Erlotinib Mylan

Package leaflet: Information for the user

Erlotinib Mylan 100 mg film-coated tablets, 150 mg film-coated tablets

erlotinib
Generic Medicine
Please 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 any questions, ask your doctor or pharmacist.
• 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet:

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

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

Erlotinib Mylan contains the active substance erlotinib. Erlotinib Mylan is a medicine used to treat cancer and works 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 Mylan is indicated for adults. This medicine may be prescribed to you if you have advanced non-small cell lung cancer. It may be prescribed as initial treatment or as treatment when the disease has remained largely unchanged after initial chemotherapy, provided that the tumour cells have specific EGFR mutations. It may also be prescribed if previous chemotherapy has failed to stop 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 Mylan

Do not take Erlotinib Mylan

• if you are allergic to erlotinib or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions

• if you are taking other medicines that may increase or reduce 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 Mylan, and your doctor may need to adjust your treatment. Your doctor may ensure that you do not take these medicines during treatment with Erlotinib Mylan.
• if you are taking anticoagulants (medicines that help prevent blood clotting or thrombosis, e.g. warfarin), Erlotinib Mylan may increase your tendency to bleed. Consult your doctor, who will need to monitor you and may periodically prescribe blood tests.
• if you are taking statins (medicines to lower cholesterol in the blood), Erlotinib Mylan 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 front part of the eye (cornea), or ulcers affecting the front part of the eye, consult your doctor.

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

• if you experience sudden breathing difficulties associated with cough or fever, as your doctor may need to prescribe other medicines and interrupt treatment with Erlotinib Mylan;
• 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 interrupt treatment with Erlotinib Mylan and hospital treatment may be required.
• if you have ever had liver problems. Erlotinib 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 or peeling. Your doctor may consider it necessary to interrupt or discontinue treatment.
• if you develop sudden eye redness or worsening of redness accompanied by pain, increased tearing, blurred vision and/or light sensitivity, 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 discontinue treatment.

See also section 4 “Possible side effects”.
Liver and kidney disease
It is not known whether the effects of Erlotinib Mylan 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 must treat you with caution.
Smoking
If you are taking Erlotinib Mylan, you should stop smoking, as smoking can reduce the amount of medicine in your blood.
Children and adolescents
Erlotinib Mylan 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 Mylan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Erlotinib Mylan with food and drink
Do not take Erlotinib Mylan with food. See also section 3 “How to take Erlotinib Mylan”.
Pregnancy and breastfeeding
Avoid becoming pregnant during treatment with Erlotinib Mylan. 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 Mylan, inform your doctor immediately. Your doctor will decide whether it is appropriate to continue treatment.
Do not breastfeed during treatment with Erlotinib Mylan and for at least 2 weeks after taking the last tablet.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies have been conducted on the possible effects of Erlotinib Mylan on the ability to drive and use machines, but it is very unlikely that the treatment affects this ability.
Erlotinib Mylan contains sodium
This medicine contains less than 1 mmol (less than 23 mg) of sodium per tablet, i.e. Erlotinib Mylan is essentially “sodium-free”.
Erlotinib Mylan contains a sugar called lactose monohydrate
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking Erlotinib Mylan.

3. How to take Erlotinib Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The tablet should be taken at least one hour before or two hours after eating.
The recommended dose is one 150 mg Erlotinib Mylan tablet daily if you have non-small cell lung cancer.
The recommended dose is one 100 mg Erlotinib Mylan tablet daily if you have metastatic pancreatic cancer. Erlotinib Mylan is administered in combination with gemcitabine.
Your doctor may adjust the dose in increments of 50 mg.
If Erlotinib Mylan is not available in the strength you require, you should take other medicines available on the market. Ask your doctor or pharmacist.
For oral use.
If you take more Erlotinib Mylan than you should
Contact your doctor or pharmacist immediately.
Side effects may worsen, and your doctor may instruct you to stop treatment.
If you forget to take Erlotinib Mylan
If you miss one or more doses of Erlotinib Mylan, 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 Mylan
It is important to continue taking Erlotinib Mylan every day for the full duration prescribed by your doctor.
If you have any doubts 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 Mylan or stop treatment.

• Diarrhoea and vomiting (very common, may affect more than 1 in 10 people). Persistent and severe diarrhoea can lead to low potassium levels in the blood and kidney problems, especially if you are also receiving other chemotherapy medicines. If you have severe or persistent diarrhoea, contact your doctor immediately, as treatment in hospital 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 patients 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 experience 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 Mylan.
• 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.
• Rarely (may affect up to 1 in 1,000 people), liver inflammation (hepatitis) has been observed. 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 your blood tests show severe abnormalities in liver function, your doctor may decide to stop treatment.

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

• Skin rash, which may develop or worsen in sun-exposed areas. If you go out in the sun, it may be advisable to wear protective clothing and/or use sunscreens (e.g. mineral-based)
• Infection
• Loss of appetite, weight loss
• Depression
• Headache, skin sensitivity changes or numbness in the extremities
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion and flatulence
• Abnormal liver function tests
• Itching, dry skin and hair loss
• Fatigue, fever, chills

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

• Dry skin
• Hair loss
• Nosebleeds
• Bleeding from the stomach or intestine
• Inflammatory reactions around the nails
• Infection of hair follicles
• Acne
• Cracked skin (skin fissures)
• Reduced kidney function (when administered outside the 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 facial and body hair growth with a male pattern distribution
• Excessive skin pigmentation
• Changes in eyebrows
• Brittle nails and nail loss

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

• Redness or pain on the palms of the hands or 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 or perforation
• Severe skin reactions such as blistering or peeling (indicative of Stevens-Johnson syndrome)
• Inflammation of the coloured part of the eye

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 https://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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Erlotinib Mylan contains:

• The active substance is erlotinib. Erlotinib Mylan 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Mylan 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• The other ingredients (excipients) are: Tablet core: monohydrate lactose, microcrystalline cellulose (E460), sodium starch glycolate type A, magnesium stearate (E470b). Tablet coating: poly (vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), methacrylic acid - ethyl acrylate copolymer (1:1), type A, sodium bicarbonate.

Description of the appearance of Erlotinib Mylan and pack sizes:
Erlotinib Mylan 100 mg film-coated tablets: Round, biconvex, film-coated tablets, white to yellowish in colour, marked "100" on one side, approximately 8.9 mm in diameter.
Erlotinib Mylan 150 mg film-coated tablets: Round, biconvex, film-coated tablets, white to yellowish in colour, marked "150" on one side, approximately 10.5 mm in diameter.
Available in aluminum-OPA/Alu/PVC blister packs containing 30 tablets, or in unit-dose divisible blisters of 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: