Capsule, hard 0.5 mg
(Capsule size 4 (14.3 mm x 5.3 mm) with opaque white base and top. The capsule is filled with white to off-white powder.)
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 may harm them, even if they show symptoms 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 you will find information about:
1. What the medicine is and what it is used for
2. What you need to know before using this medicine
3. How to use this medicine
4. Possible side effects
5. How to store the medicine
6. Contents of the pack and other information
1. What the medicine is and what it is used for
Anagrelide Orion contains the active substance anagrelide. Anagrelide Orion 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. For this reason, it is used to treat patients with essential thrombocythaemia .
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 clot formation.
Anagrelid contained in Anagrelid Orion 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.
2. What you need to know before using this medicine
Do not use this medicine
- 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 Anagrelid Orion:
- 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 Orion”),
- if you have any problems with your liver or kidneys. Concomitant use of acetylsalicylic acid (a substance also known as aspirin / ASA 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 Anagrelid Orion”). ).
Children and young people
There is limited information on the use of Anagrelid Orion in children and adolescents, therefore this medicine should be used with caution.
Use of other medicines
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 known as aspirin / ASA 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 are recommended (eg condoms). See the instructions in the package leaflet for the contraceptive pill you are taking.
Anagrelide Orion or these medicines may not work properly if taken together.
Ask your doctor or pharmacist if you are unsure.
Pregnancy, breastfeeding, and fertility
Tell your doctor if you are pregnant or planning to become pregnant. Anagrelide Orion should not be taken by pregnant women. Women who are at risk of becoming pregnant should make sure that they use effective contraception while taking Anagrelid Orion. 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 Orion should not be taken while breast-feeding. You must stop breast-feeding if you are taking Anagrelid Orion.
Driving and using machines
Dizziness has been reported in some patients taking anagrelide. 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.
The medicine contains excipients
Anagrelide Orion 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. Anagrelide Orion contains 28.0 mg of lactose monohydrate and 32.9 mg of anhydrous lactose per capsule.
Other ingredients
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost “sodium-free”.
3. How to use the medicine
Always take Anagrelid Orion exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Different people may take different amounts of Anagrelid Orion depending on the condition. Your doctor will prescribe the dose that is best for you.
The usual starting dose of Anagrelid Orion 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 a glass of 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 use the medicine
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.
If you notice any of these serious side effects, contact your doctor immediately.
Less common (may affect up to 1 in 100): heart failure (the sign of this is shortness of breath, chest pain, and leg swelling due to fluid accumulation), severe problems with the heart rate or heart rhythm ( ventricular tachycardia, supraventricular tachycardia atrial fibrillation ), inflammation of the pancreas causes severe pain in the abdomen and back ( pancreatitis ), blood in vomit 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 pulmonary artery s (pulmonary hypertension; signs of this are shortness of breath, swollen legs or ankles and that lips and skin may have a bluish tint).
Rare (may affect up to 1 in 1,000 people) :
kidney failure (little or no urination) or heart attack.
Other side effects:
Very common (may affect more than 1 user in 10):
headache.
Common (may affect up to 1 in 10 people):
dizziness, fatigue, rapid heartbeat, irregular or severe heartbeat ( palpitation ), nausea, diarrhea, stomach pain, gas, vomiting, reduction in red blood cell count ( anemia ), fluid retention, or rash.
Uncommon (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 feeling or tingling and tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, mucus formation; hair loss, itchy skin or discoloration, impotence, chest pain, decreased platelet count that increases the risk of bleeding or bruising ( thrombocytopenia), fluid accumulation around the lungs or an increase in enzymes the liver. Your doctor may take a blood test that may show an increase in enzymes in your liver.
Rare (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 retention around the heart, loss of coordination, speech difficulties, dry skin, migraines, visual disturbances or double vision, ringing in the ears, dizziness when getting up (especially from a sitting or lying position), 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 and mucus, abdominal pain and fever ), inflammation of the stomach (signs of this are pain, nausea, and vomiting), area with abnormal density in the lungs, elevated levels of creatinine in blood tests that may be a sign of kidney problems.
Has been reported (occurs in an unknown number of users):
- potentially life-threatening, irregular heartbeat ( torsade de points )
- 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 causing scarring of the lungs), (allergic alveolitis, including interstitial lung disease and pneumonitis )
- renal inflammation (tubulointerstitial nephritis).
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
Läkemedelsverket Box 26
751 03 Uppsala
5. How to store the medicine
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 after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Sensitive to light. Moisture sensitive.
If your doctor stops your treatment with the medicine, you should not keep any leftover capsules 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 monohydrate).
- The other ingredients are: The
the capsule contains lactose monohydrate, croscarmellose sodium, povidone (E1201), anhydrous lactose, microcrystalline cellulose (E460), and magnesium stearate.
Capsule housing: gelatin and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Anagrelide Orion is opaque, white, hard 14 mm long capsules. The capsules are filled with a white to off-white powder. The capsules are supplied in jars of 100 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Synthon Hispania SL
C / Castelló, no 1,
Terminal. Las Salinas
Sant Boi de Llobregat,
Barcelona, 08830
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands