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ERLOTINIB 25 MG FILM-COATED TABLETS

Active substance(s): ERLOTINIB HYDROCHLORIDE

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Package leaflet: Information for the user
Erlotinib 25 mg, 100 mg and 150 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.

If you have 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.
What is in this leaflet
1.
What Erlotinib Film-coated Tablets are and what they are used for
2.
What you need to know before you take Erlotinib Film-coated Tablets
3.
How to take Erlotinib Film-coated Tablets
4.
Possible side effects
5.
How to store Erlotinib Film-coated Tablets
6.
Contents of the pack and other information
1.

What Erlotinib Film-coated Tablets is and what it is used for

Erlotinib Film-coated Tablets contains the active substance erlotinib. Erlotinib is a medicine used to
treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR).
This protein is known to be involved in the growth and spread of cancer cells.
Erlotinib is indicated for adults. This medicine can be prescribed to you if you have non-small cell
lung cancer at an advanced stage. It can be prescribed as initial therapy or as therapy if your disease
remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR
mutations. It can also be prescribed if previous chemotherapy has not helped to stop your disease.
This medicine can also be prescribed to you in combination with another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.

What you need to know before you take Erlotinib Film-coated Tablets

Do not take Erlotinib Film-coated Tablets:

if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions
You should tell your doctor:

if you use contact lenses and/or have a history of eye problems such as severe dry eyes,
inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye

if you have sudden difficulty in breathing associated with cough or fever because your doctor
may need to treat you with other medicines and interrupt your Erlotinib treatment

if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for
example loperamide)

immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting
because your doctor may need to interrupt your Erlotinib treatment and may need to treat you
in the hospital

if you have severe pain in the abdomen, severe blistering or peeling of skin. Your doctor may
need to interrupt or stop your treatment.

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if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred
vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need
urgent treatment (see ‘Possible Side Effects’ below)
if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or
cramps. Your doctor may need to interrupt or stop your treatment.

See also section 4 ‘Possible side effects’.
Liver or kidney disease
It is not known whether Erlotinib has a different effect if your liver or kidneys are not functioning
normally. The treatment with this medicine is not recommended if you have a severe liver disease or
severe kidney disease.
Glucuronidation disorder like Gilbert’s syndrome
Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert’s
syndrome.
Smoking
You are advised to stop smoking if you are treated with Erlotinib as smoking could decrease the
amount of your medicine in the blood.
Children and adolescents
Erlotinib has not been studied in patients under the age of 18 years. The treatment with this medicine
is not recommended for children and adolescents.
Other medicines and Erlotinib Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take
any other medicines.





if you are taking other medicines that may increase or decrease the amount of erlotinib in your
blood or influence its effect (for example antifungals like ketoconazole, itraconazole,
voriconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine,
barbiturates, rifampicin, ciprofloxacin, fluvoxamine, omeprazole, ranitidine, St. John’s Wort or
proteasome inhibitors), talk to your doctor. In some cases these medicines may reduce the
efficacy or increase the side effects of Erlotinib and your doctor may need to adjust your
treatment. Your doctor might avoid treating you with these medicines while you are receiving
Erlotinib.
if you are taking anticoagulants (a medicine which helps to prevent thrombosis or blood clotting
e.g. warfarin), Erlotinib may increase your tendency to bleed. Talk to your doctor, he will need
to regularly monitor you with some blood tests.
if you are taking statins (medicines to lower your blood cholesterol), Erlotinib may increase the
risk of statin related muscle problems, which on rare occasions can lead to serious muscle
breakdown (rhabdomyolysis) resulting in kidney damage, talk to your doctor.

Erlotinib Film-coated Tablets with food and drink
Do not take Erlotinib with food. See also section 3 ‘How to take Erlotinib Film-coated Tablets’
Pregnancy and breast-feeding
Avoid pregnancy while being treated with Erlotinib. If you could become pregnant, use adequate
contraception during treatment, and for at least 2 weeks after taking the last tablet.
If you become pregnant while you are being treated with Erlotinib, immediately inform your doctor
who will decide if the treatment should be continued.
Do not breast-feed if you are being treated with Erlotinib.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines

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Erlotinib has not been studied for its possible effects on the ability to drive and use machines but it is
very unlikely that your treatment will affect this ability.
Erlotinib Film-coated Tablets contains lactose anhydrous
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking Erlotinib.
3.

