Xagrid 0.5 mg hard capsules

Xagrid is a medicine which interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level. For this reason it is used to treat patients with essential thrombocythaemia.

Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets. Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.

Do not take Xagrid

• If you are allergic (hypersensitive) to anagrelide or any of the other ingredients of Xagrid. Check the ingredients of Xagrid listed in Section 6 of this leaflet. An allergic reaction may be recognised 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.

Take special care with Xagrid

Before treatment with Xagrid, tell your doctor:

• If you have or think you might have a problem with your heart;
• If you have any problems with your liver or kidneys;
• If you are pregnant or breastfeeding;
• If you have been told by a doctor that you have an intolerance to some sugars.

In combination with acetylsalicylic acid (aspirin), there is an increased risk of major haemorrhages (bleeding) (see Section ?Taking other medicines?).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following medicines:

• Fluvoxamine, used to treat depression;
• Omeprazole, used to treat gastro-intestinal problems like reflux oesophagitis and duodenal and gastric ulcers;
• Theophylline, used to treat severe asthma and breathing problems;
• Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol;
• Acetylsalicylic acid (aspirin), used to treat mild to moderate pain, for example, headaches;
• Other medicines used to treat conditions affecting the platelets in your blood.

Xagrid or these medicines may not work properly if taken together.

If you are not sure, speak to your doctor or pharmacist for advice.

Taking Xagrid with food and drink

Your capsules may be taken with food or after a meal or on an empty stomach. For more information on how to take your medicine, please refer to section 3.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or are planning to become pregnant. Xagrid should not be taken by pregnant women. Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking Xagrid. Speak to your doctor if you need advice with contraception.

Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby. Xagrid should not be taken while breast-feeding. You must stop breast-feeding if you are taking Xagrid.

Driving and using machines

Dizziness has been reported by some patients taking Xagrid. Do not drive or use machines if you feel dizzy.

Important information about some of the ingredients of Xagrid

Lactose is an ingredient in Xagrid. If you have been told that you have an intolerance to some sugars, contact your doctor before taking the capsules.

Always take Xagrid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The amount of Xagrid that people take can be different, and this depends on your condition. Your doctor will prescribe the best dose for you. There is limited information on the use of Xagrid in children and adolescents and therefore Xagrid should be used with caution.

The usual starting dose of Xagrid is 1 mg (2 of these capsules) per day, taken as one capsule twice a day, for at least one week.

After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.

Your capsules should be swallowed whole with a glass of water. They may be taken with food or after a meal or on an empty stomach. It is best to take the capsules at the same time every day.

Do not take more capsules than your doctor has recommended.

Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively.

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

If you forget to take Xagrid

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

Like all medicines, Xagrid can cause side effects, although not everybody gets them. If you are worried, speak to your doctor.

Serious side effects:
Severe chest pain, palpitations associated with dizziness or feeling faint, fainting, severe abdominal or gastro-intestinal pain, vomiting blood or passing bloody or black stools, breathing difficulties or shortness of breath, particularly if your lips or skin turn a bluish colour. These have not occurred commonly, but are serious conditions. If you notice any of these side effects, contact your doctor immediately.

Very common side effects (affect more than 1 user in 10): Headache.

Common side effects (affect 1 to 10 users in 100):
Dizziness (rarely when standing up or getting out of bed), tiredness, palpitations (awareness of a forceful heartbeat which may be rapid or irregular), nausea, diarrhoea, stomach pain, indigestion and wind, vomiting, anaemia (a small reduction in red blood cell count and iron deficiency), fluid retention (including swelling of your ankles) or rash.

Uncommon side effects (affect 1 to 10 users in 1,000):
A feeling of weakness or feeling unwell, high blood pressure, chills or fever, heartburn, anorexia, constipation, bruising, localised swelling with fluid (oedema), weight loss, muscle aches, painful joints, back pain, reduced feeling or tingling in toes or fingers, sleeplessness, depression, confusion, nervousness, dry mouth, loss of memory, allergic coughing, breathlessness, nosebleed, lung infection, hair loss, skin itching or discolouration, impotence, or an increase in liver enzymes. Your doctor may do a blood test which may show an increase in your liver enzymes.

Rare side effects (affect 1 to 10 users in 10,000):
Heart attack, bleeding gums, weight gain, heart muscle disease, loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, increased need to pass water at night, pain, ?flu-like? symptoms.

The following side effects have been reported but it is not known exactly how often they occur:

• Hepatitis (inflammation of the liver) with an increase in liver enzymes
• Allergic alveolitis (inflammation of the lungs)
• Tubulointerstitial nephritis (inflammation of the kidneys).

If any of these side effects cause you a problem, speak to your doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Xagrid after the expiry date which is stated on the carton 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 stops your medicine, do not keep any leftover 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. These measures will help to protect the environment.

What Xagrid contains

The active substance is anagrelide. Each capsule contains 0.5 mg 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 ammonium solution, potassium hydroxide (E525), black iron oxide (E172).

What Xagrid looks like and contents of the pack

Xagrid is supplied as opaque, white, hard capsules. They are marked with ?S 063?. The capsules are provided in bottles containing 100 hard capsules.

Marketing Authorisation Holder
Shire Pharmaceutical Contracts Limited
Hampshire International Business Park
Chineham, Basingstoke
Hampshire
RG24 8EP
United Kingdom
Tel: +44(0) 1256 894000
Fax: +44(0) 1256 894708
Email: medinfoglobal@shire.com

Manufacturer
Wasdell Packaging Limited
Upper Mills Estate
Bristol Road, Stonehouse
Gloucestershire
GL10 2BJ
United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

--------, -eská Republika, Latvija, Lietuva,
Magyarország, Österreich, Polska, România,
Slovenija, Slovenská republika
Shire Pharmaceuticals Ltd
Hampshire International Business Park
Chineham, Basingstoke
Hampshire, RG24 8EP
--------------, Velká Británie, Lielbrit-nija,
Jungtin- Karalyst-, Nagy-Britannia, Vereinigtes
Königreich, Wielka Brytania, Marea Britanie,
Velika Britanija, Vel?ká Británia
Te-/Tel: +44 1256 894 000

Italia Shire Italia S.p.A Corso Italia, 29 I-50123, Firenze Tel 39 055 288860 BelgiëBelgiqueBelgien LuxembourgLuxemburgNederland Shire Belgium BVBA Lambroekstraat 5C B-1831 Diegem BelgiëBelgique TélTel 32 2 711 02 30

K Genesis Pharma Cyprus Ltd 2 Danmark Swedish Orphan Biovitrum AS Wilders Plads 5 DK-1403 København K Tlf 45 32 96 68 69 1 , 2025 357 22 76 99 46

Deutschland Shire Deutschland GmbH Friedrichstrasse 149D-10117 BerlinTel 49 30 206 582 0 Malta Vivian Corporation Ltd Sanitas Building, Tower Str. Msida MSD 1824 Tel 356 21 320338

Eesti United Pharma Services UAB PK 209, Tartu, 50002 Tel 372 55596234 Norge Swedish Orphan Biovitrum AS Trollåsveien 6 N-1414 Trollåsen Tlf 47 66 82 34 00

Genesis Pharma S.A. . 274 , GR-152 32 30 210 877 1500 Portugal Shire Pharmaceuticals Ibérica, S.L. Paseo Pintor Rosales, 44 Bajo Izda. E-28008 Madrid Espanha Tel 34 915 500 691

SuomiFinland Oy Swedish Orphan Biovitrum AB España Shire Pharmaceuticals Ibérica, S.L. Paseo Pintor Rosales, 44 Bajo Izda. E-28008 Madrid Tel 34 915 500 691 Keilaranta 19 7th Floor FIN-02150 Espoo PuhTel 358 201 558 840

Sverige Swedish Orphan Biovitrum Sverige AB SE-112 76 Stockholm Tel 46 8 697 2000 France Shire France S.A. 88, rue du Dôme F-92514 Boulogne-Billancourt Cedex Tél 33 1 46 10 90 00

United Kingdom Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP Tel 0800 055 6614 Ireland Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP United Kingdom Tel 1800 818 016

Ísland

Swedish Orphan Biovitrum A/S
Wilders Plads 5
DK-1403 Kaupmannahöfn K
Danmörk
Sími: +45 32 96 68 69

This leaflet was last approved in

This medicine has been authorised under ?Exceptional Circumstances?. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.

The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.