ANAGRELIDE 0.5 MG Hard capsules

Зміст інструкції

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

Anagrelide Accord 0.5 mg hard capsules

Equivalent Medicinal Product

Anagrelide Accord 1 mg hard capsules

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

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

Anagrelide Accord contains the active substance anagrelide. Anagrelide 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 Accord

Do not take Anagrelide Accord

• If you are allergic to anagrelide or any of the other ingredientsof this medicine (listed in section 6). Possible signs of an allergic reaction are 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:

• 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 Accord”);

• 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 Accord”).

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

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

• Medicines that can alter the heart rhythm, for example 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, for example 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 disorders affecting blood platelets, for example clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives: If severe diarrhoea 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 (to

taking.
Anagrelide Accord or these medicines may not work properly 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 should not
be taken by pregnant women. Women at risk of becoming pregnant must use
effective methods of contraception when taking anagrelide. 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 should not
be taken by women who are breastfeeding. If you take anagrelide you should stop breastfeeding.

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

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

3. How to take Anagrelide Accord

Take Anagrelide Accord following exactly the instructions of your doctor. If you have any doubts ask your
doctor or pharmacist.
The amount of anagrelide to be taken may vary from person to person, and depends on your condition.
Your doctor will prescribe the most suitable dose for you.
The usual starting dose of anagrelide is 1 mg. You must take this dose in a 0.5 mg capsule
twice a day, for at least one week. Afterwards, your doctor may increase or decrease the
number of capsules to be taken, to determine the most suitable dose for you, i.e. the one 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 takemore 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 correct functioning of the liver and kidneys.

If you take more Anagrelide Accord than you should
If you take more anagrelide than you should, or if someone else has taken your medicine, immediately inform
your doctor or pharmacist, showing them the Anagrelide packaging.

If you forget to take Anagrelide Accord
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 are concerned, 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 stools 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, fast heartbeat, irregular or strong heartbeats (palpitations), feeling unwell (nausea),
diarrhoea, stomach pain, flatulence, feeling sick (vomiting), reduced red blood cells
in the blood (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
(edema), weight loss, muscle pain, joint pain, back pain, reduced or loss of
sensation or numbness, especially in 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 (especially if you have been sitting or lying down), increased need to urinate at night, pain, flu-like symptoms,
drowsiness, widening 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 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, potentially life-threatening (torsades de pointes);
• Inflammation of the liver, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, change in the color of stools and urine (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, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Accord

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 label and the packaging after
Exp. The first two digits indicate the month and the last four indicate the year. 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 light and moisture.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from moisture.
If your doctor stops 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 Accord contains
The active ingredient is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride
monohydrate).
The active ingredient is anagrelide. Each capsule contains 1 mg of anagrelide (as anagrelide hydrochloride
monohydrate)
The other ingredients are:

Capsule content:Lactose monohydrate ,Sodium croscarmellose ,Povidone (K29/32) ,Lactose ,
Microcrystalline cellulose ,Magnesium stearate

Capsule shell:Gelatin ,Titanium dioxide (E171)

Capsule shell:Gelatin ,Titanium dioxide (E171) ,Black iron oxide (E172)

Description of the appearance of Anagrelide Accord and package contents
Anagrelide 0.5 mg is presented as a hard capsule (size 4) with an opaque white body and cap.
The capsule is filled with white to off-white powder.
Anagrelide 1 mg is presented as a hard capsule (size 4) with a grey body and cap. The
capsule is filled with white to off-white powder.
The capsules are available in bottles containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer:
Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat
Barcelona, 08830
Spain
Synthon BV
Microweg 22
Nijmegen, 6545 CM
Netherlands