150 mm

10 mm 15 mm

Package leaflet: Information for the patient Common side effects: may affect up to 6. Contents of the pack and other 1 in 10 people information Anagrelide 0.5 mg Capsules, Hard • dizziness, tiredness Anagrelide • rapid heartbeat, irregular or strong heartbeat What Anagrelide capsules contain (palpitations) The active substance is anagrelide. Read all of this leaflet carefully before you start taking this medicine because it contains important • feeling sick (nausea), diarrhoea, stomach pain, Each capsule contains 0.5 mg anagrelide information for you. wind, being sick (vomiting) (as anagrelide hydrochloride). • Keep this leaflet. You may need to read it again. • reduction in red blood cell count (anaemia) • If you have further questions, ask your doctor or pharmacist. • fluid retention or rash The other ingredients are: • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if Capsule contents: povidone K-30 (E-1201); Uncommon side effects: may affect up to crospovidone Type A (E-1202); lactose; lactose their signs of illness are the same as yours. 1 in 100 people • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not monohydrate; microcrystalline cellulose (E-460) and • a feeling of weakness or feeling unwell magnesium stearate. listed in this leaflet. See section 4. • high blood pressure, irregular heart beat Capsule shell: gelatine (E-441) and titanium dioxide What is in this leaflet If you are not sure, speak to your doctor or • fainting, chills or fever (E-171). 1. What Anagrelide is and what it is used for pharmacist for advice. • indigestion, loss of appetite, constipation 2. What you need to know before you • bruising, bleeding, swelling (oedema) What Anagrelide capsules look like and take Anagrelide Pregnancy and breastfeeding • weight loss contents of the pack 3. How to take Anagrelide Tell your doctor if you are pregnant or are planning • muscle aches, painful joints, back pain Anagrelide is supplied as opaque white hard 4. Possible side effects to become pregnant. Anagrelide should not be • decreased or loss of feeling or sensation such gelatine capsules, size n°4 (14.4 mm), containing 5. How to store Anagrelide taken by pregnant women. Women who are at risk as numbness, especially in the skin white or almost white fine powder. 6. Contents of the pack and other information of becoming pregnant should make sure that they • abnormal feeling or sensation such as tingling The capsules are provided in bottles containing are using effective contraception when taking and ‘pins and needles’ 100 hard capsules. 1. What Anagrelide is and what it is Anagrelide. Speak to your doctor if you need advice • sleeplessness, depression, confusion, used for with contraception. nervousness Marketing Authorisation Holder Tell your doctor if you are breastfeeding or if you • dry mouth Dr. Reddy’s Laboratories (UK) Ltd., Anagrelide capsules contain the active substance are planning to breastfeed your baby. Anagrelide • loss of memory 6 Riverview Road, Beverley, East Yorkshire, anagrelide. Anagrelide is a medicine which should not be taken while breastfeeding. You must • breathlessness, nosebleed, serious lung HU17 0LD, United Kingdom. interferes with the development of platelets. It stop breastfeeding if you are taking Anagrelide. infection with fever, shortness of breath, cough, reduces the number of platelets produced by the phlegm Manufacturer bone marrow, which results in a decrease in the Driving and using machines • hair loss, skin itching or discolouration J.Uriach y Compañía S.A., Avda. platelet count in the blood towards a more normal Dizziness has been reported by some patients • impotence Camí Reial, 51-57, Palau-Solità i Plegamans, level. For this reason it is used to treat patients with taking Anagrelide. Do not drive or use machines if • chest pain, reduction in blood platelets, which 08184 Barcelona, Spain essential thrombocythaemia. increases the risk of bleeding or bruising you feel dizzy. This leaflet was last revised in 10/2020 (thrombocytopenia) Essential thrombocythaemia is a condition which Anagrelide capsules contain lactose occurs when the bone marrow produces too many • accumulation of fluid around the lungs or an Lactose is an ingredient in this medicine. If you increase in liver enzymes. Your doctor may do of the blood cells known as platelets. Large have been told by your doctor that you have an numbers of platelets in the blood can cause serious a blood test which may show an increase in intolerance to some sugars, contact your doctor your liver enzymes problems with blood circulation and clotting. before taking this medicinal product. Rare side effects: may affect up to 2. What you need to know before you 3. How to take Anagrelide 1 in 1,000 people take Anagrelide • bleeding gums, weight gain Always take Anagrelide exactly as your doctor has • severe chest pain (angina pectoris), heart Do not take Anagrelide told you. Check with your doctor or