25 mg, 100 mg, 150 mg film-coated tablets 
erlotinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you. 

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Erlotinib Sandoz is and what it is used for 
2. What you need to know before you take Erlotinib Sandoz 
3. How to take Erlotinib Sandoz 
4. Possible side effects 
5. How to store Erlotinib Sandoz 
6. Contents of the packaging and other information 

What Erlotinib Sandoz is and what it is used for

Erlotinib Sandoz contains the active substance erlotinib. Erlotinib Sandoz 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 Sandoz is used in adults. This medicine can be prescribed for you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as an initial treatment or as treatment if your disease is largely unchanged after initial chemotherapy, provided that your cancer cells have specific EGFR mutations. It can also be prescribed if previous chemotherapy has not been able to stop your disease.

This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have pancreatic cancer with the spread.

Erlotinib contained in Erlotinib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Erlotinib Sandoz

Do not take Erlotinib Sandoz: 

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Erlotinib Sandoz;

  • if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or affect the effect of erlotinib (eg antifungals such as ketoconazole (besides shampoo ), protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampin, rifampicin, rifampicin omeprazole, ranitidine, St. John’s wort or proteasome inhibitors). In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Sandoz and your doctor may need to adjust your treatment. Your doctor may avoid treating you with these medicines during your Erlotinib Sandoz treatment.
  • If you are taking anticoagulants (medicines that help prevent blood clots or clotting the blood, such as warfarin ), Erlotinib Sandoz may increase your tendency to bleed. Your doctor will regularly need to examine you with some blood tests.
  • If you are taking statins (medicines that lower your blood cholesterol), Erlotinib Sandoz may increase the risk of statin-related muscle problems, which in rare cases can lead to severe muscle breakdown ( rhabdomyolysis ) leading to kidney damage.
  • if you wear contact lenses and/or if you have previously had eye problems such as severe dry eyes, inflammation, or sores in the front of the eye ( cornea ).

See also below “Other medicines and Erlotinib Sandoz”

You should inform your doctor:

  • if you suddenly have difficulty breathing associated with cough or fever because your doctor may need to treat you with other medicines and stop your treatment with Erlotinib Sandoz;
  • if you have diarrhea because your doctor may need to treat you with medicines for diarrhea (eg loperamide);
  • immediately if you have severe or persistent diarrhea, nausea, loss of appetite, or vomiting as your doctor may need to stop your Erlotinib Sandoz treatment and you may need hospitalization;
  • if you have severe abdominal pain, severe blisters, or flaking of the skin. Your doctor may need to stop or stop your treatment.
  • If you develop acute or worsening redness and pain in the eye, increased tear flow, blurred vision, and/or photosensitivity, contact your doctor or nurse immediately as you may need urgent care (see Possible side effects below).
  • if you also take a statin and notice unexplained muscle pain, soreness, weakness, or cramps. Your doctor may need to stop or stop your treatment.

See also section 4 “Possible side effects”.

Liver or kidney disease 

It is not known if Erlotinib Sandoz has a different effect if your liver or kidneys do not function normally. Treatment with this medicine is not recommended if you have severe liver disease or severe kidney disease.

Disruption of glucuronidation such as Gilbert’s disease 

Tell your doctor if you have Gilbert’s disease or any other glucuronidation disorder.

Smoking 

You should stop smoking when you are being treated with Erlotinib Sandoz as smoking may reduce the amount of your medicine in your blood.

Children and young people

Erlotinib Sandoz has not been studied in patients under 18 years of age. Treatment with this drug is not recommended for children and adolescents.

Other medicines and Erlotinib Sandoz

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

Erlotinib Sandoz with food and drink

Do not take Erlotinib Sandoz with food. See also section 3 “How to take Erlotinib Sandoz”.

Pregnancy and breastfeeding 

Avoid getting pregnant during your treatment with Erlotinib Sandoz. If you can get pregnant, use reliable contraception during treatment, and for at least 2 weeks after taking the last tablet. If you become pregnant during your treatment with Erlotinib Sandoz, tell your doctor immediately who will decide whether to continue treatment. Do not breast-feed if you are being treated with Erlotinib Sandoz 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 Sandoz has not been studied for its possible effects on the ability to drive or use machines, but it is very unlikely that your treatment will affect this ability.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Erlotinib Sandoz 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 Erlotinib Sandoz.

How to take Erlotinib Sandoz

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The tablet should be taken at least one hour before or two hours after food.

The recommended dose is one tablet of Erlotinib Sandoz 150 mg daily if you have non-small cell lung cancer.

