Bilefix 300 Tablet (Ursodeoxycholic Acid 300mg)

INTRODUCTION

BILEFIX contains Ursodeoxycholic acid (ursodiol) which belongs to the group of medicine called choleretic agents. It is used in the treatment of primary biliary cirrhosis in patients without decompensated cirrhosis. Primary biliary cholangitis is a chronic disease of the biliary tract, in which liver tissues are damaged by an impaired drainage of bile. It is also used to dissolve gallstones caused by excess cholesterol in gall bladder where the gallstones are not visible on a plain x-ray. It can also be used for liver disease associated with cystic fibrosis (an inherited disorder in which, mucus is particularly tough in whole body) in children aged 6 to less than 18 years.

Ursodeoxycholic acid is a bile acid normally only found in small amounts in human bile. When administered orally, ursodeoxycholic acid decreases biliary cholesterol saturation and allows solubilization of cholesterol from gallstones, resulting in galls stone dissolution. Along with the treatment, your doctor might recommend you to eat foods that are high in fiber such as fruits, vegetables, beans, and peas.

Avoid eating unhealthy fats, like those found in desserts and fried foods. Try to exercise more regularly, which will improve your overall health, may also lower your chances of developing gallstones. The most common side effect of taking this medicine is diarrhea. Before taking this medicine, inform your doctor if you are pregnant. Do not take this medicine, if you have gastric or duodenal ulcer, narrowing or blockage of bile ducts or acute inflammation of gallbladder or bile ducts.

USES OF BILEFIX

Treats primary biliary cirrhosis in patients without decompensated cirrhosis
Dissolve gallstones not more than 15 mm in diameter
Treats liver disease associated with cystic fibrosis in children aged 6 to less than 18 years

HOW BILEFIX WORKS

When administered orally, ursodeoxycholic acid enters the bile and decreases the biliary cholesterol saturation by suppressing hepatic synthesis and secretion of cholesterol, and by inhibiting its intestinal absorption. This reduced cholesterol saturation allows gradual solubilization of cholesterol from gallstones, resulting in galls stone dissolution.

DIRECTIONS FOR USE

Always take this medicine as directed by your physician. It can be taken after a meal with a glass of milk or a small snack. Your doctor will decide the correct dose for you depending upon your condition. Swallow the medicine as a whole with a glass of water. Do not crush or chew the medicine. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF BILEFIX

Pasty stools or diarrhea

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

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

WARNING & PRECAUTIONS

PREGNANCY
BILEFIX should be used with caution in pregnant women. Consult your doctor before taking this medicine.

BREASTFEEDING
BILEFIX should be used with caution in breastfeeding women. Consult your doctor before taking this medicine.

DRIVING AND USING MACHINES
Do not drive or operate any machines if your ability is affected by this medicine.

ALCOHOL
Avoid consumption of alcohol while taking this medicine.

LIVER
BILEFIX should be taken with caution in patients with other severe liver disease. Consult your doctor for advice.

ALLERGY
Do not take this medicine if you are allergic (hypersensitive) to ursodeoxycholic acid.

OTHERS
Do not take this medicine, if you have severe stomach pain, active gastric or duodenal ulcer, narrowing or blockage of bile ducts or acute inflammation of gallbladder or bile ducts.

INTERACTIONS

Talk to your doctor, if you are taking,

Medicines used to treat high cholesterol levels (e.g., colestipol, colestyramine, rosuvastatin, clofibrate)
Medicines used to treat stomach acid (such as antacids containing aluminium hydroxide or smectite)
Medicines used to treat infection (e.g., ciprofloxacin and dapsone)
Ciclosporin (reduces the chances of graft rejection)
Nitrendipine (used to treat high blood pressure)
Oral contraceptives (birth control pills)
Medicines used for menopause (oestrogenic hormones)