Anagrelide Zentiva 0.5 mg hard capsules

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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.

Talk to your doctor before taking Anagrelide:

• 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”);
• 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”).

While taking Anagrelide 0.5mg hard capsules, 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.

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

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.

Tell your doctor if you are pregnant or are planning to become pregnant. Anagrelide 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 should not be taken while breast-feeding. You must stop breast-feeding if you are taking anagrelide.

Dizziness has been reported by some patients taking Anagrelide. Do not drive or use machines if you feel dizzy.

Lactose is an ingredient in this medicine. 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”.

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

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.

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 heart beat
• 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

• Potentially life-threatening, irregular heart beat (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).

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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is anagrelide.

Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride monohydrate).

The other ingredients are:

Capsule contents: Lactose monohydrate, croscarmellose sodium, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capsule Shell: Gelatin, titanium dioxide (E171).

Anagrelide 0.5 mg is supplied as a hard capsule (size 4) with an opaque white body and cap. The capsule is filled with white to off-white powder.

The capsules are provided in bottles containing 42 or 100 hard capsules.

Not all pack sizes may be marketed.

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