XAGRID 0.5 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Xagrid 0.5mg hard capsules

anagrelide

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 any 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.

Contents of the pack and other information

1. What is Xagrid and what is it used for
2. What you need to know before you take Xagrid
3. How to take Xagrid
4. Possible side effects
5. Storing Xagrid
6. Contents of the pack and other information

1. What is Xagrid and what is it used for

Xagrid contains the active substance anagrelide. Xagrid is a medicine that interferes with the production of platelets. It reduces the number of platelets produced by the bone marrow, which leads to a reduction in the platelet count in the blood to a more normal level. For this reason, it is used to treat patients with essential thrombocythemia.

Essential thrombocythemia is a condition that occurs when the bone marrow produces too many of the blood cells known as platelets. A high number of platelets in the blood can cause serious problems with blood circulation and clotting.

2. 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). Allergic reactions may appear as a rash, itching, swelling of the face and lips or difficulty breathing (dyspnea);
• if you have moderate or severe liver problems;
• if you have moderate or severe kidney problems.

Warnings and precautions

Talk to your doctor before you start taking Xagrid:

• if you have or think you may have a heart problem;
• if you were born with a prolonged QT interval or have a family history of prolonged QT interval (observed in the ECG, electrical recording of the heart) or if you are taking other medicines that cause abnormal changes in the ECG or if you have low levels of electrolytes, e.g. potassium, magnesium or calcium (see the section "Taking Xagrid with other medicines");
• if you have liver or kidney problems.
• 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 a greater risk of major bleeding (see section "Taking Xagrid with other medicines").

Children and adolescents

• Information on the use of Xagrid in children and adolescents is limited, and therefore this medicine should 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:

• Fluvoxamine, used to treat depression;
• Certain types of antibiotics, such as enoxacin, used to treat infections;
• Theophylline, used to treat asthma and severe respiratory problems;
• Medicines for heart conditions, such as 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 for treating conditions that affect platelets in the blood, such as clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives. If you experience severe diarrhea while taking this medicine, it may reduce the effect of the oral contraceptive and it is recommended to use an additional contraceptive method (e.g. condom). Consult the instructions in the package leaflet of the oral contraceptive you are taking.

If they are used together, either Xagrid or these medicines may not work properly.

Ask your doctor or pharmacist if you have any questions.

Pregnancy and breastfeeding

Talk to your doctor if you are pregnant or planning to become pregnant. If you are pregnant, you should not take Xagrid. Women who may become pregnant should ensure they take effective contraceptive measures while taking Xagrid. Talk to your doctor if you need advice on contraceptives.

Talk to your doctor if you are breastfeeding or planning to breastfeed. You should not take Xagrid while breastfeeding. If you are taking Xagrid, you should stop breastfeeding.

Driving and using machines

Some patients taking Xagrid have reported symptoms of dizziness. Do not drive or operate machinery if you feel dizzy.

Xagrid contains lactose

Lactose is a component of this medicine. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Xagrid

Follow the instructions for taking Xagrid exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

The amount of Xagrid that different patients can take may vary, as this depends on the condition. Your doctor will prescribe the most suitable dose for your case.

The normal initial dose of Xagrid is 1 mg. This dose is taken with a 0.5 mg capsule twice a day for at least one week. After this period, your doctor may increase or decrease the number of capsules you should take until they find the dose that best suits your case and treats the condition most effectively.

The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve the contents in a liquid. You can take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) always at the same time.

Do nottake more capsules than your doctor has recommended.

Your doctor will tell you to have regular blood tests to check if the medicine is working and if your liver and kidneys are working properly.

If you take more Xagrid than you should

If you take more Xagrid than you should or if someone else has taken this medicine, tell your doctor or pharmacist immediately. You should show them the Xagrid pack.

If you forget to take Xagrid

Take the capsules as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Xagrid can cause side effects, although not everybody gets them. If this worries you, talk to your doctor.

Serious side effects:

Uncommon: heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious heart rhythm problems (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), pancreatitis (inflammation of the pancreas that causes severe back and abdominal pain), vomiting blood or black stools, severe decrease in blood cell count that can cause weakness, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and blue discoloration of the lips and skin).

Rare: kidney failure (when little or no urine is produced), 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 patients

Headache.

Common side effects: may affect up to 1 in 10 patients

Dizziness, fatigue, rapid heartbeat, strong or irregular heartbeat (palpitations), nausea, diarrhea, stomach pain, gas, vomiting, decrease in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 patients

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, loss or decrease in sensation or feeling like numbness (especially in the skin), sensitivity or abnormal feeling like tingling and numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough or sputum, hair loss, itching of the skin, changes in skin color, impotence, chest pain, decrease in platelet count in the blood that increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or an increase in liver enzymes. Your doctor may perform blood tests that may indicate an increase in liver enzymes.

Rare side effects: may affect up to 1 in 1,000 patients

Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the heart, painful spasm of the heart's blood vessels (usually at rest, normally at night or early in the morning) (Prinzmetal's angina), loss of coordination, difficulty speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness when standing up (especially when standing up after sitting or lying down), increased need to urinate at night, pain, "flu-like" symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine (symptoms include diarrhea accompanied by blood or mucus, stomach pain, fever), stomach inflammation (symptoms include pain, nausea, vomiting), abnormal area in the lungs, increase in creatinine levels in blood tests that may indicate kidney problems.

The following side effects have been reported, but the exact frequency with which they occur is unknown:

• Potentially life-threatening irregular heartbeat (torsade de pointes);
• Liver inflammation, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, abnormal color of stools and urine (hepatitis);
• Lung inflammation (symptoms include fever, cough, difficulty breathing or wheezing; this causes lung scarring) (allergic alveolitis including interstitial lung disease and pneumonitis);
• Kidney inflammation (tubulointerstitial nephritis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Xagrid

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 or bottle after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

If your doctor stops your treatment, do not keep the remaining 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. This will help protect the environment.

6. Contents of the pack and other information

Xagrid composition

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

The other ingredients are:

Capsule contents: povidone (E1201), crospovidone, anhydrous lactose, lactose monohydrate, microcrystalline cellulose (E460), and magnesium stearate.

Capsule shell: gelatin and titanium dioxide (E171).

Printing ink: shellac, strong ammonia solution, potassium hydroxide (E525), black iron oxide (E172).

Appearance and pack contents

Xagrid is presented as hard white capsules with 'S 063' printed on them. The capsules are packed in bottles of 100 hard capsules. The bottle also contains a small sealed container with a desiccant to keep the capsules dry. Keep this sealed container in the bottle. Do not remove or eat the desiccant.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicines.