0.5 mg hard anagrelide capsules
1. What Anagrelide Sandoz is and what it is used for
Anagrelide Sandoz contains the active substance anagrelide. Anagrelide Sandoz is a medicine 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 thrombocythemia .
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.
Anagrelide contained in Anagrelide Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Anagrelide Sandoz
Do not take Anagrelide Sandoz
- if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6).
An allergic reaction can manifest itself 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 Sandoz:
- 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 Sandoz”)
- 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 Sandoz”).
Children and young people
Data on the use of Anagrelide Sandoz in children and adolescents are limited and this medicine should therefore be used with caution.
Other medicines and Anagrelide Sandoz
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 Sandoz 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 Sandoz should not be taken by pregnant women. Women who are at risk of becoming pregnant should use effective contraception while taking Anagrelide Sandoz. 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 Sandoz should not be taken while breast-feeding. You must stop breast-feeding if you are taking Anagrelide Sandoz.
Driving and using machines
Dizziness has been reported in some patients taking Anagrelide Sandoz. Avoid driving or using machines if you feel dizzy.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Anagrelide Sandoz contains lactose
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.
How to take Anagrelide Sandoz
Always take Anagrelide Sandoz exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure
Different people may take different amounts of Anagrelide Sandoz depending on the disease state. Your doctor will prescribe the dose that is best for you.
The usual starting dose of Anagrelide Sandoz 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 forget to take Anagrelide Sandoz
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:
Uncommon: Heart failure (signs of this are shortness of breath, chest pain, and leg swelling due to fluid retention), severe problems with the heart rate or heart rhythm ( ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation ), inflammation of the pancreas which causes severe pain in the abdomen and back ( pancreatitis ) 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.
A very common side effect is (can occur in more than 1 in 10):
Headache.
Common side effects are (may affect up to 1 in 10) :
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.
Less common side effects are (may affect up to 1 in 100) :
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 are (may affect up to 1 in 1000 users) :
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, loss of coordination, speech difficulties, dry skin, migraine, 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 of 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 point )
- hepatitis. Signs of this are nausea, vomiting, itching, yellowing of the skin and eyes, and discoloration of stools and urine ( hepatitis ).
- pneumonia (signs of this are fever, cough, difficulty breathing and wheezing causing 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 Sandoz
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.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
After opening: use within 100 days and store the jar dry and tightly closed.
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 0.5 mg of anagrelide (as anagrelide hydrochloride).
Other ingredients are:
Capsule contents: povidone K30 (E1201), crospovidone type A (E1202), anhydrous lactose, lactose monohydrate, microcrystalline cellulose (E460), and magnesium stearate.
Capsule shell: gelatin (E441) and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Anagrelide Sandoz is a clear, white, hard gelatin capsules, size nº4 (14.4 mm), containing white or almost white fine powder. The capsules are supplied in jars of 100 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
J. Uriach y Compañía SA, Avda. Camí Reial, 51-57 Pau Solità and Plegamans, 08184 Barcelona, Spain
or
Galenicum Health SL, Avda / Conellà 144, 7º 1ª Edificio LEKLA, Esplugues de Llobregat, 08950 Barcelona, Spanien
or
SAG Manufacturing, SLU, Carretera A-1, Km 36, San Agustín del Guadalix, 28750 Madrid, Spain