Anagrelide Sandoz

Package leaflet: Information for the patient

Anagrelide Sandoz 0.5 mg hard capsules

Generic medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• 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 Sandoz is and what it is used for
2. What you need to know before taking Anagrelide Sandoz
3. How to take Anagrelide Sandoz
4. Possible side effects
5. How to store Anagrelide Sandoz
6. Contents of the pack and other information

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

Anagrelide Sandoz contains the active substance anagrelide. Anagrelide Sandoz is a medicine that interferes with platelet development. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in platelet count 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 blood clotting problems.

2. What you need to know before taking Anagrelide Sandoz

Do not take Anagrelide Sandoz

• 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 skin rashes, 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 Sandoz:

• 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 such as potassium, magnesium, or calcium (see section “Other medicines and Anagrelide Sandoz”);
• 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 (haemorrhage) (see section “Other medicines and Anagrelide Sandoz”).
Children and adolescents
Information on the use of Anagrelide Sandoz in children and adolescents is limited; therefore, this medicine should be used with caution.
Other medicines and Anagrelide Sandoz
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, for the treatment of depression;
• Certain types of antibiotics, such as enoxacin, used to treat infections;
• Theophylline, for the treatment of asthma and severe breathing difficulties;
• Medicines for the treatment of 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 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 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). Please read the patient information leaflet of the contraceptive pill you are taking.

The effect of Anagrelide Sandoz or these other medicines may be reduced when taken together.
If you have any doubts, consult your doctor or pharmacist for advice.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant or planning to become pregnant. Anagrelide Sandoz must not be taken by women who are pregnant. Women of childbearing potential must use effective contraceptive methods while taking Anagrelide Sandoz. Consult your doctor for advice on contraceptive methods.
Inform your doctor if you are breastfeeding or intend to breastfeed. Anagrelide Sandoz must not be taken by women who are breastfeeding. If you take Anagrelide Sandoz, you must stop breastfeeding.
Driving and using machines
Some patients taking Anagrelide Sandoz have reported dizziness. If you experience dizziness, do not drive and do not operate machinery.
Anagrelide Sandoz contains lactose
Lactose is an ingredient of this medicine. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Anagrelide Sandoz

Take Anagrelide Sandoz exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The amount of Anagrelide Sandoz you need to take may vary from patient to patient, depending on your condition. Your doctor will prescribe the most suitable dose for you.
The usual starting dose of Anagrelide Sandoz is 1 mg. This dose should be taken as one 0.5 mg capsule twice daily for at least one week. Afterwards, your doctor may increase or decrease the number of capsules you take in order to determine the most appropriate dose for you—that is, the dose that treats your condition most effectively.
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 recommended by your doctor.
Your doctor will ask you to have regular blood tests to monitor the effectiveness of the medicine and to check that your liver and kidneys are functioning properly.
If you take more Anagrelide Sandoz than you should
If you take more Anagrelide Sandoz than you should, or if someone else has taken your medicine, inform your doctor or pharmacist immediately, showing them the Anagrelide Sandoz packaging.
If you forget to take Anagrelide Sandoz
Take the missed dose as soon as you remember. Take the next dose at your usual time. Do not take a double dose to make up for the 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 (symptoms 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 cell count, which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (symptoms include breathlessness, 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 notice 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, 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 sensations of 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, 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 carry out blood tests which could show increased 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 (symptoms 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 at night, pain, flu-like symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine (symptoms include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (symptoms 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 (torsades de pointes);
inflammation of the liver, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, change in stool and urine colour (hepatitis);
inflammation of the lungs (symptoms include fever, cough, breathing difficulties, wheezing; which may lead to lung scarring) (allergic alveolitis, including interstitial lung disease, pneumonia);
inflammation of the kidneys (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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
After first opening, use within 100 days, keep the bottle tightly closed and store under dry conditions.
If your doctor advises you to stop taking this medicine, do not keep any remaining capsules, unless your doctor specifically tells you to do so. 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 Sandoz contains
The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide
hydrochloride).
The other components are:
Capsule contents: povidone K-30 (E-1201); crospovidone type A (E-1202); anhydrous lactose;
monohydrate lactose; microcrystalline cellulose (E-460); and magnesium stearate.
Capsule shell: gelatin (E-441) and titanium dioxide (E-171).
Description of the appearance of Anagrelide Sandoz and the contents of the pack
Anagrelide Sandoz is supplied as white, opaque, hard gelatin capsules of size No.
4 (14.4 mm), containing a white or almost white fine powder. The capsules are available in bottles
containing 100 hard capsules.
Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy
Manufacturers
J. Uriach y Compañía S.A.,
Avda. Camí Reial, 51-57
Pau Solità i Plegamans,
08184 Barcelona, Spain
or
Galenicum Health S.L.
Avda. Conellà 144, 7º 1ª Edificio LEKLA
08950 Esplugues de Llobregat, Barcelona, Spain
or
SAG Manufacturing, S.L.U.
Carretera A-1, Km 36, 28750 San Agustín del Guadalix
28750 Madrid, Spain
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Austria Anagrelid Sandoz 0.5 mg - Hard capsules
Belgium Anagrelid Sandoz 0.5 mg hard capsules
Cyprus Anagrelide Sandoz
Denmark Anagrelide Sandoz
Finland Anagrelide Sandoz
France Anagrélide Sandoz 0.5 mg, capsule
Germany Anagrelid HEXAL 0.5 mg Hard capsules
Greece Anagrelide Sandoz
Italy Anagrelide Sandoz
Norway Anagrelide Sandoz
Netherlands Anagrelide Sandoz 0.5 mg, hard capsules
Poland Anagrelide Sandoz
Czech Republic Anagrelid Sandoz
United Kingdom Anagrelide Sandoz 0.5 mg capsule, hard
Slovak Republic Anagrelid Sandoz 0.5 mg
Romania Anagrelidă Sandoz 0.5 mg capsules
Slovenia Anagrelid Sandoz 0.5 mg trde kapsule
Sweden Anagrelide Sandoz
Hungary Anagrelide Sandoz 0.5 mg kemény kapszula
The reference medicinal product containing anagrelide has been granted a marketing authorization 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 on this medicinal product annually, and this package leaflet will be updated if necessary.