Cozycol

Treatment of mild to moderately active Ulcerative Colitis & Crohn’s Disease. Maintenance of remission of Ulcerative Colitis. Maintenance of remission of Crohn’s disease.

Swallow the tablets or capsules whole with a glass of water .The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water.

Ulcerative colitis- Adults: Active disease: Individual dosage, up to 4 gm once daily or divided into 2-4 doses. Maintenance treatment: Individual dosage. Recommended dosage, 2 gm once daily. Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.

Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose). Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

Elderly patients are more likely to have decreased renal function, 5-aminosalicylic acid ( mesalazine) should be used with care.

Not recommended for patients who have a known hypersensitivity to salicylates or to any other component of the formulation.

It appears to work by blocking the production of inflammatory chemicals in the intestines. This helps to reduce inflammation and improve symptoms of IBD, including ulcerative colitis and Crohn's disease..

Inform your doctor about all medications you are taking, including prescription, over-the-counter, and herbal supplements. Some medications may interact with 5-aminosalicylic acid (mesalazine), increasing the risk of side effects. Drink plenty of fluids while taking 5-aminosalicylic acid (mesalazine). This will help an avoid dehydration and kidney problems. Do not take 5-aminosalicylic acid (mesalazine) if you are allergic to it or to other aminosalicylates.

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc. Other potential side effects of 5-aminosalicylic acid (mesalamine) include: Kidney problems, Liver problems, Pancreatitis, Hair loss, Joint pain, Fever, Fatigue, Loss of appetite, Weight loss.

Pregnancy: It should be given during pregnancy only if the potential benefit justifies the risk to the fetus. Lactation: It should be used during breastfeeding only if the potential benefits outweigh the potential risks. 5-aminosalicylic acid (mesalazine) has been shown to pass into breast milk. A lactating mother should be advised to exercise caution.

Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reaction

Store below 30°C . Protect from light and moisture. Keep all medicines out of the reach of children.