SPRYCEL 20 mg film-coatedtablets

SPRYCEL is a leukaemia treatment for adults with chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. SPRYCEL inhibits the growth of these leukaemic cells.

SPRYCEL is also a treatment for adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL), and lymphoid blast CML who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. SPRYCEL inhibits the growth of these leukaemic cells.

If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.

SPRYCEL will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.

Do not take SPRYCEL
if you are allergic ( hypersensitive) to dasatinib or any of the other ingredients of SPRYCEL. If you could be allergic, ask your doctor for advice.

Take special care with SPRYCEL
if you are taking medicines to thin the blood or prevent clots (see Using other medicines) if you have a liver or heart problem, or used to have one
if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older).

If any of these affects you, tell your doctor. Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect. You will also have blood tests regularly while you are taking SPRYCEL.

Children, adolescents and SPRYCEL

SPRYCEL is not recommended in patients below 18 years of age. There is limited experience with the use of SPRYCEL in this age group.

Older people and SPRYCEL

SPRYCEL can be used by people over 65 at the same doses as other adults.

Using other medicines

SPRYCEL is mainly handled by the liver. Certain medicines may interfere with the effect of SPRYCEL when taken together.

These medicines are not to be used with SPRYCEL:

ketoconazole, itraconazole - these are antifungal medicineserythromycin, clarithromycin, telithromycin - these are antibioticsritonavir - this is an antiviral medicinedexamethasone - this is a corticosteroidphenytoin, carbamazepine, phenobarbital - these are treaments for epilepsyrifampicin - this is a treatment for tuberculosis
famotidine, omeprazole - these are medicines that block stomach acids
St. John?s wort - a herbal preparation obtained without a prescription used to treat depression and other conditions(also known as Hypericum perforatum)

Medicines that neutralise stomach acids (antacids such as aluminium hydroxide/magnesium hydroxide) may be taken up to 2 hours before or 2 hours after taking SPRYCEL.

You should tell your doctor if you are taking medicines to thin the blood or prevent clots.

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

Pregnancy and breast-feeding
If you are pregnant or think you may be, tell your doctor immediately. SPRYCELis not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy. Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.

If you are breast-feeding, tell your doctor. Breast-feeding should be stopped if you are taking SPRYCEL.

Driving and using machines

Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision. It is not known if SPRYCEL will affect your ability to drive or use machines.

Important information about some of the ingredients of SPRYCEL

SPRYCEL contains lactose. If you have been diagnosed with an intolerance to some sugars, talk to your doctor before taking this medicine.

Always take SPRYCEL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. SPRYCEL is prescribed for adults.

The starting dose recommended for patients with chronic phase CML is 100 mg once a day.

The starting dose recommended for patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day.

Tabletsshould be taken at the same time every day.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly. For higher or lower doses, use of combinations of the different tablet strengths may be necessary.

The tablets may come in calendar packs. These are blister packs showing the days of the week. There are arrows to show the next tablet to be taken according to your treatment schedule.

How to take SPRYCEL

The tablets must be swallowed whole, not crushed. They can be taken with or without a meal.

Special handling instructions for SPRYCEL

In the unlikely event of the tablets being broken, persons other than the patient are recommended to use gloves when handling SPRYCEL .

How long to take SPRYCEL

You should take SPRYCEL daily until your doctor tells you to stop. Make sure you take SPRYCEL for as long as it is prescribed.

If you take more SPRYCEL than you should

If you have accidentally taken too many tablets, talk to your doctor immediately. You may require medical attention.

If you forget to take SPRYCEL

Do not take a double dose to make up for a forgotten tablet. Take the next scheduled dose at the regular time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, SPRYCEL can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following:
if you have chest pain, difficulty breathing, coughing and faintingif you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools
if you get signs of infections such as fever, severe chills
These can all be signs of serious side effects.

Frequencies are defined as follows:

very common affects more than 1 user in 10 common affects 1 to 10 users in 100

uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data

Very common side effects
Infections (including bacterial, viral and fungal)
Heart and lungs: shortness of breath
Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting)
Skin, hair, eye, general: skin rash, fever, swelling around hands and feet, headache, feeling tired or weak, bleeding
Pain: pain in the muscles, abdominal (tummy) pain
Tests may show: low blood platelet count, low white blood cells count (neutropenia), anaemia, fluid around the lungs

Common side effects
Infections: pneumonia, herpes viral infection, upper respiratory infection
Heart and lungs: cough, palpitations, flushing, dizziness, congestive heart failure, cardiac dysfunction, high blood pressure, increased blood pressure in the arteries that supply the lungs Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis
Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflamation of the skin, persistant noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, haematoma, depression, insomnia, contusion, anorexia, somnolence, generalised oedema
Pain: pain in joints, muscle inflammation, muscular weakness, chest pain, pain around hands and feet, chills
Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, deficiency in all blood cells, gastrointestinal bleeding

Other side effects that have been reported (frequency not known) include: inflammation of the lungs, blood clots in the blood vessels, and irregular heart rhythm.

Your doctor will check for some of these effects during your treatment.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use SPRYCEL after the expiry date which is stated on the label, blister or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 SPRYCEL contains

The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).The other ingredients are:
Tablet core: lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium; hydroxypropyl cellulose; magnesium stearate
Film-coating: hypromellose; titanium dioxide; macrogol 400

What SPRYCEL looks like and contents of the pack

SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with ?BMS? debossed on one side and ?527? on the other side.

SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with ?BMS? debossed on one side and ?528? on the other side.

SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with ?BMS? debossed on one side and ?524? on the other side.

SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with ?BMS 80? debossed on one side and ?855? on the other side.

SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with ?BMS 100? debossed on one side and ?852? on the other side.

SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with ?BMS 140? debossed on one side and ?857? on the other side.

SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 blisters of 14 film-coated tablets each, and in cartons containing 60 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child resistant closure containing 60 film-coated tablets. Each carton contains one bottle.

SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child resistant closure containing 30 film-coated tablets. Each carton contains one bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

BRISTOL-MYERS SQUIBB PHARMA EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Manufacturer

Bristol-Myers Squibb
Rue du Docteur André Gilles
28230 Epernon
France

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

03012 Anagni (FR)

Italy

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

BelgiqueBelgiëBelgien BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11 LuxembourgLuxemburg BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11

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Deutschland BRISTOL-MYERS SQUIBB GMBH CO. KGAA Tel 49 89 121 42-0 Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf 47 67 55 53 50

Österreich BRISTOL-MYERS SQUIBB GESMBH Tel 43 1 60 14 30 Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 372 6827 400

BRISTOL-MYERS SQUIBB A.E. 30 210 6074300 Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel. 48 22 5796666

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IrelandSlovenija
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDBRISTOL-MYERS SQUIBB SPOL. S R.O. Tel: + 353 (1 800) 749 749 Tel: + 386 1 236 47 00

Ísland VISTOR HF Sími 354 535 7000 Slovenská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 421 2 59298411

Italia BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61 SuomiFinland OY BRISTOL-MYERS SQUIBB FINLAND AB PuhTel 358 9 251 21 230

BRISTOL-MYERS SQUIBB A.E 357 800 92666 Sverige BRISTOL-MYERS SQUIBB AB Tel 46 8 704 71 00

United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDTel 44 0800 731 1736 Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 371 67 50 21 85

Lietuva
BRISTOL-MYERS SQUIBB
GYÓGYSZERKERESKEDELMI KFT.
Tel: + 370 5 2790 762

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