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

What Erlotinib Glenmark is and what it is used for

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

What you need to know before you take Erlotinib Glenmark 

Do not take Erlotinib Glenmark:

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

Warnings and cautions

  • 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, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, St. John’s wort or proteasome inhibitor), talk to your doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Glenmark and your doctor may need to adjust your treatment. Your doctor may avoid treating you with these medicines during your treatment with Erlotinib Glenmark.
  • if you are taking anticoagulants (medicines that help prevent blood clots or clotting of the blood, such as warfarin ), Erlotinib Glenmark may increase your tendency to bleed. Talk to your doctor, he or she will need to examine you regularly with some blood tests.
  • if you are taking statins (medicines that lower your blood cholesterol) you should talk to your doctor. Erlotinib Glenmark may increase the risk of statin-related muscle problems. These can in rare cases 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 ), tell your doctor.

See also “Other medicines and Erlotinib Glenmark” below.

You should inform your doctor:

  • if you suddenly have breathing difficulties associated with cough or fever because your doctor may need to treat you with other medicines and discontinue your treatment with Erlotinib Glenmark
  • if you have diarrhea because your doctor may need to treat you with anti-diarrhea medicines (eg loperamide)
  • immediately if you have severe or persistent diarrhea, nausea, loss of appetite, or vomiting as your doctor may need to stop your treatment with Erlotinib Glenmark and you may need hospitalization
  • if you have severe abdominal pain, severe blisters, or skin flaking. 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 Glenmark has a different effect if your liver or kidneys do not function normally. Treatment with this drug is not recommended if you have severe liver disease or severe kidney disease.

Disruption of glucuronidation such as Gilbert’s disease 

Your doctor must exercise caution if you have a glucuronidation disorder such as Gilbert’s disease.

Smoking 

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

Children and young people

Erlotinib Glenmark 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 Glenmark

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

Erlotinib Glenmark with food and drink

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

Pregnancy and breastfeeding

Avoid getting pregnant during your treatment with Erlotinib Glenmark. 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 Glenmark, tell your doctor immediately who will decide whether to continue treatment.

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

Hypersensitivity

Erlotinib Glenmark contains lactose

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

How to take Erlotinib Glenmark

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 Glenmark 150 mg daily if you have non-small cell lung cancer.

The recommended dose is one tablet of Erlotinib Glenmark 100 mg every day if you have spread pancreatic cancer. Erlotinib Glenmark is given in combination with gemcitabine treatment.

Your doctor may need to adjust the dose one step at a time with 50 mg.

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

If you take more Erlotinib Glenmark 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 Glenmark

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

It is important to continue taking Erlotinib Glenmark 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 Glenmark 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 (uncommon 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 Glenmark.
  • 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 (may affect more than 1 user in 10):

  • 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, chills

Common side effects (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 given outside the approved indication in combination with chemotherapy )

Uncommon side effects (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 (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 (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 Glenmark

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 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 Glenmark 25 mg film-coated tabletEachch film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Glenmark 100 mg film-coated tabletEachch film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Glenmark 150 mg film-coated tabletEachch 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 (E470b).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 Glenmark 25 mg film-coated tablet

White to off-white, round, biconvex film-coated tablet, “25” engraved on one side. The diameter of the tablet is 6.1 mm.

Erlotinib Glenmark 100 mg film-coated tablet

White to off-white, round, biconvex film-coated tablet, “100” engraved on one side. The diameter of the tablet is 8.9 mm.

Erlotinib Glenmark 150 mg film-coated tablet

White to off-white, round, biconvex film-coated tablet, “150” engraved on one side. The diameter of the tablet is 10.5 mm.

The tablets are supplied in aluminum OPA / Alu / PVC blisters with 30 tablets, packed in cartons.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Muhammad Nadeem

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