0.5 mg hard anagrelide capsules

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Anagrelide Mylan is and what it is used for 
2. What you need to know before you take Anagrelide Mylan 
3. How to take Anagrelide Mylan 
4. Possible side effects 
5. How to store Anagrelide Mylan 
6. Package contents and other information 

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

Anagrelide Mylan contains the active substance anagrelide. Anagrelide is a drug that affects the development of platelets. It reduces the number of platelets produced by the bone marrow and thus the number of platelets in the blood becomes more normal. Therefore, it is used to treat patients with essential thrombocytopenia.

Essential thrombocythaemia is a condition that occurs when the bone marrow produces too many of the blood cells called platelets. A large number of platelets in the blood can cause serious problems with blood circulation and blood clotting.

What you need to know before you take Anagrelide Mylan

Do not take Anagrelide Mylan

  • if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swollen face or swollen lips, or shortness of breath;
  • if you have moderate or severe liver problems;
  • if you have moderate or severe kidney problems.

Warnings and cautions

Talk to your doctor before taking Anagrelide Mylan:

  • if you have or think you may have heart problems;
  • if you were born with a prolonged QT interval (seen on ECG, electrical recording of the heart) or if it is present in your family, or if you are taking other medicines that lead to abnormal ECG changes, or if you have low levels of electrolytes, for example, potassium, magnesium or calcium (see section “Other medicines and Anagrelide Mylan”);
  • if you have any problems with your liver or kidneys.

Concomitant use of acetylsalicylic acid (a substance also known as aspirin and found in many medicines used to relieve pain and lower fever and also to prevent blood clots) increases the risk of major bleeding (see section “Other medicines and Anagrelide Mylan”).

Children and young people

Data on the use of anagrelide in children and adolescents are limited and this medicine should therefore be used with caution.

Other medicines and Anagrelide Mylan

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:

  • Drugs that can change the heart rhythm, e.g. sotalol and amiodarone
  • Fluvoxamine used to treat depression
  • Some types of antibiotics, such as enoxacin which are used to treat the infection your
  • Theophylline used to treat severe asthma and respiratory problems
  • Drugs used to treat heart disease, e.g. milrinone, enoximone, amrinone, olprinone, and cilostazol
  • Acetylsalicylic acid (a substance also called aspirin and found in many medicines used to relieve pain and lower fever and also to prevent blood clots)
  • Other drugs used to treat conditions that affect the platelets in the blood, e.g. clopidogrel
  • Omeprazole used to reduce the amount of acid produced in the stomach
  • Oral contraceptives: If you get severe diarrhea while taking this medicine, it may affect how well the oral contraceptive works, and the use of another method of contraception is recommended (eg condoms). See the instructions in the package leaflet for the contraceptive pill you are taking.

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

Ask your doctor or pharmacist if you are unsure.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or planning to become pregnant. Anagrelide Mylan should not be taken by pregnant women. Women who are at risk of becoming pregnant should ensure that they use effective contraception while taking anagrelide. Talk to your doctor if you need advice on contraception.

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

Driving and using machines

Dizziness has been reported in some patients taking anagrelide. Avoid driving or using machines if you feel dizzy.

Anagrelide Mylan 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 (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

How to take Anagrelide Mylan

Always take Anagrelide Mylan exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Different people may take different amounts of anagrelide depending on the disease state. Your doctor will prescribe the dose that is best for you.

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

The capsules should be swallowed whole and rinsed with water. They must not be crushed and the contents must not be dissolved in liquid. You can take the capsules with a meal or after a meal or on an empty stomach. You should preferably take the capsules at the same time each day.

Do not take more capsules than your doctor has recommended.

Your doctor will take blood samples at regular intervals to check that the medicine is working effectively and that your liver and kidneys are working well.

If you take more Anagrelide Mylan than you should

If you take more Anagrelide Mylan than you should, or if someone else has taken your medicine, tell your doctor or pharmacist immediately. Show them the Anagrelide Mylan pack.

If you forget to take Anagrelide Mylan

Take your 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. Talk to your doctor if you are worried.

Serious side effects are

Uncommon: Heart failure (signs of shortness of breath, chest pain, and leg swelling due to fluid retention), severe heart rate or heart rhythm problems ( ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation ), inflammation of the pancreas causing severe pain in the stomach and back ( pancreas ) vomiting blood or black or bloody stool, severe reduction of the amount of blood s that can cause weakness, bruising, bleeding or infection s (pancytopenia), increased pressure in the artery are the lungs ( pulmonary hypertension, signs that include shortness of breath, swollen legs or ankles and that the lips and skin get a bluish tint).

Rare: Kidney failure (little or no urination) or heart attack.

If you notice any of these side effects, talk to 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, rapid heartbeat, irregular or heavy heartbeat ( palpitation ), nausea, diarrhea, stomach pain, gas, vomiting, reduction in red blood cell count ( anemia ), fluid retention, or rash.

Uncommon side effects: may affect up to 1 in 100 people 

Feeling weak or sick, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling ( edema), weight loss, muscle aches, joint pain, back pain, decreased or lost sensation, especially sensation or loss of sensation abnormal sensation, or tingling and prickling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nose bleeds, severe lung infection with fever, shortness of breath, cough, sputum production, hair loss, skin itching or discoloration, impotence, chest pain, decreased number of blood platelets which increases the risk of bleeding or bruising ( thrombocytopenia), fluid accumulation around the lungs or an increase in enzymes in the liver. Your doctor may do a blood test that may show an increase in the enzyme in your liver.

Rare side effects: may affect up to 1 in 1,000 people

Bleeding gums, weight gain, severe chest pain (angina), heart muscle disease (signs of this are fatigue, chest pain, and palpitations ), heart enlargement, fluid accumulation around the heart, painful cramps in the blood vessels of the heart (at rest, usually during the night or early morning) (Prinzmetal’s angina ), loss of coordination, difficulty speaking, dry skin, migraines, visual or double vision, ringing in the ears, dizziness when getting up from sitting or lying down, increased need to urinate at night, pain, flu-like symptoms, drowsiness, dilated blood vessels, inflammation in the colon (signs of this are diarrhea, often with blood or mucus in the stool, abdominal pain, fever), inflammation in the stomach (signs of this are pain, nausea, and vomiting), area with abnormal density in the lungs or elevated creatinine levels in the blood 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 );
  • hepatitis. Signs of this are nausea, vomiting, itching, yellowing of the skin and eyes, and discoloration of feces and urine ( hepatitis );
  • pneumonia (signs of this are fever, cough, difficulty breathing, and wheezing that causes scarring of the lungs), (allergic alveolitis, including interstitial lung disease and pneumonitis );
  • renal inflammation (tubulointerstitial nephritis).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Anagrelide Mylan

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 can label after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Moisture sensitive. No special temperature instructions.

If your doctor interrupts your treatment with the medicine, you should not keep any capsules left unless your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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 Mylan contains lactose and sodium”.

What the medicine looks like and the contents of the pack

Anagrelide Mylan 0.5 mg hard capsules have a white bottom and top. The capsule contains white or almost white powder.

The dimensions of the capsule are approximately 14.3 x 5.3 mm.

Anagrelide Mylan is supplied in 30 ml or 75 ml plastic jars with desiccant and a safety-sealed, child-resistant lid. Each jar contains 100 hard capsules.

Marketing Authorisation Holder

Mylan SAS

117 Allée des Parcs

Saint-Priest

69800, France

Manufacturer

Synthon Hispania SL

C / Castelló no1

TERMINAL. Las Salinas

Sant Boi de Llobregat

08830 Barcelona

Spain

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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