LAPATINIB STADA 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lapatinib Stada 250 mg film-coated tablets EFG

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• 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. Do not pass it on to others. It may harm them, even if their signs of illness are 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.

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1. What is Lapatinib Stada and what is it used for
2. What you need to know before you take Lapatinib Stada
3. How to take Lapatinib Stada
4. Possible side effects

5 Storage of Lapatinib Stada

1. Contents of the pack and further information

1. What is Lapatinib Stada and what is it used for

Lapatinib is used to treat some types of breast cancer (those that overexpress HER2 receptors) that have spread beyond the original tumor or to other organs (advanced or metastatic breast cancer). This medicine may decrease or stop the growth of cancer cells, or it may get rid of them.

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

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

Lapatinib is prescribed in combination with trastuzumabin patients with metastatic breast cancer with negative hormonal receptors and who have received prior treatment for metastatic breast cancer.

Lapatinib 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.

Information about these medicines is described in separate package leaflets. Ask your doctorto provide you with information about these medicines.

2. What you need to know before you take Lapatinib Stada

Do not take Lapatinib Stada

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

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

Before taking lapatinib, tell your doctor if you have any heart problems.

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

• if you have any lung disease
• if you have lung inflammation
• if you have any liver problems
• if you have any kidney problems.
• if you have diarrhea (see section 4)

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

Tell your doctorif you are in any of these situations.

Severe Skin Reactions

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

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

Other Medicines and Lapatinib Stada

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 that you buy without a prescription.

It is especially important that you tell your doctorif you are using or have recently used any of the following medicines. Some medicines may affect how lapatinib works or lapatinib 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
• cyclosporin – a medicine used to suppress the immune system, such as 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 some digestive system problems
• pimozide – a medicine used to treat some mental health problems
• quinidine, digoxin – medicines used to treat some heart problems
• repaglinide – a medicine used to treat diabetes
• verapamil – a medicine used to treat high blood pressureor heart problems(angina pectoris)
• nefazodone – a medicine used to treat depression
• topotecan, paclitaxel, irinotecan, docetaxel – medicines used to treat some types of cancer
• rosuvastatin – a medicine used to treat high cholesterol
• medicines that reduce stomach acidity - used to treat stomach ulcersor indigestion.

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

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

Taking Lapatinib Stada with Food and Drinks

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

Pregnancy and Breast-feeding

The effect of lapatinib during pregnancy is not known. You should not use lapatinib if you are pregnant, unless your doctor specifically recommends it.

• Tell your doctor if you are pregnantor planning to become pregnant.
• Use an effective method of contraceptionto avoid becoming pregnant while taking lapatinib and for at least 5 days after the last dose.
• Tell your doctor if you become pregnantduring treatment with lapatinib.

It is not known if lapatinib passes into breast milk. Do not breast-feed while taking lapatinib and for at least 5 days after the last dose.

• Tell your doctor if you are breast-feedingor planning to breast-feed.

If you have any doubts, ask your doctor or pharmacistbefore taking lapatinib.

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

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

3. How to take Lapatinib Stada

Follow exactly the administration instructions of this medicine given by your doctor.In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of lapatinib depending on the type of breast cancer being treated.

If you are prescribed lapatinib in combination with capecitabine, the normal dose is 5 tablets of lapatinib per day, in a single dose.

If you are prescribed lapatinib in combination with trastuzumab, the normal dose is 4 tablets oflapatinib per day, in a single dose.

If you are prescribed lapatinib in combination with an aromatase inhibitor, the normal dose is 6 tablets oflapatinibper day, in a single dose.

Take the dose that has been prescribed to you every day for the time indicated by your doctor.

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

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

Monitoring

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

SpecialPrecautions

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. If possible, show them the package.

SpecialPrecautions

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

4. Possible Side Effects

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

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

The symptoms may include:

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

Tell your doctor immediatelyif you have any of these symptoms. Do not take any more tablets.

Very Common Side Effects(may affect more than 1 in 10 people)

• diarrhea (which can cause dehydration and lead to more serious complications) Tell your doctor immediately if you have any sign of diarrhea, as it is very important that diarrhea is treated immediately. Also, tell 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.
• rash, dry skin, itching

Tell 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.

OtherSideEffects

• loss of appetite
• nausea
• vomiting
• fatigue, weakness
• indigestion
• constipation
• mouth inflammation/ulcers in the mouth
• stomach pain
• sleep problems
• back pain
• pain in hands and feet
• pain in joints and back
• 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
• nosebleed
• hot flashes
• unusual hair loss or fragility.

Tell your doctorif any of these side effects become serious or troublesome.

Common Side Effects(may affect up to 1 in 10 people):

• an effect on the functioning of your heart.

In most cases, the effect on your heart will not have any symptoms. If you experience symptoms associated with this side effect, they are likely to include irregular heartbeat and difficult breathing.

• liver problems, which can cause itching, yellow eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right stomach area
• changes in the nails, such as a tendency to develop infections and inflammation of the cuticles
• skin cracks (deep cracks in the skin or cracked skin)

Information

Uncommon Side Effects(may affect up to 1 in 100 people):

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

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Other uncommon side effects include:

• blood test results showing 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)

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

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Tell your doctor or pharmacistif you notice any side effects not mentioned in this leaflet.

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If you experience diarrhea while taking lapatinib:

• 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).

Tell your doctorif your diarrhea continues.

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Your doctor will perform skin checks before and during treatment.

To care for sensitive skin:

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

Tell your doctorif you have a skin rash.

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If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lapatinib Stada

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 carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines that you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition

• The active substance of Lapatinib Stada is lapatinib. Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg of lapatinib.
• The other ingredients are: microcrystalline cellulose (type 101) (E460), povidone K30 (E1201), sodium carboxymethyl starch (potato) (type A), magnesium stearate (E470b), hypromellose (3 mPa·s and 6 mPa·s) 2910 (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433), yellow iron oxide (E172).

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The film-coated tablets of Lapatinib Stada are oval, biconvex, white, marked with “250” on one side and flat on the other.

Lapatinib Stada is supplied in blister packs.

Each pack contains 70 or 84 tablets in aluminum paper blisters of 10 or 6 tablets each.

Each pack contains 70 x 1 or 84 x 1 tablets in perforated aluminum paper blisters of 10 or 6 tablets each.

Lapatinib Stada is also available in multiple packs containing 140 tablets, which consist of 2 packs, each with 70 tablets in aluminum paper blisters.

Lapatinib Stada is also available in multiple packs containing 140 x 1 tablets, which consist of 2 packs, each with 70 x 1 tablet in perforated aluminum paper blisters.

Not all pack sizes may be marketed.

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Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

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Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Building 10

3056, Limassol

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Lapatinib Stada 250 mg, film-coated tablets

Germany: Lapatinib Stada 250 mg Filmtabletten

Spain: Lapatinib Stada 250 mg film-coated tablets EFG

Malta: Lapatinib PharOS 250 mg film-coated tablets

Romania: Lapatinib Stada 250 mg film-coated tablets

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Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)