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ERLOTINIB 100MG FILM-COATED TABLETS

Active substance(s): ERLOTINIB HYDROCHLORIDE

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Package leaflet: Information for the user
Erlotinib 25 mg film-coated tablets
Erlotinib 100 mg film-coated tablets
Erlotinib 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 is and what it is used for
2.
What you need to know before you take Erlotinib
3.
How to take Erlotinib
4.
Possible side effects
5
How to store Erlotinib
6.
Contents of the pack and other information
1.

What Erlotinib is and what it is used for

Erlotinib 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

Do not take Erlotinib

if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions

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, protease
inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin,
ciprofloxacin, 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.
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,
tell your doctor.

See also below “Other medicines and Erlotinib”.
You should tell your doctor:

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;

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
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might
take any other medicines.
Erlotinib with food and drink
Do not take Erlotinib with food. See also section 3 ‘How to take Erlotinib’
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
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 contains a sugar called lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3.

How to take Erlotinib

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 recommended dose is one tablet of Erlotinib 150 mg each day if you have non-small cell lung
cancer.
The recommended 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.
For oral use.
If you take more Erlotinib 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
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
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.



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

bleeding from the nose

bleeding from the stomach or the intestines

inflammatory 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 side effects (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.

Rare side effects (may affect up to 1 in 1,000 people):

flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome).
Very rare side effects (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 at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5.

How to store Erlotinib

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 carton and blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 protect the environment.
6.

Contents of the pack and other information

What Erlotinib contains
The active substance is erlotinib.
- Erlotinib 25 mg film-coated tablets:
Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).
- Erlotinib 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride).
- Erlotinib 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
The other ingredients are:
- Tablet core: lactose monohydrate, cellulose microcrystalline (E460), sodium starch
glycolate type A, magnesium Stearate (E470b).
- Tablet coat: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350
(E1521), talc (E553b), methacrylic acid – ethyl acrylate copolymer (1:1), type A, sodium
hydrogen carbonate.
What Erlotinib looks like and contents of the pack
Erlotinib 25 mg film-coated tablets: White to yellowish, round biconvex, film-coated tablet, engraved
with “25” on one side. The diameter of the tablet is 6.1 mm ± 5 %.
Erlotinib 100 mg film-coated tablets: White to yellowish, round biconvex, film-coated tablet,
engraved with “100” on one side. The diameter of the tablet is 8.9 mm ± 5 %.
Erlotinib 150 mg film-coated tablets: White to yellowish, round biconvex, film-coated tablet,
engraved with “150” on one side. The diameter of the tablet is 10.5 mm ± 5 %.

The tablets are available in Aluminium - OPA/Alu/PVC blisters of 30 tablets, packed into carton
boxes and in Aluminium - OPA/Alu/PVC perforated unit dose blisters of 30 x1 tablets, packed into
carton boxes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
This leaflet was last revised in 11/2017.

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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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