Brastib

Package Leaflet: Information for the User

Brastib,

250 mg, coated tablets

Lapatinib

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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.

Contents of the pack and other information

• 1. What Brastib is and what it is used for
• 2. What you need to know before you take 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 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 destroy them. Brastib is prescribed in combination with another anticancer medicine. Brastib is prescribed in combination with capecitabine for patients who have previously received treatment for advanced or metastatic breast cancer. Previous treatment for metastatic breast cancer must have included trastuzumab. Brastib is prescribed in combination with trastuzumab for patients with hormone-sensitive metastatic breast cancer who have previously received treatment for advanced or metastatic breast cancer. Brastib is prescribed in combination with an aromatase inhibitor for patients with hormone-sensitive metastatic breast cancer (the spread of this type of breast cancer is more likely in the presence of hormones), for whom chemotherapy is not currently planned. Information about these medicines is contained in separate patient information leaflets. You shouldask your doctorfor information about these other medicines.

2. What you need to know before you take Brastib

When not to take Brastib

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

When to be cautious with Brastib

Before starting treatment and during treatment with Brastib, your doctor will perform teststo assess whether your heart is working properly. Before starting treatment with Brastib, you must inform your doctor if you have heart disease. Before starting treatment with Brastib, you should also inform your doctor:

• if you have lung disease,
• if you have pneumonia,
• if you have liver disease,
• if you have kidney disease,
• if you have diarrhea (see section 4).

Before starting treatment and during treatment with Brastib, your doctor will recommend that you have teststo assess whether your liver is working properly.

You must inform your doctor in case of these circumstances.

Severe skin reactions

Severe skin reactions have been observed with Brastib. Symptoms may include skin rash, blisters, and peeling of the skin. You should inform your doctor as soon as possible if you experience any of these symptoms.

Brastib with other medicines

You must tell your doctor or pharmacist about all medicines you are taking

now or have recently taken, as well as any medicines you plan to take. This includes herbal medicines and other medicines that are available without a prescription. It is especially important to inform your doctorif you are taking or have 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 following groups:

• St. John's Wort - herbal medicines used to treat depression,
• erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin - medicines used to treat infections,
• cyclosporin - a medicine used to weaken the immune system, for example after organ transplantation,
• ritonavir, saquinavir - medicines used to treat 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 pressureor heart disease(ischemic 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 cholesterolin the blood,
• medicines that reduce stomach acid - used to treat stomach ulcersor indigestion. You must inform your doctorif you are taking or have recently taken any of these medicines. Your doctor will review the medicines you are currently taking to ensure that none are taken at the same time as Brastib. Your doctor will provide information about alternative treatments.

Brastib with food and drink

During treatment with Brastib, you should not drink grapefruit juice

This may affect the action of the medicine.

Pregnancy and breastfeeding

The effect of Brastib on pregnancy is not known

Do not take Brastib during pregnancy unless your doctor recommends it.

• You must inform your doctor if you are pregnantor plan to become pregnant.
• During treatment with Brastib and for at least 5 days after taking the last dose, you must use an effective method of contraceptionto prevent pregnancy.
• You must inform your doctor if you become pregnantwhile taking Brastib.

It is not known whether Brastib passes into breast milk. Do not breastfeed while taking Brastib and for at least 5 days after taking the last dose.

• You must inform your doctor if you are breastfeedingor plan to breastfeed.

In case of doubt before taking Brastib, you should consult your doctor or pharmacist.

Driving and using machines

You are responsible for deciding whether you are able to drive a vehicle or perform other activities that require increased attention. Due to possible side effects, Brastib may impair your ability to drive or operate machinery. These actions are described in the "Possible side effects" section.

Brastib contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Brastib

Take this medicine always as directed by your doctor

If you are unsure, consult your doctor or pharmacist. Your doctor will decide what dose of Brastib is right for you, depending on the type of breast cancer being treated. If Brastib is prescribed in combination with capecitabine, the usual dose is 5 tablets per day, taken once daily. If Brastib is prescribed in combination with trastuzumab, the usual dose is 4 tablets per day, taken once daily. If Brastib is prescribed in combination with an aromatase inhibitor, the usual dose is 6 tablets per day, taken once daily. The recommended dose should be taken every day, for as long as your doctor recommends. Your doctor will inform you about the doses and how to take other anticancer medicines.

