LANSOPRAZOLE: 60,931 Adverse Event Reports & Safety Profile

The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole has the following structure: Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.

The

15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc.

Prevacid

SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame Phenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet. , glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.

Chemical

Structure

AND USAGE Lansoprazole delayed-release orally disintegrating tablet is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) Maintenance of healed duodenal ulcers in adults. ( 1.3) Treatment of active benign gastric ulcer in adults. (1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) Maintenance of healing of EE in adults. ( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10 )

1.1 Treatment of Active Duodenal Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer <span class="opacity-50 text-xs">[see Clinical Studies ( 14.1 ) ]</span>.

1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence <span class="opacity-50 text-xs">[see Clinical Studies ( 14.2 ) ]</span>. Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual

Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 ) ]. Please refer to the full prescribing information for amoxicillin.

1.3 Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months <span class="opacity-50 text-xs">[see Clinical Studies ( 14.3 ) ]</span>.

1.4 Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer <span class="opacity-50 text-xs">[see Clinical Studies ( 14.4 ) ]</span>.

1.5 Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks <span class="opacity-50 text-xs">[see Clinical Studies ( 14.5 )]</span> .

1.6 Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks <span class="opacity-50 text-xs">[see Clinical Studies ( 14.6 ) ]</span>.

1.7 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD <span class="opacity-50 text-xs">[see Clinical Studies ( 14.7 ) ]</span>.

1.8 Treatment of Erosive Esophagitis (EE) Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE. For adults who do not heal with lansoprazole delayed-release orally disintegrating tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release orally disintegrating tablets may be considered <span class="opacity-50 text-xs">[see Clinical Studies ( 14.8 ) ]</span>.

1.9 Maintenance of Healing of EE Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months <span class="opacity-50 text-xs">[see Clinical Studies ( 14.9 ) ]</span>.

1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome <span class="opacity-50 text-xs">[see Clinical Studies ( 14.10 ) ]</span>.

1.8 Treatment of Erosive Esophagitis (EE) Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE. For adults who do not heal with lansoprazole delayed-release orally disintegrating tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release orally disintegrating tablets may be considered <span class="opacity-50 text-xs">[see Clinical Studies ( 14.8 ) ]</span>.

AND ADMINISTRATION Recommended Dosage : See full prescribing information for complete dosing information for PREVACID and PREVACID SoluTab by indication and age group and dosage adjustment in patients with severe hepatic impairment. ( 2.1 , 2.2 , 2.3 )

Administration

Instructions ( 2.4 ) PREVACID capsules Should be swallowed whole. See full prescribing information for alternative administration options.

Prevacid

SoluTab Should not be broken or cut. Should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. See full prescribing information for alternative administration options.

2.1 Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients.

Triple

Therapy: PREVACID or PREVACID SoluTab 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Twice daily for 10 or 14 days Clarithromycin 500 mg Twice daily for 10 or 14 days Dual Therapy: PREVACID or PREVACID SoluTab 30 mg Three times daily for 14 days Amoxicillin 1 gram Three times daily for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-Associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks Controlled studies did not extend beyond indicated duration.

Risk Reduction

15 mg Once daily for up to 12 weeks Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks For patients who do not heal with PREVACID or PREVACID SoluTab for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of PREVACID or PREVACID SoluTab may be considered. Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including

Zollinger-Ellison Syndrome 60 mg Once daily Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with PREVACID for more than four years.

2.2 Recommended Pediatric Dosage by Indication Pediatric Patients 1 to 11 Years of Age In clinical studies, PREVACID was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below <span class="opacity-50 text-xs">[see Use in Specific Populations (8.4) ]</span> .

Indication Recommended Dose Frequency

Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤30 kg 15 mg Once daily for up to 12 weeks >30 kg 30 mg Once daily for up to 12 weeks Pediatric Patients 12 to 17 Years of Age Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD Non-erosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks

2.3 Hepatic Impairment The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) <span class="opacity-50 text-xs">[see Use in Specific Populations (8.6) ]</span> .

2.4 Important Administration Information Take PREVACID or PREVACID SoluTab before meals. Do not crush or chew PREVACID capsule or PREVACID SoluTab. Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate <span class="opacity-50 text-xs">[see Drug Interactions (7) ]</span> . Antacids may be used concomitantly with PREVACID or PREVACID SoluTab. Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. PREVACID capsules Swallow whole; do not chew. For patients who have difficulty swallowing capsules, PREVACID capsules can be opened and administered orally or via a nasogastric tube in the soft foods or liquids specified below. Administration of PREVACID in foods or liquids other than those discussed below have not been studied clinically and therefore are not recommended. Administration in Soft Foods (applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears): Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Administration in Liquids (apple juice, orange juice or tomato juice): Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, rinse the glass with two or more volumes of juice and swallow the contents immediately. Administration with Apple Juice Through a Nasogastric Tube (≥16 French) Open capsule. Sprinkle intact granules into 40 mL of apple juice. Mix briefly. Using a catheter-tipped syringe, draw up the mixture. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.

Prevacid

SoluTab Do not break or cut. Place the tablet on the tongue, allow it to disintegrate, with or without water, until the microgranules can be swallowed. Do not chew the microgranules. The tablet typically disintegrates in less than one minute. Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be administered with water via oral syringe or NG tube as follows: Administration with Water in an Oral Syringe Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes of mixing into the mouth. Do not save the water and microgranule mixture for later use. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents. Administration with Water via a NG Tube (≥8 French) Place a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or place a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, shake the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach within 15 minutes of mixing. Do not save the water and microgranule mixture for later use. Refill the catheter-tip syringe with approximately 5 mL of water, shake gently, and flush the tube.

4. CONTRAINDICATIONS

• Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsules formulation. ( 4 )
• Patients receiving rilpivirine-containing products. ( 4.7 ) Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [ see Adverse Reactions (6) ].

Proton Pump

Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ].

Proton Pump

Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ].

Proton Pump

Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ].

Proton Pump

Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ]. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole, refer to the Contraindications section of their prescribing information.

REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3) ]

Bone

Fracture [see Warnings and Precautions (5.4 )]

Severe Cutaneous Adverse

Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ]

Fundic Gland

Polyps [see Warnings and Precautions (5.12) ] Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience 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 clinical practice. Worldwide, over 10,000 patients have been treated with lansoprazole delayed-release capsules in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, lansoprazole delayed-release capsules treatment has been well-tolerated in both short-term and long-term trials. The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole delayed-release capsules-treated patients and occurred at a greater rate in lansoprazole delayed-release capsules-treated patients than placebo-treated patients in Table 1.

Table

1. Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Lansoprazole delayed release capsules Studies Body System/ Adverse Reaction Lansoprazole delayed release capsules (N=2768) Placebo (N=1023) Body as a Whole Abdominal Pain 2.1

1.2 Digestive System Constipation 1.0

0.4 Diarrhea 3.8

2.3 Nausea 1.3

1.2 Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of lansoprazole delayed-release capsules, but higher in the patients who received 60 mg of lansoprazole delayed-release capsules (2.9, 1.4, 4.2, and 7.4%, respectively). The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea. In the risk reduction study of lansoprazole delayed-release capsules for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with lansoprazole delayed-release capsules, misoprostol, and placebo was 5, 22, and 3%, respectively. Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with lansoprazole delayed-release capsules included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment. Additional adverse experiences occurring in less than 1% of patients or subjects who received lansoprazole delayed-release capsules in domestic trials are shown below: Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis Endocrine System – diabetes mellitus, goiter, hypothyroidism Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy Metabolism and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

6.2 Postmarketing Experience Additional adverse experiences have been reported since lansoprazole delayed-release capsules have been marketed. The majority of these cases are foreign-sourced and a relationship to lansoprazole delayed-release capsules has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system. Body as a Whole – anaphylactic/anaphylactoid reactions, systemic lupus erythematosus; Digestive System – hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Infections and Infestations – Clostridium difficile–associated diarrhea; Metabolism and Nutritional Disorders – hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), DRESS, AGEP, cutaneous lupus erythematosus; Special Senses – speech disorder; Urogenital System – interstitial nephritis, urinary retention

6.3 Combination Therapy with Amoxicillin and Clarithromycin In clinical trials using combination therapy with lansoprazole delayed-release capsules plus amoxicillin and clarithromycin, and lansoprazole delayed-release capsules plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with lansoprazole delayed-release capsules, amoxicillin, or clarithromycin.

Triple

Therapy: Lansoprazole delayed-release capsules/amoxicillin/clarithromycin The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10 and 14 day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual

Therapy: Lansoprazole delayed-release capsules/amoxicillin The most frequently reported adverse reactions for patients who received lansoprazole delayed-release capsules three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with lansoprazole delayed-release capsules three times daily plus amoxicillin three times daily dual therapy than with lansoprazole delayed-release capsules alone. For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with lansoprazole delayed-release capsules, refer to the Adverse Reactions section of their prescribing information.

6.4 Laboratory Values The following changes in laboratory parameters in patients who received lansoprazole delayed-release capsules were reported as adverse reactions: Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported. In the placebo-controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and lansoprazole delayed-release capsules, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received lansoprazole delayed-release capsules reported jaundice at any time during the study. In clinical trials using combination therapy with lansoprazole delayed-release capsules plus amoxicillin and clarithromycin, and lansoprazole delayed-release capsules plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed. For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with lansoprazole delayed-release capsules, refer to the Adverse Reactions section of their prescribing information.

AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response with lansoprazole delayed-release orally disintegrating tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing (5.1)

Acute Interstitial

Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs. (5.2) Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile -associated diarrhea. (5.3)

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. ( 5.4)

Severe Cutaneous Adverse

Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue lansoprazole delayed-release orally disintegrating tablets and refer to specialist for evaluation. (5.6) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7) Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.8) Interactions with Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. ( 5.9 , 7 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of lansoprazole. ( 5.10 , 7 ) Patients with Phenylketonuria: Each 15 mg lansoprazole delayed-release orally disintegrating tablet contains 2.52 mg and each 30 mg lansoprazole delayed-release orally disintegrating tablet contains 5.04 mg of phenylalanine. ( 5.11 )

Fundic Gland

Polyps: Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy. ( 5.12 ) Risk of Heart Valve Thickening in Pediatric Patients Less than One Year of Age: Lansoprazole delayed-release orally disintegrating tablets are not recommended in pediatric patients less than 1 year of age. ( 5.13 , 8.4 )

5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole delayed-release orally disintegrating tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2 Acute Tubulointerstitial Nephritis Acute tubulointerstial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue lansoprazole delayed-release orally disintegrating tablets and evaluate patients with suspected acute TIN <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span>.

5.3 Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like lansoprazole delayed-release orally disintegrating tablets may be associated with an increased risk of Clostridium difficile -associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve <span class="opacity-50 text-xs">[see Adverse Reactions (6.2) ]</span>. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with lansoprazole delayed-release orally disintegrating tablets, refer to Warnings and Precautions section of their prescribing information.

5.4 Bone Fracture Several published observational studies suggest that 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 <span class="opacity-50 text-xs">[see Dosage and Administration (2) ,Adverse Reactions (6.2 ) ]</span>.

5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.2 )]</span>. Discontinue lansoprazole delayed-release orally disintegrating tablets at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

5.6 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including lansoprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI-associated SLE is usually milder than nondrug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving lansoprazole delayed-release orally disintegrating tablets, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in four to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

5.7 Cyanocobalamin (Vitamin B12)

Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo-or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with lansoprazole delayed-release orally disintegrating tablets.

5.8 Hypomagnesemia and Mineral Metabolism Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.2 )]</span>. Consider monitoring magnesium and calcium levels prior to initiation of lansoprazole delayed-release orally disintegrating tablets and periodically while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI.

5.9 Interactions with Investigations for Neuroendocrine Tumors Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop lansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary <span class="opacity-50 text-xs">[see Drug Interactions ( 7 ) , Clinical Pharmacology ( 12.2 ) ]</span>.

5.10 Interaction with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients <span class="opacity-50 text-xs">[see Drug Interactions ( 7 ), Clin ical Pharmacology ( 12.3 ) ]</span>.

5.11 Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). Lansoprazole delayed-release orally disintegrating tablets contains phenylalanine, a component of aspartame.

Each

15 mg tablet contains 2.52 mg and each 30 mg tablet contains 5.04 mg of phenylalanine. Before prescribing lansoprazole delayed-release orally disintegrating tablets to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including lansoprazole delayed-release orally disintegrating tablets.

5.12 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.

5.13 Risk of Heart Valve Thickening in Pediatric Patients Less Than One Year of Age Lansoprazole delayed-release orally disintegrating tablets are not approved in pediatric patients less than one year of age. Nonclinical studies in juvenile rats with lansoprazole have demonstrated an adverse effect of heart valve thickening. The risk of heart valve injury does not appear to be relevant to patients one year of age and older <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.4 )]</span>.

5.10 Interaction with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients <span class="opacity-50 text-xs">[see Drug Interactions ( 7 ), Clin ical Pharmacology ( 12.3 ) ]</span>.

5.11 Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). Lansoprazole delayed-release orally disintegrating tablets contains phenylalanine, a component of aspartame.

Each

15 mg tablet contains 2.52 mg and each 30 mg tablet contains 5.04 mg of phenylalanine. Before prescribing lansoprazole delayed-release orally disintegrating tablets to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including lansoprazole delayed-release orally disintegrating tablets.

INTERACTIONS Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole delayed-release orally disintegrating tablets and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table

2.

Clinically Relevant Interactions Affecting Drugs

Coadministered with Lansoprazole Delayed-Release Orally Disintegrating Tablets and Interactions with Diagnostics Antiretrovirals C li n i ca l I mpact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.

• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with lansoprazole may reduce antiviral effect and promote the development of drug resistance.
• Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with lansoprazole may increase toxicity of the antiretroviral drugs.
• There are other antiretroviral drugs which do not result in clinically relevant interactions with lansoprazole I nte rv ent i on : Rilpivirine-containing products: Concomitant use with lansoprazole delayed-release orally disintegrating tablets are contraindicated [ see Contra i nd i cat i ons ( 4 ) ]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with lansoprazole delayed-release orally disintegrating tablets. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin C li n i ca l Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. I nte rv ent i on : Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Methotrexate C li n i ca l Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warn i ngs a nd Precaut i ons ( 5.10 )]. I nte rv ent i on : A temporary withdrawal of lansoprazole delayed-release orally disintegrating tablets may be considered in some patients receiving high-dose methotrexate. Digoxin Cl i n i cal Impact: Potential for increased exposure of digoxin. Intervent i on : Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin. Theophylline Cl i n i cal Impact: Increased clearance of theophylline [see Cl i n i cal Pharmacology ( 12.3 ) ] . Intervent i on : Individual patients may require additional titration of their theophylline dosage when lansoprazole delayed-release orally disintegrating tablets are started or stopped to ensure clinically effective blood concentrations.

Drugs

Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Cl i n i cal Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervent i on : Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving lansoprazole and MMF. Use lansoprazole delayed-release orally disintegrating tablets with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.

Combination

Therapy with Clarithromy c in and Am o xicillin C li n i cal Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. Intervent i on :

• See Contraindications and Warnings and Precautions in prescribing information for clarithromycin.
• See Drug Interactions in prescribing information for amoxicillin. Tacrolimus C li n i cal Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervent i on : Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. Interactions with Investigations of Neuroendocrine Tumors C li n i cal Impact: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warn i ngs and Precaut i ons ( 5.9 ), C li n i ca l Pha r m a cology ( 12.2 ) ]. Intervent i on : Temporarily stop lansoprazole delayed-release orally disintegrating tablets treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. Interaction with Secretin Stimulation Test C li n i cal Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. Intervent i on : Temporarily stop lansoprazole delayed-release orally disintegrating tablets treatment at least 28 days before assessing to allow gastrin levels to return to baseline [see Clinica l Pharmacology ( 12.2 )].

False Positive Urine

Tests for THC C li n i cal Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs. Intervent i on : An alternative confirmatory method should be considered to verify positive results.

Table

3.

Clinically Relevant Interactions Affecting Lansoprazole

Delayed-Release Orally Disintegrating Tablets When Coadministered with Other Drugs CYP2C19 OR CYP3A4 Inducers C li n i cal Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers [see C li n i ca l Pha r m a co l ogy ( 12.3 )]. Intervent i on : St John's Wort, rifampin: Avoid concomitant use with lansoprazole delayed-release orally disintegrating tablets. Ritonavir-containing products: See prescribing information. CYP2C19 or CYP3A4 Inhibitors C li n i cal Impact: Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors [see C li n i ca l Ph a r m a co l ogy ( 12.3 )]. Intervent i on : Voriconazole: See prescribing information. Sucralfate C li n i cal Impact: Decreased and delayed absorption of lansoprazole [see C li n i c a l Pha r maco l ogy ( 12.3 )]. Intervent i on : Take lansoprazole at least 30 minutes prior to sucralfate [see Dosage a nd Adm i nist r at i on ( 2.4 ) ]. See full prescribing information for a list of clinically important drug interactions. ( 7 )

Active ingredient (in each capsule) Lansoprazole USP, 15 mg

Inactive ingredients D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide Consumer Information Treats Frequent Heartburn Lansoprazole Delayed-Release Capsules 15 mg / Acid Reducer

• May take 1 to 4 days for full effect
• Sodium Free Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg. Save for future reference.

How Lansoprazole

Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach.

Lansoprazole

Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When

Taking Lansoprazole Delayed-Release Capsules 15 mg Frequent heartburn can occur anytime during the 24-hour period (day or night).

Take Lansoprazole

Delayed-Release Capsules 15 mg in the morning before eating.

Lansoprazole

Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole

Delayed-Release Capsules 15 mg Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who

Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg People who have one episode of heartburn a week or less, or who want immediate relief of heartburn. How to Take Lansoprazole Delayed-Release Capsules 15 mg 14-DAY Course of Treatment

• Swallow 1 capsule with a glass of water before eating in the morning.
• Take every day for 14 days.
• Do not take more than 1 capsule a day.
• Swallow whole. Do not crush or chew capsules.
• Do not use for more than 14 days unless directed by your doctor. When to Take Lansoprazole Delayed-Release Capsules 15 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to Ask Your Doctor Allergy alert: Do not use if you are allergic to lansoprazole Do not use
• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have
• liver disease
• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain Ask a doctor or pharmacist before use if you are
• taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if
• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea
• you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Tips for Managing Heartburn
• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• Eat slowly and do not eat big meals.
• Do not eat late at night or just before bedtime.
• Do not lie flat or bend over soon after eating.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.
• If you are overweight, lose weight.
• If you smoke, quit smoking. Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole

Delayed-Release Capsules 15 mg is Sold Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For

Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg Call 1-800-719-9260 Distributed By Perrigo® Allegan, MI 49010 : 3T300 00 J6