ERLOTINIB 25 mg Film-Coated Tablets

Зміст інструкції

1. Erlotinib Tillomed 25 mg film-coated tablets
   1. What is Erlotinib Tillomed and what it is used for
   2. What you need to know before taking Erlotinib Tillomed
   3. How to take Erlotinib Tillomed
   4. Possible side effects
   5. How to store Erlotinib Tillomed
   6. Package contents and other information

Erlotinib Tillomed 25 mg film-coated tablets

Erlotinib Tillomed 100 mg film-coated tablets
Erlotinib Tillomed 150 mg film-coated tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1.What Erlotinib Tillomed is and what it is used for
• 2.What you need to know before you take Erlotinib Tillomed
• 3.How to take Erlotinib Tillomed
• 4.Possible side effects
• 5.How to store Erlotinib Tillomed
• 6.Contents of the pack and other information

1. What is Erlotinib Tillomed and what it is used for

Erlotinib Tillomed contains the active substance erlotinib. Erlotinib Tillomed is a medicine
used to treat cancer by obstructing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the growth and spread of
cancer cells.
Erlotinib Tillomed is indicated for adults. This medicine may be prescribed if you have an
advanced non-small cell lung cancer. It may be prescribed as
initial therapy or as therapy if the disease remains largely unchanged after the
initial chemotherapy, provided that the cancer cells present specific
mutations of the EGFR. It may also be prescribed if previous chemotherapy has not
succeeded in stopping the disease.
This medicine may also be prescribed in combination with another treatment
called gemcitabine if you have metastatic pancreatic cancer.

2. What you need to know before taking Erlotinib Tillomed

Do not take Erlotinib Tillomed if:

• If you are allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

• If you are taking other medicines that can increase or decrease the amount of erlotinib in the blood or affect its effectiveness (for example, antifungals such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St John's Wort or proteasome inhibitors) tell your doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Tillomedand, if this happens, your doctor may need to adjust your therapy. Your doctor may advise you not to take these medicines while you are being treated with Erlotinib Tillomed.
• If you are taking anticoagulants (medicines that help prevent blood clots, e.g. warfarin), Erlotinib Tillomedmay increase your tendency to bleed. Tell your doctor, who will need to monitor you by prescribing periodic blood tests.
• If you are taking statins (medicines to lower cholesterol), ErlotinibTillomedmay increase the risk of muscle problems related to statins, which in rare cases can lead to severe muscle breakdown (rhabdomyolysis) with subsequent kidney damage. Tell your doctor.
• If you use contact lenses and/or have had eye problems in the past such as severe dry eyes, inflammation of the surface of the eye (cornea) or ulcers involving the front of the eye, tell your doctor.

See also “Other medicines and Erlotinib Tillomed”,
You must tell your doctor:

• if you have sudden difficulty breathing accompanied by cough or fever, because your doctor may need to prescribe other medicines and stop treatment with Erlotinib Tillomed;
• if you have diarrhoea, because your doctor may need to prescribe anti-diarrhoeal medicines (e.g. loperamide);
• immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite or vomiting because your doctor may need to stop treatment with Erlotinib Tillomed and hospital treatment may be necessary;
• if you have severe abdominal pain, severe skin reactions such as blisters and peeling. Your doctor may consider it necessary to interrupt or discontinue treatment;

See also section 4 “Possible side effects!
Liver and kidney disease
It is not known whether the effects of Erlotinib Tillomed change if the liver or kidneys
do not function normally. If you have severe liver or kidney disease, treatment with this medicine is not recommended.
Glucuronidation disorder such as Gilbert's syndrome
If you have a glucuronidation disorder, such as Gilbert's syndrome, your
doctor will need to treat you with caution.
Smoking
If you are taking Erlotinib Tillomed, you should stop smoking as smoking can reduce the amount
of medicine in the blood.
Children and adolescents

Erlotinib Tillomedhas not been studied in patients under the age of 18. Treatment
with this medicine is not recommended in children and adolescents.

Other medicines and Erlotinib Tillomed
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Erlotinib Tillomed with food and drink
Do not take Erlotinib Tillomedwith food. See also section 3 “How to take

Erlotinib Tillomed”.

Pregnancy and breastfeeding
Avoid pregnancy during treatment with Erlotinib Tillomed. If you think you might become
pregnant, use adequate contraception during treatment and for at least 2
weeks after taking the last tablet.
If pregnancy occurs during treatment with Erlotinib Tillomed, tell your doctor immediately
who will decide whether it is appropriate to continue treatment. Do not breastfeed during
treatment with Erlotinib Tillomedand for at least 2 weeks after taking the last tablet.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies have been performed on the possible effects of Erlotinib Tillomed on the ability to drive and
use machines, but it is very unlikely that treatment will alter this ability.

Erlotinib Tillomed contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact him before taking
this medicine.

Erlotinib Tillomed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically
sodium-free.

3. How to take Erlotinib Tillomed

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The tablet must be taken at least one hour before or two hours after food intake.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.
The usual dose is one Erlotinib Tillomed 150 mg tablet per day if you have non-small cell
lung cancer.
The usual dose is one Erlotinib Tillomed 100 mg tablet per day if you have metastatic
pancreatic cancer. Erlotinib Tillomed is administered in association with
gemcitabine. The doctor may modify the dose by 50 mg at a time. For different dosage
regimens, Erlotinib Tillomed is available in dosages of 25 mg, 100 mg or 150 mg.

