Fertilix 300mg Softgel 10'S

INTRODUCTION

FERTILIX 300MG contains Ursodeoxycholic acid (also known as Ursodiol) which is a Gallstone dissolving agent. It is used to dissolve gall bladder stones (made up of cholesterol) and prevents them from forming back. It can also be used to treat a type of liver disease called primary biliary cholangitis. Primary biliary cholangitis (also known as primary biliary cirrhosis) is a long-term liver disease in which the tubes carrying a digestive fluid called bile (bile ducts) are injured, inflamed, and permanently damaged. As a result, it can cause yellow or white bumps under the skin or eyes, dark urine, and abnormally swollen stomach with pain with frequent nausea, weight loss and tiredness. FERTILIX 300MG can also be used to treat liver and biliary diseases caused due to cystic fibrosis (an inherited disorder that affects major organs) in children aged between 6-18 years.

FERTILIX 300MG is a liver protectant medication. It works by reducing cholesterol levels in the blood which is dissolving the gall bladder stones made up of cholesterol. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid.

Before taking FERTILIX 300MG inform your doctor, if you have any other liver problems apart from gall stones and biliary cirrhosis. While taking FERTILIX 300MG, your doctor would regularly monitor your liver function to access how you respond to the treatment. FERTILIX 300MG is not recommended for use in pregnant women. Women of childbearing age should use a suitable non-hormonal contraceptive method like condemn or copper-IUD to avoid getting pregnant. The most common side effect of FERTILIX 300MG is pasty stools. Consult your doctor if it bothers you.

USES OF FERTILIX 300MG

• Treats primary biliary cholangitis
• Treats and prevents gall bladder stones
• Treats liver and biliary diseases caused due to cystic fibrosis in children aged between 6-18 years

HOW FERTILIX 300MG WORKS

FERTILIX 300MG is a liver protectant medication. It works by reducing cholesterol levels in the blood by decreasing its production in the liver and by inhibiting its absorption in the intestines. As a result, it slowly breaks down the gall bladder stones made up of cholesterol. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid, thereby improving liver health in diseased patients.

DIRECTIONS FOR USE

FERTILIX 300MG should only be used under medical supervision. Swallow FERTILIX 300MG with a glass of water and do not crush or chew it. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition. You can take FERTILIX 300MG after a meal with a glass of milk or a small snack.

SIDE EFFECTS OF FERTILIX 300MG

HOW TO MANAGE SIDE EFFECTS

Pasty stools or diarrhea:

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

WARNING & PRECAUTIONS

INTERACTIONS

Before taking FERTILIX 300MG, inform your doctor, if you are taking any of the following medicine:

• medicines that can bind to cholesterol and inactive them (Ex. bile acid sequestrants (such as colestipol, colestyramine))
• medicines used to neutralize stomach acid (such as antacids containing aluminium hydroxide or smectite)
• ciprofloxacin (used to treat bacterial infection)
• dapsone (used to treat leprosy)
• nitrendipine (a medicine used to treat high blood pressure)
• ciclosporin (used to suppress immune function and prevent graft rejection)
• oral contraceptives (birth control pills) Ex. norethindrone
• oestrogens (used to treat menopause, PMS, and other hormonal conditions in females) Ex. Estradiol

Overdosage:

If you or anyone else accidentally take excess of FERTILIX 300MG, consult your doctor immediately or visit the nearby hospital. Symptom of overdose can be prolonged diarrhea.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Do not store above 25°C

FAQs ABOUT FERTILIX 300MG

Can FERTILIX 300MG cause constipation?

There is no proper information regarding incidence of constipation while taking FERTILIX 300MG. If you feel constipated, try to include fiber rich diet in your meals and drink plenty of water. Try to perform a brisk walk at least for 30 minutes regularly after consulting your doctor. If the symptom bothers you, contact your physician.

How to take FERTILIX 300MG?

FERTILIX 300MG is preferably taken after meals along with a glass of milk or a small snack. Swallow FERTILIX 300MG with a glass of water and do not crush or chew it. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition.

How FERTILIX 300MG works on my body?

FERTILIX 300MG works by reducing cholesterol levels in the blood which eventually causes break down of the gall bladder stones. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid, thereby improving liver health in diseased patients.

Is FERTILIX 300MG safe to use in children?

Yes. FERTILIX 300MG can be used to treat liver disease associated with cystic fibrosis in children aged between 6-18 years. However, consult your doctor for the correct dose and duration that suits your child.

How long should I use FERTILIX 300MG to dissolve gall stones?

Your doctor will advise you to use FERTILIX 300MG based on your condition. Generally, the duration of the treatment ranges between 3-4 months but may further get extended depending on the size of the gallstone that need to be dissolved. Make sure that you receive an uninterrupted therapy during this period and your doctor might suggest having a periodic X-ray or an ultrasound to access whether the stones were completely dissolved or not. Even after dissolution of gall stones, your doctor might still prescribe you FERTILIX 300MG to avoid its recurrence.

What precaution I need to follow while taking FERTILIX 300MG?

FERTILIX 300MG must be used only under medical supervision. Do not stop taking FERTILIX 300MG once your symptoms subside, without consulting your doctor, because it may lead to recurrence of gallbladder stones. Avoid alcohol consumption as it could further aggravate your liver disease and make sure to have regular check-ups of liver function as instructed by your doctor without fail to access your improvement.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 671.

2. Keith A. Sharkey and John L. Wallace. Treatment of disorders of bowel motility and water flux; Antiemetics; Agents used in biliary and pancreatic disease. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1347.

3. Mitsubishi Tanabe Pharma Corporation. Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on March 2012] [Accessed on 24th March 2022] https://clinicaltrials.gov/ct2/show/NCT00200343

4. Keith D. Lindor, Kris V. Kowdley, Velimir A. C. Luketic, M. Edwyn Harrison, Timothy McCashland, Alex S. Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Jill Keach, Jody Mooney, Carol Sargeant, Julie Braaten, Tamara Bernard, Debra King, Ellen Miceli, Jeff Schmoll, Tanya Hoskin, Prabin Thapa and Felicity Enders. High Dose Ursodeoxycholic Acid for the Treatment of Primary Sclerosing Cholangitis. NCBI; PMC US National Library of Medicine, National Institute of Health. September 2010. [Accessed on 24th March 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758780/

5. G Dinler,  N Koçak, A Yüce, F Gürakan, H Ozen. Ursodeoxycholic acid therapy in children with cholestatic liver disease. NIH. National Library of Medicine. National Center for Biotechnology Information. Pubmed.gov. January-March 1999. [Accessed on 24th March 2022] https://pubmed.ncbi.nlm.nih.gov/10770681/

6. Glenmark Pharmaceuticals Europe Limited. Electronic Medicines Compendium (EMC). [Revised on March 2019] [Accessed on 24th March 2022] https://www.medicines.org.uk/emc/files/pil.10064.pdf

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Abdominal ultrasound