Package leaflet: Information for the patient

Anagrelide Viatris 0.5 mg hard capsules

anagrelide

Read this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as 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

What Anagrelide Viatris is and what it is used for
What you need to know before taking Anagrelide Viatris
How to take Anagrelide Viatris
Possible side effects
How to store Anagrelide Viatris
Contents of the pack and other information

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

Anagrelide Viatris contains the active substance anagrelide. Anagrelide is a medicine that interferes
with platelet development. 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 to treat patients with essential thrombocythaemia.
Essential thrombocythaemia is a disorder that arises when the bone marrow produces excessive
amounts of blood cells called 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 Viatris

Do not take Anagrelide Viatris

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 rash, 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 may have heart problems;
if you were born with or have a family history of QT interval prolongation (seen on 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, e.g., potassium, magnesium, or calcium (see section "Other medicines and Anagrelide Viatris");
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 (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 must not stop taking this medicine suddenly without consulting your doctor first. Sudden discontinuation of this 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; sudden difficulty speaking or understanding speech; sudden trouble 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 immediate medical attention.

Children and adolescents
Information on 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.
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, 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 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 severe diarrhea occurs while taking this medicine, the effectiveness of oral contraceptives may be reduced, and use of an additional contraceptive method (such as a condom) is recommended. Read the package leaflet of the contraceptive pill you are taking.

The effect of anagrelide or of 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 if you are planning to become pregnant. Anagrelide Viatris must not be taken by women who are pregnant. Women of childbearing potential must use effective contraceptive methods while taking anagrelide. Consult your doctor for advice on contraceptive methods.

Inform your doctor if you are breastfeeding or planning to breastfeed. Anagrelide Viatris must not be taken by women who are breastfeeding. If you take Anagrelide Viatris, you must stop breastfeeding.

Driving and using machines
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 an intolerance to certain sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., it is practically "sodium-free".

3. How to take Anagrelide Viatris

Take Anagrelide Viatris exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The amount of anagrelide you need to take may vary from patient to patient, depending on your condition. Your doctor will prescribe the dose most suitable for you.
The usual starting dose of this medicine is 1 mg. You should take this dose 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, i.e. 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 their contents in a liquid. You may take the capsules with food, after food, or on an empty stomach. It is recommended to take the capsule(s) at the same time each day.
Do not take more or fewer capsules than your doctor has advised. Do not stop taking this medicine without first talking to your doctor. You must not decide independently to stop taking the medicine.
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 Viatris than you should
If you take more Anagrelide Viatris than you should, or if someone else has taken your medicine, inform your doctor or pharmacist immediately, showing them the Anagrelide Viatris packaging.
If you forget to take Anagrelide Viatris
Take the missed dose as soon as you remember. Then take your 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, speak with your doctor.

Serious side effects:
Uncommon: heart failure (signs include breathlessness, chest pain, swelling of the legs due to fluid accumulation), 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 presence of blood in the stool or black stools, severe reduction in blood cells which may cause weakness, bruising, bleeding or infections (pancytopenia), increased pressure in the pulmonary arteries (signs include: shortness of breath, swelling of legs or ankles, and lips or skin turning blue).
Rare: kidney failure (when urine output is low or absent), heart attack.
If you notice 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, rapid heartbeat, irregular or strong heartbeats (palpitations), feeling unwell (nausea), diarrhoea, stomach pain, flatulence, feeling unwell (vomiting), reduction in 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 (hypertension), 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 tingling sensations, 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 the blood, leading to increased risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs or increased liver enzymes. Your doctor may prescribe blood tests that could 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 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 disorders 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 (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, possibly life-threatening (Torsade de pointes);
Inflammation of the liver, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, and changes in stool and urine colour (hepatitis);
Inflammation of the lungs (signs include fever, cough, breathing difficulties, wheezing, and may lead to lung scarring) (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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed 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 stated on the carton and label of the
bottle after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
If your doctor advises you to stop taking this medicine, do not keep the remaining capsules unless
your doctor specifically instructs 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 Viatris contains
The active substance is anagrelide. Each capsule contains anagrelide hydrochloride monohydrate
equivalent to 0.5 mg of anagrelide.
The other components 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 cap both of white colour. The capsule
is filled with a white to off-white powder.
The capsule size is approximately 14.3 × 5.3 mm.
Anagrelide Viatris is available in 30 ml or 75 ml bottles with a child-resistant polypropylene (PP) closure and tamper-evident seal, containing a desiccant and 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
The Netherlands
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: + 31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 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.

Patient information leaflet

Anagrelide Viatris 1 mg hard capsules

anagrelide
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Anagrelide Viatris is and what it is used for
What you need to know before taking Anagrelide Viatris
How to take Anagrelide Viatris
Possible side effects
How to store Anagrelide Viatris
Contents of the pack and other information

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

Anagrelide Viatris contains the active substance anagrelide. Anagrelide 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 called 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 Viatris

Do not take Anagrelide Viatris

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 rash, 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 may have heart problems;
if you were born with or have a family history of QT interval prolongation (seen on 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, e.g., potassium, magnesium, or calcium (see section "Other medicines and Anagrelide Viatris");
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 (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. Do not stop taking this medicine suddenly without consulting your doctor. Stopping this medicine suddenly 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 understanding speech, sudden trouble seeing in one or both eyes, sudden walking difficulties, dizziness, loss of balance or lack of coordination, and sudden severe headache with no known cause. Seek immediate medical attention.
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.
Inform your doctor if you are taking any of the following medicines:

Medicines that may affect heart rhythm, such as sotalol, amiodarone;
Fluvoxamine, used to treat depression;
Certain types of antibiotics, such as enoxacin, used to treat infections;
Theophylline, used to treat asthma and severe breathing difficulties;
Medicines used to treat 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 used to treat platelet disorders in the blood, such as clopidogrel;
Omeprazole, used to reduce stomach acid production;
Oral contraceptives: if you develop severe diarrhoea while taking this medicine, the effectiveness of oral contraceptives may be reduced, and use of an additional contraceptive method (such as a condom) is recommended. Read the package leaflet of the contraceptive pill you are taking.

The effect of anagrelide or these other medicines may be reduced when taken together.
If in doubt, consult your doctor or pharmacist for advice.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant or planning to become pregnant. Anagrelide Viatris must not be taken by women who are pregnant. Women of childbearing potential must use effective contraception while taking anagrelide. Consult your doctor for advice on contraceptive methods.
Inform your doctor if you are breastfeeding or intend to breastfeed. Anagrelide Viatris must not be taken by women who are breastfeeding. If you take Anagrelide Viatris, you must stop breastfeeding.
Driving and using machines
Some patients taking anagrelide have reported dizziness. If you feel dizzy, do not drive or operate machinery.
Anagrelide Viatris contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule and is therefore considered practically "sodium-free".

3. How to take Anagrelide Viatris

Take Anagrelide Viatris exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The amount of anagrelide you need to take may vary from patient to patient, depending on your condition. Your doctor will prescribe the dose most suitable for you.
The usual starting dose of anagrelide is 1 mg. You should take this dose 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, i.e. the dose that provides the most effective treatment for your condition.
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 food, 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 or fewer capsules than your doctor has advised. Do not stop taking this medicine without first talking to your doctor. You should not decide on your own to stop taking this medicine.
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 Viatris than you should
If you take more Anagrelide Viatris than you should, or if someone else has taken your medicine, inform your doctor or pharmacist immediately, showing them the Anagrelide Viatris packaging.
If you forget to take Anagrelide Viatris
Take the missed dose as soon as you remember. Then take the next dose at your 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 everyone gets them. If you have any concerns, speak with your doctor.

Serious side effects:

Uncommon: heart failure (signs include breathlessness, chest pain, swelling of the legs due to fluid accumulation), 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 presence of blood in stools or black stools, severe reduction in blood cells which may cause weakness, bruising, bleeding or infections (pancytopenia), increased pressure in the pulmonary arteries (signs include: shortness of breath, swelling of legs or ankles, and 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.

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, 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 (hypertension), 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 tingling sensations, especially of the skin, abnormal perception or sensations such as tingling, insomnia, depression, confusion, restlessness, 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, reduced platelet count in the blood, leading to increased risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs or increased liver enzymes. Your doctor may prescribe blood tests that could 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 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 standing up (particularly if previously 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: 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, and changes in stool and urine colour (hepatitis);
Inflammation of the lungs (signs include fever, cough, breathing difficulties, wheezing, and may lead to lung scarring) (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, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the carton and label of the bottle after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
If your doctor advises you to stop taking this medicine, do not keep any remaining capsules unless your doctor specifically tells you to. 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 Viatris contains
The active substance is anagrelide. Each capsule contains anagrelide hydrochloride monohydrate
equivalent to 1 mg of anagrelide.
The other components 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 package contents
Anagrelide Viatris 1 mg hard capsules have a grey body and cap. The capsule is filled with a white to almost white powder.
The capsule size is approximately 14.3 × 5.3 mm.
Anagrelide Viatris is available in 30 ml or 75 ml bottles with a child-resistant polypropylene (PP) closure and a tamper-evident seal, together 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
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕОД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: + 31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 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.