ANAGRELIDE 0.5 MG Hard capsules

Зміст інструкції

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

Anagrelide Viatris 0.5 mg hard capsules

anagrelide

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

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

Anagrelide Viatris 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, 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 Viatris

Do not take Anagrelide Viatris

• 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 include skin rashes, itching, swelling of the face or lips and 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 Viatris:

• 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 Viatris");
• 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 Viatris").

While taking Anagrelide Viatris, you must take the exact dose prescribed by your doctor. Do not
stop taking the medicine without first talking to your doctor. You should not suddenly stop
taking this medicine without consulting your doctor. Suddenly stopping the medicine may increase
the risk of stroke.
Signs and symptoms of stroke may include sudden numbness or weakness of the face, arm
or leg, especially on one side of the body, sudden confusion, difficulty speaking or
difficulty understanding speech, sudden difficulty seeing in one or both eyes, sudden problems
with walking, dizziness, loss of balance or lack of coordination, and
sudden severe headache with no known cause. Seek medical attention immediately.

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

Other medicines and Anagrelide Viatris
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;
• 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, 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 diarrhoea 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 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 Viatris
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 Viatris should not
be taken by women who are breastfeeding. If you are taking Anagrelide Viatris you should stop
breastfeeding.

Driving and operating machinery
Some patients taking anagrelide have reported dizziness. If you experience dizziness, do not drive and
do not operate machinery.

Anagrelide Viatris contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with intolerance to certain sugars,
contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say it is practically “sodium-free”.

3. How to take Anagrelide Viatris

Take Anagrelide Viatris following the doctor's instructions exactly. If you have any doubts, consult
your doctor or pharmacist.
The amount of anagrelide 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 this medicine is 1 mg. You should take this dose as 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 appropriate dose for you, i.e. the one that
allows for the most effective treatment of 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 a higher or lower number of capsules than recommended by your doctor. Do not
stop taking the medicine without first talking to your doctor. Do not decide on your own to stop
taking the medicine.
The 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 Viatris than you should
If you take more Anagrelide Viatris than you should, or if someone else has taken your medicine,
immediately inform your doctor or pharmacist, showing them the packaging of Anagrelide Viatris.

If you forget to take Anagrelide Viatris
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 missed 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 with 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), increased pressure
in the pulmonary arteries (signs include: shortness of breath, swelling of the legs or ankles and
lips and skin that may turn bluish).
Rare: kidney failure (when urine output is poor or absent), heart attack.

If you experience any of these side effects, contact your doctor immediately.
Other possible side effects
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 (hypertension), 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, difficulty breathing, 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 accumulation around the lungs or
increased liver enzymes. Your doctor may prescribe blood tests that can 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, painful spasm of blood vessels in the heart (at rest, usually at night or
early morning) (Prinzmetal's angina), loss of coordination, difficulty speaking, dry skin,
migraine, vision disturbances or double vision, ringing in the ears, dizziness when getting up
(particularly if you have been 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: 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 levels of creatinine in the blood, which can
indicate the presence of kidney problems.

The following side effects have been reported, but their frequency is unknown:

• irregular heartbeats, with potential life-threatening danger (Torsades de Pointes);
• inflammation of the liver, with symptoms including nausea, vomiting, itching, yellowing 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);
• stroke (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anagrelide Viatris

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
bottle label after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
This medicine does not require any particular storage temperature.
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 waste water 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 Viatris contains
The active ingredient is anagrelide. Each capsule contains anagrelide hydrochloride monohydrate
equivalent to 0.5 mg of anagrelide.
The other ingredients are: lactose, sodium croscarmellose, povidone, microcrystalline cellulose,
magnesium stearate, gelatin and titanium dioxide (E171). See section 2, “Anagrelide Viatris contains
lactose and sodium”.

Description of the appearance of Anagrelide Viatris and contents of the pack
The hard capsules of Anagrelide Viatris 0.5 mg have a body and a cap of white color. The capsule
is filled with a powder from white to off-white.
The dimensions of the capsule are approximately 14.3 × 5.3 mm.
Anagrelide Viatris is available in bottles of 30 ml or 75 ml with a child-resistant polypropylene (PP) closure and
evident tamper-evident seal, containing 100 hard capsules.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer
Synthon Hispania SL
C/ Castelló n. 1
POL. Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Eesti
Viatris OÜ
Tel: + 372 6363 052

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Additionally, links to other websites on rare diseases and
related therapeutic treatments are provided.

