ANAGRELIDE 0.5 MG Kapsułki twarde

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1. Anagrelide Teva 0.5 mg hard capsules
   1. What is Anagrelide Teva and what it is used for
   2. What you need to know before taking Anagrelide Teva
   3. How to take Anagrelide Teva
   4. Possible side effects
   5. How to store Anagrelide Teva
   6. Contents of the pack and other information

Anagrelide Teva 0.5 mg hard capsules

anagrelide

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 their symptoms are the same as yours, 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 Teva is and what it is used for
• 2. What you need to know before you take Anagrelide Teva
• 3. How to take Anagrelide Teva
• 4. Possible side effects
• 5. How to store Anagrelide Teva
• 6. Contents of the pack and other information

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

Anagrelide Teva contains the active substance anagrelide. Anagrelide Teva 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 elements 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 Teva

DO NOT TAKE Anagrelide Teva:

• 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 are skin rashes, itching, swelling of the face or lips and 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 Teva:

• if you have or think you have heart problems;
• if you were 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 Teva”);
• if you have liver or kidney problems.

When taken with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower 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 Teva”).

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

Other medicines and Anagrelide Teva
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 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 lower 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 (such as

The action of Anagrelide Teva or these medicines may not be effective if 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 Teva should not be taken by pregnant women. Women at risk of becoming pregnant must use effective methods of contraception when taking Anagrelide Teva. Consult your doctor if you need advice on methods of contraception.
Tell your doctor if you are breastfeeding or if you intend to breastfeed your baby. Anagrelide Teva should not be taken by women who are breastfeeding. If you are taking Anagrelide Teva you must stopbreastfeeding.

Driving and using machines
Some patients taking Anagrelide Teva have reported dizziness. If you experience dizziness, do notdrive and do not use machines.

Anagrelide Teva contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Anagrelide Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The amount of Anagrelide Teva to take may vary from patient to patient, depending on the condition you
have. Your doctor will prescribe the most suitable dose for you.
The usual starting dose of Anagrelide Teva is 1 mg. You should take this dose by taking one 0.5 mg capsule
twice a day, 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 notcrush the capsules and do not dilute
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) every day at the same time.

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 Teva than you should
If you take more Anagrelide Teva than you should, or if someone else has taken your medicine, inform

immediatelyyour doctor or pharmacist, showing them the Anagrelide Teva packaging.

If you forget to take Anagrelide Teva
Take the capsules as soon as you remember. Take the next dose at the usual time. Do nottake a double
dose to make up for a missed dose.

4. Possible side effects

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

Serious side effects:
Not common: heart failure (signs include shortness of breath, chest pain, swelling of the
legs due to fluid accumulation), severe 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 presence of blood in the stools or
black stools, severe reduction in the number of blood cells, which can cause weakness, bruising,
bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling
in 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 heartbeat, 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,
with a consequent 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, visual disturbances or
double vision, ringing in the ears, dizziness when getting up (especially when getting up from a
sitting or lying position), 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 (the
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 of occurrence is unknown:

• irregular heartbeats, potentially life-threatening (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 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 Teva

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 pack 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.
Keep the medicine in its original packaging to protect it from light and moisture.
If your doctor prescribes stopping the use of the medicine, do not keep the remaining capsules, unless
your doctor explicitly asks you to. Do not dispose of any medicine in the wastewater and household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Anagrelide Teva contains
The active ingredient is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride).
The other ingredients are:
Capsule content: lactose monohydrate, sodium croscarmellose, povidone K 29/32, lactose, microcrystalline
cellulose and magnesium stearate (see section 2, “Anagrelide Teva contains lactose”).
Capsule shell: gelatin and titanium dioxide (E171).

Description of Anagrelide Teva and contents of the pack
Anagrelide Teva 0.5 mg is presented as opaque white hard capsules approximately 14.3
mm long. The capsules are supplied in bottles containing 42 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva BV
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer
Synthon Hispania S.L., C/Castelló, n° 1, Pol. Las Salinas, Sant Boi de Llobregat, Barcelona, 08830 – Spain
Synthon BV, Microweg 22, Nijmegen, 6545CM – Netherlands
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 – Germany
An authorization has been granted for the reference medicinal product containing anagrelide under
“exceptional circumstances”. This means that, due to the rarity of the disease, complete
information on this medicinal product could not be obtained.
The European Medicines Agency will annually review any new information on this