possible signs of an allergic reaction are skin rash, itching, swelling of the face or lips, or shortness of breath;
• if you have moderate or severe liver problems;
• if you have moderate or severe kidney problems.

Warnings and precautions
Talk to your doctor before taking Anagrelide Aurobindo:

• if you have or think you have heart problems;
• if you have been born with or have a family history of prolonged QT interval (observed on an ECG, the recording of the heart's electrical activity), if you are taking other medicines that cause abnormal changes to the ECG, or if you have low levels of electrolytes, such as potassium, magnesium or calcium (see section “Other medicines and Anagrelide Aurobindo”);
• if you have liver or kidney problems.

In combination with acetylsalicylic acid (a substance present in many medicines used to relieve
pain and reduce fever, as well as to prevent blood clot formation, also known as aspirin), there is an
increased risk of major bleeding (bleeding) (see section “Other medicines and Anagrelide Aurobindo”).

Children and adolescents
Information regarding the use of Anagrelide Aurobindo in children and adolescents is
limited, therefore this medicine should be used with caution.

Other medicines and Anagrelide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking any of the following medicines:

• Medicines that can alter the heart rhythm, such as sotalol, amiodarone;
• Fluvoxamine, for the treatment of depression;
• Some types of antibiotics, such as enoxacin, for the treatment of infections;
• Theophylline, for the treatment of asthma and severe breathing difficulties;
• Medicines for the treatment of heart disorders, such as milrinone, enoximone, amrinone, olprinone and cilostazol;
• Acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation, also known as aspirin).
• Other medicines for the treatment of platelet disorders in the blood, such as clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives: if severe diarrhea occurs during the use of this medicine, the effectiveness of oral contraceptives may be reduced and the use of an additional method of contraception is recommended

The action of Anagrelide Aurobindo or these medicines may not be effective if they are
taken together.
If you have any doubts, ask your doctor or pharmacist for advice.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. Anagrelide Aurobindo should
not be taken by pregnant women. Women at risk of becoming pregnant must use effective
contraceptive methods when taking Anagrelide Aurobindo. Consult your doctor if you need
advice on methods of contraception.
Anagrelide Aurobindo should not be taken by women who are breastfeeding. If you take Anagrelide
Aurobindo you should stop breastfeeding.

Driving and using machines
Some patients taking Anagrelide Aurobindo have reported dizziness. If you experience dizziness,
do not drive vehicles or use machines.

Anagrelide Aurobindo contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Anagrelide Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The amount of Anagrelide Aurobindo to take may vary from patient to patient, depending on the
condition you suffer from. Your doctor will prescribe the most suitable dose for you.
The usual starting dose of Anagrelide Aurobindo is 1 mg. You should take this dose as a 0.5 mg
capsule twice a day, for at least one week. After this period, your doctor may
increase or decrease the number of capsules to take, to determine the most suitable dose for you and that
allows to treat your condition with maximum effectiveness.
The capsules must be swallowed whole, with a glass of water. Do not crush the capsules and do not
dissolve the contents in a liquid. You can take the capsules with meals, after meals or on an
empty stomach. It is recommended to take the capsule(s) at the same time each day.
Do not take more capsules than recommended by your doctor.
Your doctor will ask you to undergo blood tests at regular intervals, to check the effectiveness of the
medicine and the proper functioning of the liver and kidneys.

If you take more Anagrelide Aurobindo than you should
If you take more Anagrelide Aurobindo than you should, or if someone else has taken your
medicine, inform your doctor or pharmacist immediately, and show them the packaging of Anagrelide
Aurobindo.

If you forget to take Anagrelide Aurobindo
Take the capsules as soon as you remember. Take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any concerns, talk to your doctor.

Serious side effects:
Uncommon: heart failure (signs include shortness of breath, chest pain, swelling of the
legs due to fluid retention), serious problems with the heart rate or rhythm
(ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the
pancreas causing severe abdominal and back pain (pancreatitis), vomiting blood or
blood in the stool or black stools, severe reduction in the number of blood cells, which can
cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (the
signs include shortness of breath, swelling of the legs or ankles and possible bluish discoloration
of the lips and skin).
Rare: kidney failure (when urine output is poor or absent), heart attack.

If you experience any of these side effects, 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, increased heart rate, irregular or strong heartbeats (palpitations),
feeling unwell (nausea), diarrhea, stomach pain, flatulence, feeling sick (vomiting), reduced
red blood cells in the blood (anemia), fluid retention or skin rashes.

Uncommon side effects: may affect up to 1 in 100 people
Feeling weak or unwell, high blood pressure (hypertension), irregular heartbeats,
fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding,
swelling (edema), weight loss, muscle pain, painful joints, back pain, reduced or
loss of sensation or numbness, especially of the skin, abnormal perception or
sensations such as tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss,
shortness of breath, nosebleeds, severe lung infection with fever, shortness of
breath, coughing, phlegm, hair loss, skin discoloration or itching, impotence, chest pain, low
platelet count in the blood, resulting in an increased risk of bleeding or
bruising (thrombocytopenia), fluid accumulation around the lungs or increased liver enzymes.
Your doctor may prescribe blood tests that may reveal an increase in liver enzymes.

Rare side effects: may affect up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (signs include fatigue, chest pain and palpitations), enlarged heart, fluid accumulation
around the heart, loss of coordination, difficulty speaking, dry skin, migraine, vision disturbances or double vision, ringing in the ears, dizziness when getting up (particularly
if you have been sitting or lying down), increased need to urinate during the night, pain,
flu-like symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine
(signs include: diarrhea, usually with blood and mucus, stomach pain,
fever), inflammation of the stomach (signs include: pain, nausea, vomiting), areas of abnormal density
in the lungs, increased levels of creatinine in the blood, which may indicate
kidney problems.

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

• irregular heartbeats, with potential life-threatening risk (torsades de pointes);
• inflammation of the liver, with symptoms including nausea, vomiting, itching, jaundice of the skin and eyes, altered stool and urine color (hepatitis);
• inflammation of the lungs (signs include fever, cough, difficulty breathing, wheezing and can cause scarring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonia);
• inflammation of the kidneys (tubulo-interstitial nephritis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Anagrelide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the blister
and on the bottle label after EXP. The expiry date refers to the last day of that
month.
Blister pack:
Do not store at a temperature above 30 °C.
HPDE bottle pack:
Do not store at a temperature above 30 °C. Store in the original package to
protect the medicine from moisture.
After first opening, keep the bottle tightly closed and store in a dry place.
If your doctor prescribes discontinuation of the medicine, do not store the remaining capsules, unless
your doctor specifically tells you to. Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package Contents and Other Information

What Anagrelide Aurobindo contains
The active ingredient is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide
monohydrate hydrochloride).

The other ingredients are:
Capsule content: lactose monohydrate (Pharmatose 200M), microcrystalline cellulose (Avicel
PH 101), croscarmellose sodium, hydroxypropylcellulose (Klucel LF), magnesium stearate.
Capsule shell: gelatin, black iron oxide (E172), titanium dioxide (E171)
Printing ink: shellac, black iron oxide (E172), potassium hydroxide.

Description of the appearance of Anagrelide Aurobindo and package contents
Hard gelatin capsule, size “4”, with a light grey opaque cap and a white opaque body, with “1453” printed on the cap and “0.5 mg” on the body in black ink, containing
a white to off-white powder.
Blister pack in OPA/Al/PVC-Al:

Packs:84, 90 and 100 hard capsules.
Bottle pack in HDPE: Available in opaque round HDPE bottles with
continuous screw closure.
HDPE bottle packs contain silica gel as a desiccant.

Pack: 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102
21047-Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far,Birzebbugia,
BBG3000, Malta
Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487 Amadora, Portugal
Arrow Génériques, 26 avenue Tony Garnier, Lyon 69007, France
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6Qd,
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic Anagrelid Aurovitas
France Anagrelide Arrow 0.5 mg capsule
Germany Anagrelid PUREN 0.5 mg hard capsules
Italy Anagrelide Aurobindo
Poland Anagrelid Aurovitas
Portugal Anagrelid Aurovitas
Romania Anagrelidă Aurobindo 0.5 mg capsules
Spain Anagrelida Aurovitas 0.5 mg hard capsules EFG
United Kingdom Anagrelide Milpharm 0.5 mg hard capsules
The reference medicinal product containing anagrelide was authorised under “exceptional circumstances”.
This means that because the disease is rare, complete information on this medicinal product could not be obtained.
The European Medicines Agency will annually review any new information that
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu. There are also links to other websites on
rare diseases and related therapeutic treatments.