ERLOTINIB 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ERLOTINIB 25 MG FILM-COATED TABLETS

1. what erlotinib tablets is and what it is used for

Erlotinib tablets contains the active substance erlotinib. Erlotinib tabletsis 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 involved in the growth and spread of cancer cells.

Erlotinib tablets is indicated for adults. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It can also be prescribed if previous chemotherapy has not helped to stop your disease.

This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.

2. what you need to know before you take erlotinib tablets

Do not take Erlotinib tablets

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Erlotinib tablets:

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

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 tablets 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 tablets 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

It is not known whether Erlotinib tablets 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 Erlotinib tablets as smoking could decrease the amount of your medicine in the blood.

Children and adolescents

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

Other medicines and Erlotinib tablets >

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

Erlotinib tablets with food and drink

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

Pregnancy and breast-feeding

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

Do not breast-feed if you are being treated with Erlotinib tablets.

Driving and using machines

Erlotinib tablets 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.

Erlotinib tablets contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Erlotinib tablets.

Erlotinib tabletscontains sodium

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

3. how to take erlotinib tablets

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re 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 tablets150 mg each day if you have non-small cell lung cancer.

The usual dose is one tablet of Erlotinib tablets100 mg each day if you have metastatic pancreatic cancer. Erlotinib tablets is given in combination with gemcitabine treatment.

Your doctor may adjust your dose in 50 mg steps. For the different dose regimens Erlotinib tablets is available in strengths of 25 mg, 100 mg or 150 mg.

If you take more Erlotinib tablets than you should

Contact your doctor or pharmacist immediately.

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

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If you forget to take Erlotinib tablets

If you miss one or more doses of Erlotinib tablets , 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 tablets

It is important to keep taking Erlotinib tablets 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.

4. 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 tablets or interrupt treatment:

Diarrhoea and vomiting (very common: may affect more than 1 in 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 in 10 people) and keratitis (common: may affect up to 1 in 10 people).
Form of lung irritation 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 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 tablets.
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 up to 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 side effects (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 sun screen (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 side effects (may affect up to 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 side effects (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 side effects (may affect up to 1 in 1,000 people):

Flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome)

Very rare side effects (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.

5. how to store erlotinib tablets

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 carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
This product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Erlotinib tablets contains

The active substance is erlotinib.

■ Each film-coated tablet contains 25 mg of erlotinib (as hydrochloride).

■ Each film-coated tablet contains 100 mg of erlotinib (as hydrochloride).

■ Each film-coated tablet contains 150 mg of erlotinib (as hydrochloride).

The other ingredients are:
■ Tablet core: Microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate (Type A), sodium lauryl sulfate (E487), magnesium stearate (E572).
■ Tablet coat: Hy promellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), macrogol (E1521).

What Erlotinib tablets looks like and contents of the pack

Erlotinib tablets 25 mg film-coated tablets

White round biconvex film coated tablet debossed with ‘C1’ on one side and plain on the other. Diameter: 5.50 mm ± 0.20 mm (5.30 mm-5.70 mm).

Erlotinib tablets 100 mg film-coated tablets

White round biconvex film coated tablet debossed with ‘C2’ on one side and plain on the other. Diameter: 9.00 mm ± 0.20 mm (8.80 mm-9.20 mm).

Erlotinib tablets 150 mg film-coated tablets

White round biconvex film coated tablet debossed with ‘C3’ on one side and plain on the other. Diameter: 10.50 mm ± 0.20 mm (10.30 mm-10.70 mm).

Erlotinib tablets is supplied as 25 mg, 100 mg and 150 mg film-coated tablets in blister packs of 30 tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder

Cipla (EU) Limited

Dixcart House, Addlestone Road,

Bourne Business Park,

Addlestone, Surrey, KT15 2LE,

United Kingdom

Manufacturer

Cipla (EU) Limited