Xagrid 0.5 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Xagrid 0.5 mg hard capsules

anagrelide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Xagrid is and what it is used for

Xagrid contains the active substance anagrelide. Xagrid is a medicine that interferes with platelet development. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in blood platelet count towards 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 an excessive number of blood cells known as platelets. A high number of platelets in the blood can cause serious circulation and blood clotting problems.

2. What you need to know before you start taking Xagrid

Do not take Xagrid

• if you are allergic to anagrelide or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may present as 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 starting to take Xagrid:

• if you have or think you might have a heart problem;
• if you were born with long QT interval or have a family history of long QT interval (seen on ECG, the 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 section “Taking Xagrid with other medicines”);
• if you have liver or kidney problems.
• When used together with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin), there is an increased 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 need to take any other medicines.

Inform 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 serious breathing problems;
• Medicines to treat heart conditions, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• Acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin);
• Other medicines to treat conditions affecting blood platelets, 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, the effectiveness of the oral contraceptive may be reduced, and it is recommended to use an additional contraceptive method (e.g., condom). Please refer to the instructions in the leaflet of the oral contraceptive you are taking.

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

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

Consult your doctor if you are pregnant or planning to become pregnant. If you are pregnant, you must not take Xagrid. Women who could become pregnant should ensure they use effective contraception while taking Xagrid. Consult your doctor if you need advice on contraception.

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

Driving and using machines

Some patients taking Xagrid have reported 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Xagrid

Follow exactly the administration instructions for Xagrid given by your doctor. If in doubt, consult your doctor or pharmacist again.

The amount of Xagrid that different patients may take can vary, depending on the condition being treated. Your doctor will prescribe the most appropriate dose for your case.

The usual starting dose of Xagrid is 1 mg. This dose consists of one 0.5 mg capsule taken twice daily for at least one week. After this period, your doctor may increase or decrease the number of capsules you should take until finding the dose best suited to your condition and that treats it most effectively.

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

Do not take more capsules than your doctor has recommended.

Your doctor will instruct you to have regular blood tests to check whether the medicine is working and to ensure your liver and kidneys are functioning properly.

If you take more Xagrid than you should

If you take more Xagrid than prescribed or if someone else has taken this medicine, inform your doctor or pharmacist immediately. Show them the Xagrid packaging.

If you forget to take Xagrid

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

4. Possible adverse effects

Like all medicines, Xagrid can cause adverse effects, although not everyone experiences them. If you are concerned about this, consult your doctor.

Serious adverse effects:

Uncommon: heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious problem with heart rate or rhythm (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas causing severe back and abdominal pain (pancreatitis), vomiting blood or passing dark or bloody stools, severe reduction in blood cell count leading to weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, leg or ankle swelling, and bluish discoloration of lips and skin).

Rare: kidney failure (when urinating little or not at all), heart attack.

If you notice any of these adverse effects, contact your doctor immediately.

Very common adverse effects: may affect more than 1 in 10 patients

Headache.

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

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

Uncommon adverse 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 reduced sensation or numbness (especially in the skin), abnormal sensation such as tingling or numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling short of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough or phlegm, hair loss, skin itching, changes in skin color, impotence, chest pain, decreased platelet count in the blood increasing the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or increased liver enzymes. Your doctor may perform blood tests that could indicate elevated liver enzymes.

Rare adverse 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), enlarged heart, fluid accumulation around the heart, painful spasm of the heart's blood vessels (while at rest, usually at 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 upon standing (especially when getting 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 usually accompanied by blood or mucus, stomach pain, fever), inflammation of the stomach (symptoms include pain, nausea, vomiting), area of abnormal density in the lungs, increased creatinine levels in blood tests which may indicate kidney problems.

The following adverse effects have been reported, although the exact frequency is unknown:

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

Reporting of adverse effects

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

5. Storage of 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 label of the bottle or the carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

If your doctor discontinues treatment, do not keep any leftover capsules unless your doctor advises you otherwise. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused capsules and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xagrid

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

The other components 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 ammonium hydroxide solution, potassium hydroxide (E525), black iron oxide (E172).

Appearance of the product and contents of the pack

Xagrid is presented as white, opaque hard capsules with the imprint 'S 063' printed on them. The capsules are supplied in bottles containing 100 hard capsules. The bottle also contains a small sealed packet with a desiccant to keep the capsules dry. Keep this sealed packet inside the bottle. Do not remove or ingest the desiccant.

Date of the most recent review of this leaflet:

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