Anagrelide Aurobindo

Patient Information Leaflet

Anagrelide Aurobindo 0.5 mg Hard Capsules

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including 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 taking 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 Anagrelide Aurobindo is and what it is used for

Anagrelide Aurobindo contains the active substance anagrelide. Anagrelide Aurobindo is a medicine
that interferes with platelet development. 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. For this reason, it is used to treat patients with essential thrombocythemia.
Essential thrombocythemia is a disorder that occurs when the bone marrow produces excessive amounts of blood cells known as platelets. Having a high number of platelets in the blood can cause serious circulation and clotting problems.

2. What you need to know before taking Anagrelide Aurobindo

Do not take Anagrelide Aurobindo

• if you are allergic to anagrelide or to any of the other ingredients of this medicine (listed in section 6). Possible signs of an allergic reaction include 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 may have heart problems;
• if you were born with or have a family history of QT interval prolongation (seen on an ECG, the recording of the heart's electrical activity), if you are taking other medicines that cause abnormal changes in the ECG, or if you have low levels of electrolytes, e.g. potassium, magnesium or calcium (see section “Other medicines and Anagrelide Aurobindo”);
• if you have liver or kidney problems.

When used together with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots, also known as aspirin), there is an increased risk of major bleeding (bleeding). (See section “Other medicines and Anagrelide Aurobindo”).

Children and adolescents
Information on 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.
Inform your doctor if you are taking any of the following medicines:

• Medicines that may affect heart rhythm, such as sotalol, amiodarone;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotics, such as enoxacin, used to treat infections;
• Theophylline, used to treat asthma and severe breathing difficulties;
• Medicines used to treat heart conditions, such as milrinone, enoximone, amrinone, olprinone and cilostazol;
• Acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots, also known as aspirin);
• Other medicines used to treat platelet disorders in the blood, such as clopidogrel;
• Omeprazole, used to reduce stomach acid production;
• Oral contraceptives: if you develop severe diarrhoea while taking this medicine, the effectiveness of oral contraceptives may be reduced and you are advised to use an additional contraceptive method (such as a condom). Read the package leaflet of the contraceptive pill you are taking. The effect of Anagrelide Aurobindo or of these medicines may be reduced when taken together.

If you have any doubts, consult your doctor or pharmacist for advice.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Anagrelide Aurobindo must not be taken by women who are pregnant. Women who could become pregnant must use effective contraception while taking Anagrelide Aurobindo. Consult your doctor for advice on contraceptive methods.

Anagrelide Aurobindo must not be taken by women who are breastfeeding. If you take Anagrelide Aurobindo, you must stop breastfeeding.

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

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

3. How to take Anagrelide Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The amount of Anagrelide Aurobindo you need to take may vary from patient to patient, depending on your condition. Your doctor will prescribe the dose most suitable for you.
The usual starting dose of Anagrelide Aurobindo is 1 mg. This corresponds to one capsule of 0.5 mg taken twice daily for at least one week. After this period, your doctor may increase or decrease the number of capsules you take in order to determine the most appropriate dose for you and to effectively treat your condition.
The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dilute the contents in a liquid. You may 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 your doctor has advised.
Your doctor will ask you to have regular blood tests to monitor the medicine's effectiveness and to check that your liver and kidneys are functioning properly.

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

If you forget to take Anagrelide Aurobindo
Take the missed dose as soon as you remember. Then take your 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, speak with your doctor.
Serious side effects:
Uncommon: heart failure (signs include breathlessness, chest pain, swelling of the legs due to fluid accumulation), serious problems with heart rate or heartbeat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas causing severe abdominal and back pain (pancreatitis), vomiting blood or presence of blood in stools or black stools, severe reduction in blood cells which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles, and possible bluish discoloration of lips and skin).
Rare: kidney failure (when urine output is low 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, tiredness, increased heart rate, irregular or strong heartbeats (palpitations), feeling unwell (nausea), diarrhoea, stomach pain, flatulence, feeling unwell (vomiting), reduction in red blood cells (anaemia), 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 (oedema), weight loss, muscle pain, painful joints, back pain, reduced or loss of sensation or tingling sensations, 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, breathlessness, cough, phlegm, hair loss, skin discolouration or itching, impotence, chest pain, low platelet count in blood, leading to increased risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs or increased liver enzymes.
Your doctor may prescribe blood tests which could reveal elevated 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 standing up (particularly if previously 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: diarrhoea, 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 blood creatinine levels, which may indicate kidney problems.
The following side effects have been reported, but their frequency is unknown:

• Irregular heartbeats, potentially life-threatening (torsade de pointes);
• Liver inflammation, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, changes in stool and urine colour (hepatitis);
• Lung inflammation (signs include fever, cough, breathing difficulties, wheezing, and may lead to lung scarring) (allergic alveolitis, including interstitial lung disease, pneumonia);
• Kidney inflammation (tubulo-interstitial nephritis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton, blister, and on the label of the bottle after EXP. The expiry date refers to the last day of that month.

Blister pack:
Do not store above 30 °C.

HDPE bottle pack:
Do not store above 30 °C. Store in the original packaging to protect the medicine from moisture.
After first opening, keep the bottle tightly closed and store in a dry place.

If your doctor prescribes stopping treatment with this medicine, do not keep any remaining capsules, unless your doctor specifically instructs you otherwise. Do not dispose of any medicine via 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 substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide
hydrochloride monohydrate).
The other components are:
Capsule contents: lactose monohydrate (Pharmatose 200M), microcrystalline cellulose (Avicel
PH 101), sodium croscarmellose, 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 contents of the pack
Hard gelatin capsule, size “4”, with a grey opaque cap and a white opaque body, printed with “1453” on the cap and “0.5 mg” on the body in black ink, containing a white to almost white powder.
Blister pack made of OPA/Al/PVC-Al:
Pack sizes: 84, 90 and 100 hard capsules.
HDPE bottle: Available in opaque round HDPE bottles with continuous thread closure.
HDPE bottle packs contain silica gel as a desiccant.
Pack size: 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), Italy
Manufacturers
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 European Economic Area Member States under the
following names:
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 capsule
Spain Anagrelida Aurovitas 0.5 mg hard capsules EFG
United Kingdom Anagrelide Milpharm 0.5 mg hard capsules
The reference medicinal product containing anagrelide has been authorised under “exceptional circumstances”.
This means that, due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information available on an annual basis and this Patient Information Leaflet will be updated accordingly, if necessary.
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.