Xagrid
Italy
Table of Contents
Patient Information Leaflet: Information for the Patient
Xagrid 0.5 mg Hard Capsules
anagrelide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Xagrid is and what it is used for
- What you need to know before taking Xagrid
- How to take Xagrid
- Possible side effects
- How to store Xagrid
- 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 platelet count in the blood to a level closer to normal. For this reason, it is used to treat patients with essential thrombocythemia.
Essential thrombocythemia is a disorder that occurs when the bone marrow produces excessive amounts of blood cells called platelets. Having a high number of platelets in the blood can cause serious circulation and blood clotting problems.
2. What you need to know before 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). Possible signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and 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 or have a family history of QT interval prolongation (seen on an ECG, the recording of the heart's electrical activity), if you are taking other medicines that cause abnormal changes in the ECG, or if you have low levels of electrolytes such as potassium, magnesium, or calcium (see section “Other medicines and Xagrid”);
- if you have liver or kidney problems.
When taken together with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots, also known as aspirin), there is an increased risk of major bleeding (haemorrhage) (see section “Other medicines and Xagrid”).
While taking Xagrid, you must take exactly the dose prescribed by your doctor. Do not stop taking the medicine without first talking to your doctor. You must not stop taking this medicine suddenly without consulting your doctor. Stopping this medicine suddenly may increase the risk of stroke.
Signs and symptoms of stroke may include sudden numbness or weakness of 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 problems with walking, dizziness, loss of balance or lack of coordination; and sudden severe headache with no known cause. Seek immediate medical attention.
Children and adolescents
Information on the use of Xagrid in children and adolescents is limited; 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.
Inform your doctor if you are taking any of the following medicines:
- Medicines that may affect heart rhythm, such as sotalol, amiodarone;
- Fluvoxamine, used to treat depression;
- Certain types of antibiotics, such as enoxacin, used to treat infections;
- Theophylline, used to treat asthma and severe breathing difficulties;
- Medicines used 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 clots, also known as aspirin);
- Other medicines used to treat platelet disorders in the blood, such as clopidogrel;
- Omeprazole, used to reduce the amount of acid produced in the stomach;
- Oral contraceptives: if severe diarrhoea occurs while taking this medicine, the effectiveness of oral contraceptives may be reduced and use of an additional contraceptive method (such as a condom) is recommended. Read the package leaflet of the contraceptive pill you are taking.
The effect of Xagrid or of these other medicines may be reduced when taken together.
If in doubt, consult your doctor or pharmacist for advice.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant or planning to become pregnant. Xagrid must not be taken by women who are pregnant. Women of childbearing potential must use effective contraception while taking Xagrid. Consult your doctor for advice on contraceptive methods.
Inform your doctor if you are breastfeeding or intend to breastfeed. Xagrid must not be taken by women who are breastfeeding. If you take Xagrid, you must stop breastfeeding.
Driving and using machines
Some patients taking Xagrid have reported dizziness. If you experience dizziness, do not drive and do not operate machinery.
Xagrid contains lactose
Lactose is a component of this medicine. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
3. How to take Xagrid
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The amount of Xagrid you need may vary from patient to patient, depending on your condition. Your doctor will prescribe the dose most suitable for you.
The usual starting dose of Xagrid is 1 mg. You should take this dose as one 0.5 mg capsule twice daily for at least one week. Afterwards, your doctor may increase or decrease the number of capsules you take in order to determine the most appropriate dose for you, i.e. the dose that provides the most effective treatment for your condition.
The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dilute the contents in a 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 or fewer capsules than your doctor has advised. Do not stop taking this medicine without first talking to your doctor. You must not decide on your own to stop taking the medicine.
Your doctor will ask you to have regular blood tests to monitor the effectiveness of the medicine and to check that your liver and kidneys are functioning properly.
If you take more Xagrid than you should
If you take more Xagrid than you should, or if someone else has taken your medicine, inform your doctor or pharmacist immediately, showing 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 the forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any concerns, speak with your doctor.
Serious side effects:
Uncommon: heart failure (signs include breathlessness, chest pain, swelling of the legs due to fluid accumulation), serious problems with heart rate or heartbeat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas causing severe abdominal and back pain (pancreatitis), vomiting blood or presence of blood in the stool or black stools, severe reduction in blood cells which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles and possible bluish discoloration of lips and skin).
Rare: kidney failure (when urine is reduced or absent), 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, increased heart rate, irregular or strong heartbeats (palpitations), feeling unwell (nausea), diarrhoea, stomach pain, flatulence, feeling unwell (vomiting), reduction in red blood cells in the blood (anaemia), fluid retention or skin rashes.
Uncommon side effects: may affect up to 1 in 100 people
Feeling weak or unwell, high blood pressure (hypertension), irregular heartbeats, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle pain, painful joints, back pain, reduced or loss of sensation or tingling sensations, especially of the skin, abnormal perception or sensations such as tingling, insomnia, depression, confusion, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, breathlessness, cough, phlegm; hair loss, skin discolouration or itching, impotence, chest pain, low platelet count in the blood, leading to increased risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs or increased liver enzymes. Your doctor may carry out blood tests which could reveal elevated liver enzymes.
Rare side effects: may affect up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (signs include fatigue, chest pain and palpitations), enlarged heart, fluid accumulation around the heart, painful spasm of blood vessels in the heart (at rest, usually at night or early morning) (Prinzmetal's angina), loss of coordination, difficulty speaking, dry skin, migraine, vision disturbances or double vision, ringing in the ears, dizziness when standing up (particularly if previously sitting or lying down), increased need to urinate at night, pain, flu-like symptoms, drowsiness, blood vessel dilation, inflammation of the large intestine (signs include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (signs include: pain, nausea, vomiting), areas of abnormal density in the lungs, increased levels of creatinine in the blood, which may indicate kidney problems.
The following side effects have been reported, but their frequency is unknown:
- Irregular heartbeats, possibly life-threatening (torsade de pointes);
- Liver inflammation, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, change in stool and urine colour (hepatitis);
- Lung inflammation (signs include fever, cough, breathing difficulties, wheezing, and may lead to lung scarring) (allergic alveolitis, including interstitial lung disease, pneumonia);
- Kidney inflammation (tubulo-interstitial nephritis);
- Stroke (see section 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Xagrid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If your doctor prescribes stopping treatment with this medicine, do not keep any remaining capsules, unless your doctor specifically tells you to do so. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Xagrid contains
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; lactose, anhydrous; lactose monohydrate;
microcrystalline cellulose (E460); and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171).
Printing ink: shellac; strong ammonium solution; potassium hydroxide (E525); and black iron oxide (E172).
Description of the appearance of Xagrid and the contents of the pack
Xagrid is supplied as opaque white hard capsules. They are marked with the characters 'S 063'.
The capsules are provided in bottles containing 100 hard capsules. The bottle also includes a sealed container containing a desiccant to keep the capsules dry. Keep the sealed container in the bottle. Do not remove or ingest the desiccant.
Marketing Authorisation Holder and Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]
България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]
Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]
Danmark
Takeda Pharma A/S
Tlf: +45 46 77 10 10
[email protected]
Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]
Eesti
Takeda Pharma AS
Tel: +372 6177 669
[email protected]
Ελλάδα
Takeda ΕΛΛΑΣ Α.Ε.
Tηλ: +30 210 6387800
[email protected]
España
Takeda Farmacéutica España S.A
Tel: +34 917 90 42 22
[email protected]
France
Takeda France SAS
Tél: +33 1 40 67 33 00
[email protected]
Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]
Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]
Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]
Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]
Κύπρος
A.POTAMITIS MEDICARE LTD
Τηλ: +357 22583333
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Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]
Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]
Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]
Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]
Malta
Drugsales Ltd
Tel: +356 21419070
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Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]
Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]
Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]
Polska
Takeda Pharma Sp. z o.o.
Tel.: +48 22 306 2447
[email protected]
Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: +351 21 120 1457
[email protected]
România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]
Slovenija
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: +386 (0) 59 082 480
[email protected]
Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]
Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]
Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]
United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 2830 640 902
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.