The recommended dose is one Erlotinib Sandoz 100 mg tablet daily if you have spread pancreatic cancer. Erlotinib Sandoz is given with

gemcitabine treatment.

Your doctor may need to adjust your dose step by step with 50 mg at a time.

For the different dosages, Erlotinib Sandoz is available in strengths of 25 mg, 100 mg, and 150 mg.

For oral use.

If you take more Erlotinib Sandoz then you should

Contact your doctor or pharmacist immediately.

You may experience increased side effects and your doctor may stop your treatment.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Erlotinib Sandoz

If you forget to take one or more doses of Erlotinib Sandoz, 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 Sandoz

It is important to continue taking Erlotinib Sandoz every day for as long as your doctor prescribes it for you.

If you have any further questions on the use of this product, 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 get any of the following side effects. In some cases, your doctor may need to reduce your dose of Erlotinib Sandoz or discontinue treatment:

  • Diarrhea or vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhea can cause low levels of potassium in the blood and impair your kidney function, especially if you are receiving other chemotherapy at the same time. If you experience severe or persistent diarrhea, contact your doctor immediately as you may need hospitalization.
  • Eye irritation due to corneal and/or conjunctivitis (very common: may affect more than 1 in 10 people) and keratitis ( corneal inflammation ) (common: may affect up to 1 in 10 people).
  • A form of a lung disease called interstitial lung disease (less common in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This disease can also be associated with the natural course of your medical condition and can in some cases be fatal. If you get symptoms such as sudden difficulty breathing associated with cough and fever, contact your doctor immediately, as you may be suffering from this disease. Your doctor may decide to stop your treatment with Erlotinib Sandoz.
  • Perforation in the gastrointestinal tract has been observed (less common: may affect up to 1 in 100 people). Tell your doctor if you have severe abdominal pain. Also tell your doctor if you have had a stomach ulcer or diverticular disease before, as it may increase this risk.
  • In rare cases, liver failure has been 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 stop your treatment.

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

  • Skin rashes may appear or worsen on sun-exposed surfaces. If you are exposed to the sun, protective clothing and/or the use of sunscreen (eg minerals) may be appropriate.
  • Infection
  • Loss of appetite, weight loss
  • Depression
  • Headache, altered sensitivity of the skin, or numbness in the arms and legs
  • Breathing difficulties, cough
  • Nausea
  • Irritation in the mouth
  • Stomach pain, stomach upset, flatulence
  • Abnormal liver function values
  • Itching, dry skin, and hair loss
  • Fatigue, fever, stiffness

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

  • Nasal bleeding
  • Bleeding from the stomach or intestines
  • Inflammatory reactions around fingernails
  • Inflammation of hair follicles
  • Acne
  • Skin cracks (skin fissures)
  • Renal impairment (when erlotinib is given outside the approved indication in combination with chemotherapy )

Less common side effects are (may affect up to 1 in 100 people):

  • Changes to lash s
  • Increased hair with a male pattern on the body and face
  • Changes in eyebrows
  • Fragile and loose nails

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

  • Reddened or painful palms or soles of the feet (hand-foot syndrome)

Very rare side effects are (may affect up to 1 in 10,000 people):

  • Cases of ulceration or perforation of the cornea
  • Severe blisters or flaking of the skin (may indicate Stevens-Johnson syndrome)
  • Inflammation of the colored part of the eye

5. How to store Erlotinib Sandoz

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 outer carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is erlotinib.

Erlotinib Sandoz 25 mg film-coated tablets

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

Erlotinib Sandoz 100 mg film-coated tablets

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

Erlotinib Sandoz 150 mg film-coated tablets

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

  • Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate type A, magnesium stearate (E470 b).

Tablet cover: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), methacrylic acid-ethyl acrylate copolymer (1: 1), type A, sodium bicarbonate.

What the medicine looks like and the contents of the pack

Erlotinib Sandoz 25 mg film-coated tablets: White to yellowish, round, biconvex tablets with “25” engraved on one side. The tablet diameter is 6.1 mm ± 5%.

Erlotinib Sandoz 100 mg film-coated tablets: White to yellowish, round, biconvex tablets with “100” engraved on one side. The tablet diameter is 8.9 mm ± 5%.

Erlotinib Sandoz 150 mg film-coated tablets: White to yellowish, round, biconvex tablets with “150” engraved on one side. The tablet diameter is 10.5 mm ± 5%.

The tablets are available in aluminum – OPA / Alu / PVC blister packs of 30 tablets packed in an outer carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

Lek Pharmaceuticals dd

Verovskova ulica 57, 1526 Ljubljana

Slovenia

Muhammad Nadeem

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