If you take more Erlotinib Tillomed than you should
If you take more Erlotinib Tillomed than you should, contact your doctor or
pharmacist immediately.
Side effects may worsen and your doctor may make you stop the
treatment.

If you forget to take Erlotinib Tillomed
If you forget one or more doses of Erlotinib Tillomed, contact your doctor or pharmacist as
soon as possible. Do not take a double dose to make up for a missed dose.
If you stop taking Erlotinib Tillomed
It is important to continue taking Erlotinib Tillomed every day, for the entire duration of the
doctor's prescription.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, contact your doctor as soon as possible. In some cases, your doctor may need to reduce the dose of Erlotinib Tillomed or
discontinue treatment:

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhea can lead to a decrease in blood potassium and kidney failure, especially if you are being treated at the same time with other chemotherapeutic agents. If you experience more severe or persistent diarrhea, contact your doctor immediately, who may decide to treat it in hospital.
• Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more than 1 in 10 people) and keratitis (common: may affect up to 1 in 10 people).
• A form of lung inflammation 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 may also be related to the natural progression of your medical condition and in some cases may be fatal. If you experience symptoms such as sudden difficulty breathing accompanied by cough or fever, contact your doctor immediately, as you may be affected by this disease. Your doctor may decide to permanently discontinue therapy with Erlotinib Tillomed.
• Cases of gastrointestinal perforation have been observed (uncommon: may affect up to 1 in 100 people). Tell your doctor if you experience severe abdominal pain. Also, tell your doctor if you have previously had a peptic ulcer or diverticular disease, as this may increase the risk of perforation.
• Liver failure has been observed in rare cases (rare: may affect up to 1 in 1,000 people). If your blood tests show serious abnormalities in liver function, your doctor may decide to discontinue treatment.

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

• Skin rash that may occur or worsen in areas exposed to the sun. If you are exposed to the sun, it may be advisable to use protective clothing and/or sunscreens (e.g. based on mineral substances)
• Infection
• Loss of appetite, weight loss
• Depression
• Headache, altered skin sensitivity or numbness in the extremities
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion and flatulence
• Changes in blood tests related to liver function
• Itching, dry skin and hair loss
• Fatigue, fever, chills

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

• Nosebleeds
• Bleeding from the stomach and intestines
• Inflammatory reactions around the nails
• Infections of the hair follicles
• Acne
• Cracked skin (skin fissures)
• Reduced kidney function (when administered outside of approved indications in association with chemotherapy)

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

• Changes in eyelashes
• Excessive body and facial hair with a male-type distribution
• Changes in eyebrows
• Brittle nails that detach

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

• Redness and pain on the palms of the hands and soles of the feet (palmo-plantar erythrodysesthesia syndrome)

Very rare side effects (may affect up to 1 in 10,000 people):

• Cases of corneal ulceration and perforation
• Severe skin reactions such as blistering or peeling (indicative of Stevens-Johnson syndrome)
• Inflammation of the colored part of the eye (iris)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Erlotinib Tillomed

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 packaging
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Unused medicine and waste derived from this medicine must be disposed of in
accordance with local regulations. This will help to protect the environment.

6. Package contents and other information

What Erlotinib Tillomed contains

• The active ingredient of Erlotinib Tillomed is erlotinib. Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the dosage.
• The other ingredients are:Tablet core: lactose monohydrate, microcrystalline cellulose (E460), type A sodium starch glycolate, sodium lauryl sulfate, magnesium stearate (E572) Tablet coating: Opadry White consisting of HPMC 2910/ Hypromellose (E464), Hydroxypropyl cellulose, Titanium dioxide (E171), Propylene glycol (E1520).

Description of the appearance of Erlotinib Tillomed and package contents
Erlotinib Tillomed 25 mg film-coated tablets are film-coated tablets of
white color, round, biconvex, imprinted with “E25” on one side and smooth on the other side. The
tablet diameter is 6.45 mm ±0.2 mm.
Erlotinib Tillomed 100 mg film-coated tablets are film-coated tablets of
white color, round, biconvex, imprinted with “E100” on one side and smooth on the other side. The
tablet diameter is 8.89 mm ±0.2 mm.
Erlotinib Tillomed 150 mg film-coated tablets are film-coated tablets of
white color, round, biconvex, imprinted with “E150” on one side and smooth on the other side. The
tablet diameter is 10.50 mm ±0.2 mm.
The product is available in unit dose perforated blisters in transparent Aluminum/PVC with 30 x
1 film-coated tablets.

Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Torre A
20143 Milano (MI)
Italy

Manufacturer:
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Germany Erlotinib Tillomed 25 mg, 100 mg, 150 mg Filmtabletten
Italy Erlotinib Tillomed
Spain Erlotinib Tillomed 25 mg, 100 mg, 150 mg comprimidos
recubiertos con pelicula EFG
United Kingdom (Northern
Ireland)
Erlotinib Tillomed 25 mg, 100 mg, 150 mg Film-coated Tablets