{"id":8310,"date":"2021-03-10T07:49:01","date_gmt":"2021-03-10T07:49:01","guid":{"rendered":"https:\/\/zeepedia.com\/?p=8310"},"modified":"2021-04-26T13:21:32","modified_gmt":"2021-04-26T13:21:32","slug":"erlotinib-sandoz","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/erlotinib-sandoz\/","title":{"rendered":"Erlotinib Sandoz &#8211; Erlotinib uses, dose and side effects"},"content":{"rendered":"\n<p> 25 mg, 100 mg, 150 mg\u00a0film-coated tablets\u00a0<br>erlotinib<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Erlotinib Sandoz is and what it is used for<\/h2>\n\n\n\n<p>Erlotinib Sandoz contains the active substance erlotinib.&nbsp;Erlotinib Sandoz is a medicine used to treat cancer by preventing the activity of a&nbsp;protein&nbsp;called&nbsp;epidermal growth&nbsp;factor&nbsp;receptor (EGFR).&nbsp;This&nbsp;protein&nbsp;is known to be involved in the growth and spread of cancer cells.<br><\/p>\n\n\n\n<p>Erlotinib Sandoz is used in adults.&nbsp;This medicine can be prescribed for you if you have non-small cell lung cancer&nbsp;at an advanced stage.&nbsp;It can be prescribed as&nbsp;an initial treatment or as treatment if your disease is largely unchanged after&nbsp;initial chemotherapy, provided that your cancer cells have specific EGFR&nbsp;mutations.&nbsp;It can also be prescribed if previous chemotherapy has not been able to stop your disease.<br><\/p>\n\n\n\n<p>This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have pancreatic cancer with the spread.<br><\/p>\n\n\n\n<p>Erlotinib contained in Erlotinib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you take Erlotinib Sandoz<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Erlotinib Sandoz:&nbsp;<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before taking Erlotinib Sandoz;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>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&nbsp;antifungals&nbsp;such as&nbsp;ketoconazole&nbsp;(besides&nbsp;shampoo&nbsp;),&nbsp;protease inhibitors, erythromycin, clarithromycin,&nbsp;phenytoin, carbamazepine,&nbsp;barbiturates, rifampin,&nbsp;rifampicin,&nbsp;rifampicin&nbsp;omeprazole, ranitidine,&nbsp;St. John&#8217;s wort&nbsp;or proteasome inhibitors).&nbsp;In some cases, these medicines may reduce the effectiveness or increase the&nbsp;side effects&nbsp;of Erlotinib Sandoz and your doctor may need to adjust your treatment.&nbsp;Your doctor may avoid treating you with these medicines during your Erlotinib Sandoz treatment.<\/li><li>If you are taking&nbsp;anticoagulants&nbsp;(medicines that help prevent blood clots or clotting the blood, such as&nbsp;warfarin&nbsp;), Erlotinib Sandoz may increase your tendency to bleed.&nbsp;Your doctor will regularly need to examine you with some blood tests.<\/li><li>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 (&nbsp;rhabdomyolysis&nbsp;) leading to kidney damage.<\/li><li>if you wear contact lenses and\/or if you have previously had eye problems such as severe dry eyes,&nbsp;inflammation,&nbsp;or sores in the front of the eye (&nbsp;cornea&nbsp;).<\/li><\/ul>\n\n\n\n<p>See also below &#8220;Other medicines and Erlotinib Sandoz&#8221;<br><\/p>\n\n\n\n<p>You should inform your doctor:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you&nbsp;<strong>suddenly<\/strong>&nbsp;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;<\/li><li>if you have diarrhea because your doctor may need to treat you with medicines for diarrhea (eg loperamide);<\/li><li>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&nbsp;and you may need hospitalization;<\/li><li>if you have severe abdominal pain, severe blisters, or flaking of the skin.&nbsp;Your doctor may need to stop or stop your treatment.<\/li><li>If you develop&nbsp;acute&nbsp;or worsening&nbsp;redness&nbsp;and pain in the eye, increased tear flow, blurred vision, and\/or photosensitivity, contact your doctor or nurse immediately as you may need&nbsp;urgent&nbsp;care (see Possible&nbsp;side effects&nbsp;below).<\/li><li>if you also take a statin and notice unexplained muscle pain, soreness, weakness, or cramps.&nbsp;Your doctor may need to stop or stop your treatment.<\/li><\/ul>\n\n\n\n<p>See also section 4 \u201cPossible side effects\u201d.<br><\/p>\n\n\n\n<p><strong>Liver or kidney disease<\/strong>&nbsp;<\/p>\n\n\n\n<p>It is not known if Erlotinib Sandoz has a different effect if your liver or kidneys do not function normally.&nbsp;Treatment with this medicine is not recommended if you have severe liver disease or severe kidney disease.<br><\/p>\n\n\n\n<p><strong>Disruption of glucuronidation such as Gilbert&#8217;s disease<\/strong>&nbsp;<\/p>\n\n\n\n<p>Tell your doctor if you have Gilbert&#8217;s disease or any other glucuronidation disorder.<br><\/p>\n\n\n\n<p><strong>Smoking<\/strong>&nbsp;<\/p>\n\n\n\n<p>You should stop smoking when you are being treated with Erlotinib Sandoz as smoking may reduce the amount of your medicine in your blood.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Erlotinib Sandoz has not been studied in patients under 18 years of age.&nbsp;Treatment with this drug is not recommended for children and adolescents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Erlotinib Sandoz<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Erlotinib Sandoz with food and drink<\/h2>\n\n\n\n<p>Do not take Erlotinib Sandoz with food.&nbsp;See also section 3 \u201cHow to take Erlotinib Sandoz\u201d.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding&nbsp;<\/h2>\n\n\n\n<p>Avoid getting pregnant during your treatment with Erlotinib Sandoz.&nbsp;If you can get pregnant, use reliable contraception during treatment, and for at least 2 weeks after taking the last tablet.&nbsp;If you become pregnant during your treatment with Erlotinib Sandoz, tell your doctor immediately who will decide whether to continue treatment.&nbsp;Do not breast-feed if you are being treated with Erlotinib Sandoz and for at least 2 weeks after taking the last tablet.<\/p>\n\n\n\n<p>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.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>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.<br><\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Erlotinib Sandoz contains a sugar called lactose monohydrate.<\/h2>\n\n\n\n<p>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Erlotinib Sandoz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Erlotinib Sandoz<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p>The tablet should be taken at least one hour before or two hours after food.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is one tablet of Erlotinib Sandoz 150 mg daily if you have non-small cell lung cancer.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is one Erlotinib Sandoz 100 mg tablet daily if you have spread pancreatic cancer.&nbsp;Erlotinib Sandoz is given with<\/p>\n\n\n\n<p>gemcitabine treatment.<br><\/p>\n\n\n\n<p>Your doctor may need to adjust your&nbsp;dose&nbsp;step by step with 50 mg at a time.<\/p>\n\n\n\n<p>For the different&nbsp;dosages, Erlotinib Sandoz is available in strengths of 25 mg, 100 mg, and 150 mg.<br><\/p>\n\n\n\n<p>For&nbsp;oral&nbsp;use.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Erlotinib Sandoz then you should<\/h2>\n\n\n\n<p>Contact your doctor or pharmacist immediately.<\/p>\n\n\n\n<p>You may experience increased&nbsp;side effects&nbsp;and your doctor may stop your treatment.<\/p>\n\n\n\n<p>If you have ingested too much medicine or if e.g.&nbsp;If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Erlotinib Sandoz<\/h2>\n\n\n\n<p>If you forget to take one or more&nbsp;doses&nbsp;of Erlotinib Sandoz, contact your doctor or pharmacist as soon as possible.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Erlotinib Sandoz<\/h2>\n\n\n\n<p>It is important to continue taking Erlotinib Sandoz every day for as long as your doctor prescribes it for you.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p>Contact your doctor as soon as possible if you get any of the following&nbsp;side effects.&nbsp;In some cases, your doctor may need to reduce your&nbsp;dose&nbsp;of Erlotinib Sandoz or discontinue treatment:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Diarrhea or vomiting (very common: may affect more than 1 in 10 people).&nbsp;Persistent and severe diarrhea can cause low levels of&nbsp;potassium&nbsp;in the blood and impair your kidney function, especially if you are receiving other chemotherapy at the same time.&nbsp;If you experience severe or persistent diarrhea,&nbsp;<strong>contact your doctor immediately<\/strong>&nbsp;as you may need hospitalization.<\/li><li>Eye irritation due to corneal and\/or conjunctivitis (very common: may affect more than 1 in 10 people) and&nbsp;keratitis&nbsp;(&nbsp;corneal inflammation&nbsp;) (common: may affect up to 1 in 10 people).<\/li><li>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).&nbsp;This disease can also be associated with the natural course of your medical condition and can in some cases be fatal.&nbsp;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.&nbsp;Your doctor may decide to stop your treatment with Erlotinib Sandoz.<\/li><li>Perforation&nbsp;in the gastrointestinal tract has been observed (less common: may affect up to 1 in 100 people).&nbsp;Tell your doctor if you have severe abdominal pain.&nbsp;Also tell your doctor if you have had a&nbsp;stomach ulcer&nbsp;or diverticular disease before, as it may increase this risk.<\/li><li>In rare cases, liver failure has been observed (rare: may affect up to 1 in 1,000 people).&nbsp;If your blood tests indicate severe changes in your liver function, your doctor may need to stop your treatment.<\/li><\/ul>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Skin rashes may appear or worsen on sun-exposed surfaces.&nbsp;If you are exposed to the sun, protective clothing and\/or the use of sunscreen (eg minerals) may be appropriate.<\/li><li>Infection<\/li><li>Loss of appetite, weight loss<\/li><li>Depression<\/li><li>Headache, altered sensitivity of the skin, or numbness in the arms and legs<\/li><li>Breathing difficulties, cough<\/li><li>Nausea<\/li><li>Irritation in the mouth<\/li><li>Stomach pain, stomach upset, flatulence<\/li><li>Abnormal liver function values<\/li><li>Itching, dry skin, and hair loss<\/li><li>Fatigue, fever, stiffness<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 10 people):&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nasal bleeding<\/li><li>Bleeding from the stomach or intestines<\/li><li>Inflammatory reactions around fingernails<\/li><li>Inflammation&nbsp;of hair follicles<\/li><li>Acne<\/li><li>Skin cracks (skin fissures)<\/li><li>Renal impairment (when erlotinib is given outside the approved indication in combination with&nbsp;chemotherapy&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Less common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Changes to&nbsp;lash&nbsp;s<\/li><li>Increased hair with a male pattern on the body and face<\/li><li>Changes in eyebrows<\/li><li>Fragile and loose nails<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Reddened or painful palms or soles of the feet (hand-foot syndrome)<\/li><\/ul>\n\n\n\n<p><strong>Very rare&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 10,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Cases of ulceration or&nbsp;perforation&nbsp;of the cornea<\/li><li>Severe blisters or flaking of the skin (may indicate&nbsp;Stevens-Johnson&nbsp;syndrome)<\/li><li>Inflammation&nbsp;of the colored part of the eye<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Erlotinib Sandoz<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the blister and the outer carton after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>No special storage instructions.<br><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is erlotinib.<\/li><\/ul>\n\n\n\n<p><em>Erlotinib Sandoz 25 mg film-coated tablets<\/em><\/p>\n\n\n\n<p>Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).<\/p>\n\n\n\n<p><em>Erlotinib Sandoz 100 mg film-coated tablets<\/em><\/p>\n\n\n\n<p>Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride).<\/p>\n\n\n\n<p><em>Erlotinib Sandoz 150 mg film-coated tablets<\/em><\/p>\n\n\n\n<p>Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Other ingredients are:<\/li><\/ul>\n\n\n\n<p><em>Tablet core:&nbsp;<\/em>lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate type A, magnesium stearate (E470 b).<\/p>\n\n\n\n<p><em>Tablet cover:<\/em>&nbsp;Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), methacrylic acid-ethyl acrylate copolymer (1: 1), type A, sodium bicarbonate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p><em>Erlotinib Sandoz 25 mg film-coated tablets:<\/em>&nbsp;White to yellowish, round, biconvex tablets with \u201c25\u201d engraved on one side.&nbsp;The tablet diameter is 6.1 mm \u00b1 5%.<\/p>\n\n\n\n<p><em>Erlotinib Sandoz 100 mg film-coated tablets:<\/em>&nbsp;White to yellowish, round, biconvex tablets with \u201c100\u201d engraved on one side.&nbsp;The tablet diameter is 8.9 mm \u00b1 5%.<\/p>\n\n\n\n<p><em>Erlotinib Sandoz 150 mg film-coated tablets:<\/em>&nbsp;White to yellowish, round, biconvex tablets with \u201c150\u201d engraved on one side.&nbsp;The tablet diameter is 10.5 mm \u00b1 5%.<br><\/p>\n\n\n\n<p>The tablets are available in aluminum &#8211; OPA \/ Alu \/ PVC blister packs of 30 tablets packed in an outer carton.<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Sandoz A \/ S<\/p>\n\n\n\n<p>Edvard Thomsens Vej 14<\/p>\n\n\n\n<p>2300 Copenhagen S<\/p>\n\n\n\n<p>Denmark<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Lek Pharmaceuticals dd<\/p>\n\n\n\n<p>Verovskova ulica 57, 1526 Ljubljana<\/p>\n\n\n\n<p>Slovenia<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2205,2200],"tags":[3897,3906,3908,3898,2213,2211,3899,3907],"class_list":["post-8310","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-erlotinib","tag-erlotinib-sandoz","tag-erlotinib-sandoz-side-effects","tag-erlotinib-side-effects","tag-medicines","tag-tablets","tag-what-is-erlotinib","tag-what-is-erlotinib-sandoz"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=8310"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8310\/revisions"}],"predecessor-version":[{"id":10420,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8310\/revisions\/10420"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}