ANAGRELIDE 0.5 MG Kapsułki twarde

Treść ulotki

1. Anagrelide Sandoz 0.5 mg hard capsules
   1. What is Anagrelide Sandoz 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. Package Contents and Other Information

Anagrelide Sandoz 0.5 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 may 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 Sandoz is and what it is used for
• 2. What you need to know before you take 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 is Anagrelide Sandoz and what it is used for

Anagrelide Sandoz contains the active substance anagrelide. Anagrelide Sandoz is a medicine that
interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, with
the result of 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 Sandoz

Do not take Anagrelide Sandoz

• 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 rashes, itching, swelling of the face or lips, or difficulty breathing;
• 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 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 Sandoz”);
• 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 Sandoz”).

Children and adolescents
Information regarding 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.
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;
• Certain 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 conditions, 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 while using 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 Sandoz 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
Tell your doctor if you are pregnant or planning to become pregnant. Anagrelide Sandoz
should not be taken by pregnant women. Women of childbearing potential must
use effective methods of contraception when taking Anagrelide Sandoz. Consult your doctor if
you need advice on methods of contraception.
Tell your doctor if you are breastfeeding or intend to breastfeed your baby. Anagrelide Sandoz should
not be taken by women who are breastfeeding. If you take Anagrelide Sandoz you should stop
breastfeeding.

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

Anagrelide Sandoz contains lactose
Lactose is a component of this medicine. If your doctor has diagnosed you with intolerance to
certain sugars, contact them before taking this medicine.

3. How to take Anagrelide Sandoz

Take Anagrelide Sandoz following exactly the instructions of your doctor. If you have any doubts ask your
doctor or pharmacist.
The amount of Anagrelide Sandoz to be taken 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 Sandoz is 1 mg. You must take this dose in a 0.5 mg capsule twice
daily, for at least one week. Afterwards, your doctor may increase or decrease the number of capsules to
take, to determine the most suitable dose for you, i.e. the one that most effectively treats your condition.
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 nottake more capsules than recommended by your doctor.
Your doctor will ask you to undergo regular blood tests to check the effectiveness of the
medicine and the proper functioning of the liver and kidneys.

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,
immediately inform your doctor or pharmacist, showing them the packaging of Anagrelide Sandoz.

If you forget to take Anagrelide Sandoz
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 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, irregular heartbeats,
fainting, chills or fever, indigestion, loss of appetite, constipation, bruising,
bleeding, swelling (edema), weight loss, muscle pain, joint pain, 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, cough, 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 buildup around the lungs or
increased liver enzymes. Your doctor may prescribe blood tests that may
reveal 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 (signs include fatigue, chest pain and palpitations), enlarged heart, fluid buildup
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 were 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 (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 creatinine levels in the blood, which may indicate
kidney problems.

The following side effects have been reported, but the frequency with which
they occur is unknown:
irregular heartbeats, potentially life-threatening (torsades de pointes);
liver inflammation, with symptoms including nausea, vomiting, itching, jaundice
of the skin and eyes, altered stool and urine color (hepatitis);
lung inflammation (signs include fever, cough, difficulty breathing, wheezing; which
can cause scarring of the lungs) (allergic alveolitis, including interstitial lung disease,
pneumonia);
kidney inflammation (tubulo-interstitial nephritis).

Reporting of side effects
If you get any side effects, talk to 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 Sandoz

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 and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
After first opening, use within 100 days, keep the bottle tightly closed and store in dry conditions.
If your doctor prescribes stopping the use of the medicine, do not keep the remaining capsules, unless
your doctor specifically asks 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 Sandoz contains
The active ingredient is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide
hydrochloride).
The other ingredients are:
Capsule content: povidone K-30 (E-1201); crospovidone type A (E-1202); anhydrous lactose;
lactose monohydrate; 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 package contents
Anagrelide Sandoz is supplied as opaque white hard gelatin capsules, size no.
4 (14.4 mm) containing a white or almost white fine powder. The capsules are supplied in bottles
containing 100 hard capsules.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following designations:
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 hard capsules
Sweden Anagrelide Sandoz
Hungary Anagrelide Sandoz 0.5 mg hard capsule
A reference medicinal product containing anagrelide has been granted an authorisation in “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 annually review any new information on this