Erlotinib TilloMed

PACKAGE LEAFLET

Package leaflet: Information for the user

Erlotinib Tillomed 25 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 taking 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 Erlotinib Tillomed is and what it is used for

Erlotinib Tillomed contains the active substance erlotinib. Erlotinib Tillomed is a medicine
used to treat cancer by inhibiting 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 to you if you have advanced non-small cell lung cancer.
It may be prescribed to you as initial therapy or as a subsequent treatment if the disease has remained largely unchanged after initial chemotherapy,
provided that the cancer cells carry specific EGFR mutations.
It may also be prescribed to you if previous chemotherapy has failed to stop the progression of the disease.
This medicine may also be prescribed to you 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:

• You are allergic to erlotinib or to any of the other 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 affect its efficacy (for example antifungals such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John’s wort, or proteasome inhibitors), consult your doctor. In some cases, these medicines may reduce the efficacy or increase the side effects of Erlotinib Tillomed, and your doctor may need to adjust your treatment. Your doctor may decide that you should not take these medicines during treatment with Erlotinib Tillomed.
• If you are taking anticoagulants (medicines that help prevent thrombosis or blood clotting, e.g. warfarin), Erlotinib Tillomed may increase the risk of bleeding. Consult your doctor, who will monitor you and periodically prescribe blood tests.
• If you are taking statins (medicines to lower blood cholesterol), Erlotinib Tillomed may increase the risk of statin-related muscle problems, which in rare cases may lead to severe muscle breakdown (rhabdomyolysis) and subsequent kidney damage. Consult your doctor.
• If you wear contact lenses and/or have previously had eye problems such as severe dry eyes, inflammation of the surface of the eye (cornea), or ulcers affecting the front part of the eye, consult your doctor.

See also “Other medicines and Erlotinib Tillomed”.
You must inform your doctor:

