Tyverb 250 mg film-coated tablets

• 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.

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

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

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 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.

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.

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

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 and for at least 5 days after the last dose.
• 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 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 Tyverb if you are unsure.

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’.

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

• 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.

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

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

• 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)

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.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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), and iron oxide red (E172).

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.