How to take the tablets

• Swallow the tablets whole, one after the other, with water, at the same time every day.

Brastib should be taken either at least 1 hour before eating or at least

1 hour after eating. The tablets should be taken every day at the same time in relation to meals - for example, the tablets can be taken 1 hour before breakfast.

During treatment with Brastib

• Depending on the side effects you experience, your doctor may recommend reducing the dose or stopping treatment for a while.
• Before starting treatment and during treatment with Brastib, your doctor will also recommend that you have tests to assess your heart and liver function.

What to do if you take more Brastib than you should

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

What to do if you forget to take Brastib

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Severe allergic reactionis a rare side effect (may affect up to 1 in 1,000 people) and may be severe. Symptoms may include:

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

You must inform your doctor immediatelyif you experience any of these symptoms. Do not take any more tablets. Very common side effects(may affect more than 1 in 10 people):

• diarrhea (which may cause dehydration and lead to more serious complications),

You must inform your doctor immediately if you experience the first symptoms of diarrhea (loose stools)

Because it is essential to start treatment immediately. You must also inform your doctor immediatelyif diarrhea worsens.

• rash, dry skin, itching, You must inform your doctor if you experience a rash. More information about recommendations for reducing the risk of rash is contained at the end of section 4.

Other very common side effects:

• loss of appetite
• nausea
• vomiting
• fatigue, weakness
• indigestion
• constipation
• mouth pain/oral ulcers
• abdominal pain
• sleep disturbances
• back pain
• hand and foot pain
• 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 flashes
• increased hair loss or thinning

You must inform your doctorif any of these symptoms worsen or become troublesome. Common side effects(may affect up to 1 in 10 people):

• unfavorable effect on heart function,

In most cases, the unfavorable effect on heart function does not cause any symptoms. If you experience symptoms related to this side effect, 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 right upper abdomen,
• nail disorders - such as painful infection and swelling of the skin around the nail,
• skin cracks (deep cracks in the skin or dry skin),

You must inform your doctor immediately if you experience any of these symptoms

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

• drug-induced pneumonia, which may cause shortness of breath or cough,

You must inform your doctor immediately if you experience any of these symptoms

Other uncommon side effects include:

• blood test results indicating liver function disorders (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

(cannot be estimated from the available data):

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

If you experience other side effects

You must inform your doctor or pharmacistif you experience any side effects not listed in this leaflet.

Reducing the risk of diarrhea and rash

Brastib may cause severe diarrhea

If you experience diarrhea while taking Brastib, you should:

• drink plenty of fluids (8 to 10 glasses per day), such as water, sports drinks, or other clear fluids,
• eat foods that are low in fat and high in protein, and avoid fatty and spicy foods,
• eat cooked vegetables instead of raw ones and peel fruits before eating them,
• avoid milk and dairy products (including ice cream),
• avoid herbal medicines (some may cause diarrhea).

You must inform your doctorif diarrhea does not improve.

Brastib may cause rash

Before starting treatment and during treatment, your doctor will assess your skin condition. When caring for sensitive skin, you should:

• use soap-free cleansers,
• use non-perfumed, hypoallergenic cosmetics,
• use sun protection products (Sun Protection Factor [SPF] 30 or higher).

You must inform your doctorif you experience a rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you must inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 after EXP. The expiry date refers to the last day of the month.
• There are no special precautions for storing 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 of 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 carboxymethylcellulose (type A), magnesium stearate, hypromellose 2910 (3 mPa·s and 6 mPa·s), titanium dioxide (E171), macrogol 400, polysorbate 80, yellow iron oxide (E172).

What Brastib looks like and contents of the pack

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

Marketing authorization 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 authorized in the Member States of the EEA under the following names:

Netherlands: Brastib 250 mg, filmomhulde tabletten; Poland: Brastib; For more information, contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

Date of last revision of the leaflet: