25 mg, 100 mg and 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.

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

What Erlotinib Orion is and what it is used for

Erlotinib Orion contains the active substance erlotinib. Erlotinib Orion 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 Orion 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 Orion 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 Orion

Do not take Erlotinib Orion

  • 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 Orion and your doctor may need to adjust your treatment. Your doctor may avoid treating you with these medicines during your treatment with Erlotinib Orion.
  • If you are taking anticoagulants (medicines that help prevent blood clots or clotting of the blood, such as warfarin ), Erlotinib Orion 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 a doctor. Erlotinib Orion 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 Orion” 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 Orion
  • 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 Orion 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 Orion 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 treated with Erlotinib Orion as smoking may reduce the amount of your medicine in your blood.

Children and young people

Erlotinib Orion 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 Orion

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

Erlotinib Orion with food, drink, and alcohol

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

Pregnancy and breastfeeding

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

Do not breast-feed if you are being treated with Erlotinib Orion 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 Orion 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 Orion contains lactose and sodium

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

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

How to use Erlotinib Orion

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

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

If you take more Erlotinib Orion 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 Orion

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

It is important to continue taking Erlotinib Orion every day for as long as your doctor prescribes it to 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 Orion or discontinue treatment:

  • Diarrhea or vomiting (very common: 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 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 Orion.
  • 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.

A very common side effect is (can occur in more than 1 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 are (may affect up to 1 in 10):

  • 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 Orion is given outside of the approved indication in combination with chemotherapy )

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

  • 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 1000): 

  • 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 users): 

  • 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

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Erlotinib Orion

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 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. Each tablet contains erlotinib hydrochloride equivalent to 25 mg, 100 mg, or 150 mg erlotinib.
  • Other ingredients are Tablet core: lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica (see section 2 “Erlotinib Orion contains lactose and sodium”).Tablet coating: hypromellose, hydroxypropylcellulose, triethyl citrate, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

25 mg: White to off-white, round, biconvex coated tablet, 5.6 mm in diameter. “ER” engraved above “25” on one side and “APO” engraved on the other side.

100 mg: White to off-white, round, biconvex coated tablet, 8.7 mm in diameter. “ER” is engraved above “100” on one side and “APO” engraved on the other side.

150 mg: White to off-white, round, biconvex coated tablet, 10.3 mm in diameter. “YOUR”

engraved above “150” on one side and “APO” engraved on the other side.

Erlotinib Orion is available in blister packs of 30 tablets.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Muhammad Nadeem

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