Tyverb 250 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tyverb 250 mg film-coated tablets

lapatinib

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Tyverb is and what it is used for
2. What you need to know before taking Tyverb
3. How to take Tyverb
4. Possible adverse 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 (those that overexpress HER2 receptors) that have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer). This medicine may reduce or halt the growth of cancer cells, or may destroy them.

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

Tyverb is prescribed in combination with capecitabine in patients who have received prior treatment for advanced or metastatic breast cancer. Prior treatment for metastatic breast cancer must have included trastuzumab.

Tyverb is prescribed in combination with trastuzumab in patients with metastatic breast cancer who are hormone receptor-negative and who have received prior treatment for metastatic breast cancer.

Tyverb is prescribed in combination with an aromatase inhibitor in 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 appropriate.

Information on these medicines is described in separate leaflets. Ask your doctor to provide you with information on these medicines.

2. What you need to know before taking Tyverb

Do not take Tyverb

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

Take special care with Tyverb

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

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

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

• you have any lung disease
• you have inflammation in the lungs
• you have any liver problems
• you have any kidney problems
• you have diarrhoea (see section 4)

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

Tell your doctor if you are in any of these situations.

Serious skin side effects

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

Inform your 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 recently taken, or might need to take any other medicines. This includes herbal medicines and other non-prescription medicines.

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

• St. John’s wort – a herbal extract used to treat depression
• erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin – medicines used to treat infections
• ciclosporin – a medicine used to suppress the immune system, for example after an organ transplant
• ritonavir, saquinavir – medicines used to treat HIV
• phenytoin, carbamazepine – medicines used to treat epileptic seizures
• cisapride – a medicine used to treat certain digestive system problems
• pimozide – a medicine used to treat certain mental health conditions
• 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 pectoris)
• 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 reduce stomach acidity – used to treat stomach ulcers or indigestion

Inform your doctor if you are taking or have recently taken any of these medicines.

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

Taking Tyverb with food and drinks

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

Pregnancy and breastfeeding

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

• Inform your doctor if you are pregnant or planning to become pregnant.
• Use an effective method of contraception to prevent pregnancy while taking Tyverb and for at least 5 days after the last dose.
• Inform your doctor if you become pregnant during treatment with Tyverb.

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

• Inform your doctor if you are breast-feeding or planning to breast-feed.

If you have any doubts, ask your doctor or pharmacist before taking Tyverb.

Driving and using machines

It is your responsibility to decide whether you are fit to drive a vehicle or perform tasks requiring high concentration. Because of the possible side effects of Tyverb, your ability to drive or operate machinery may be affected. These effects are described in section 4, “Possible side effects”.

Tyverb contains sodium

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

3. How to take Tyverb

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate 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 per day, taken as a single daily dose.

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

If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets per day, taken as a single daily dose.

Take the prescribed dose every day for as long as your doctor has instructed.

Your doctor will inform you about the dose of the other anticancer medicine and how you should take it.

Taking the tablets

• Swallow the tablets whole with water, one after another, at the same time each day.
• Take Tyverb at least one hour before or one hour after eating. Take Tyverb every day at the same time relative to meals; for example, you may take the tablets every day one hour before breakfast.

While taking Tyverb

• Depending on any side effects you may experience, your doctor may recommend reducing the dose or temporarily interrupting treatment.
• Your doctor will carry out tests to monitor the function of your heart and liver before and during treatment with Tyverb.

If you take more Tyverb than you should

Contact your doctor or pharmacist immediately. If possible, show them the packaging.

If you forget to take Tyverb

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

4. Possible adverse effects

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

A severe allergic reaction is a rare adverse effect that may affect up to 1 in 1,000 people and can occur rapidly.

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

Contact your doctor immediately if you experience any of these symptoms. Do not take any more tablets.

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

• diarrhoea (which may lead to dehydration and potentially more serious complications)

Contact your doctor immediately at the first sign of diarrhoea, as it is very important that diarrhoea is treated promptly. Also, contact your doctor immediately if diarrhoea worsens. You can find further advice on how to reduce the risk of diarrhoea at the end of section 4.

• rash, dry skin, itching

Contact your doctor if you develop a skin rash. You can find further advice on how to reduce the risk of skin rash in section 4.

Other very common adverse effects:

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

Contact your doctor if any of these adverse effects become severe or troublesome.

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

• an effect on heart function

In most cases, the effect on the heart will not cause any symptoms. If you experience symptoms related to this adverse effect, these may include irregular heartbeat and difficulty breathing.

• liver problems, which may cause itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right part of the stomach
• nail changes, such as tendency for infection and inflammation of the cuticles
• skin fissures (deep cracks or split skin)

Contact your doctor if you experience any of these symptoms.

Uncommon adverse effects (may affect up to 1 in 100 people):

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

Contact your doctor immediately if you experience any of these symptoms.

Other uncommon adverse effects include:

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

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

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

Frequency not known (cannot be estimated from available data):

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

If you experience other adverse effects

Contact your doctor or pharmacist if you notice any adverse effects not listed in this leaflet.

Reducing the risk of diarrhoea and skin rash

Tyverb can cause severe diarrhoea

If you experience diarrhoea while taking Tyverb:

• drink plenty of fluids (8 to 10 glasses per 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 fruit before eating
• avoid milk and dairy products (including ice cream)
• avoid herbal supplements (some may cause diarrhoea)

Contact your doctor if your diarrhoea continues.

Tyverb can cause skin rash

Your doctor will perform skin examinations before and during treatment.

To care for sensitive skin:

• wash with a soap-free cleanser
• use hypoallergenic, fragrance-free skincare products
• use sunscreen (sun protection factor (SPF) 30 or higher)

Contact your doctor if you develop a skin rash.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tyverb

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

Do not use this medicine after the expiry date stated on the blister pack or on the bottle and carton.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tyverb

• The active substance of Tyverb is lapatinib. Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg of lapatinib.
• The other components are: microcrystalline cellulose, povidone (K30), sodium carboxymethylstarch (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-shaped, biconvex, yellow, film-coated tablets, marked with "GS XJG" on one side.

Tyverb is supplied in blister packs or bottles:

Blister packs

Each Tyverb pack contains 70 or 84 tablets in an aluminum blister of 10 or 12 tablets. Each blister has a perforation in the middle allowing it to be divided into two blisters of 5 or 6 tablets, depending on the pack size.

Tyverb is also available in multiple packs containing 140 tablets, consisting of 2 boxes of 70 tablets each.

Bottles

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer responsible for manufacturing

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharmaceuticals 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 contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.