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

What Erlotinib STADA is and what it is used for

Erlotinib Stada contains the active substance erlotinib. Erlotinib Stada 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 Stada 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 Stada 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 use Erlotinib STADA

Do not take Erlotinib Stada

  • 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, ranitidine, St. John’s wort proteasome inhibitor), talk to your doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Stada and your doctor may need to adjust your treatment. Your doctor may avoid treating you with these medicines during your Erlotinib Stada treatment
  • If you are taking anticoagulants (medicines that help prevent blood clots or clotting of the blood, such as warfarin ), Erlotinib Stada may increase your tendency to bleed. Talk to your doctor, he will regularly need to examine you with some blood tests
  • if you are taking statins (medicines that lower cholesterol in the blood), Erlotinib Stada may increase the risk of statin-related muscle problems, which in rare cases can lead to severe muscle breakdown ( rhabdomyolysis ) leading to kidney damage, talk to your doctor
  • 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 below “Other medicines and Erlotinib Stada”

You should inform your doctor:

  • if you suddenly have difficulty breathing associated with coughing or fever as your doctor may need to treat you with other medicines and discontinue your Erlotinib Stada treatment;
  • 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 Stada treatment and you may need hospitalization;
  • if you have severe abdominal pain, severe blisters, or flaking of the skin. Your doctor may need to discontinue or discontinue 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,s 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 Stada 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 Stada as smoking may reduce the amount of your medicine in your blood.

Children and young people

Erlotinib Stada 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 STADA

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

Erlotinib Stada with food and drink

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

Pregnancy, breastfeeding, and fertility

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

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

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 Stada 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 STADA contains lactose and sodium

Erlotinib Stada 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.

Erlotinib Stada contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Erlotinib STADA

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

The recommended dose is one tablet of Erlotinib Stada 100 mg every day if you have spread pancreatic cancer. Erlotinib Stada 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 Stada is available in strengths of 25 mg, 100 mg, and 150 mg.

To be swallowed.

If you take more Erlotinib Stada 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 accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for assessment of the risk and advice.

If you forget to take Erlotinib Stada

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

It is important to continue taking Erlotinib Stada 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 Stada or discontinue treatment:

  • Diarrhea or vomiting (may affect more than 1 user in 10). 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 occur in more than 1 in 10 users) and keratitis ( corneal inflammation ) (common: may occur in up to 1 in 10 users).
  • 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 users in Europe and may affect up to 1 in 10 users 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 Stada.
  • 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 (may affect more than 1 user in 10):

  • the rash 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
  • difficulty breathing, 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 (may affect up to 1 in 10 people):

  • nosebleeds
  • bleeding from the stomach or intestines
  • inflammatory reactions around fingernails
  • inflammation of the hair follicles
  • acne
  • skin cracks (skin fissures)
  • renal impairment (when Erlotinib Stada is given outside the approved indication in combination with chemotherapy ).

Uncommon (may affect up to 1 in 100 people):

  • changes eyelash s
  • increased hair with the male pattern on body and face
  • changes of eyebrows
  • brittle and loose nails.

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

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

Very rare (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 in the colored part of the eye.

5. How to store Erlotinib STADA

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 Stada 25 mg film-coated tablets

Each film-coated tablet contains erlotinib hydrochloride equivalent to 25 mg erlotinib.

Erlotinib Stada 100 mg film-coated tablets

Each film-coated tablet contains erlotinib hydrochloride equivalent to 100 mg erlotinib.

Erlotinib Stada 150 mg film-coated tablets

Each film-coated tablet contains erlotinib hydrochloride equivalent to 150 mg erlotinib.

Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate Type A, magnesium stearate (E470b).

Tablet coating: poly (vinyl 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 Stada 25 mg film-coated tablets: White to yellowish, round, biconvex film-coated tablets with “25” engraved on one side. The diameter of the tablet is 6.1 mm ± 5%

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

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

The tablets are available in blisters of 30, 90 and 100 tablets or 30×1, 90×1, or 100×1 tablets (single-dose blisters), packaged in cartons.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Centrafarm Services BV

New Donk 9

4879 AC Etten-Leur

Netherlands

STADAPHARM GmbH

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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