Mesacol Tablets (Generic Mesalamine Delayed Release Tablets)

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

2. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Mesacol tablets (Generic Mesalamine Delayed Release tablets) are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. This medicine is also used for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Mesacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established. © The Swiss Pharmacy

3. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Mesacol tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of 400 mg and 800 mg. © The Swiss Pharmacy

4. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Chemical Structure © The Swiss Pharmacy

5. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) The active pharmaceutical ingredients contained in Mesacol tablets is Mesalamine (Mesalazine). Each tablet of Mesacol contains 400 mg or 800 mg of Mesalamine. © The Swiss Pharmacy

6. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Uses of Mesacol 400 mg and 800 mg Tablets: Mesacol (Generic Mesalamine Delayed Release tablets) is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. Mesacol tablets 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. Management of mild to moderate Crohn’s Disease and maintenance of Crohn’s Disease in remission induced by surgery or medication. URL: https://www.theswisspharmacy.com/product_info.php?info=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

7. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Recommended Adult Dosage The dosage of Mesacol tablets Mesacol tablets (Generic Mesalamine Delayed Release tablets) is given below: Two Mesacol 400 mg tablets have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. Evaluate renal function prior to initiation of Mesacol. You may take this medicine with or without food. Drink extra fluids so you will urinate more often and help prevent kidney problems (eg, kidney stones). Swallow the capsules whole; do not cut, break, crush or chew. For patients who are unable to swallow the capsules, the capsules can be opened and the inner tablets swallowed. Drink an adequate amount of fluids. URL: https://www.theswisspharmacy.com/product_info.php?info=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

8. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Recommended Adult Dosage The dosage of Mesacol tablets Mesacol tablets (Generic Mesalamine Delayed Release tablets) is given below: Treatment of Mildly to Moderately Active Ulcerative Colitis: Treatment of Mildly to Moderately Active Ulcerative Colitis: Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks Maintenance of Remission of Ulcerative Colitis: Maintenance of Remission of Ulcerative Colitis: Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses URL: https://www.theswisspharmacy.com/product_info.php?info=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

9. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Contraindications ➔Mesacol 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

10. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Storage Instructions Mesacol tablets (Generic Mesalamine Delayed 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

11. Mesacol Tablets (Generic Mesalamine Delayed 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 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

12. Mesacol Tablets (Generic Mesalamine Delayed 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 tablets: Consider the iron content of Mesacol tablets in patients taking iron supplementation and those at risk of iron overload. Interference with Laboratory Tests: Use of Mesalamine 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

13. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Possible Side Effects The most common Mesalamine tablets (Mesacol Delayed Release tablets) with an incidence rate of 2% or greater are headache, nausea, nasopharyngitis, abdominal pain, and worsening of ulcerative colitis. URL: https://www.theswisspharmacy.com/product_info.php?info=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

14. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Overdosage Mesalamine (Mesacol Delayed 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 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

15. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Mesacol Tablets During Pregnancy Mesalamine (Mesacol Delayed 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

16. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Mesacol Tablets During Pregnancy There are no adequate and well controlled studies of Mesalamine (Mesacol Delayed 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=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy

17. Mesacol Tablets (Generic Mesalamine Delayed Release Tablets) Mesacol Delayed Release Tablets Mesacol Delayed Release Tablets are manufactured by Sun Pharmaceutical Industries Limited, India. URL: https://www.theswisspharmacy.com/product_info.php?info=p9970_Generic-Mesalamine-Delayed-Release-Tablets.html © The Swiss Pharmacy