Introduction

Prospecto: information for the user

Lapatinib Stada 250 mg film-coated tablets

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

Keep this prospectus, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed only for you, and you must not give it to other people 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 prospectus. See section 4.

Content of the prospectus

What Lapatinib Stada is and for what it is used
What you need to know before starting to take Lapatinib Stada
How to take Lapatinib Stada
Possible adverse effects

5Storage of Lapatinib Stada

6.Contents of the package and additional 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 medication may decrease or stop the growth of cancer cells, or may eliminate them.

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

Lapatinib is prescribed incombination with capecitabinein patients who have received previous treatment for advanced or metastatic breast cancer. The previous treatment for metastatic breast cancer must have included trastuzumab.

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

Lapatinib is prescribed incombination with an aromatase inhibitorin patients withmetastatic hormone-sensitive 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 doctorto provide you with the information for these medications.

2. What you need to know before starting to 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).

Special precautions for Lapatinib Stada

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

Before taking lapatinib,inform 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 inflammation in the lungs
if you have anyliver problems
if you have anykidney problems.
if you have diarrhea (see section 4)

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

Inform 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 peeling of the skin.

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

Other medicines and Lapatinib Stada

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 lapatinib works or lapatinib 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 ofstomach ulcersorindigestion.

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 lapatinib. Your doctor will advise you if there is any alternative available.

Taking Lapatinib Stada with food and drink

Do not drink grapefruit juice while taking lapatinib. It may affect how this medicine works.

Pregnancy and breastfeeding

The effect of lapatinib during pregnancy is unknown. Do not use lapatinib 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 lapatinib and for at least 5 days after the last dose.
Inform your doctor if you become pregnantwhile taking lapatinib.

Lapatinib is unknown to pass into breast milk. Do not breastfeed while taking lapatinib 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 your doctor or pharmacistbefore taking lapatinib.

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 lapatinib, your ability to drive or operate machinery may be affected. These effects are described in section 4, “Possible side effects”.

Lapatinib Stada contains sodium

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

3. How to Take Lapatinib Stada

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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

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

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

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

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

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

How to take the tablets

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 eating. 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.

While takingLapatinibas prescribed

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 lapatinib.

If you take moreLapatinibthan you should

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

If you forget to takeLapatinibas prescribed

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

4. Possible Adverse Effects

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

A severe allergic reaction is arare 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 immediatelyif you have any of these symptoms. Do not take more tablets.

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

diarrhea (which can 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 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)
coughs, difficulty breathing
headache
nosebleeds
hot flushes
unusual hair loss or fragility.

Inform your doctorif any of these side effects become severe or troublesome.

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

affect on the functioning of your heart.

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 can cause itching, yellow eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right part of the stomach
changes in the 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.

Uncommon side effects(can affect up to 1 in 100 people):

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

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

Other uncommon side effects include:

results of blood tests showing changes in liver function (usually mild and temporary)

Rare side effects(can 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 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 arterial hypertension (high blood pressure in the arteries (blood vessels) that go to the lungs)

See if you have any other side effects.

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

Reduction of the risk of diarrhea and skin rash

Lapatinib can cause severe diarrhea.

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).

Inform your doctorif your diarrhea continues.

Lapatinib can cause skin rash.

Your doctor will perform skin checks before and during treatment.

To care for sensitive skin:

wash with a product that does not contain soap
use hypoallergenic beauty products, fragrance-free
use sunscreen (sun protection factor (SPF) 30 or higher).

Inform your doctorif you have a skin rash.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lapatinib Stada

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

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Lapatinib Stada

The active ingredient of Lapatinib Stada is lapatinib. Each film-coated tablet contains lapatinib ditosilato monohydrate, equivalent to 250 mg of lapatinib.
The other components are: cellulose, microcrystalline (type 101) (E460), povidone K30 (E1201), carboxymethylmethyl cellulose sodium (from 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).

Appearance of the product and contents of the package

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

Lapatinib Stada is supplied in blister packs.

Each package contains 70 or 84 film-coated tablets in blister packs of aluminum paper of 10 or 6 tablets each.

Each package contains 70 x 1 or 84 x 1 film-coated tablets in perforated aluminum paper blister packs of 10 or 6 tablets each.

Lapatinib Stada is also available in multiple-pack containers containing 140 film-coated tablets, which comprise 2 packages, each with 70 film-coated tablets in aluminum paper blister packs.

Lapatinib Stada is also available in multiple-pack containers containing 140 x 1 film-coated tablets, which comprise 2 packages, each with 70 x 1 film-coated tablet in perforated aluminum paper blister packs.

Only some package sizes may be marketed.

Trade name of the marketing authorization holder and responsible manufacturer

Trade name of the marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Building 10

3056, Limassol

Cyprus

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands: Lapatinib Stada 250 mg, filmomhulde tabletten

Germany: Lapatinib Stada 250 mg Filmtabletten

Spain: Lapatinib Stada 250 mg comprimidos recubiertos con película EFG

Malta: Lapatinib PharOS 250 mg film-coated tablets

Romania: Lapatinib Stada 250 mg comprimate filmate

Revision date of this leaflet:

July 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )

Lapatinib stada 250 mg comprimidos recubiertos con pelicula efg