How to take Erlotinib Film-coated Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The tablet should be taken at least one hour before or two hours after the ingestion of food.
The usual dose is one tablet of Erlotinib 150 mg each day if you have non-small cell lung cancer.
The usual dose is one tablet of Erlotinib 100 mg each day if you have metastatic pancreatic cancer.
Erlotinib is given in combination with gemcitabine treatment.
Your doctor may adjust your dose in 50 mg steps. For the different dose regimens Erlotinib is
available in strengths of 25 mg, 100 mg or 150 mg.
If you take more Erlotinib Film-coated Tablets than you should
Contact your doctor or pharmacist immediately.
You may have increased side effects and your doctor may interrupt your treatment.
If you forget to take Erlotinib Film-coated Tablets
If you miss one or more doses of Erlotinib, contact your doctor or pharmacist as soon as possible.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Erlotinib Film-coated Tablets It is important to keep taking Erlotinib every day,
as long as your doctor prescribes it for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor as soon as possible if you suffer from any of the below side effects. In some cases
your doctor may need to reduce your dose of Erlotinib or interrupt treatment:


Diarrhoea and vomiting (very common: may affect more than 1 out of 10 people). Persistent
and severe diarrhoea may lead to low blood potassium and impairment of your kidney function,
particularly if you receive other chemotherapy treatments at the same time. If you experience
more severe or persistent diarrhoea contact your doctor immediately as your doctor may need
to treat you in the hospital.



Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more
than 1 out of 10 people) and keratitis (common: may affect up to 1 in 10 people).



Form of lung irritation called interstitial lung disease (uncommon in European patients;
common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 in
Japan). This disease can also be linked to the natural progression of your medical condition and
can have a fatal outcome in some cases. If you develop symptoms such as sudden difficulty in
breathing associated with cough or fever contact your doctor immediately as you could suffer
from this disease. Your doctor may decide to permanently stop your treatment with Erlotinib.

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Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100
people). Tell your doctor if you have severe pain in your abdomen. Also, tell your doctor if you
had peptic ulcers or diverticular disease in the past, as this may increase this risk.



In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people). If your blood
tests indicate severe changes in your liver function, your doctor may need to interrupt your
treatment.

Very common (may affect more than 1 in 10 people):

rash which may occur or worsen in sun exposed areas. If you are exposed to sun, protective
clothing, and/or use of sun screen (e.g. mineral-containing) may be advisable.

infection

loss of appetite, decreased weight

depression

headache, altered skin sensation or numbness in the extremities

difficulty in breathing, cough

nausea

mouth irritation

stomach pain, indigestion and flatulence

abnormal blood tests for the liver function

itching, dry skin and loss of hair

tiredness, fever, rigors
Common (may affect up to 1 in 10 people):

bleeding from the nose

bleeding from the stomach or the intestines

iInflammatory reactions around the fingernail

infection of hair follicles

acne

cracked skin (skin fissures)

reduced kidney function (when given outside the approved indications in combination with
chemotherapy)
Uncommon (may affect up to 1 in 100 people):

eyelash changes

excess body and facial hair of a male distribution pattern

eyebrow changes

brittle and loose nails

mild skin reactions such as change in colour of the skin (hyperpigmentation)

kidney inflammation

protein in urine.
Rare (may affect up to 1 in 1,000 people):

flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome).
Very rare (may affect up to 1 in 10,000 people):

cases of perforation or ulceration of the cornea

severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)

inflammation of the coloured part of the eye.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gove.uk/yellowcard or search for MHRA Yellow Card in the Google Play or

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Apple App Store. By reporting side effects you can help provide more information on the safety of this
medicine.
5.

How to store Erlotinib Film-coated Tablets

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 blister and the carton after EXP.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Erlotinib Film-coated Tablets contains

The active substance of Erlotinib Film-coated Tablets is erlotinib. Each film-coated tablet
contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the
strength.

The other ingredients are:
Tablet core: lactose anhydrous, cellulose microcrystalline, sodium starch glycolate type A,
sodium laurilsulfate, sodium stearyl fumarate, silica hydrophobic colloidal (see also section 2
for lactose anhydrous).
Tablet coat: hypromellose (E464), titanium dioxide (E171), macrogol (E1521).
What Erlotinib Film-coated Tablets looks like and contents of the pack
Erlotinib 25 mg Film-coated Tablets is supplied as a white, round, biconvex film-coated tablets of
6 mm with uniform appearance and intact edges, engraved with A105 on one side and is available in
pack sizes of 30 tablets.
Erlotinib 100 mg Film-coated Tablets is supplied as a white, round, biconvex film-coated tablets of
10 mm with uniform appearance and intact edges, engraved with A116 on one side and is available in
pack sizes of 30 tablets.
Erlotinib 150 mg Film-coated Tablets is supplied as a white, round, biconvex film-coated tablets of
11 mm with uniform appearance and intact edges, engraved with A127 on one side and is available in
pack sizes of 30 tablets.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer
S.C. SINDAN-PHARMA S.R.L., 11th Ion Mihalache Mihalache Ave, the 1st district 011171,
Bucharest 1, Romania
This leaflet was last revised in 02/2018
PL 00289/2189, PL 00289/2190 and PL 00289/2191

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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