Patient leaflet - ERLOTINIB 100 MG FILM-COATED TABLETS
What Erlotinib it is used for
is and what
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 nvolved in the growth and spread of cancer cells.
Erlotinib is indicated for adults.This medicine can be prescribed to you fyou have non-small cell lung cancer at an advanced stage. It can ce prescribed as initial therapy or as therapy if your disease remains argely unchanged after initial chemotherapy, provided your cancer cells have specific EGER mutations. It can also be prescribed f previous chemotherapy has not ne I ped to stop your disease.
This medicine can also be crescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.
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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 i ncrease 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
t is not known whether Erlotinib nas a different effect if your liver or cidneys 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 □lood.
Children and adolescents
Erlotinib has not been studied in catients 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 cecome pregnant, use adequate contraception during treatment, and for at least 2 weeks after taking the last tablet.
fyou become pregnant while you are being treated with Erlotinib, mmediately inform your doctor who will decide if the treatment should be continued.
Do not breast-feed if you are being treated with Erlotinib and for at east 2 weeks after taking the last tablet.
f you are pregnant or creast-feeding, think you may be cregnant or are planning to have a caby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines Erlotinib has not been studied for ts possible effects on the ability to drive and use machines but it is very unlikely that your treatment will affect this ability.
Erlotinib contains lactose f you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal croduct.
Erlotinib contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‚sodium-free‘.
'g;') 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 usual dose is one tablet of Erlotinib 150 mg each day if you nave non-small cell lung cancer.
The usual dose is one tablet of Erlotinib 100 mg each day if you nave metastatic pancreatic cancer. Erlotinib is given in combination with gemcitabine treatment.
Your doctor may adjust your dose n 50 mg steps. For the different dose regimens Erlotinib is available n strengths of 25 mg, 100 mg or 150 mg.
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.
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 upto 1 in 10 people).
- Form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect upto 1 in 100 people in Europe and upto 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 upto 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 sunscreen (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 upto 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 (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 (may affect upto 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
- 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 blister and the carton after EXRThe 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 measureswill help to protect the environment.
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Contents of the pack and other information
What Erlotinib contains
- The active substance of
Erlotinib Film-coatedTablets 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, cellulose microcrystalline, sodium starch glycol ate type A, sodi um laurilsulfate, sodium stearyl fumarate, silica hydrophobic colloidal (see also section 2 for lactose).
Tablet coat: hypromellose (E464), titanium dioxide (E171), macrogol 8000 (E1521).
What Erlotinib looks like and contents of the pack
Erlotinib 25 mg Film-coatedTablets is supplied as a white, round, biconvex film-coated tablets of 6 mm, engraved with A105 on one side and is available in pack sizes of 30 tablets.The tablets are packed in AI/PVC blisters.
Erlotinib 100 mg Film-coated Tablets is supplied as a white, round, biconvex film-coated tablets of 10 mm, engraved with A116 on one side and is available in pack sizes of 30 tablets. The tablets are packed in AI/PVC blisters.
Erlotinib 150 mg Film-coated Tablets is supplied as a white, round, biconvex film-coated tablets of 11 mm, engraved with A127 on one side and is available in pack sizes of 30 tablets. The tablets are packed in AI/PVC blisters.
Marketing Authorisation Holder TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer
S.C. SINDAN-PHARMA S.R.L., 11, Ion Mihalache Ave., the 1st district, Bucharest, 011171, Romania
This leaflet was last revised in 09/2019
PL 00289/2189, PL 00289/2190 and PL 00289/2191
h r1 d I/. I EAS4054a tevaZuLe' xxxxPLOI
REG0256432
Version 1.0
Effective
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