0.5 mg hard capsules
anagrelide
What Xagrid is and what it is used for
Xagrid contains the active substance anagrelide. Xagrid is a drug 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 thrombocythemia is a condition that occurs when the bone marrow produces too many the blood cells called platelets. A large number of platelets in the blood can cause serious problems with blood circulation and blood clot formation.
What you need to know before you take Xagrid
Do not take Xagrid
- if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may show up 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 Xagrid:
- if you have or think you may have heart problems;
- if you were born with a prolonged QT interval (seen on the EKG, electrical recording of the heart) or if it runs in your family, if you take other medicines that lead to abnormal EKG changes, or if you have low levels of electrolytes, for example, potassium, magnesium or calcium (see section “Other medicines and Xagrid”);
- if you have any problems with your liver or kidneys.
With the simultaneous use of acetylsalicylic acid (a substance also called aspirin and found in many medicines used to relieve pain and reduce fever and also to prevent blood clots) the risk of major bleeding increases (see the section “Other medicines and Xagrid”).
As long as you are taking Xagrid, you must take precisely the dose prescribed by your doctor. Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop taking the medication without first talking to your doctor. This can lead to an increased risk of stroke.
Symptoms of a stroke may include sudden numbness or weakness in the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or 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. If these symptoms occur, seek medical attention immediately.
Children and young people
Data regarding the use of Xagrid in children and adolescents is limited and this medicine should therefore be used with caution.
Other medicines and Xagrid
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:
- Medicines that can change the heart rhythm, e.g. sotalol and amiodarone
- Fluvoxamine used to treat depression
- Certain types of antibiotics, such as enoxacin, are used to treat infections
- Theophylline used to treat severe asthma and breathing problems
- Medicines used to treat heart disease, e.g. milrinone, enoximone, amrinone, olprinone, and cilostazol
- Acetylsalicylic acid (a substance also known as aspirin and found in many medicines used to relieve pain and reduce fever and also to prevent blood clots)
- Other medicines used to treat conditions that affect the platelets in the blood, e.g. clopidogrel
- Omeprazole is 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 an additional method of contraception (eg condoms) are recommended. See the instructions in the package insert for the birth control pill you are taking.
Xagrid 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. Xagrid should not be taken by pregnant women. Women who are at risk of becoming pregnant should ensure that they use effective contraception while taking Xagrid. Talk to your doctor if you need advice on contraception.
Tell your doctor if you are breastfeeding or if you plan to breastfeed your child. Xagrid should not be taken while breastfeeding. You must stop breastfeeding if you are taking Xagrid.
Driving ability and use of machinery
Dizziness has been reported by some patients taking Xagrid. Avoid driving or using machines if you feel dizzy.
Xagrid contains lactose
Lactose is an ingredient in this medicine. If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
How to take Xagrid
Always take Xagrid as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Different people can take different amounts of Xagrid depending on the condition of the disease. Your doctor will prescribe the dose that is best for you.
The usual starting dose of Xagrid is 1 mg. You take this dose as a 0.5 mg capsule twice daily for at least one week. After that, 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 washed down with water; They must not be crushed and the contents must not be dissolved in liquid. You can take the capsules with 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 or fewer capsules than your doctor has prescribed. Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop treatment with this medicine on your initiative.
Your doctor will take blood tests at regular intervals to check that the medicine is working effectively and that your liver and kidneys are working well.
If you have taken too much Xagrid
If you have taken too much Xagrid, or if someone else has taken your medicine, you must tell your doctor or pharmacist immediately. Show them the Xagrid packaging.
If you forget to take Xagrid
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 missed dose.
Possible side effects
Like all medicines, Xagrid can cause side effects, although not everybody gets them. Talk to your doctor if you are concerned.
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 rhythm ( ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation ), inflammation of the pancreas causing severe pain in the stomach and back ( pancreatitis ), vomiting blood or bloody or black stools, a severe reduction in the number of blood cells which can cause weakness, bruising, bleeding or infection (pancytopenia), increased pressure in the arteries in the lungs ( pulmonary hypertension, signs that include shortness of breath, swollen legs or ankles, and a bluish tint to the lips and skin).
Rare: Kidney failure (little or no urination) or heart attack.
If you notice any of these side effects, contact your doctor immediately.
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 ), nausea, diarrhea, stomach pain, gas, vomiting, decrease in the number of red blood cells ( anemia ), fluid retention, or rash.
Uncommon side effects: may affect up to 1 in 100 people
Feeling weak or unwell, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling ( edema ), weight loss, muscle pain, joint pain, back pain, decreased or lost feeling or numbness, especially in the skin, abnormal sensation or crawling and tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleed, severe lung infection with fever, shortness of breath, cough, mucus production, hair loss, itchy skin or skin discoloration, impotence, chest pain, decreased number of platelets that increase 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 enzymes in your liver.
Rare side effects: 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 build-up around the heart, painful spasms in the blood vessels of the heart (at rest, usually during the night or early morning) (Prinzmetal’s angina ), loss of coordination, difficulty speaking, dry skin, migraine, visual disturbances 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, sleepiness, dilated blood vessels, inflammation in the large intestine (signs of this are pain, nausea, and vomiting), area of abnormal density in the lung or increased 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 pointes );
- liver inflammation. 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 that causes scarring of the lungs), (allergic alveolitis, including interstitial lung disease and pneumonitis );
- kidney inflammation (tubulointerstitial nephritis).
- stroke ( see section 2).
How Xagrid should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and bottle label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
If your doctor stops your treatment with the medicine, you should not keep any remaining capsules unless your doctor tells you to do so. Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is anagrelide. Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride).
Other ingredients are:
Capsule content: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460), and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171).
Marking ink: shellac, strong ammonium solution, potassium hydroxide (E525), black iron oxide (E172).
Appearance and package sizes of the medicine
Xagrid is supplied as opaque, hard, white capsules. They are marked with “S 063”.
The capsules are supplied in bottles of 100 hard capsules. The jar also contains a small sealed container. It contains a desiccant that keeps the capsules dry. Store the sealed container in the jar. The desiccant must not be removed or ingested.
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Phone: +800 66838470
Email: medinfoEMEA@takeda.com