- erlotinib hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 17780/0951, PL 17780/0952, PL 17780/0953.
Erlotinib Zentiva 25 mg 100 mg & 150 mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Erlotinib Zentiva 25 mg film-coated tablets
Erlotinib Zentiva 100 mg film-coated tablets
Erlotinib Zentiva 150 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What erlotinib is and what it is used for
2. What you need to know before you take erlotinib
3. How to take erlotinib
4. Possible side effects
5. How to store erlotinib
6. Contents of the pack and other information
1. WHAT ERLOTINIB IS AND WHAT IT IS USED FOR
Erlotinib Zentiva contains the active substance erlotinib and is 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 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
Do not take Erlotinib if you:
Warnings and precautions
Talk to your doctor before using Erlotinib if you:
See also the section “Other medicines and Erlotinib” below.
Talk to your doctor if you:
See also section 4 “Possible side effects”
Liver or kidney disease
It is not known whether erlotinib has a different effect if your liver or kidneys are not functioning normally. The treatment with this medicine is not recommended if you have 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.
You are advised to stop smoking if you are treated with erlotinib as smoking could decrease the amount of your medicine in the blood.
Children and adolescents
Erlotinib 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Erlotinib with food and drink
Do not take this medicine with food (see also section 3 “How to take Erlotinib”).
Pregnancy and breast-feeding
Avoid pregnancy while being treated with erlotinib. 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, immediately inform your doctor who will decide if the treatment should be continued.
Do not breast-feed if you are being treated with erlotinib, 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.
Driving and using machines
Erlotinib 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 contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Erlotinib contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE ERLOTINIB
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are 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 150 mg each day if you have non-small cell lung cancer
The usual dose is one tablet of erlotinib 100 mg each day if you have metastatic pancreatic cancer. Erlotinib is given in combination with gemcitabine treatment.
Your doctor may adjust your dose in 50 mg steps. For the different dose regimens, erlotinib is available in strengths of 25 mg, 100 mg or 150 mg.
Erlotinib 100 mg tablets can be divided into equal doses.
If you take more erlotinib than you should
Contact your doctor or pharmacist immediately. You may have increased side effects and your doctor may interrupt your treatment.
If you forget to take erlotinib
If you miss one or more doses of erlotinib, 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
It is important to keep taking this medicine 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 side effects listed below. In some cases your doctor may need to reduce your dose of erlotinib or interrupt treatment:
Very common side effects (affects more than 1 in 10 people)
Common side effects (affects less than 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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 at: www.mhra.gov.uk/yellowcard 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
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 carton. The expiry date refers to the last day of that month.
This medicine 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Erlotinib Zentiva contains
What Erlotinib Zentiva looks like and contents of the pack
The 25 mg tablet is a white, round, biconvex tablet with “E9OB” debossed on one side and “25” on the other, with a diameter of approximately 6 mm.
The 100 mg tablet is a white, round, biconvex tablet with a score line on both sides, on one side the tablet is debossed with “E9OB” above the score line and “100” below the score line, with a diameter of approximately 10 mm.
The 150 mg tablet is a white, round, biconvex tablet with “E9OB” debossed on one side and “150” on the other, with a diameter of approximately 10.4 mm.
Each box contains 30 film-coated tablets in a single blister.
The Marketing Authorisation Holder is
The manufacturer is
This leaflet was last updated in November 2019