Ursoren 300mg Tablet 1 Strip

✔️ Ursoren 300 may be used for:

• Dissolution of cholesterol-rich gallstones
• Primary biliary cholangitis (PBC), formerly called primary biliary cirrhosis
• Prevention of gallstone formation during rapid weight loss in selected patients
• Cholestatic liver disorders
• Selected cases of viral hepatitis
• Alcoholic fatty liver disease
• Primary sclerosing cholangitis (PSC)
• Non-alcoholic fatty liver disease/steatohepatitis, when prescribed by a specialist

✔️ How Ursoren 300 Works

Ursodeoxycholic Acid reduces hepatic cholesterol production and cholesterol secretion into bile and may also decrease intestinal cholesterol absorption. This makes bile less saturated with cholesterol and helps gradually dissolve cholesterol-based gallstones.

It also improves bile flow and may protect liver cells and bile-duct cells from injury caused by hydrophobic bile acids. These effects can help improve certain cholestatic liver conditions.

✔️ Common Side Effects

Possible side effects include:

• Diarrhea
• Abdominal pain or discomfort
• Nausea or vomiting
• Indigestion
• Dizziness
• Headache
• Back pain
• Itching
• Skin rash
• Hair loss
• Flatulence
• Fatigue

Less commonly, biliary pain, peripheral oedema, changes in blood glucose, peptic ulcer, urinary tract infection, or changes in blood-cell counts may occur.

If diarrhea becomes persistent or severe, contact your doctor. The dose may need to be reduced or treatment temporarily discontinued.

✔️ Dosage & Administration

The appropriate dose depends on the patient's body weight, medical condition, and response to treatment.

• Cholesterol gallstones: 8–12 mg/kg/day, taken as a single bedtime dose or in divided doses. Treatment may need to continue for several months after radiological disappearance of the stones.
• Primary biliary cholangitis: 10–15 mg/kg/day in 2–4 divided doses, according to medical advice.
• Gallstone prevention during rapid weight loss: 300 mg twice daily.
• Non-alcoholic fatty liver disease/steatohepatitis: approximately 13–15 mg/kg/day when prescribed.
• Other hepatobiliary conditions require individualized dosing by a physician.

Take Ursoren 300 with food, preferably after a meal, with a glass of water. Swallow the medicine whole; do not crush, chew, or break it unless specifically instructed.

✔️ Duration of Treatment

Treatment duration varies according to the condition. Gallstone dissolution may require several months and sometimes up to 2 years. Once gallstones have disappeared, treatment may still need to continue for several weeks or months, as advised by the doctor.

✔️ Words of Advice:

• Take Ursoren 300 with or after food as directed by your doctor.
• Swallow the medicine whole with water.
• Take it regularly and maintain the prescribed treatment schedule.
• Maintain a healthy diet and regular physical activity.
• Avoid excessive alcohol consumption.
• Drink adequate fluids, particularly if diarrhea occurs.
• Inform your doctor if diarrhea is persistent or severe.
• Regular liver-function tests and imaging may be required during prolonged treatment.
• Do not discontinue the medicine without consulting your doctor.
• If you are taking antacids, cholestyramine, or other bile-acid-binding medicines, ask your doctor or pharmacist about appropriate timing.

✔️ Ursoren 300 may not be suitable for patients with:

• Acute inflammation of the gallbladder or bile ducts
• Blockage of the biliary tract
• Frequent episodes of biliary colic
• Calcified or radiopaque gallstones
• A non-functioning gallbladder
• Severely impaired gallbladder contractility
• Certain inflammatory bowel diseases
• Conditions affecting the normal enterohepatic circulation of bile acids
• Severe or active liver disease
• Known hypersensitivity to Ursodeoxycholic Acid

✔️ What If You Forget a Dose?

If you miss a dose, take it when you remember unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular schedule.

Do not take two doses together to make up for a missed dose.

✔️ Drug Interactions

Some medicines can interfere with the absorption or effectiveness of Ursoren 300.

• Cholestyramine and other bile-acid-binding medicines: May reduce Ursodeoxycholic Acid absorption.
• Activated charcoal: May decrease absorption.
• Aluminium-containing antacids: May reduce absorption and should generally be taken separately.
• Oestrogens: May increase cholesterol secretion into bile and potentially reduce the effectiveness of gallstone-dissolution therapy.
• Clofibrate: May also counteract the cholesterol-lowering effect in bile.
• Ursodeoxycholic Acid may affect the blood levels or effectiveness of certain medicines, including ciclosporin, dapsone, ciprofloxacin, and nitrendipine.

✔️ Pregnancy & Breastfeeding

Ursodeoxycholic Acid has been used during pregnancy for certain cholestatic conditions under medical supervision, and available clinical experience has not demonstrated evidence of significant harm. However, it should only be used during pregnancy when recommended by a doctor.

Information regarding its excretion into human breast milk is limited. Breastfeeding patients should consult their doctor before using Ursoren 300.

✔️ Precautions & Warnings

Tell your doctor if you have liver disease, gallbladder or bile-duct inflammation, recurrent upper abdominal pain, or any condition affecting bile flow.

During long-term treatment, your doctor may recommend regular liver-function tests and bilirubin monitoring. For gallstone treatment, periodic ultrasound or other imaging may also be required to assess the response.

Avoid excessive dietary intake of calories and cholesterol while being treated for cholesterol gallstones.

Do not stop treatment simply because your symptoms have improved. Continue the medicine for the duration prescribed by your doctor.

✔️ Storage:

Store below 25°C, protected from light and moisture. Keep out of reach of children.