Tarceva 100 mg film-coated tablets

• 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.

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

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

• 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 Tarceva and your doctor may need to adjust your treatment. Your doctor might avoid treating you with these medicines while you are receiving Tarceva.
• if you are taking anticoagulants (a medicine which helps to prevent thrombosis or blood clotting e.g. warfarin), Tarceva 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), Tarceva 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 Tarceva”

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 Tarceva 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 Tarceva treatment and may need to treat you in the hospital;
• if you have ever had problems with your liver. Tarceva may 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 functions properly;
• 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 Tarceva 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 Tarceva as smoking could decrease the amount of your medicine in the blood.

Children and adolescents

Tarceva has not been studied in patients under the age of 18 years. The treatment with this medicine is not recommended for children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.

Do not take Tarceva with food. See also section 3 ‘How to take Tarceva’

Avoid pregnancy while being treated with Tarceva. 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 Tarceva, immediately inform your doctor who will decide if the treatment should be continued.

Do not breast-feed if you are being treated with Tarceva, and for at least 2 weeks after taking the last tablet.

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.

Tarceva 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.

This medicine contains less than 1 mmol sodium (less than 23 mg) per tablet, that is to say Tarceva is essentially ‘sodium -free’.

Tarceva 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 Tarceva.

Contact your doctor or pharmacist immediately.

You may have increased side effects and your doctor may interrupt your treatment.

If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.

Do not take a double dose to make up for a forgotten dose.

It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance of Tarceva 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 monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate and sodium).
  Tablet coat: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.

Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25’ engraved on one side and is available in pack sizes of 30 tablets.

Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 100’ engraved on one side and is available in pack sizes of 30 tablets.

Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 150’ engraved on one side and is available in pack sizes of 30 tablets.