Tyverb 250 mg film-coated tablets

Tyverb is used to treat certain types of breast cancer(HER2-overexpressing) which have spread beyond the original tumour ( 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 other treatment for advanced or metastatic breast cancerbefore.

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.

Do not take Tyverb

• if you are allergic ( hypersensitive) to lapatinib or any of the other ingredients of Tyverb.

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 any liver problems.
• if you have any kidney problems.

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.

Taking other medicinesTell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any 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 ? medicinesused 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?re 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.

Taking Tyverb with food and drink

Take Tyverb either at least one hour before or at least one hour after food.

Tyverb is affected by food intake. It is important that you take your tablets at the same time in relation to food each day - for example, you could always take your tablet one hour before breakfast.

Don?t drink grapefruit juice while you are being treated with Tyverb.

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

No studies have been performed on the effects of Tyverb on your ability to drive or use 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 machinery could be affected. These effects are described in section 4, ?Possible side effects?.

Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

Always take Tyverb 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 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. See ?Taking Tyverb with food and drink? in section 2 for more information.

While you are taking Tyverb

• Depending on your response to treatment, 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.

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

Severe allergic reaction

This rare side effect may affect up to 1 in 1000 people and 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

These may affect more than 1 in 10 people:

• diarrhoea (which may make you dehydrated and lead to more severe complications) Tell your doctor if you get diarrhoea. There is more advice on reducing the risk of diarrhoea at the end of section 4.
• rash, dry skin, itchingTell 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

These 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.

Tell your doctor if you get any of these symptoms.

Other common side effects

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

Tell your doctor or pharmacist if this side effect gets severe or troublesome.

Uncommon side effects

These 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

This may affect up to 1 in 1000 people:

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

If you get other side effects

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

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.

Keep out of the reach and sight of children.

Do not use Tyverb after the expiry date which is stated on the blister or bottle and the carton.

Do not store above 30ºC

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 Tyverb contains

The active substance in Tyverb islapatinib. 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. Always take the number of Tyverb tablets each day exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 or 140 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.

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

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

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

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Lietuva

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Tel: + 370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in {MM/YYYY}.

This medicine has been given ?conditional approval?.
This means that there is more evidence to come about this medicine.
The European Medicines Agency (EMA) will review new information on the medicine every year and this leaflet will be updated as necessary.