Package leaflet: Information for the user

Tyverb 250 mg film-coated tablets

lapatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Don’t pass it on to others. It may harm them, even if their signs of illness seem the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  
  

  What is in this leaflet

  
  

  1. What Tyverb is and what it is used for

  2. What you need to know before you take Tyverb

  3. How to take Tyverb

  4. Possible side effects

  5. How to store Tyverb

  6. Contents of the pack and other information

  
  

  1. What Tyverb is and what it is used for

     
     

     Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer). It may slow or stop cancer cells from growing, or may kill them.

     
     

     Tyverb is prescribed to be taken in combination with another anti-cancer medicine.

     
     

     Tyverb is prescribed in combination with capecitabine, for patients who have had treatment for advanced or metastatic breast cancer before. This previous treatment for metastatic breast cancer must have included trastuzumab.

     
     

     Tyverb is prescribed in combination with trastuzumab, for patients who have hormone receptor- negative metastatic breast cancer and have had other treatment for advanced or metastatic breast cancer before.

     
     

     Tyverb is prescribed in combination with an aromatase inhibitor, for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy.

     
     

     Information about these medicines is described in separate patient information leaflets. Ask your doctor to give you information about these other medicines.

     
     

  2. What you need to know before you take Tyverb Do not take Tyverb

• if you are allergic to lapatinib or any of the other ingredients of this medicine (listed in Section 6).

  Take special care with Tyverb

  
  

  Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.

  Tell your doctor if you have any heart problems before you take Tyverb. Your doctor also needs to know before you take Tyverb:

• if you have lung disease

• if you have inflammation of the lung

• if you have any liver problems

• if you have any kidney problems

• if you have diarrhoea (see section 4).

  
  

  Your doctor will run tests to check that your liver is working properly before and during your treatment with Tyverb.

  
  

  Tell your doctor if any of these apply to you.

  
  

  Serious skin reactions

  Serious skin reactions have been seen with Tyverb. Symptoms may include skin rash, blisters and skin peeling.

  
  

  Tell your doctor as soon as possible if you get any of these symptoms.

  
  

  Other medicines and Tyverb

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and other medicines you bought without a prescription.

  
  

  It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines. Some medicines may affect the way Tyverb works or Tyverb may affect how other medicines work. These medicines include some medicines in the following groups:

  
  

• St John’s Wort – a herb extract used to treat depression

• erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin – medicines used to treat infections

• cyclosporine – a medicine used to suppress the immune system for example after organ transplantations

• ritonavir, saquinavir – medicines used to treat HIV

• phenytoin, carbamazepine – medicines used to treat seizures

• cisapride – a medicine used to treat certain digestive system problems

• pimozide – a medicine used to treat certain mental health problems

• quinidine, digoxin – medicines used to treat certain heart problems

• repaglinide – a medicine used to treat diabetes

• verapamil – a medicine used to treat high blood pressure or heart problems (angina)

• nefazodone – a medicine used to treat depression

• topotecan, paclitaxel, irinotecan, docetaxel – medicines used to treat certain types of cancer

• rosuvastatin – a medicine used to treat high cholesterol

• medicines that decrease stomach acidity - used to treat stomach ulcers or indigestion

  
  

  Tell your doctor if you are taking, or have recently taken, any of these.

  
  

  Your doctor will review the medicines you are currently taking to make sure you are not taking something that can’t be taken with the Tyverb. Your doctor will advise you whether an alternative is available.

  Tyverb with food and drink

  
  

  Don’t drink grapefruit juice while you are being treated with Tyverb. It can affect the way the medicine works.

  
  

  Pregnancy and breast-feeding

  
  

  The effect of Tyverb during pregnancy is not known. You should not use Tyverb if you are pregnant unless your doctor specifically recommends it.

  
  

• If you are pregnant or planning to become pregnant, tell your doctor.

• Use a reliable method of contraception to avoid becoming pregnant while you’re taking Tyverb and for at least 5 days after the last dose.

• If you become pregnant during treatment with Tyverb, tell your doctor.

  
  

  It is not known whether Tyverb passes into breast-milk. Do not breast-feed while taking Tyverb and for at least 5 days after the last dose.

• If you are breast-feeding or planning to breast-feed, tell your doctor.

  
  

  Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure. Driving and using machines

  You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration. Because of the possible side effects of Tyverb, your ability to drive or operate machines could be affected. These effects are described in section 4, ‘Possible side effects’.

  
  

  Tyverb contains sodium

  
  

  This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

  
  

  1. How to take Tyverb

     
     

     Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you’re not sure.

     
     

     Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.

     
     

     If you are prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day, as a single dose.

     
     

     If you are prescribed Tyverb in combination with trastuzumab, the usual dose is 4 Tyverb tablets a day, as a single dose.

     
     

     If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is

     6 Tyverb tablets a day, as a single dose.

     
     

     Take the prescribed dose every day for as long as your doctor tells you to.

     
     

     Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it.

     Taking your tablets

     
     

• Swallow the tablets whole with water, one after the other, at the same time each day.

