INTRODUCTION

GIFAXIN 400MG contains Rifaximin which belongs to the group of medicines called antibiotics. It is used to treat and prevent the recurrence of hepatic encephalopathy in adults. Hepatic encephalopathy can be defined as a decline in brain function that occurs as a result of severe liver disease like liver cirrhosis or hepatitis. It is a spectrum of neuropsychiatric abnormalities characterized by agitation, confusion, muscle problems, difficulty in speaking and in some cases coma.

GIFAXIN 400MG can also be used in the treatment of irritable bowel syndrome with diarrhea in adults. Rifaximin kills the toxic bacteria in the GI tract and which relieve the symptoms of hepatic encephalopathy and irritable bowel syndrome. This medicine can either be used alone or can be combined with medicines containing a laxative called lactulose. Taking this medicine, may cause a reddish discolouration of urine. If this symptom bothers you, contact your doctor.

The most common side effect of taking this medicine are severe diarrhea, depression and headache. If you experience severe diarrhea during or after using this medicine, contact your doctor immediately. This medicine should be used with extreme caution in patients with severe liver disease. Regular monitoring of liver function is required. Before taking this medicine, inform your doctor if you have any blockage in your intestine or if you are pregnant or breastfeeding. GIFAXIN 400MG is not recommended for use in children (aged less than 18 years). Consult your doctor before taking.

USES OF GIFAXIN 400MG

• Treats and prevents hepatic encephalopathy in adults
• Treats irritable bowel syndrome with diarrhea in adults

HOW GIFAXIN 400MG WORKS

Rifaximin works by inhibiting the growth of ammonia-producing bacteria in the digestive tract which are important to the pathogenesis of hepatic encephalopathy. This helps to relieve the symptoms of hepatic encephalopathy such as agitation, confusion, muscle problems and reduces its recurrence. Inhibition of toxic micro organisms in the gut wall also relieves the symptoms of irritable bowel syndrome like abdominal cramping, bloating, and diarrhea or constipation.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. It can be taken with or without food. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF GIFAXIN 400MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

Bloating or wind:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor immediately.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

Headache:

Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• antibiotics (medicines used to treat infections) e.g. clarithromycin
• warfarin (used to prevent blood clotting)
• medicines used to treat epilepsy (e.g. phenytoin)
• medicines to treat abnormal heartbeat (e.g. digoxin, amiodarone)
• ciclosporin (used to suppress immune system)
• oral contraceptives (medicines used to prevent pregnancy)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT GIFAXIN 400MG

Can GIFAXIN 400MG be used in children?

No. It is not recommended for use in children (aged less than 18 years). Consult your doctor before taking.

Can GIFAXIN 400MG cause constipation?

Yes. It may rarely cause constipation in some individuals. Eat fibre rich foods like fresh fruit, vegetables and cereals and drink plenty of water.

How to take GIFAXIN 400MG?

It can be taken with or without food. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your condition.

REFERENCES

1. KD. Tripathi. Drugs for constipation and diarrhea. Essentials of Pharmacology. Seventh edition. 2013. Page – 681-682.

2. Gerald G. Briggs and Roger K. Freeman. R. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3404-3405.

3. University of Miami. RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on September 2019] [Accessed 29th October 2020] https://www.clinicaltrials.gov/ct2/show/NCT00364689

4. Bausch Health Americas, Inc. A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on September 2019] [Accessed 29th October 2020] https://www.clinicaltrials.gov/ct2/show/NCT00298038

5. Bausch Health Americas, Inc. Irritable Bowel Syndrome with Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on December 2017] [Accessed 29th October 2020] https://clinicaltrials.gov/ct2/show/NCT01543178

6. Steven L. Flamm. Rifaximin treatment for reduction of risk of overt hepatic encephalopathy recurrence. NCBI; PMC National National Library of Medicine, National Institute of Health. May 2011 [Accessed 29th October 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3105611/

7. Kamesh Gupta, Harparam Singh Ghuman and Shivani Vijay Handa. Review of Rifaximin: Latest Treatment Frontier for Irritable Bowel Syndrome Mechanism of Action and Clinical Profile. NCBI; PMC National National Library of Medicine, National Institute of Health. August 2017 [Accessed 29th October 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5582649/

8. Alfasigma S.p.A. Electronic Medicines Compendium (EMC); [Revised on July 2019] [Accessed 29th October 2020] https://www.medicines.org.uk/emc/files/pil.2976.pdf

9. Valeant Pharmaceuticals North America LLC. U.S. Food & Drug Administration; [Revised on December 2017] [Accessed 29th October 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Ammonia
• Liver Function Test
• Potassium
• Sodium