pharmacist if muscle disease, (signs include fatigue, chest • if you are allergic to anagrelide or any of the you are not sure. pain and palpitations), enlarged heart, other ingredients of this medicine (listed in The amount of Anagrelide that people take can be accumulation of fluid around the heart section 6). An allergic reaction may be • painful spasm of the blood vessels on the heart recognised as a rash, itching, swollen face or different, and this depends on your condition. Your doctor will prescribe the best dose for you. (while resting, usually at night or early morning) lips, or shortness of breath (Prinzmetal angina) • if you have moderate or severe liver problems The usual starting dose of Anagrelide is 1 mg. You • loss of coordination, difficulty in speaking • if you have moderate or severe take this dose as one capsule of 0.5 mg twice a day, • dry skin kidney problems. for at least a week. After this time, your doctor may • migraine, visual disturbances or double vision, either increase or decrease the number of capsules Warnings and precautions ringing in the ears, dizziness on standing up, that you take to find the dose best suited to you and (especially when getting up from a sitting or Talk to your doctor before taking Anagrelide: which treats your condition most effectively. lying position) • if you have or think you might have a problem • increased need to pass water at night, pain, with your heart Your capsules should be swallowed whole with a ‘flu-like’ symptoms, sleepiness, widening of • if you were born with or have family history of glass of water. Do not crush the capsules or dilute

400 mm 400 blood vessels prolonged QT interval (seen on ECG, the contents in a liquid. You can take the capsules • inflammation of the large bowel (signs include: electrical recording of the heart), or you are with food or after a meal or on an empty stomach. diarrhoea, usually with blood and mucus, taking other medicines that result in It is best to take the capsule(s) at the same time stomach pain, fever), inflammation of the abnormal ECG changes or if you have low every day. stomach (signs include: pain, nausea, vomiting) levels of electrolytes e.g. potassium, Do not take more capsules than your doctor has • area of abnormal density in the lung magnesium or calcium (see section “Other recommended. • increased creatinine level in blood tests, which medicines and Anagrelide”) may be a sign of kidney problems • if you have any problems with your liver Your doctor will ask you to have blood tests at or kidneys. regular intervals to check that your medicine is The following side effects have been reported working effectively and that your liver and kidneys but it is not known exactly how often they occur: In combination with acetylsalicylic acid (a are working well. • potentially life-threatening, irregular heart beat substance present in many medicines used to (torsade de pointes) relieve pain and lower fever, as well as to prevent If you take more Anagrelide than you should • inflammation of the liver, symptoms include blood clotting, also known as aspirin), there is an If you take more Anagrelide than you should, or if nausea, vomiting, itching, yellowing of the skin increased risk of major haemorrhages (bleeding) someone else has taken your medicine, tell a and eyes, discolouration of stool and urine (see section “Other medicines and Anagrelide”). doctor or pharmacist immediately. Show them the (hepatitis) pack of Anagrelide. Artwork Children and adolescents • lung inflammation (signs include fever, There is limited information on the use of If you forget to take Anagrelide Brand: Dr Reddy’s coughing, difficulty breathing, wheezing; which Anagrelide in children and adolescents and Take your capsules as soon as you remember. causes scarring of the lungs) (allergic alveolitis, therefore this medicine should be used with caution. Take your next dose at the usual time. Do not take Product Name: Anagrelide including interstitial lung disease, pneumonitis) a double dose to make up for a forgotten dose. • inflammation of the kidneys Other medicines and Anagrelide Strength: 0.5 mg (Tubulointerstitial nephritis). Tell your doctor or pharmacist if you are taking or have 4. Possible side effects Hard Capsules recently taken or might take any other medicines. Form: Reporting of side effects Like all medicines, this medicine can cause side If you get any side effects talk to your doctor or Tell your doctor if you are taking any of the following effects, although not everybody gets them. If you pharmacist. This includes any possible side effects medicines: are worried, speak to your doctor. Component: Leaflet not listed in this leaflet. You can also report side • medicines that can alter your heart rhythm; effects directly via the Yellow Card Scheme website e.g. sotalol, amiodarone Serious side effects: Pack Size: N/A Uncommon: www.mhra.gov.uk/yellowcard or search for MHRA • fluvoxamine, used