Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets)

1. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) © The Swiss Pharmacy

2. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) are a locally-acting aminosalicylate used for the treatment of mild to moderate attacks of ulcerative colitis and for the maintenance of remission of ulcerative colitis in adults. Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed. Mesacol OD tablets release the active ingredient slowly which then acts locally to reduce the inflammation and help relieve or stop the pain. © The Swiss Pharmacy

3. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Uses of Mesacol OD 1200 mg Tablets: Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets 1.2 g) are indicated for treatment of mild to moderate active ulcerative colitis and for long-term maintenance therapy in order to maintain remission and prevent relapse of active disease. Mesacol OD is also used for the management of mild to moderate Crohn’s Disease and maintenance of Crohn’s Disease in remission induced by surgery or medication. It works inside the bowels to reduce inflammation and other symptoms of the disease. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

4. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Mesacol OD tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of 1200 mg. © The Swiss Pharmacy

5. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Chemical Structure © The Swiss Pharmacy

6. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) The active pharmaceutical ingredients contained in Mesacol OD tablets is Mesalamine (Mesalazine). Each tablet of Mesacol OD contains 1200 mg of Mesalamine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

7. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Recommended Adult Dosage The dosage of Mesacol OD tablets Mesacol OD tablets (Generic Mesalamine Prolonged Release tablets) is given below: Ulcerative colitis Ulcerative colitis Treatment of active disease: Adults: Individual dosage, up to 4 g given once daily or in divided doses Maintenance treatment: Adults: 2 g once daily OR individual dosage, starting with 1.5 g to 2 g daily in divided doses URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

8. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Recommended Adult Dosage The dosage of Mesacol OD tablets Mesacol OD tablets (Generic Mesalamine Prolonged Release tablets) is given below: Crohn’s disease Crohn’s disease Treatment of active disease: Adults: Individual dosage, up to 4 g daily in divided doses Maintenance treatment: Adults: Individual dosage, up to 4 g daily in divided doses URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

9. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Contraindications ➔Mesacol OD tablets are contraindicated in patients with a known hypersensitivity to Mesalamine, Salicylates or Aminosalicylates or any component of the tablet. ➔Patients with existing gastric or duodenal ulcer ➔Patients with urinary tract obstruction, renal parenchymal disease or severe renal impairment. ➔Patients with severe hepatic impairment ➔Infants under 2 years of age URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

10. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Storage Instructions Mesacol OD tablets (Generic Mesalamine Prolonged Release tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

11. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Warnings Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue Mesacol OD tablets if renal function deteriorates. Mesalamine-induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation; monitor for worsening symptoms; discontinue if acute intolerance syndrome suspected. Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

12. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Warnings 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. Photosensitivity: Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. Nephrolithiasis: Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. Iron Content of Mesacol OD tablets: Consider the iron content of Mesacol OD tablets in patients taking iron supplementation and those at risk of iron overload. Interference with Laboratory Tests: Use of Mesalamine OD may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

13. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Possible Side Effects The most common Mesalamine Prolonged Release tablets (Mesacol OD tablets) with an incidence rate of 3% or greater are Headache, Diarrhea, Upper Abdominal Pain, Nausea, Nasopharyngitis, Influenza and Influenza-like Illness and Sinusitis. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

14. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Possible Side Effects The following side effects, presented by body system, were reported at a frequency less than 3% in patients treated with Mesalamine prolonged release capsules (Mesacol OD tablets) for up to 24 months in controlled and open-label trials. Ear and Labyrinth Disorders: tinnitus, vertigo Dermatological Disorder: alopecia Gastrointestinal: abdominal pain lower, rectal hemorrhage Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin General Disorders and Administration Site Disorders: fatigue Hepatic: hepatitis cholestatic, transaminases increased Renal Disorders: creatinine clearance decreased, hematuria Musculoskeletal: pain, arthralgia Respiratory: dyspnea URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

15. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Overdosage Mesalamine (Mesacol OD Prolonged Release tablets) is an aminosalicylate, and symptoms of overdose can include tinnitus (ringing in the ears), vertigo (a spinning sensation), headache, confusion, rapid breathing, drowsiness, sweating, seizures, hyperventilation, dyspnea, vomiting, and diarrhea. There is no specific antidote for Mesalamine overdose and treatment for suspected acute severe toxicity with Mesacol OD tablets should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. Mesacol is a pH dependent delayed-release medicine and this factor should be considered when treating a suspected overdose. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

16. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Mesacol Tablets During Pregnancy Mesalamine (Mesacol Prolonged Release tablets) is classified by the US FDA as Pregnancy Category C. No fetal harm was seen during animal reproduction studies of Mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. However, dibutyl phthalate (DBP) is an inactive ingredient in Mesacol’s enteric coating, and in animal studies in rats at doses greater than 190 times the human dose, maternal DBP was associated with external and skeletal malformations and adverse effects on the reproductive system of male offspring. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

17. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Mesacol Tablets During Pregnancy There are no adequate and well controlled studies of Mesalamine (Mesacol Prolonged Release tablets) use in pregnant women. Pregnant women must be advised of the potential risk to the fetus. During pregnancy, this medicine must be used only when clearly needed. The underlying condition itself (Inflammatory bowel disease/IBD) may increase risks for the pregnancy outcome. Discuss the risks and benefits with your doctor. Mesalamine passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy

18. Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets) Mesacol OD Tablets Mesacol OD Tablets are manufactured by Sun Pharmaceutical Industries Limited, India. URL: https://www.theswisspharmacy.com/product_info.php?info=p9969_Generic-Mesalamine-Prolonged-Release-Tablets.html © The Swiss Pharmacy