Brastbi

Patient Information Leaflet

Brastib,
250 mg, film-coated tablets
Lapatinibum
Please read all of this leaflet carefully before taking this medicine, because it
contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Brastib is and what it is used for
2. Important information before taking Brastib
3. How to take Brastib
4. Possible side effects
5. How to store Brastib
6. Contents of the pack and other information

1. What Brastib is and what it is used for

Brastib is used to treat certain types of breast cancer (with HER2 receptor overexpression)
when the cancer has spread beyond the original tumor or to other organs
(advanced or metastatic breast cancer). The medicine may slow down or stop the growth of
cancer cells or may destroy them.
Brastib is prescribed for use in combination with another anticancer medicine.
Brastib is prescribed for use in combination with capecitabine in patients who have
previously been treated for advanced or metastatic breast cancer. Prior treatment for metastatic
breast cancer must have included trastuzumab.
Brastib is prescribed for use in combination with trastuzumab in patients with
hormone receptor-negative metastatic breast cancer who have previously been treated for
advanced or metastatic breast cancer.
Brastib is prescribed for use in combination with an aromatase inhibitor in patients
with hormone receptor-positive metastatic breast cancer (the spread of this type of breast
cancer is more likely in the presence of hormones), when chemotherapy is not currently planned.
Information about these medicines is provided in separate patient leaflets. Please ask your
doctor for information about these other medicines.

2. Important information before using Brastib

When not to use Brastib

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

When to take special care with Brastib
Before starting treatment and during treatment with Brastib, the doctor will perform tests to
assess whether heart function is normal.
Before starting treatment with Brastib, the patient should inform the doctor if they have a
heart condition.
Before starting treatment with Brastib, the patient should also inform the doctor:

• if they have a lung disease,
• if they have pneumonia,
• if they have liver disease,
• if they have kidney disease,
• if they have diarrhoea (see section 4).

Before starting treatment and during treatment with Brastib, the doctor will recommend
tests to assess whether liver function is normal.
The patient should inform the doctor if any of these conditions occur.
Severe skin reactions
Severe skin reactions have been observed with the use of Brastib. Symptoms may include
skin rash, blisters and skin peeling.
The patient should inform the doctor as soon as possible if any of these symptoms occur.
Brastib and other medicines
The patient should tell their doctor or pharmacist about any medicines they are currently
taking or have recently taken, or any medicines they plan to take. This includes herbal
medicines and other over-the-counter medicines.
It is especially important to inform the doctor if the patient is currently or has recently taken
any of the following medicines. Some medicines may affect the action of Brastib or Brastib may
affect the action of other medicines. This applies to certain medicines from the groups listed below:

• Medicines containing St. John’s wort – herbal medicines used in the treatment of 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 transplantation,
• ritonavir, saquinavir – medicines used in the treatment of HIV,
• phenytoin, carbamazepine – medicines used to treat seizures,
• cisapride – a medicine used to treat certain gastrointestinal disorders,
• pimozide – a medicine used to treat certain psychiatric disorders,
• quinidine, digoxin – medicines used to treat certain heart conditions,
• repaglinide – a medicine used to treat diabetes,
• verapamil – a medicine used to treat high blood pressure or heart conditions (ischaemic heart disease),
• 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 levels in the blood,
• medicines that reduce gastric acid – used to treat peptic ulcer disease or dyspepsia. The patient should inform the doctor if they are currently or have recently taken any of these medicines. The doctor will review all medicines currently taken by the patient to ensure that no medicines are

being used that should not be taken together with Brastib. The doctor
will provide advice on possible alternative treatments.
Brastib with food and drink
During treatment with Brastib, grapefruit juice should not be consumed. It may affect the
medicine’s action.
Pregnancy and breastfeeding
It is not known whether Brastib affects pregnancy. Brastib should not be used during
pregnancy unless specifically advised by a doctor.

• The patient should inform the doctor if they are pregnant or planning to become pregnant.
• While taking Brastib and for at least 5 days after the last dose, an effective method of contraception must be used to prevent pregnancy.
• The patient should inform the doctor if they become pregnant while taking Brastib.

It is not known whether Brastib passes into human milk. Breastfeeding must not be performed
during treatment with Brastib and for at least 5 days after the last dose.

• The patient should inform the doctor if they are breastfeeding or planning to breastfeed.

If in doubt, before using Brastib, the patient should consult their doctor or pharmacist.
Driving and using machines
The patient is responsible for deciding whether they are fit to drive a motor vehicle or perform
other activities requiring increased concentration. Due to possible adverse effects, Brastib may
impair the ability to drive and operate machinery. These effects are described in the section
"Possible side effects".
Brastib contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Brastib

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Brastib based on the type of breast cancer being treated.
If Brastib has been prescribed for use in combination with capecitabine, the usual dose is 5 tablets per day, taken as a single dose.
If Brastib has been prescribed for use in combination with trastuzumab, the usual dose is 4 tablets per day, taken as a single dose.
If Brastib has been prescribed for use in combination with an aromatase inhibitor, the usual dose is 6 tablets per day, taken as a single dose.
The recommended dose should be taken every day, for as long as your doctor directs.
Your doctor will inform you about the doses and administration of any other anticancer medicines you are taking.

