TYKERB® 250 mg film coated tablets
Lapatinib Ditosylate
What is in this leaflet
Read all of this leaflet carefully before you start taking this
medicine.
This leaflet answers some common questions about TYKERB.
TYKERB has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
If you have any questions about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What TYKERB is used for
TYKERB is a medicine that may slow, stop or kill cancer cells from growing.
It is used to treat certain types of breast cancer and it is given in
combination with another medicine called capecitabine.
Your doctor may have prescribed TYKERB for another reason.
Information about capecitabine is described in the capecitabine patient
information leaflet.
Ask your doctor to provide you with information about capecitabine.
This medicine is available only with a doctor's prescription.
Before you take TYKERB
Tell your doctor if:
- You have any problems with your heart.
- You have any lung problems/problems with your breathing
- You have any liver problems.
- You are pregnant or plan to become pregnant.
- You are breast feeding.
Taking other medicines
There are certain groups of medicines that interact with TYKERB and you may
not be able to take them while receiving TYKERB. These medications include
some drugs within the following groups:
- drugs used to treat infections (antibiotics and anti-fungals)
- HIV (AIDS) treatment
- drugs used to treat chronic inflammation/asthma (steroids)
- drugs used to treat seizures (anticonvulsant drugs)
- drugs used to treat certain heart disorders and high blood pressure
(calcium channel blockers) - antidepressants
- drugs used to treat gastrointestinal ulcers
- herbal supplements
Your doctor will review the medicines you are currently taking to make sure
you are not taking something that cannot be taken with TYKERB. Your doctor
will advise you of what to do in the event you need any of these medications.
Because TYKERB is given with another drug called capecitabine, you
should also discuss with your doctor any medicines that should be avoided when
taking capecitabine.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
You should avoid becoming pregnant while taking TYKERB because the effect
of TYKERB on pregnancy is not known.
You should use a reliable method of contraception (a way to prevent you
from becoming pregnant).
If you become pregnant during treatment, tell your doctor.
Do not breast feed while you are taking TYKERB. It is not known whether
TYKERB passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if
you are unsure.
How to take TYKERB
Always take TYKERB exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
How much to take and when to take it
TYKERB should be taken at least one hour before or one hour after food.
The usual dose is 5 TYKERB tablets a day. Five TYKERB tablets will give you
a total dose of 1250 mg a day. Swallow the five tablets whole with water, one
after the other, at the same time each day.
TYKERB is given in combination with capecitabine. Your doctor will advise
you about the dose of capecitabine you should receive and when you should take
it.
Your doctor will also carry out blood tests to check your liver function
before and during treatment with TYKERB.
You should not drink grapefruit juice while you are being treated with
TYKERB.
How to take it
Swallow TYKERB with a glass of water.
If you forget to take TYKERB
Do not take a double dose to make up
for a forgotten dose on a given day; simply take your next scheduled dose at
the normal time.
If you have any further questions on the use of TYKERB, ask your doctor or
pharmacist.
Follow all directions given to you by your doctor or pharmacist
carefully.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
Your doctor will tell you when your treatment should be stopped.
Once you have started taking TYKERB
Do not stop taking TYKERB until your doctor advises you to do so.
If you have any problems/questions regarding the use of TYKERB, please
consult with your doctor.
Side effects
Like all medicines, TYKERB can cause side effects, although not everybody
gets them.
Because TYKERB is given with another drug called capecitabine, you may
also get side effects associated with capecitabine therapy.
The following side effects have been reported to be associated with TYKERB
alone and TYKERB when given in combination with capecitabine:
Very common side effects
(Occurring in more than 1 in 10 people treated)
The following side effects have been reported in patients taking TYKERB
alone:
- Diarrhoea
- Loss of appetite
- Feeling of an upset stomach like you want to be sick/throw up (nausea)
- Being sick/throwing up (vomiting)
- Rash
- Tiredness
The following additional side effects have been reported in patients taking
TYKERB in combination with capecitabine:
- Indigestion
- Constipation
- Sore mouth/mouth ulcers
- Stomach pain
- Trouble sleeping
- Back pain
- Pain in hands and feet
- Dry skin
- Hand-and-foot skin-reaction (palms of the hands or soles of the feet
tingle, become numb, painful, swollen or red)
Common side effects
(Occurring in up to 1 in 10 people treated)
The following side effects have been reported in patients taking TYKERB
alone:
- Irregular heartbeat, shortness of breath due to a decrease in the amount
of blood pumped by your heart
The following additional side effects have been reported in patients taking
TYKERB in combination with capecitabine:
- Headache
- Feeling weak/loss of strength
Uncommon side effects
(Occurring in up to 1 in 100 people treated)
- 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. - Drug induced lung inflammation, which may cause shortness of breath or
cough.
Tell your doctor immediately if you get either of these symptoms. These
symptoms may persist after you stop taking TYKERB.
If any of the side effects listed in this leaflet get serious, or if
you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Storage
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use TYKERB after the expiry date which is stated on the carton.
Disposal
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required.
Product description
What TYKERB looks like
TYKERB is presented in packs of 70 tablets.
TYKERB tablets are oval, biconvex, yellow film-coated, with GS XJG debossed
on one side.
Ingredients
TYKERB contains the active ingredient lapatinib ditosylate monohydrate.
TYKERB also contains Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Magnesium Stearate, Hypromellose, Titanium Dioxide, Macrogol/PEG400,
Polysorbate, Iron Oxide Yellow and Iron Oxide Red.