Anagrelide 0.5 mg Hard Capsules

Read all of 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 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.

What is in this leaflet

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

Do not take Anagrelide:

• 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:

• 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”).

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

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 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.

Driving and using machines

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

Anagrelide contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, 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 forget to take 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.

Contact a doctor immediately if you experience any of the following side effects:

Uncommon (may affect up to 1 in 100 people):

• 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 heart beat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation)
• serious lung infection with fever, shortness of breath, cough, phlegm
• inflammation of the pancreas which causes severe abdominal and back pain (pancreatitis)
• bleeding, including vomiting blood or passing bloody or black stools
• unexplained bruising or bleeding for longer than usual. These are signs of a reduction in blood platelets (thrombocytopenia)
• severe reduction in all types of blood cells which can cause weakness, bruising, bleeding or frequent or recurrent infections (pancytopenia).
• increased pressure in the lung arteries (signs include: shortness of breath and lips and skin can turn bluish colour)

Rare (may affect up to 1 in 1,000 people):

• passing little or no urine, with lower back pain, pain when passing urine, cloudy or dark urine. These may be signs of severe problems with your kidneys
• severe chest pain (angina pectoris), heart muscle disease, (signs include fatigue, chest pain and palpitations), 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).
• severe, sudden chest pain, which can travel to the neck and arm, pale skin and clammy skin. These may be signs of a heart attack.

Not known (frequency cannot be estimated from the available data):

• 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).

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• headache.

Common (may affect up to 1 in 10 people):

• dizziness, tiredness
• rapid heart-beat, irregular or strong heartbeat (palpitations)
• feeling sick (nausea), diarrhoea, stomach pain, wind, being sick (vomiting)
• reduction in red blood cell count (anaemia)
• fluid retention
• rash.

Uncommon (may affect up to 1 in 100 people):

• a feeling of weakness or feeling unwell
• high blood pressure, fainting, chills or fever
• indigestion, loss of appetite, constipation
• bruising
• 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
• hair loss, skin itching or discolouration
• impotence
• chest pain
• accumulation of fluid around the lungs
• an increase in liver enzymes. Your doctor may do a blood test which may show an increase in your liver enzymes.

Rare (may affect up to 1 in 1,000 people):

• bleeding gums, weight gain
• loss of coordination, difficulty in speaking
• dry skin, migraine
• enlarged heart
• 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.

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 Yellow Card Scheme at: 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.

What Anagrelide contains:

The active substance in anagrelide. Each capsule contains 0.5 mg (as anagrelide hydrochloride).

The other ingredients are lactose, croscarmellose sodium, povidone, microcrystalline cellulose, magnesium stearate, gelatin and titanium dioxide. See section 2 ‘Anagrelide contains lactose’.

What Anagrelide looks like and contents of the pack:

Anagrelide 0.5 mg hard capsules have a white body and cap. The capsule is filled with a white to off-white powder.

Anagrelide are available in plastic bottles with child-resistant screw cap containing 100 hard capsules.

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