FDA label 82499be5-dbd9-435f-9645-e1af7c3cfd38

FDA-Approved Patient Labeling Omeprazole Delayed-Release Capsules, USP Read the patient information that comes with omeprazole delayed-release capsules before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about omeprazole delayed-release capsules, ask your doctor. What is Omeprazole Delayed-Release Capsules? Omeprazole delayed-release capsule is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Omeprazole delayed-release capsule is used in adults: • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). • GERD is a chronic condition (lasts a long time) that occurs when acid from the stomach backs up into the esophagus (food pipe) causing symptoms, such as heartburn, or damage to the lining of the esophagus. Common symptoms include frequent heartburn that will not go away, a sour or bitter taste in the mouth, and difficulty swallowing. • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) • to maintain healing of the esophagus. Omeprazole delayed-release capsule has not been studied for treatment lasting longer than 12 months (1 year) • for up to 8 weeks for healing stomach ulcers • for up to 8 weeks for healing ulcers in the first part of the small bowel (duodenal ulcers) • to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin. • for lowering the amount of stomach acid in people with certain conditions which cause them to make too much acid, including those with Zollinger-Ellison Syndrome. For children and adolescents 1 to 17 years of age, omeprazole delayed-release capsule is used: • for up to 4 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) • to maintain healing of the esophagus Omeprazole delayed-release capsule is not recommended for children under the age of 1 year. Omeprazole delayed-release capsule may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Who Should not Take Omeprazole Delayed-Release Capsules? Do not take Omeprazole delayed-release capsules if you: • are allergic to any of the ingredients in omeprazole delayed-release capsules. See the end of this leaflet for a complete list of ingredients in omeprazole delayed-release capsules. • are allergic to any other Proton Pump Inhibitor (PPI) medicine. What Should I Tell my Doctor Before Taking Omeprazole Delayed-Release Capsules? Tell your doctor about all your medical conditions, including if you: • have liver problems • are pregnant or plan to become pregnant. It is not known if omeprazole delayed-release capsules will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. • are breastfeeding or planning to breastfeed. You and your doctor should decide if you will take omeprazole delayed-release capsules or breast-feed. You should not do both. Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works. Especially tell your doctor if you take: • atazanavir (Reyataz) • nelfinavir (Viracept) • saquinavir (Fortovase) • cilostazol (Pletal) • ketoconazole (Nizoral) • voriconazole (Vfend) • ampicillin (Unasyn) • products that contain iron • warfarin (Coumadin) • digoxin (Lanoxin, Lanoxincaps) • tacrolimus (Prograf) • diazepam (Valium) • phenytoin (Dilantin) • disulfiram (Antabuse) How Should I Take Omeprazole Delayed-Release Capsules? • Take omeprazole delayed-release capsules exactly as prescribed by your doctor. • Do not change your dose or stop omeprazole delayed-release capsules without talking to your doctor. • Take omeprazole delayed-release capsules at least 1 hour before a meal. • Swallow omeprazole delayed-release capsules whole. Never chew orcrush Omeprazole delayed-release capsules . • If you have difficulty swallowing omeprazole delayed-release capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Be sure to swallow the applesauce right away. Do not store it for later use. • If you forget to take a dose of omeprazole delayed-release capsule, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose. • If you take too much omeprazole delayed-release capsule, tell your doctor right away. What are the Possible Side Effects of Omeprazole Delayed-ReleaseCapsules? Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole delayed-release capsules. • rash • face swelling • throat tightness • difficulty breathing Your doctor may stop omeprazole delayed-release capsules if these symptoms happen. The most common side effects with omeprazole delayed-release capsules in adults and children include: • Headache • Abdominal pain • Nausea • Diarrhea • Vomiting • Gas • Respiratory system events • Fever People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine. Tell your doctor about any side effects that bother you or that do not go away. These are not all the possible side effects with omeprazole delayed-release capsules. Talk with your doctor or pharmacist if you have any questions about side effects. You may report side effects to Sandoz Inc at 1-800-525--8747 or FDA at 1-800-FDA1088. How Should I Store Omeprazole Delayed-Release Capsules? Store omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep the container of omeprazole delayed-release capsules closed tightly. Keep omeprazole delayed-release capsules and all medicines out ofthe reach of children. General Advice Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet provides a summary of the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals. Patient Instructions For Use For instructions on taking Delayed-Release Capsules, please see “How Should I Take Omeprazole Delayed-Release Capsules?” What are the Ingredients in Omeprazole Delayed-Release Capsules? Active ingredient in omeprazole delayed-release capsules delayed-release capsules: Omeprazole Inactive ingredients in omeprazole delayed-release capsules acetone, anhydrous lactose, croscarmellose sodium, dehydrated alcohol, dibutyl sebacate, hypromellose phthalate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 80, povidone and talc. The capsule shells have the following inactive ingredients: hypromellose and titanium dioxide. In addition, the 10 mg and 40 mg capsule also contains red iron oxide and yellow iron oxide. The capsule shell may contain carrageenan and potassium chloride. The ink used for printing contains black iron oxide. Manufactured in Slovenia by Lek Pharmaceutical d. d. for Sandoz Inc., Princeton, NJ 08540 Rev. October 2010 Cardinal Health Zanesville, OH 43701 OI85160411

5 WARNINGS AND PRECAUTIONS • Symptomatic response does not preclude the presence of gastric malignancy ( 5.1 ) • Atrophic Gastritis: has been noted with long-term therapy ( 5.2 ) • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.3) • Triple therapy for H. pylori – there are risks due to antibiotics; see separate prescribing information for individual antibiotics ( 5.4, 5.5 ) 5.1 Concomitant Gastric Malignancy Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy. 5.2 Atrophic Gastritis Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole. 5.3 Bone Fracture Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines. [See DOSAGE AND ADMINISTRATION (2) AND ADVERSEREACTIONS (6.3) ] 5.4 Combination use of Omeprazole with Amoxicillin Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. 5.5 Combination Use of Omeprazole with Clarithromycin Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus. (See Warnings in prescribinginformation for clarithromycin .) Co-administration of omeprazole and clarithromycin has resulted in increases in plasma levels of omeprazole, clarithromycin, and 14-hydroxy-clarithromycin. [See CLINICALPHARMACOLOGY (12) ] Concomitant administration of clarithromycin with cisapride or pimozide, is contraindicated.

6 ADVERSE REACTIONS Adults: Most common adverse reactions in adults (incidence ≥2%) are: • Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6 ) Pediatric patients (1 to 16 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. ( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience with Omeprazole Monotherapy Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%). Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%). The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less. The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to <2 and 2 to 16 year age groups (75% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33%), and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [See USE IN SPECIFIC POPULATIONS (8.4) ] 6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone. Dual Therapy (omeprazole/clarithromycin) Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n = 346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section). Triple Therapy (omeprazole/clarithromycin/amoxicillin) The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections). 6.3 Post-marketing Experience The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules.Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure. Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise; Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine: Gynecomastia Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors. Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin] Metabolic/Nutritional: Hypoglycemia, hypomagnesemia, hyponatremia, weight gain Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture. Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo Respiratory: Epistaxis, pharyngeal pain Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis Special Senses: Tinnitus, taste perversion Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis