INTRODUCTION

ROWASA PELLET contains Mesalamine which belongs to the group of medicines called Salicylates. ROWASA PELLET is used to treat mild to moderate attacks of ulcerative colitis, which is a chronic inflammatory bowel disease that affects last part of colon and rectum (back passage) in affected individuals.

ROWASA PELLET is not recommended for use in patients allergic to Mesalamine, salicylates (such as acetylsalisylic acid) and/or sulphasalazine. It is also not recommended for use in patients with bleeding disorders and/or serious kidney/liver disease.

Before taking ROWASA PELLET, inform your doctor if you suffer from an active peptic ulcer (stomach/duodenal ulcer) and/or have lung problems (such as asthma), mild to moderate kidney/liver problems.

ROWASA PELLET should be used with caution in pregnant and breastfeeding women only if it is clearly necessary. It is advised to be used with caution in children and adolescents (aged 6-18 years) and in elderly patients (aged above 65 years) after consulting the doctor.

The most common side effects after taking ROWASA PELLET are abdominal pain, nausea/vomiting, diarrhoea, flatulence, headache and/or rash. Consult your doctor if any of these symptoms worsens.

USES OF ROWASA PELLET

• Treats mild to moderate attacks of ulcerative colitis in affected individuals

HOW ROWASA PELLET WORKS

ROWASA PELLET works by suppressing the production of prostaglandins (chemical messengers responsible for inflammation in the intestines) which results in reduced inflammation and ulceration thus providing relief from ulcerative colitis (and its associated symptoms) in affected individuals.

DIRECTIONS FOR USE

Take ROWASA PELLET as advised by your physician. Empty the contents of the sachet onto the tongue and wash the granules down immediately with some water/orange juice or mix the entire content of the sachet with yogurt and immediately intake it without chewing the medicine. Your doctor will decide the exact dose and duration of treatment for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ROWASA PELLET

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take ROWASA PELLET with or just after a meal. Stick to simple meals. Avoid eating oil rich or spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, drink slowly in between meals. Inform your doctor if the condition worsens.

Diarrhea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult and inform your doctor if the symptom worsens.

Headache:

If ROWASA PELLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of using ROWASA PELLET. If it lasts more than a week or severe, inform your doctor.

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking ROWASA PELLET, inform your doctor if you are taking any of the following medicine:

• antacids (medicines used to relieve indigestion and heartburn) Ex. aluminum hydroxide, magnesium carbonate
• azathioprine (used after transplantations or to treat autoimmune diseases)
• mercaptopurine, thioguanine (medicines used to treat leukaemia)
• medicines used to prevent blood clotting (Ex. warfarin)
• non- steroidal anti-inflammatory drugs (medicines used to reduce fever and provide relief from pain) Ex. ibuprofen, diclofenac, ketorolac

Overdosage:

If you or anyone else accidentally takes too much of ROWASA PELLET, consult your doctor immediately or visit the nearby hospital to manage the overdose symptoms.

SYNOPSIS

MORE INFORMATION

• Keep ROWASA PELLET out of reach of children
• Store ROWASA PELLET at room temperature

FAQs ABOUT ROWASA PELLET

What is ROWASA PELLET used for?

ROWASA PELLET is used to treat mild to moderate attacks of ulcerative colitis, which is a chronic inflammatory bowel disease that affects last part of colon and rectum (back passage) in affected individuals.

How to take ROWASA PELLET?

Take ROWASA PELLET as advised by your physician. Empty the contents of the sachet onto the tongue and wash the granules down immediately with some water/orange juice or mix the entire content of the sachet with yogurt and immediately intake it without chewing the medicine. Your doctor will decide the exact dose and duration of treatment for you depending upon your age, body weight and disease condition.

What are the side effects of ROWASA PELLET?

The most common side effects after taking ROWASA PELLET are abdominal pain, nausea/vomiting, diarrhoea, flatulence, headache and/or rash. Consult your doctor if any of these symptoms worsens.

How ROWASA PELLET works?

ROWASA PELLET works by suppressing the production of prostaglandins (chemical messengers responsible for inflammation in the intestines) which results in reduced inflammation and ulceration thus providing relief from ulcerative colitis (and its associated symptoms) in affected individuals.

Can ROWASA PELLET be used in pregnant and breastfeeding women?

Yes, ROWASA PELLET can be used but with caution in pregnant and breastfeeding women only if it is clearly necessary. Consult your doctor before taking ROWASA PELLET.

REFERENCES

1. KD. Tripathi. Drugs for Constipation and Diarrhoea. Essentials of medical pharmacology. Seventh edition. 2013. Page – 684.

2. Marietta Iacucci, Shanika de Silva, Subrata Ghosh.  Mesalazine in inflammatory bowel disease: A trendy topic once again? NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in February 2010] [Accessed on 18th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2852235/

3. Ashwin N. Ananthakrishnan, Tamara Donaldson, Karen Lasch, Vijay Yajnik. Management of Inflammatory Bowel Disease in the Elderly Patient: Challenges and Opportunities. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in June 2018] [Accessed on 18th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5687915/

4. Ferring GmbH. Health Products Regulatory Authority (HPRA). [Revised in February 2022] [Accessed on 18th October 2022] https://www.hpra.ie/img/uploaded/swedocuments/9945a6a2-aeec-49e9-80b5-90d028e5154b.pdf

5. Taj Pharma India. Meslataj 0.5gm/1gm/2gm. [Accessed on 18th October 2022] https://tajpharma.in/portfolio-item/mesalazine-sachet-1gm-prolonged-release-granules-meslataj-taj-pharma/

USEFUL DIAGNOSTIC TESTS

• Colonoscopy
• Sigmoidoscopy