Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - anagrelide

Document Subject

Generated Narrative: MedicinalProductDefinition mp6993a685d10576536183960090af1fdd

identifier: http://ema.europa.eu/identifier/EU/1/17/1256/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Anagrelide Viatris 0.5 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6993a685d10576536183960090af1fdd

identifier: http://ema.europa.eu/identifier/EU/1/17/1256/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - anagrelide

Attesters

What is in 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

Anagrelide Viatris contains the active substance, anagrelide. Anagrelide is a medicine which interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level. For this reason, it is used to treat patients with essential thrombocythaemia.

Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets. Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.

Do not take Anagrelide Viatris

• If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen 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 Viatris:

• If you have or think you might have a problem with your heart;
• If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes, e.g., potassium, magnesium or calcium (see section Other medicines and Anagrelide Viatris );
• If you have any problems with your liver or kidneys.

In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk

of major haemorrhages (bleeding) (see section Other medicines and Anagrelide Viatris ).

While taking Anagrelide Viatris, you should take the exact dose prescribed by your doctor. Do not stop taking the medicine without first talking to your doctor. Do not abruptly stop taking this medicine without consulting your doctor. Abrupt withdrawal of medicine may lead to increased risk of stroke.

Signs and symptoms of stroke may include sudden numbness or weakness in the face, arm, or leg, especially on one side of the body, sudden confusion, trouble speaking, or difficulty understanding speech, sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance, or lack of coordination and sudden severe headache with no known cause. Please seek immediate medical help.

Children and adolescents There is limited information on the use of anagrelide in children and adolescents and therefore this medicine should be used with caution.

Other medicines and Anagrelide Viatris Tell your doctor or pharmacist if you are taking or 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 your heart rhythm, e.g., sotalol, amiodarone;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotic, such as enoxacin, used to treat infections;
• Theophylline, used to treat severe asthma and breathing problems;
• Medicines used to treat heart disorders, for example, 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 clotting, also known as aspirin);
• Other medicines used to treat conditions affecting the platelets in your blood, e.g., clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g., condom). See the instructions in the patient leaflet of the contraceptive pill you are taking.

Anagrelide or these medicines may not work properly if taken together.

If you are not sure, speak to your doctor or pharmacist for advice.

Pregnancy and breast-feeding Tell your doctor if you are pregnant or are planning to become pregnant. Anagrelide Viatris should not be taken by pregnant women. Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking anagrelide. Speak to your doctor if you need advice with contraception.

Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby. Anagrelide Viatris should not be taken while breast-feeding. You must stop breast-feeding if you are taking Anagrelide Viatris.

Driving and using machines Dizziness has been reported by some patients taking anagrelide. Do not drive or use machines if you feel dizzy.

Anagrelide Viatris contains lactose and sodium

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium-free .

Always take Anagrelide Viatris exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The amount of anagrelide that people take can be different, and this depends on your condition. Your doctor will prescribe the best dose for you.

The usual starting dose of this medicine is 1 mg. You take this dose as one capsule of 0.5 mg twice a day, for at least a week. After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.

Your capsules should be swallowed whole with a glass of water. Do not crush the capsules or dilute the contents in a liquid. You can take the capsules with food or after a meal or on an empty stomach. It is best to take the capsule(s) at the same time every day.

Do not take more or less capsules than your doctor has recommended. Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop taking this medicine on your own.

Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well.

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, tell a doctor or pharmacist immediately. Show them the pack of Anagrelide Viatris.

If you forget to take Anagrelide Viatris Take your capsules as soon as you remember. Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you are worried, speak to your doctor.

Serious side effects Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of the legs due to fluid build-up), severe problem with the rate or rhythm of the heartbeat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas which causes severe abdominal and back pain (pancreatitis), vomiting blood or passing bloody or black stools, severe reduction in blood cells which can cause weakness, bruising, bleeding or infections (pancytopenia), increased pressure in the lung arteries (signs include shortness of breath, swelling in legs or ankles and lips and skin can turn bluish colour). Rare: Kidney failure (when you pass little or no urine), 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, rapid heartbeat, irregular or strong heartbeat (palpitations), feeling sick (nausea), diarrhoea, stomach pain, wind, being sick (vomiting), reduction in red blood cell count (anaemia), fluid retention or rash.

Uncommon side effects (may affect up to 1 in 100 people): A feeling of weakness or feeling unwell, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle aches, painful joints, back pain, decreased or loss of feeling or sensation such as numbness, especially in the skin, abnormal feeling or sensation such as tingling and pins and needles , sleeplessness, depression, confusion, nervousness, dry mouth, loss of memory, breathlessness, nosebleed, serious lung infection with fever, shortness of breath, cough, phlegm; hair loss, skin itching or discolouration, impotence, chest pain, reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia), accumulation of fluid around the lungs or an increase in liver enzymes. Your doctor may do a blood test which may show an increase in your 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, accumulation of fluid around the heart, painful spasm of the blood vessels on the heart (while resting, usually at night or early morning) (Prinzmetal angina), loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness on standing up (especially when getting up from a sitting or lying position), increased need to pass water at night, pain, flu-like symptoms, sleepiness, widening of blood vessels, inflammation of the large bowel (signs include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (signs include: pain, nausea, vomiting), area of abnormal density in the lung, increased creatinine level in blood tests, which may be a sign of kidney problems.

The following side effects have been reported but it is not known exactly how often they occur:

• Potentially life-threatening, irregular heartbeat (Torsade de pointes);
• Inflammation of the liver, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, discoloration of stool and urine (hepatitis);
• Lung inflammation (signs include fever, coughing, difficulty breathing, wheezing; which causes scaring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonitis);
• Inflammation of the kidneys (tubulointerstitial nephritis).
• Stroke (see section 2).

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

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 carton and bottle label after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.

If your doctor stops your medicine, do not keep any leftover capsules unless your doctor tells you to. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Anagrelide Viatris contains The active substance is anagrelide. Each capsule contains anagrelide hydrochloride monohydrate equivalent to 0.5 mg anagrelide. The other ingredients are lactose, croscarmellose sodium, povidone, microcrystalline cellulose, magnesium stearate, gelatin and titanium dioxide(E171). See section 2 Anagrelide Viatris contains lactose and sodium .

What Anagrelide Viatris looks like and contents of the pack Anagrelide Viatris 0.5 mg hard capsules have a white body and cap. The capsule is filled with a white to off-white powder. The capsule size is approximately 14.3 x 5.3 mm.

Anagrelide Viatris is available in plastic bottles of 30 ml or 75 ml with a tamper evident, child-resistant closure and a desiccant. Each bottle contains 100 hard capsules.

Marketing Authorisation Holder Mylan Pharmaceuticals Limited Damastown Industrial Park
Mulhuddart, Dublin DUBLIN Ireland

Manufacturer Synthon Hispania SL C/ Castell no1 POL. Las Salinas Sant Boi de Llobregat 08830 Barcelona Spain

Synthon BV
Microweg 6545 CM Nijmegen
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g Mylan EPD Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: + 31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Mylan Hrvatska d.o.o.
Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris OY Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd
: +357 2220 7Sverige Viatris AB
Tel: +46 (0)8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: