Prospecto: information for the user

Tyverb 250mg film-coated tablets

lapatinib

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isTyverband what it is used for

2.What you need to know before starting to takeTyverb

3.How to takeTyverb

4.Possible adverse effects

5Storage ofTyverb

6.Contents of the pack and additional information

Tyverb is used to treat some types of breast cancerthat overexpress HER2 receptors and have spread beyond the original tumor or to other organs (advanced or metastatic breast cancer). This medication may reduce or stop the growth of cancer cells, or eliminate them.

Tyverb is prescribed to be taken in combination with other anticancer medications.

Tyverb is prescribed in combination with capecitabinain patients who have received previous treatment for advanced or metastatic breast cancer. The previous treatment for metastatic breast cancer must have included trastuzumab.

Tyverb is prescribed in combination with trastuzumabin patients with metastatic breast cancer that is hormone receptor-negative and who have received previous treatment for metastatic breast cancer.

Tyverb is prescribed in combination with an aromatase inhibitorin patients with hormone-sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), for whom chemotherapy is not suitable.

The information for these medications is described in separate prospectuses.Ask your doctor to provide you with the information for these medications.

Do not take Tyverb

• if you are allergic to lapatinib or any of the other ingredients in this medicine (listed in section6).

Be especially careful with Tyverb

Your doctor will perform tests to check that your heart is working correctlybefore and during treatment with Tyverb.

Before taking Tyverb,inform your doctor if you have any heart problems.

Before starting to take Tyverb, your doctor also needs to know:

• if you have any lung disease
• if you have inflammation in the lungs
• if you have anyliver problems
• if you have anykidney problems.
• if you have diarrhea (see section4)

Your doctor will perform tests to check that your liver is working correctlybefore and during treatment with Tyverb.

Inform your doctorif you are in any of these situations.

Severe skin reactions

Severe skin reactions have been observed with the use of Tyverb. Symptoms may include skin rash, blisters, and skin peeling.

Informyour doctor as soon as possible if you experience any of these symptoms.

Other medicines and Tyverb

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.Also included are herbal remedies and other medicines obtained without a prescription.

It is especially important that you inform your doctorif you are using or have used recently any of the following medicines. Some medicines may affect how Tyverb works or Tyverb may affect how other medicines work. These medicines include medicines in the following groups:

• St. John's Wort – an herbal extract used for the treatment ofdepression

• erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin– medicines used for the treatment ofinfections
• ciclosporin – a medicine used tosuppress the immune systemsuch as after an organ transplant
• ritonavir, saquinavir – medicines used for the treatment ofHIV
• phenytoin, carbamazepine – medicines used for the treatment ofepileptic seizures
• cisapride – a medicine used for the treatment of somegastrointestinal problems
• pimozide – a medicine used for the treatment of somemental health problems
• quinidine, digoxin – medicines used for the treatment of someheart problems
• repaglinide – a medicine used for the treatment ofdiabetes
• verapamil – a medicine used for the treatment ofhigh blood pressureorheart problems(angina pectoris)
• nefazodone – a medicine used for the treatment ofdepression
• topotecan, paclitaxel, irinotecan, docetaxel – medicines used for the treatment of some types ofcancer
• rosuvastatin – a medicine for the treatment ofhigh cholesterol
• medicines that reduce stomach acidity – used for the treatment ofulcers in the stomachorindigestion.

Inform your doctorif you are using or have used recently any of these medicines.

Your doctor will review the medicines you are taking to ensure that you are not taking any medicine that cannot be taken with Tyverb. Your doctor will advise you if there is any alternative available.

Taking Tyverb with food and drinks

Do not drink grapefruit juice whileyou are being treated with Tyverb. It may affect how this medicine works.

Pregnancy and breastfeeding

The effect of Tyverb during pregnancy is unknown. Do not use Tyverb if you are pregnant, unless your doctor specifically recommends it.

• Inform your doctor if you are pregnantor plan to become pregnant.
• Use an effective contraceptive methodto avoid becoming pregnant while taking Tyverb and for at least 5 days after the last dose.
• Inform your doctor if you become pregnantwhile taking Tyverb.

The effect of Tyverb on breast milk is unknown. Do not breastfeed while taking Tyverb and for at least 5 days after the last dose.

• Inform your doctor if you are breastfeedingor plan to do so.

If you have any doubts, ask yourdoctor or pharmacistbefore taking Tyverb.

Driving and operating machinery

You are responsible for deciding if you are able to drive a vehicle or perform tasks that require high concentration. Due to the possible side effects of Tyverb, your ability to drive or operate machinery may be affected. These side effects are described in section 4, “Possible side effects”.

Tyverb contains sodium

This medicine contains less than 1mmol of sodium (23mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt, consult your doctor or pharmacist again.

Your doctor will decide on the appropriate dose of Tyverb depending on the type of breast cancer you are being treated for.

If you are prescribed Tyverb incombination with capecitabina, the usual dose is5 Tyverb tablets per day, in a single dose.

If you are prescribed Tyverb incombination with trastuzumab, the usual dose is4 Tyverb tablets per day, in a single dose.