to treat depression Country: UK Yellow Card in the Google Play or Apple App Store. • certain types of antibiotic, such as enoxacin, • heart failure (signs include shortness of breath, By reporting side effects you can help provide more chest pain, swelling of the legs due to fluid used to treat infections Date Created: 11 OCT 2017 information on the safety of this medicine. • theophylline, used to treat severe asthma and build-up) breathing problems • severe problem with the rate or rhythm of the Date Modified: 26 OCT 2020 5. How to store Anagrelide • medicines used to treat heart disorders, for heart beat (ventricular tachycardia, example, milrinone, enoximone, amrinone, supraventricular tachycardia or atrial fibrillation) Version: 1.6 Keep this medicine out of the sight and reach olprinone and cilostazol • inflammation of the pancreas which causes of children. • acetylsalicylic acid (a substance present in severe abdominal and back pain (pancreatitis) Technical Information Do not use this medicine after the expiry date which • vomiting blood or passing bloody or black stools many medicines used to relieve pain and lower Die Cut Guides is stated on the carton and bottle label after EXP. fever, as well as to prevent blood clotting, also • severe reduction in blood cells which can The expiry date refers to the last day of that month. known as aspirin) cause weakness, bruising, bleeding or Do not store above 30°C. Store in the original • other medicines used to treat conditions infections (pancytopenia) package in order to protect from moisture. affecting the platelets in your blood, • pulmonary hypertension (signs include After first opening use within 100 days, keep the e.g. clopidogrel shortness of breath, swelling in legs or ankles, and lips and skin can turn bluish colour) bottle tightly closed and store at dry conditions. • omeprazole, used to reduce the amount of Min Font Size: 9pt Rare: If your doctor stops your medicine, do not keep any acid produced in the stomach Printer: Galencium • oral contraceptives: If you experience bad • kidney failure (when you pass little or no urine) leftover capsules unless your doctor tells you to. Do diarrhoea whilst taking this medicine, it may • heart attack Dimensions: 150 x 400 mm not throw away any medicines via wastewater or reduce how well the oral contraceptive works household waste. Ask your pharmacist how to throw If you notice any of these side effects, contact Project: CC1000041467 away medicines you no longer use. These and use of an extra method of contraception is your doctor immediately. recommended (e.g. condom). See the measures will help protect the environment. instructions in the patient leaflet of the Very common side effects: may affect more than Colours 1 in 10 people contraceptive pill you are taking. Process Black • headache Anagrelide or these medicines may not work properly if taken together.

Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK Common side effects: may affect up to 6. Contents of the pack and other 1 in 10 people information • dizziness, tiredness • rapid heartbeat, irregular or strong heartbeat What Anagrelide capsules contain (palpitations) The active substance is anagrelide. • feeling sick (nausea), diarrhoea, stomach pain, Each capsule contains 0.5 mg anagrelide wind, being sick (vomiting) (as anagrelide hydrochloride). • reduction in red blood cell count (anaemia) • fluid retention or rash The other ingredients are: Capsule contents: povidone K-30 (E-1201); Uncommon side effects: may affect up to crospovidone Type A (E-1202); lactose; lactose 1 in 100 people monohydrate; microcrystalline cellulose (E-460) and • a feeling of weakness or feeling unwell magnesium stearate. • high blood pressure, irregular heart beat Capsule shell: gelatine (E-441) and titanium dioxide What is in this leaflet If you are not sure, speak to your doctor or • fainting, chills or fever (E-171). 1. What Anagrelide is and what it is used for pharmacist for advice. • indigestion, loss of appetite, constipation 2. What you need to know before you • bruising, bleeding, swelling (oedema) What Anagrelide capsules look like and take Anagrelide Pregnancy and breastfeeding • weight loss contents of the pack 3. How to take Anagrelide Tell your doctor if you are pregnant or are planning • muscle aches, painful joints, back pain Anagrelide is supplied as opaque white hard 4. Possible side effects to become pregnant. Anagrelide should not be • decreased or loss of feeling or sensation such gelatine capsules, size n°4 (14.4 mm), containing 5. How to store Anagrelide taken by pregnant women. Women who are at risk as numbness, especially in the skin white or almost white fine powder. 6. Contents of the pack and other information of becoming pregnant should make sure that they • abnormal feeling or sensation such as tingling The capsules are provided in bottles containing are using effective contraception when taking and ‘pins and needles’ 100 hard capsules. 