Product Description

Ursodeoxycholic Acid Tablets IP 300 mg belongs to a group of medicines known as bile acids or hepatoprotective agents. It is used to treat conditions such as gallstones (primarily cholesterol-based), primary biliary cholangitis (an autoimmune liver disease), excess cholesterol in bile, and liver diseases associated with cystic fibrosis in children over 6 years. By reducing cholesterol levels in bile and protecting liver cells, it helps manage these conditions and improve overall liver function.

Uses

• Treatment of Gallstones (cholesterol-rich types)

• Primary biliary cholangitis

• Liver and biliary diseases caused by cystic fibrosis in children over 6 years

• Other cholestatic liver disorders (as directed by a doctor).

How it works

Ursodeoxycholic Acid Tablets IP 300 mg contain ursodeoxycholic acid, a naturally occurring bile acid. It works by reducing the amount of cholesterol produced and absorbed in the bile, which helps dissolve cholesterol-based gallstones. Additionally, it protects liver cells from damage caused by toxic bile acids, increases bile flow, and reduces inflammation, thereby improving liver function and alleviating symptoms of conditions like primary biliary cholangitis.

Benefits

Ursodeoxycholic Acid Tablets IP 300 mg help dissolve cholesterol gallstones by making bile less saturated with cholesterol, reducing the risk of stone formation or complications. In primary biliary cholangitis, it slows disease progression by protecting liver cells, improving bile flow, and modulating the immune response. For liver diseases associated with cystic fibrosis, it aids in reducing cholestasis and enhancing liver health. Overall, it promotes better bile composition and liver protection, leading to improved symptoms and quality of life.

How to use

Take Ursodeoxycholic Acid Tablets IP 300 mg exactly as prescribed by your doctor. Swallow the tablet whole with a full glass of water, preferably with or after meals to reduce gastrointestinal irritation. Do not chew, crush, or break the tablet unless it is a dispersible formulation (in which case, disperse it in water as directed and consume immediately). The typical dose is once or twice daily, depending on your condition. Use a measuring device if a liquid form is prescribed, but for tablets, no shaking is required. Always follow your doctor's instructions, and do not stop or adjust the dose without consulting them.

Side Effects

Common side effects of Ursodeoxycholic Acid Tablets IP 300 mg may include:

• Abdominal discomfort or pain

• Diarrhoea

• Nausea

• Indigestion

• Dizziness

• Rash (in rare cases)

• Weakness

These side effects are usually mild and temporary. Not everyone experiences them, and they often resolve with continued use. If you experience severe or persistent symptoms, such as severe abdominal pain, allergic reactions (e.g., swelling or difficulty breathing), or any unusual bleeding, seek medical attention immediately. Contact your doctor if side effects worsen.

Safety Advice

• Alcohol: Avoid or limit alcohol consumption while taking Ursodeoxycholic Acid Tablets IP 300 mg, as it may increase the risk of dizziness and worsen liver damage, especially in patients with liver conditions.

• Pregnancy and Breastfeeding: This medication is classified as Pregnancy Category B, meaning it is generally considered safe but should only be used if the potential benefits outweigh the risks. Consult your doctor before use if you are pregnant, planning to become pregnant, or breastfeeding, as it may pass into breast milk.

• Liver Impairment: Dose adjustments may be necessary for patients with liver problems. Inform your doctor about any liver conditions, and they may recommend regular monitoring of liver function.

• Other Precautions: Use caution if you have a history of gallstones, bowel obstruction, or kidney issues. This medication may interact with certain drugs (e.g., antacids containing aluminium), so inform your doctor of all medications you are taking. Avoid driving or operating machinery if you experience dizziness.

Storage Conditions

Store at a temperature below 86°F (30 °C). Protect from light and moisture.

FAQs

Can I stop taking Ursodeoxycholic Acid Tablets IP 300 mg if I feel well?