• If you experience sudden difficulty breathing associated with cough or fever, as your doctor may need to prescribe other medicines and discontinue treatment with Erlotinib Tillomed;
• If you have diarrhoea, as 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, as your doctor may need to discontinue treatment with Erlotinib Tillomed and hospital treatment may be required;
• If you have ever had liver problems. Erlotinib Tillomed can cause serious liver problems, and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to monitor whether your liver is functioning properly;
• If you have severe abdominal pain or serious skin reactions such as blistering and peeling. Your doctor may consider it necessary to interrupt or stop treatment;
• Immediately, if you develop acute eye redness or worsening of existing redness accompanied by pain, increased tearing, blurred vision and/or sensitivity to light. Speak immediately with your doctor or nurse, as urgent treatment may be required (see section 4 “Possible side effects”);
• If you are also taking a statin and experience unexplained muscle pain, tenderness, weakness, or cramps. Your doctor may consider it necessary to interrupt or stop 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 are not functioning normally. If you have severe liver or kidney disease, treatment with this medicine is not recommended.
Glucuronidation disorders such as Gilbert’s syndrome
If you have a glucuronidation disorder such as Gilbert’s syndrome, your doctor should treat you with caution.
Smoking
If you are taking Erlotinib Tillomed, you must stop smoking, as smoking can reduce the amount of medicine in your blood.
Children and adolescents
Erlotinib Tillomed has not been studied in patients under 18 years of age. Treatment with this medicine is not recommended in children and adolescents.
Other medicines and Erlotinib Tillomed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines.
Erlotinib Tillomed with food and drink
Do not take Erlotinib Tillomed with food. See also section 3 “How to take Erlotinib Tillomed”.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Avoid pregnancy during treatment with Erlotinib Tillomed. If you think you may become pregnant, use an effective method of contraception during treatment and for at least 2 weeks after taking the last tablet.
If you become pregnant during treatment with Erlotinib Tillomed, inform your doctor immediately. Your doctor will decide whether it is appropriate to continue treatment.
Breastfeeding
Do not breastfeed during treatment with Erlotinib Tillomed and for at least 2 weeks after taking the last tablet.
Driving and using machines
No studies have been conducted on the possible effects of Erlotinib Tillomed on the ability to drive or use machines, but it is very unlikely that the treatment will impair this ability.
Erlotinib Tillomed contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The tablet must be taken at least one hour before or two hours after eating.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.
The usual dose is one 150 mg Erlotinib Tillomed tablet daily if you have non-small cell lung cancer.
The usual dose is one 100 mg Erlotinib Tillomed tablet daily if you have metastatic pancreatic cancer. Erlotinib Tillomed is administered in combination with gemcitabine.
Your doctor may adjust the dose in increments of 50 mg. For different dosage regimens, Erlotinib Tillomed is available in strengths of 25 mg, 100 mg, or 150 mg.
If you take more Erlotinib Tillomed than you should
If you take more Erlotinib Tillomed than prescribed, contact your doctor or pharmacist immediately.
Side effects may worsen, and your doctor may decide to stop your treatment.
If you forget to take Erlotinib Tillomed
If you miss 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 prescribed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Diarrhoea and vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhoea may lead to low potassium levels in the blood and kidney failure, especially if you are also receiving other chemotherapy drugs. If you develop severe or persistent diarrhoea, contact your doctor immediately, as hospital treatment may be required.
• Eye irritation due to keratoconjunctivitis (very common: may affect more than 1 in 10 people), conjunctivitis 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 condition may also be related to the natural progression of your underlying medical condition and, in some cases, may be fatal. If you develop symptoms such as sudden shortness of breath associated with cough or fever, seek immediate medical attention, as you may have this condition. Your doctor may decide to permanently discontinue treatment with Erlotinib Tillomed.
• Cases of gastrointestinal perforation have been observed (uncommon: may affect up to 1 in 100 people). Inform your doctor if you experience severe abdominal pain. Also inform your doctor if you have previously had peptic ulcer or diverticular disease, as this may increase the risk of perforation.
• In rare cases, liver inflammation has been observed (rare: may affect up to 1 in 1,000 people). Symptoms may include general malaise, with or without possible jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, and abdominal pain. In rare cases, liver failure has been observed, which may be potentially fatal. If blood tests show severe liver function abnormalities, your doctor may decide to discontinue treatment.

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

• Skin rash that may develop or worsen in sun-exposed areas. If you go out in the sun, it may be advisable to use protective clothing and/or sunscreens (e.g. mineral-based)
• Infection
• Loss of appetite, weight loss
• Depression
• Headache, altered skin sensation 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
• Fatigue, fever, chills

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

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

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

• Inflammation of the kidneys (nephritis)
• Excess protein in the urine (proteinuria)
• Changes in eyelashes
• Excessive body and facial hair growth with a male-type distribution
• Excessive skin pigmentation
• 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 (palmar-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 coloured part of the eye (iris)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide 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 on the carton
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 material derived from this medicine must be disposed of in
accordance with local regulations. This will help protect the environment.

6. Package contents and other information

What Erlotinib Tillomed contains

• The active substance in Erlotinib Tillomed 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 components are:
  Tablet core: lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (E572)
  Tablet coating: Opadry White, consisting of HPMC 2910/ hypromellose (E464), hydroxypropylcellulose, titanium dioxide (E171), propylene glycol (E1520).

Description of the appearance of Erlotinib Tillomed and package contents
Erlotinib Tillomed 25 mg film-coated tablets are white, round, biconvex, film-coated tablets with "E25" engraved 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 white, round, biconvex, film-coated tablets with "E100" engraved 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 white, round, biconvex, film-coated tablets with "E150" engraved on one side and smooth on the other side. The tablet diameter is 10.50 mm ±0.2 mm.
The product is available in perforated unit-dose blisters made of transparent Aluminium/PVC, pack size: 30 x 1 film-coated tablet.

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

Manufacturer:
Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
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 película EFG