• Ulcerative colitis – a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding, frequent diarrhoea and abdominal pain.
• Rowasa 500mg/1gm/2gm sachet act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis.

Pregnancy and breast-feeding
Women who are pregnant or breast-feeding should not take Rowasa 500mg/1gm/2gm sachet unless advised otherwise by their doctor.

Ask your doctor for advice before taking any medicine.
Tests on your liver, kidney and blood
Before you start treatment with Rowasa 500mg/1gm/2gm sachet you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine sample periodically during your treatment.

Driving and using machines
Rowasa 500mg/1gm/2gm sachet are not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Rowasa 500mg/1gm/2gm sachet

This is to avoid problems with your kidneys.
The usual dose is:
Adults and elderly: For the treatment of acute episodes of ulcerative colitis:

• Once daily 3 to 6 sachets of 500mg granules (equivalent to 1.5 – 3.0 g Mesalazine daily) preferably to be taken in the morning according to the individual clinical necessities.
• It is also possible to take the prescribed daily dose in three divided doses (1 sachet of 500mg granules three times daily, or 2 sachet of 500mg granules three times daily), if this is more convenient to the patient.

For the maintenance of remission of ulcerative colitis:

• The standard treatment is 0.5g mesalazine three times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5g mesalazine per day.( 1 sachet of 500mg granules three times daily (equivalent to 1.5 g Mesalazine daily).

Children below 6 years of age:

• Mesalazine granules should not be used in children under 6 years of age because there is very limited experience with this age group.
• Children older than 6 years of age and adolescents: Active disease: To be determined individually, starting with 30-50mg/kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose./li>
• Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose/li>
• 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/li>
• If you stop taking Rowasa 500mg/1gm/2gm sachet Keep taking the sachet for as long as your doctor tells you. Your symptoms may come back if you stop treatment too early. Remember to get a repeat prescription at the right time so that you do not miss a day of treatment./li>

If you take more Rowasa 500mg/1gm/2gm sachet than you should
Do not exceed the recommended dose. You should only take as many tablets as your doctor has instructed on the pharmacist’s label. If you take too much medicine, tell your doctor immediately or go to your nearest Accident & Emergency Department. Take the tablet pack with you if possible.
If you forget to take Rowasa 500mg/1gm/2gm sachet If you forget to take a dose at the required time, take it as soon as you remember and continue taking your tablets as before. DO NOT take more than two doses in one hour. If it is almost time for your next dose, wait until then and carry on as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

• a rash with or without itching, any shortness of breath, palpitations (rapid heart beat) or chest pain. These effects will usually disappear when you stop taking the medicine.

Tell your doctor immediatelyif you experience any of the following symptoms:

• fever, sore throat, mouth or lip ulcers, spots underneath your skin anywhere on your body, including the genital and anal regions, become very pale, swollen ankles or have unusual bleeding (e.g. unexpected nosebleeds or bleeding gums)
• skin rash with flaking, boils or sore lips or mouth
• bruising more easily or suspect blood abnormalities
• problems with kidney function

Common side effects (in more than 1 in 100 people but less than 1 in 10 people):

Rare side effects (in less than 1 in 1000 people):

• problems with heart, lung, liver or kidney function
• inflammation of the pancreas
• blood abnormalities
• numbness and tingling of the fingers and toes due to damaged nerves
• hair loss
• fever
• skin rash.

Very rare side effects (in less than 1 in 10,000 people):

Reporting of side effects

The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• Instruct patients to take the ROWASA sachets whole
• Inform patients that if they are switching from a previous oral mesalamine therapy to ROWASA they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for ROWASA. Inform patients that they should not substitute one ROWASA sachet with two ROWASA sachets [see Dosage Forms and Strengths and Clinical Pharmacology].
• Inform patients that intact, partially intact, and/or pellets have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly.
• Instruct patients to protect ROWASA sachets from moisture.

Floor, 107 to 110 & 117 to 120, First Floor, Pimplas Village, Bhiwandi,
District Thane, Tal: Bhiwandi – 16 (Thane Z5) 421302.
Maharashtra, India

Please consult your doctor for more information. Abbott India Limited shall not be liable in any manner whatsoever for any action on the basis of this information and does not hold itself liable for any consequences, legal or otherwise, arising out of information provided