Do not discontinue Ursodeoxycholic Acid Tablets IP 300 mg without consulting your doctor. To treat your condition effectively, continue taking Ursodeoxycholic Acid Tablets IP 300 mg for as long as prescribed. Do not be reluctant to speak with your doctor if you have any difficulty taking Ursodeoxycholic Acid Tablets IP 300 mg.

Do Ursodeoxycholic Acid Tablets IP 300 mg cause diarrhoea?

Diarrhoea might be a side-effect of Ursodeoxycholic Acid Tablets IP 300 mg . Drink lots of fluids and eat food rich in fibre if you experience diarrhoea. If you find blood in your stools (tarry stools) or if you experience excess diarrhoea, consult your doctor. Do not take anti-diarrheal medicine on your own.

Can I take antacids along with Ursodeoxycholic Acid Tablets IP 300 mg?

Avoid taking aluminium-containing antacids along with Ursodeoxycholic Acid Tablets IP 300 mg, as they might interfere with its absorption. Maintain a gap of 2 hours between both.

Is it safe to take Ursodeoxycholic Acid Tablets IP 300 mg with other medicines?

Ursodeoxycholic Acid Tablets IP 300 mg might reduce the absorption of antibiotics (ciprofloxacin and dapsone) and antihypertensive agents (nitrendipine). Ursodeoxycholic Acid Tablets IP 300 mg might increase the effect of immunosuppressants (cyclosporine). Cholesterol-lowering agents (clofibrate) might promote the formation of gallstones. Inform your doctor before taking Ursodeoxycholic Acid Tablets IP 300 mg with other medicines to avoid unpleasant side effects.

Can I take Ursodeoxycholic Acid Tablets IP 300 mg with oral contraceptives?

Oral contraceptives (oestrogen) might promote the formation of gallstones. Consult your doctor if you have any concerns regarding this. Your doctor may advise other contraception methods.

Will the use of Ursodeoxycholic Acid Tablets IP 300 mg affect my fertility?

There is no evidence that Ursodeoxycholic Acid Tablets IP 300 mg affects fertility. Please consult the doctor if you have any concerns regarding this.

Can I give Ursodeoxycholic Acid Tablets IP 300 mg to paediatric patients?

Ursodeoxycholic Acid Tablets IP 300 mg should be given to paediatric patients only if prescribed by the doctor. It may be used in children above 6 years with liver and biliary diseases caused by cystic fibrosis.

Is Ursodeoxycholic Acid Tablets IP 300 mg safe?

Yes, Ursodeoxycholic Acid Tablets IP 300 mg is safe to use if prescribed by the doctor. Like all medicines, Ursodeoxycholic Acid Tablets IP 300 mg may also cause side effects in some people. However, if any of the side effects are bothersome, please consult a doctor.

How do Ursodeoxycholic Acid Tablets IP 300 mg help the liver?

Ursodeoxycholic Acid Tablets IP 300 mg has a protective effect on the liver cells from injury caused by toxic bile acids and improves liver function.

Do Ursodeoxycholic Acid Tablets IP 300 mg cause weight gain?

Ursodeoxycholic Acid Tablets IP 300 mg may cause weight gain in some people. Consult the doctor if you notice rapid weight gain, especially in your face and midsection.

What should I avoid while taking Ursodeoxycholic Acid Tablets IP 300 mg?

Avoid taking other medicines concomitantly with Ursodeoxycholic Acid Tablets IP 300 mg, as it might reduce or intensify the effect of other medicines. Colestyramine and colestipol should be taken 2 hours before or after Ursodeoxycholic Acid Tablets IP 300 mg . Consult your doctor before taking Ursodeoxycholic Acid Tablets IP 300 mg with other medicines as Ursodeoxycholic Acid Tablets IP 300 mg might reduce the absorption of antibiotics (ciprofloxacin and dapsone) and antihypertensive agents (nitrendipine), increase the effect of immunosuppressants (cyclosporine), oral contraceptives (oestrogen) and cholesterol-lowering agents (clofibrate) might promote the formation of gallstones.