INTRODUCTION

ROWASA PELLETS contains Mesalamine which belongs to the group of medicines called Salicylates. ROWASA PELLETS 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 PELLETS 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 PELLETS, 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 PELLETS 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 PELLETS are abdominal pain, nausea/vomiting, diarrhoea, flatulence, headache and/or rash. Consult your doctor if any of these symptoms worsens.

USES OF ROWASA PELLETS

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

HOW ROWASA PELLETS WORKS

ROWASA PELLETS 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 PELLETS 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 PELLETS

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take ROWASA PELLETS 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 PELLETS 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 PELLETS. 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 PELLETS, 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 PELLETS, consult your doctor immediately or visit the nearby hospital to manage the overdose symptoms.

SYNOPSIS

MORE INFORMATION

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

FAQs ABOUT ROWASA PELLETS

What is ROWASA PELLETS used for?

ROWASA PELLETS 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 PELLETS?

Take ROWASA PELLETS 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 PELLETS?

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

How ROWASA PELLETS works?

ROWASA PELLETS 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 PELLETS be used in pregnant and breastfeeding women?

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

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