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Tyverb (lapatinib) – Package leaflet - L01XE07

Updated on site: 10-Oct-2017

Medication nameTyverb
ATC CodeL01XE07
Substancelapatinib
ManufacturerNovartis Europharm Limited

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.

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.

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’.

3.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 missed dose. Just take the next dose at the scheduled time.

4.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 1000 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

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 1000 people):

severe allergic reactions (see the beginning of section 4)

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.

5.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.

6. 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), 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

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.

Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain. Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom

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

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

Novartis Pharma N.V.

Тел: +359 2 489 98 28

Tél/Tel: +32 2 246 16 11

Česká republika

Magyarország

Novartis s.r.o.

Novartis Hungária Kft. Pharma

Tel: +420 225 775 111

Tel.: +36 1 457 65 00

Danmark

Malta

Novartis Healthcare A/S

Novartis Pharma Services Inc.

Tlf: +45 39 16 84 00

Tel: +356 2122 2872

Deutschland

Nederland

Novartis Pharma GmbH

Novartis Pharma B.V.

Tel: +49 911 273 0

Tel: +31 26 37 82 555

Eesti

Norge

Novartis Pharma Services Inc.

Novartis Norge AS

Tel: +372 66 30 810

Tlf: +47 23 05 20 00

Ελλάδα

Österreich

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

Novartis Pharma GmbH

Τηλ: +30 210 281 17 12

Tel: +43 1 86 6570

España

Polska

Novartis Farmacéutica, S.A.

Novartis Poland Sp. z o.o.

Tel: +34 93 306 42 00

Tel.: +48 22 375 4888

France

Portugal

Novartis Pharma S.A.S.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tél: +33 1 55 47 66 00

Tel: +351 21 000 8600

Hrvatska

România

Novartis Hrvatska d.o.o.

Novartis Pharma Services Romania SRL

Tel. +385 1 6274 220

Tel: +40 21 31299 01

Ireland

Slovenija

Novartis Ireland Limited

Novartis Pharma Services Inc.

Tel: +353 1 260 12 55

Tel: +386 1 300 75 50

Ísland

Slovenská republika

Vistor hf.

Novartis Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 5542 5439

Italia

Suomi/Finland

Novartis Farma S.p.A.

Novartis Finland Oy

Tel: +39 02 96 54 1

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

Κύπρος

Sverige

Novartis Pharma Services Inc.

Novartis Sverige AB

Τηλ: +357 22 690 690

Tel: +46 8 732 32 00

Latvija

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.

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