• Take Tyverb either at least one hour before or at least one hour after food. Take Tyverb at the same time in relation to food each day – for example, you could always take your tablet one hour before breakfast.

  
  

  While you are taking Tyverb

  
  

• Depending on the side effects you experience, your doctor may recommend lowering your dose or temporarily stopping your treatment.

• Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.

  
  

  If you take too much Tyverb

  
  

  Contact a doctor or pharmacist immediately. If possible, show them the pack.

  
  

  If you forget to take Tyverb

  
  

  Don’t take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time.

  
  

  1. Possible side effects

     
     

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

     
     

     A severe allergic reaction is a rare side effect (may affect up to 1 in 1,000 people) and may develop rapidly.

     Symptoms may include:

• skin rash (including itchy, bumpy rash)

• unusual wheezing, or difficulty in breathing

• swollen eyelids, lips or tongue

• pains in muscles or joints

• collapse or blackout.

  
  

  Tell your doctor immediately if you get any of these symptoms. Don’t take any more tablets.

  
  

  Very common side effects (may affect more than 1 in 10 people):

  
  

• diarrhoea (which may make you dehydrated and lead to more severe complications)

  Tell your doctor immediately at the first sign of diarrhoea (loose stool), as it is important that this is treated right away. Also tell your doctor immediately if your diarrhoea worsens. There is more advice on reducing the risk of diarrhoea at the end of section 4.

  
  

• rash, dry skin, itching

  Tell your doctor if you get a skin rash. There is more advice on reducing the risk of skin rash at the end of section 4.

  Other very common side effects

  
  

• loss of appetite

• feeling sick (nausea)

• being sick (vomiting)

• tiredness, feeling weak

• indigestion

• constipation

• sore mouth/mouth ulcers

• stomach pain

• trouble sleeping

• back pain

• pain in hands and feet

• joint or back pain

• a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness, pain, swelling or reddening)

• cough, shortness of breath

• headache

• nose bleed

• hot flush

• unusual hair loss or thinning

  
  

  Tell your doctor if any of these side effects get severe or troublesome.

  
  

  Common side effects (may affect up to 1 in 10 people):

  
  

• an effect on how your heart works

  
  

  In most cases, the effect on your heart will not have any symptoms. If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath.

  
  

• liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach

• nail disorders – such as a tender infection and swelling of the cuticles

• skin fissures (deep cracks on the skin or chapped skin)

  
  

  Tell your doctor if you get any of these symptoms. Uncommon side effects (may affect up to 1 in 100 people):

• treatment-induced lung inflammation, which may cause shortness of breath or cough

  Tell your doctor immediately if you get either of these symptoms.

  
  

  Other uncommon side effects include:

• blood tests results that show changes in liver function (usually mild and temporary)

  
  

  Rare side effects (may affect up to 1 in 1,000 people):

  
  

• severe allergic reactions (see the beginning of section 4)

  The frequency of some side effects is not known (it cannot be estimated from the available data):

• irregular heart-beat (change in the electrical activity of the heart)

• severe skin reaction that might include: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever or any combination of these

• pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)

  
  

  If you get other side effects

  
  

  Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.

  
  

  Reducing the risk of diarrhoea and skin rash Tyverb can cause severe diarrhoea

  If you suffer from diarrhoea while taking Tyverb:

  
  

• drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks or other clear liquids

• eat low-fat, high protein foods instead of fatty or spicy foods

• eat cooked vegetables instead of raw vegetables and remove the skin from fruits before eating

• avoid milk and milk products (including ice cream)

• avoid herbal supplements (some may cause diarrhoea).

  
  

  Tell your doctor if your diarrhoea continues.

  
  

  Tyverb can cause skin rash

  
  

  Your doctor will check your skin before and during treatment. To care for sensitive skin:

  
  

• wash with a soap-free cleanser

• use fragrance free, hypoallergenic beauty products

• use sunscreen (Sun Protection Factor [SPF] 30 or higher).

Tell your doctor if you get a skin rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

1. How to store Tyverb

   
   

   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 blister or bottle and the carton. Do not store above 30ºC.

   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

2. Contents of the pack and other information What Tyverb contains

• The active substance in Tyverb is lapatinib. Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

• The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400),

polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).

What Tyverb looks like and contents of the pack

Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG’ marked on one side. Tyverb is supplied in either blisters packs or bottles:

Blister packs

Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each. Each

foil has a perforation down the middle and can be divided into two blisters with 5 or 6 tablets in each, depending on the pack size.

Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.

Bottles

Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building

Elm Park, Merrion Road Dublin 4

Ireland

Manufacturer

Glaxo Wellcome S.A. Avenida de Extremadura 3

09400 Aranda de Duero

Burgos Spain

Novartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany

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

België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Lietuva

SIA Novartis Baltics Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD Тел: +359 2 489 98 28

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH Tel: +49 911 273 0

Nederland

Novartis Pharma B.V. Tel: +31 88 04 52 555

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc. Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB Tel: +46 8 732 32 00

Latvija

SIA Novartis Baltics Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited Tel: +44 1276 698370

This leaflet was last revised in

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