Ortyka^® 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. 

Ortyka^® is prescribed to be taken in combination with another anti-cancer medicine. 

Ortyka^® 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. 

Ortyka^® 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. 

Ortyka^® 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. 

a. Do not take Ortyka^® 

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

b. Take special care with Ortyka^® 

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

Tell your doctor if you have any heart problems before you take Ortyka^®. 

Your doctor also needs to know before you take Ortyka^®: 

• 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 Ortyka^®. 

Tell your doctor if any of these apply to you. 

Serious skin reactions 

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

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

c. Other medicines and Ortyka^® 

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 Ortyka^® works or Ortyka^® 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 Ortyka^®. Your doctor will advise you whether an alternative is available. 

d. Ortyka^® with food and drink 

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

e. Pregnancy and breast-feeding 

The effect of Ortyka^® during pregnancy is not known. You should not use Ortyka^® 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 Ortyka^® and for at least 5 days after the last dose. 

• If you become pregnant during treatment with Ortyka^®, tell your doctor. 

• It is not known whether Ortyka^® passes into breast-milk. Do not breast-feed while taking Ortyka^® 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 Ortyka^® if you are unsure. 

f. 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 Ortyka^®, your ability to drive or operate machines could be affected. These effects are described in section 4, ‘Possible side effects’. 

g. Ortyka^® contains sodium 

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

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 Ortyka^® depending on the type of breast cancer being treated. 

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

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

• If you are prescribed Ortyka^® in combination with an aromatase inhibitor, the usual dose is 6 Ortyka^® 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 Ortyka^® either at least one hour before or at least one hour after food. Take Ortyka^® 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 Ortyka^® 

• 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 Ortyka^®. 

a. If you take too much Ortyka^® 

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

b. If you forget to take Ortyka^® 

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

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 

Ortyka^® can cause severe diarrhoea 

If you suffer from diarrhoea while taking Ortyka^®: 

• 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. 

Ortyka^® 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

• 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.