Anagrelide Viatris 1 mg hard capsules

anagrelide

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

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

Anagrelide Viatris 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, 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 Viatris

Do not take Anagrelide Viatris

• 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 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 Viatris:

• if you have or think you have heart problems;
• if you were born with or have a family history of prolonged QT interval (observed in 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 Viatris");
• 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 Viatris").

While taking Anagrelide Viatris, you must take the exact dose prescribed by your doctor. Do not
stop taking the medicine without first talking to your doctor. You should not suddenly stop
taking this medicine without consulting your doctor. Sudden discontinuation of the medicine may
increase the risk of stroke.
Signs and symptoms of stroke may include sudden numbness or weakness of the face, arm
or leg, especially on one side of the body, sudden confusion, difficulty speaking or
difficulty understanding speech, sudden difficulty seeing in one or both eyes, sudden problems
with walking, dizziness, loss of balance or lack of coordination, and
sudden severe headache with no known cause. Seek medical attention immediately.

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

Other medicines and Anagrelide Viatris
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;
• 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, 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 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

The action of anagrelide 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 a pregnancy. Anagrelide Viatris
should not be taken by pregnant women. Women at risk of becoming pregnant must
use effective methods of contraception while 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 Viatris should not
be taken by women who are breastfeeding. If you take Anagrelide Viatris you will need to stop breastfeeding.

Driving and operating machinery
Some patients taking anagrelide have reported dizziness. If you experience dizziness, do not drive and
do not operate machinery.

Anagrelide Viatris contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with lactose intolerance,
contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say it is practically “sodium-free”.

3. How to take Anagrelide Viatris

Take Anagrelide Viatris following the doctor's instructions exactly. If you have any doubts, consult
your doctor or pharmacist.
The amount of anagrelide to be taken 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 is 1 mg. You should 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 appropriate 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 a higher or lower number of capsules than recommended by your doctor. Do not
stop taking the medicine without first talking to your doctor. Do not decide on your own to stop taking the
medicine.
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 Viatris than you should
If you take more Anagrelide Viatris than you should, or if someone else has taken your medicine,
immediately inform your doctor or pharmacist, showing them the Anagrelide Viatris packaging.

If you forget to take Anagrelide Viatris
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 missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 with blood or
presence of blood in the stool or black stools, severe reduction in the number of blood cells, which can
cause weakness, bruising, bleeding or infections (pancytopenia), increased pressure
in the pulmonary arteries (signs include: shortness of breath, swelling of the legs or ankles and
lips and skin that may turn bluish).
Rare: kidney failure (when urine output is poor or absent), heart attack.

If you experience any of these side effects, contact your doctor immediately.
Other possible side effects
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 (hypertension), 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 like tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, difficulty breathing, cough, phlegm; hair loss, skin discoloration or itching, impotence, chest pain, decreased platelets 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 can 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, painful spasm of blood vessels in the heart (at rest, usually at night or
early morning) (Prinzmetal's angina), 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 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: 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 can
indicate the presence of kidney problems.

The following side effects have been reported, but their frequency of occurrence is unknown:

• irregular heartbeats, with possible life-threatening danger (Torsades de Pointes);
• inflammation of the liver, with symptoms including nausea, vomiting, itching, yellowing 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);
• stroke (see section 2).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V . By reporting side effects, you can contribute
to providing more information on the safety of this medicine.

5. How to store Anagrelide Viatris

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
bottle label after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
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 waste water or
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 Viatris contains
The active ingredient is anagrelide. Each capsule contains anagrelide hydrochloride monohydrate
equivalent to 1 mg of anagrelide.
The other ingredients are: lactose, sodium croscarmellose, povidone, microcrystalline cellulose,
magnesium stearate, gelatin, titanium dioxide (E171) and black iron oxide (E172). See section 2,
“Anagrelide Viatris contains lactose and sodium”.

Description of the appearance of Anagrelide Viatris and contents of the pack
The hard capsules of Anagrelide Viatris 1 mg have a grey body and cap. The capsule is
filled with a powder ranging from white to off-white.
The capsule size is approximately 14.3 × 5.3 mm.
Anagrelide Viatris is available in bottles of 30 ml or 75 ml with a child-resistant polypropylene (PP) closure
and an evident tamper-evident seal, with a desiccant. Each bottle contains 100
hard capsules.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer
Synthon Hispania SL
C/ Castelló n. 1
POL. Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
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
related therapeutic treatments are provided.