XAGRID 0.5 MG Hard capsule

Зміст інструкції

1. Xagrid 0.5 mg hard capsules
   1. What is Xagrid and what is it used for
   2. What you need to know before taking Xagrid
   3. How to take Xagrid
   4. Possible side effects
   5. How to store Xagrid
   6. Package contents and other information

Xagrid 0.5 mg hard capsules

anagrelide

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Xagrid is and what it is used for
• 2. What you need to know before you take Xagrid
• 3. How to take Xagrid
• 4. Possible side effects
• 5. How to store 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 development
of platelets. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in the
number of platelets in the blood to a level closer to normal values. For this reason, it is used for
the treatment of patients with essential thrombocythemia.
Essential thrombocythemia is a disorder that occurs when the bone marrow produces excessive amounts of blood cells called platelets. The presence of a high number of platelets in the
blood can cause serious circulation and coagulation problems.

2. What you need to know before taking Xagrid

Do not take Xagrid

• if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Possible signs of an allergic reaction are skin rashes, 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 have heart problems;
• if you have been born with or have a family history of prolonged QT interval (seen on an ECG, the recording of the electrical activity of the heart), if you are taking other medicines that cause abnormal changes to 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 in combination with acetylsalicylic acid (a substance present in many medicines used to relieve
pain and reduce fever, as well as to prevent blood clot formation, also known as aspirin), there is an
increased risk of major bleeding (bleeding) (see section “Other medicines and Xagrid”).
While taking Xagrid, you must take the exact dose prescribed by your doctor. Do not stop
taking the medicine without first talking to your doctor. You should not suddenly stop
taking this medicine without consulting your doctor. Suddenly stopping the medicine 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
difficulty understanding speech, sudden difficulty 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 regarding 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.
Tell your doctor if you are taking any of the following medicines:

• Medicines that can alter the heart rhythm, such as sotalol, amiodarone;
• Fluvoxamine, for the treatment of depression;
• Certain types of antibiotics, such as enoxacin, for the treatment of infections;
• Theophylline, for the treatment of asthma and severe breathing difficulties;
• Medicines for the treatment of heart disorders, such as milrinone, enoximone, amrinone, olprinone and cilostazol;
• Acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation, also known as aspirin).
• Other medicines for the treatment of 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 using this medicine, the effectiveness of oral contraceptives may be reduced and the use of an additional method of contraception is recommended

The action of Xagrid or these medicines may not be effective if they are taken
together.
If in doubt, ask your doctor or pharmacist for advice.

Pregnancy and breastfeeding
Tell your doctor if you are pregnant or planning a pregnancy. Xagrid should not
be taken by pregnant women. Women at risk of pregnancy must use
effective methods of contraception when taking Xagrid. Consult your doctor if you need advice on
methods of contraception.
Tell your doctor if you are breastfeeding or intend to breastfeed your baby. Xagrid should not
be taken by women who are breastfeeding. If you take Xagrid, you should stop breastfeeding.

Driving and operating machinery
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 him/her before taking this medicine.

3. How to take Xagrid

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The amount of Xagrid to be taken may vary from patient to patient, depending on the disorder you
suffer from. Your doctor will prescribe the most suitable dose for you.
The usual starting dose of Xagrid is 1 mg. You should take this dose in a 0.5 mg capsule twice
daily, for at least one week. Afterwards, your doctor may increase or reduce the
number of capsules to be taken, to determine the most suitable dose for you, i.e. the one that allows
to treat your disorder with maximum efficacy.
The capsules must be swallowed whole, with a glass of water. Do not crush the capsules and do not
dissolve the contents in a liquid. You can take the capsules with meals, after meals or on an
empty stomach. It is recommended to take the capsule(s) at the same time each day.

Do nottake a higher or lower number of capsules than recommended by your doctor. Do not
stop taking the medicine without first talking to your doctor. Do not decide on your
own to stop taking the medicine.
Your doctor will ask you to undergo regular blood tests to check the effectiveness of the
medicine and the correct functioning of the liver and kidneys.

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 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.
If you have any concerns, talk to your doctor.

Serious side effects:
Uncommon: heart failure (signs include shortness of breath, chest pain, swelling of the
legs due to fluid retention), serious problems with the heart rate or rhythm
(ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the
pancreas causing severe abdominal and back pain (pancreatitis), vomiting with blood or
blood in the stool or black stools, a severe decrease in the number of blood cells, which can
cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (the
signs include shortness of breath, swelling of the legs or ankles and possible bluish
discoloration of the lips and skin).
Rare: kidney failure (when urine output is reduced or absent), heart attack.

If you experience 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, fatigue, increased heart rate, irregular or strong heartbeats (palpitations),
feeling unwell (nausea), diarrhea, stomach pain, flatulence, feeling sick (vomiting), decreased
red blood cells in the blood (anemia), 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 (edema), weight loss,
muscle pain, joint pain, back pain, reduced or loss of sensation or numbness, 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, shortness of
breath, cough, phlegm; hair loss, skin discoloration or itching, impotence, chest pain, decreased
platelet count in the blood, resulting in an increased risk of bleeding or bruising (thrombocytopenia), fluid
build-up around the lungs or increased liver enzymes. Your doctor may prescribe blood tests that could
reveal an increase in 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 build-up 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 getting up (particularly if you have been sitting or lying down), increased need to
urinate during the night, pain, flu-like symptoms, drowsiness, dilation of blood vessels,
inflammation of the large intestine (signs include: diarrhea, 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, with potential life-threatening consequences (torsades de pointes);
• liver inflammation, with symptoms including nausea, vomiting, itching, yellowing of the skin and eyes, altered stool and urine color (hepatitis);
• lung inflammation (signs include fever, cough, difficulty breathing, wheezing and can cause scarring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonia);
• kidney inflammation (tubulo-interstitial nephritis);
• Stroke (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the package and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
If your doctor prescribes stopping the use of the medicine, do not keep the remaining capsules, unless
your doctor specifically asks you to. Do not dispose of any medicine in wastewater or
household waste. Ask your pharmacist how to eliminate medicines that you no longer use. This
will help protect the environment.

6. Package contents and other information

What Xagrid contains
The active ingredient is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide
hydrochloride).
The other ingredients are:
Capsule content: povidone (E1201); crospovidone; lactose, anhydrous; 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).

Description of the appearance of Xagrid and contents of the pack
Xagrid is supplied in the form of opaque white hard capsules. They are marked with the
inscription ‘S 063’.
The capsules are supplied in bottles containing 100 hard capsules. The bottle also includes a small
sealed container, which contains 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, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf: +45 46 77 10 10
[email protected]

Malta
Drugsales Ltd
Tel: +356 21419070
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma AS
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Τakeda ΕΛΛΑΣ Α.Ε.
Tηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España S.A
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
T é l: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[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]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Κύπρος
A.POTAMITIS MEDICARE LTD
Τηλ: +357 22583333
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 2830 640 902
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[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
related therapeutic treatments are provided.