1. What Anagrelide is and what it is Anagrelide. Speak to your doctor if you need advice • sleeplessness, depression, confusion, used for with contraception. nervousness Marketing Authorisation Holder Tell your doctor if you are breastfeeding or if you • dry mouth Dr. Reddy’s Laboratories (UK) Ltd., Anagrelide capsules contain the active substance are planning to breastfeed your baby. Anagrelide • loss of memory 6 Riverview Road, Beverley, East Yorkshire, anagrelide. Anagrelide is a medicine which should not be taken while breastfeeding. You must • breathlessness, nosebleed, serious lung HU17 0LD, United Kingdom. interferes with the development of platelets. It stop breastfeeding if you are taking Anagrelide. infection with fever, shortness of breath, cough, reduces the number of platelets produced by the phlegm Manufacturer bone marrow, which results in a decrease in the Driving and using machines • hair loss, skin itching or discolouration J.Uriach y Compañía S.A., Avda. platelet count in the blood towards a more normal Dizziness has been reported by some patients • impotence Camí Reial, 51-57, Palau-Solità i Plegamans, level. For this reason it is used to treat patients with taking Anagrelide. Do not drive or use machines if • chest pain, reduction in blood platelets, which 08184 Barcelona, Spain essential thrombocythaemia. increases the risk of bleeding or bruising you feel dizzy. This leaflet was last revised in 10/2020 (thrombocytopenia) Essential thrombocythaemia is a condition which Anagrelide capsules contain lactose occurs when the bone marrow produces too many • accumulation of fluid around the lungs or an Lactose is an ingredient in this medicine. If you increase in liver enzymes. Your doctor may do of the blood cells known as platelets. Large have been told by your doctor that you have an numbers of platelets in the blood can cause serious a blood test which may show an increase in intolerance to some sugars, contact your doctor your liver enzymes problems with blood circulation and clotting. before taking this medicinal product. Rare side effects: may affect up to 2. What you need to know before you 3. How to take Anagrelide 1 in 1,000 people take Anagrelide • bleeding gums, weight gain Always take Anagrelide exactly as your doctor has • severe chest pain (angina pectoris), heart Do not take Anagrelide told you. Check with your doctor or pharmacist if muscle disease, (signs include fatigue, chest • if you are allergic to anagrelide or any of the you are not sure. pain and palpitations), enlarged heart, other ingredients of this medicine (listed in The amount of Anagrelide that people take can be accumulation of fluid around the heart section 6). An allergic reaction may be • painful spasm of the blood vessels on the heart recognised as a rash, itching, swollen face or different, and this depends on your condition. Your doctor will prescribe the best dose for you. (while resting, usually at night or early morning) lips, or shortness of breath (Prinzmetal angina) • if you have moderate or severe liver problems The usual starting dose of Anagrelide is 1 mg. You • loss of coordination, difficulty in speaking • if you have moderate or severe take this dose as one capsule of 0.5 mg twice a day, • dry skin kidney problems. for at least a week. After this time, your doctor may • migraine, visual disturbances or double vision, either increase or decrease the number of capsules Warnings and precautions ringing in the ears, dizziness on standing up, that you take to find the dose best suited to you and (especially when getting up from a sitting or Talk to your doctor before taking Anagrelide: which treats your condition most effectively. lying position) • if you have or think you might have a problem • increased need to pass water at night, pain, with your heart Your capsules should be swallowed whole with a ‘flu-like’ symptoms, sleepiness, widening of • if you were born with or have family history of glass of water. Do not crush the capsules or dilute blood vessels prolonged QT interval (seen on ECG, the contents in a liquid. You can take the capsules • inflammation of the large bowel (signs include: electrical recording of the heart), or you are with food or after a meal or on an empty stomach. diarrhoea, usually with blood and mucus, taking other medicines that result in It is best to take the capsule(s) at the same time stomach pain, fever), inflammation of the abnormal ECG changes or if you have low every day. stomach (signs include: pain, nausea, vomiting) levels of electrolytes e.g. potassium, Do not take more capsules than your doctor has • area of abnormal density in the lung magnesium or calcium (see section “Other recommended. • increased creatinine level in blood tests, which medicines and Anagrelide”) may be a sign of kidney problems • if you have any problems with your liver Your doctor will ask you to have blood tests at or kidneys. regular intervals to check that your medicine is The following side effects have been reported working effectively and that your liver and kidneys but it is not known exactly how often they occur: In combination with acetylsalicylic acid (a are working well. • potentially life-threatening, irregular heart beat substance present in many medicines used to (torsade de pointes) relieve pain and lower fever, as well as to prevent If you take more Anagrelide than you should • inflammation of the liver, symptoms include blood clotting, also known as aspirin), there is an If you take more Anagrelide than you should, or if nausea, vomiting, itching, yellowing of the skin increased risk of major haemorrhages (bleeding) someone else has taken your medicine, tell a and eyes, discolouration of stool and urine (see section “Other medicines and Anagrelide”). doctor or pharmacist immediately. Show them the (hepatitis) pack of Anagrelide. Children and adolescents • lung inflammation (signs include fever, There is limited information on the use of If you forget to take Anagrelide coughing, difficulty breathing, wheezing; which Anagrelide in children and adolescents and Take your capsules as soon as you remember. causes scarring of the lungs) (allergic alveolitis, therefore this medicine should be used with caution. Take your next dose at the usual time. Do not take including interstitial lung disease, pneumonitis) a double dose to make up for a forgotten dose. • inflammation of the kidneys Other medicines and Anagrelide (Tubulointerstitial nephritis). Tell your doctor or pharmacist if you are taking or have 4. Possible side effects recently taken or might take any other medicines. Reporting of side effects Like all medicines, this medicine can cause side If you get any side effects talk to your doctor or Tell your doctor if you are taking any of the following effects, although not everybody gets them. If you pharmacist. This includes any possible side effects medicines: are worried, speak to your doctor. not listed in this leaflet. You can also report side • medicines that can alter your heart rhythm; effects directly via the Yellow Card Scheme website e.g. sotalol, amiodarone Serious side effects: Uncommon: www.mhra.gov.uk/yellowcard or search for MHRA • fluvoxamine, used to treat depression Yellow Card in the Google Play or Apple App Store. • certain types of antibiotic, such as enoxacin, • heart failure (signs include shortness of breath, By reporting side effects you can help provide more used to treat infections chest pain, swelling of the legs due to fluid information on the safety of this medicine. • theophylline, used to treat severe asthma and build-up) breathing problems • severe problem with the rate or rhythm of the 5. How to store Anagrelide • medicines used to treat heart disorders, for heart beat (ventricular tachycardia, example, milrinone, enoximone, amrinone, supraventricular tachycardia or atrial fibrillation) Keep this medicine out of the sight and reach olprinone and cilostazol • inflammation of the pancreas which causes of children. • acetylsalicylic acid (a substance present in severe abdominal and back pain (pancreatitis) Do not use this medicine after the expiry date which many medicines used to relieve pain and lower • vomiting blood or passing bloody or black stools is stated on the carton and bottle label after EXP. fever, as well as to prevent blood clotting, also • severe reduction in blood cells which can The expiry date refers to the last day of that month. known as aspirin) cause weakness, bruising, bleeding or Do not store above 30°C. Store in the original • other medicines used to treat conditions infections (pancytopenia) package in order to protect from moisture. affecting the platelets in your blood, • pulmonary hypertension (signs include After first opening use within 100 days, keep the e.g. clopidogrel shortness of breath, swelling in legs or ankles, and lips and skin can turn bluish colour) bottle tightly closed and store at dry conditions. • omeprazole, used to reduce the amount of acid produced in the stomach Rare: If your doctor stops your medicine, do not keep any • oral contraceptives: If you experience bad • kidney failure (when you pass little or no urine) leftover capsules unless your doctor tells you to. Do diarrhoea whilst taking this medicine, it may • heart attack not throw away any medicines via wastewater or reduce how well the oral contraceptive works household waste. Ask your pharmacist how to throw If you notice any of these side effects, contact away medicines you no longer use. These and use of an extra method of contraception is your doctor immediately. recommended (e.g. condom). See the measures will help protect the environment. instructions in the patient leaflet of the Very common side effects: may affect more than contraceptive pill you are taking. 1 in 10 people • headache Anagrelide or these medicines may not work properly if taken together. DRXXXXXX