If you are prescribed Tyverb incombination with an aromatase inhibitor, the usual dose is6 Tyverb tablets per day, in a single dose.

Take the dose prescribed by your doctor every day for the time they indicate.

Your doctor will inform you about the dose of the other anticancer medication, and how to take it.

Tablet Taking

• Swallow the tablets whole with water, one after the other, at the same time every day.
• TakeTyverb at least one hour before or one hour after eating. Take Tyverb every day at the same time in relation to meals, for example, you can take the tablets every day one hour before breakfast.

While Taking Tyverb

• Depending on the adverse effects you experience, your doctor may recommend reducing the dose or temporarily interrupting treatment.
• Your doctor will perform tests to check the functioning of your heart and liver before and during treatment with Tyverb.

If You Take More Tyverb Than You Should

Immediately contact your doctor or pharmacist. If possible, show them the packaging.

If You Forget to Take Tyverb

Do not take a double doseto make up for the missed doses. Take the next dose at the scheduled time.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

A severe allergic reaction is a rare side effect that can affect up to 1 in 1,000 people and can appear quickly.

The symptoms may include:

• skin rash (including itching, presence of papules)
• unusual wheezing or difficulty breathing
• swollen eyelids, lips, or tongue
• muscle or joint pain
• collapse or fainting.

Inform your doctor immediately if you have any of these symptoms. Do not take more tablets.

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

• diarrhea (which may cause dehydration and lead to more serious complications)

Inform your doctor immediately at the first sign of diarrhea, as it is very important that diarrhea is treated immediately. Also, inform your doctor immediately if diarrhea worsens.You can find more advice on how to reduce the risk of diarrhea at the end of section 4.

• skin rash, dry skin, itching

Inform your doctor if you have a skin rash.You can find more advice on how to reduce the risk of skin rash in section 4.

Other very common side effects:

• loss of appetite
• nausea
• vomiting
• fatigue, weakness
• indigestion
• constipation
• mouth inflammation/ulcers in the mouth
• stomach pain
• difficulty sleeping
• back pain
• pain in hands and feet
• joint and back pain
• a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness, pain, swelling, or redness)
• cough, difficulty breathing
• headache
• nasal bleeding
• angina
• unusual hair loss or fragility.

Inform your doctor if any of these side effects become severe or problematic.

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

• an effect on your heart function.

In most cases, the effect on your heart will have no symptoms. If you experience symptoms associated with this side effect, these may include irregular heartbeat and difficult breathing.

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

• changes in nails, such as a tendency to develop infections and inflammation of the cuticles
• skin cracks (deep cracks in the skin or dry skin)

Inform your doctor if you have any of these symptoms.

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

• inflammation of the lungs caused by treatment, which may cause shortness of breath or coughing.

Inform your doctor immediately if you have any of these symptoms.

Other rare side effects include:

• blood test results showing changes in liver function (usually mild and temporary)

Unknown frequency (cannot be estimated from available data):

• irregular heart rhythm (change in heart electrical activity)
• severe skin reaction that may include: rash, skin redness, blisters on the lips, eyes, or mouth, dry skin, fever, or any combination of these.
• pulmonary hypertension (high blood pressure in the arteries that go to the lungs)

If you have any other side effects

Inform your doctor or pharmacist, if you notice any side effects not mentioned in this leaflet..

Reducing the risk of diarrhea and skin rash

Tyverb may cause severe diarrhea

If you experience diarrhea while taking Tyverb:

• drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks, or other clear drinks
• 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 them
• avoid milk and dairy products (including ice cream)
• avoid herbal supplements (some may cause diarrhea).

Inform your doctor if your diarrhea continues.

Tyverb may cause skin rash

Your doctor will perform skin checks before and during treatment.

To care for sensitive skin:

• wash with a soap-free product
• use hypoallergenic beauty products, fragrance-free
• use sunscreen (SPF 30 or higher).

Inform your doctor if you have a skin rash.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.Also, you can report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack or bottle and in the carton.

Do not store at a temperature above30°C.

Dispose of unused medications and packaging through your pharmacist. This will help protect the environment.

Composition of Tyverb

• The active ingredient of Tyverb is lapatinib. Each film-coated tablet contains lapatinib ditosilato monohydrate, equivalent to 250 mg of lapatinib.
• The other components are: microcrystalline cellulose, povidone (K30), sodium carboxymethyl starch (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

Tyverb film-coated tablets are oval, biconvex, yellow, film-coated, with "GS XJG" engraved on one side.

Tyverb is supplied in blister packs or bottles:

Blister packs

Each pack of Tyverb contains 70 or 84 film-coated tablets in an aluminium blister pack of 10 or 12 tablets. Each blister has a perforation in the middle that allows these to be divided into two blisters of 5 or 6 tablets, depending on the pack size.

Tyverb is also available in multiple packs with 140 tablets, which contain 2 packs of 70 tablets.

Bottles

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Glaxo Wellcome, S.A.

Avda.Extremadura, 3

09400 Aranda de Duero, Burgos

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu Mures

Romania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.