How to take the tablets

• Swallow the tablets whole, one at a time, with water, at the same time each day.
• Brastib should be taken either at least one hour before a meal or at least one hour after a meal. The tablets should be taken every day at the same time relative to meals – for example, always one hour before breakfast.

While taking Brastib

• Depending on any side effects experienced, your doctor may recommend reducing the dose or temporarily stopping treatment.
• Before starting treatment and during Brastib therapy, your doctor will arrange tests to assess heart and liver function.

Taking more Brastib than prescribed
Contact your doctor or pharmacist immediately. If possible, show them the medicine packaging.
If you miss a dose of Brastib
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Severe allergic reaction is a rare adverse reaction (may occur in not more than 1 in 1,000 people) and may have a sudden onset.
Symptoms may include:

• rash (including itchy, raised rash),
• wheezing or difficulty breathing,
• swelling of the eyelids, lips or tongue,
• muscle or joint pain,
• fainting or loss of consciousness.

Immediately inform the doctor if the patient experiences any of the above symptoms. Do not take further tablets.
Very common adverse reactions (may occur in more than 1 in 10 people):

• diarrhoea (which may cause dehydration and lead to more serious complications), Promptly inform the doctor about the first signs of diarrhoea (loose stools), as it is important to initiate treatment immediately. Also promptly inform the doctor if diarrhoea worsens. More information on recommendations to reduce the risk of diarrhoea can be found at the end of section 4.
• rash, dry skin, itching, Inform the doctor if a rash occurs. More information on recommendations to reduce the risk of rash can be found at the end of section 4.

Other very common adverse reactions:

• loss of appetite
• nausea
• vomiting
• fatigue, weakness
• indigestion
• constipation
• mouth pain / mouth ulcers
• abdominal pain
• sleep disturbances
• back pain
• pain in hands and feet
• joint or back pain
• skin reaction on the palms of the hands and soles of the feet (including tingling, numbness, pain, swelling or redness)
• cough, shortness of breath
• headache
• nosebleeds
• hot flushes
• increased hair loss or hair thinning

Inform the doctor if any of these symptoms worsen or become bothersome.
Common adverse reactions (may occur in not more than 1 in 10 people):

• adverse effect on heart function,

In most cases, the adverse effect on heart function does not cause any symptoms.
If the patient experiences symptoms related to this adverse reaction, they usually include irregular heartbeat and shortness of breath.

• liver disorders, which may cause itching, yellowing of the eyes or skin (jaundice), dark urine, pain or discomfort in the upper right part of the abdomen,
• nail disorders – such as painful infection and swelling of the skin around the nail,
• skin fissures (deep cracks in the skin or dry, cracked skin),

Immediately inform the doctor if the patient experiences any of the above symptoms.
Uncommon adverse reactions (may occur in not more than 1 in 100 people):

• drug-induced lung inflammation, which may cause breathlessness or cough, Immediately inform the doctor if the patient experiences any of the above symptoms.

Other uncommon adverse reactions include:

• blood test results indicating liver function abnormalities (usually mild and transient)

Rare adverse reactions (may occur in not more than 1 in 1,000 people):

• severe allergic reactions (see beginning of section 4)

The frequency of some adverse reactions is unknown (cannot be estimated from the available data):

• irregular heartbeat (change in the heart's electrical activity)
• severe skin reaction, which may include: rash, redness of the skin, formation of blisters on the lips, eyelids or mouth, skin peeling, fever, or any combination of these symptoms
• pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)

If other adverse reactions occur
Inform the doctor or pharmacist if any adverse reactions not listed in this leaflet occur.
Reducing the risk of diarrhoea and rash
Brastib may cause severe diarrhoea
If the patient experiences diarrhoea while taking Brastib, the following should be done:

• 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, and avoid fatty and spicy meals,
• eat cooked vegetables instead of raw ones, and peel fruits before eating,
• avoid milk and dairy products (including ice cream),
• avoid herbal remedies (some may cause diarrhoea).

Inform the doctor if diarrhoea does not resolve.
Brastib may cause a rash
Before starting treatment and during its course, the doctor will assess the patient's skin condition. When caring for sensitive skin, the following should be done:

• use soap-free cleansing products,
• use non-perfumed, hypoallergenic cosmetics,
• use products with sunscreen (Sun Protection Factor [SPF] 30 or higher).

Inform the doctor if a rash occurs.
Reporting adverse reactions
If the patient experiences any adverse symptoms, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Brastib

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP. The expiry date refers to the last day of the stated month.
• No special storage instructions apply for this medicine.
• 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.

6. Contents of the pack and other information

What Brastib contains

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

What Brastib looks like and contents of the pack
Brastib coated tablets are oval, biconvex, white-coated tablets with the imprint "250" on one side and smooth on the other.
Brastib is available in packs containing 70 tablets or 84 tablets in aluminum foil blisters, each containing 10 or 6 tablets.
Brastib is also available in multi-packs containing 140 tablets; these consist of 2 packs of 70 tablets in aluminum foil blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate,
Building 10, Limassol 3056,
Cyprus
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta

This medicinal product is authorised in the EEA Member States under the following names:
Netherlands: Brastib 250 mg, filmomhulde tabletten
Poland: Brastib

For further information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20