Actibile 75 mg Tablet (10 Tab)

Actibile 75 Tablet Overview:

Actibile 75 Tablet is a hepatoprotective medication, primarily used to dissolve cholesterol gallstones in patients who cannot undergo surgery and to treat primary biliary cholangitis (PBC), a chronic liver disease caused by progressive damage to the bile ducts.

It contains Ursodeoxycholic Acid (UDCA), a naturally occurring bile acid that helps improve bile flow and reduces the buildup of toxic bile acids in the liver. This action protects liver cells from damage and supports overall liver function. The medicine works by modifying bile composition, decreasing cholesterol secretion into bile, and reducing its absorption in the intestine, which aids in the gradual dissolution of gallstones.

Actibile 75 Tablet may also be prescribed for other liver-related conditions and for treating hepatobiliary disorders linked to cystic fibrosis in children and adolescents aged 6 to 18 years.

Composition:

Each uncoated tablet contains- Ursodeoxycholic Acid: 75 mg and Excipients q.s.

Uses & Benefits of Actibile 75 Tablet:

Actibile 75 Tablet offers the following therapeutic benefits:

• Used to treat Primary Biliary Cholangitis (PBC), a condition where damaged bile ducts cause bile buildup and liver scarring, provided liver function is still adequate.
• Helps dissolve small cholesterol gallstones (up to 15 mm) that are not visible on X-ray, in patients with a functioning gallbladder.
• Prescribed for managing liver disease associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

How Does Actibile 75 Tablet Work:

Actibile 75 Tablet contains Ursodeoxycholic Acid (UDCA), a hydrophilic bile acid that helps replace more harmful, toxic bile acids in the body when taken as medicine. It works by reducing cholesterol synthesis in the liver and limiting its absorption from the intestine, thereby lowering the cholesterol concentration in bile. This creates favorable conditions for the gradual breakdown and dissolution of cholesterol gallstones.

UDCA exerts cytoprotective effects by replacing toxic bile acids with safer alternatives, which helps stabilize liver cell membranes and prevent damage to hepatocytes. In Primary Biliary Cholangitis, it reduces injury to bile ducts by limiting the buildup of harmful bile components. Additionally, its anti-inflammatory and immunomodulatory actions contribute to improved liver function and healthier bile flow.

Dosage of Actibile 75 Tablet:

• Usage Direction

Take Actibile 75 Tablet strictly according to your doctor’s advice, following the prescribed dose and timing. Actibile 75 Tablet should be swallowed whole with water without crushing, chewing, or breaking it, preferably at the same time each day. Do not stop or alter the dose of Actibile 75 Tablet without consulting your doctor, as this may prevent you from achieving the desired outcome. If you are unsure about the administration procedures of Actibile 75, consult with your doctor or pharmacist.

• Missed Dose

If you miss a dose of Actibile 75 Tablet, take it as soon as you remember on the same day. But, if it is almost time for your next scheduled dose, skip the one you missed and continue following your regular dosing schedule. Do not attempt to take two doses if you have forgotten one. If you often forget to take your medication, consult with your doctor to re-evaluate your dosing schedule. Frequently missing doses could lead to undesired outcomes.

You can set reminders on your smartphone, keep drug organizer boxes, or use other audio-visual technologies to prevent missing a dose.

• Overdose

If you accidentally take Actibile 75 Tablet more than your prescribed dose, you might experience diarrhea or abdominal discomfort. Seek immediate medical advice, if you have persistant diarrhea. Seek immediate medical attention or go to the nearest hospital right away. Drink plenty of fluids to stay hydrated and let the medical team know exactly how many tablets were taken.

Contraindications of Actibile 75 Tablet:

Do not take Actibile 75 Tablet if you are hypersensitive or allergic to Ursodeoxycholic Acid, or any of its ingredients. It should be avoided in patients with acute inflammation of the gallbladder or bile ducts, obstruction or cyst of the common bile duct, frequent episodes of biliary colic (upper abdominal pain), and impaired contractility of the gallbladder.

Actibile 75 Tablet is also contraindicated in case you have calcified (hardened) gallstones visible on X-ray, as this may render the treatment ineffective. Use is also restricted in patients with active gastric or duodenal ulcers, and in pediatric cases involving cystic fibrosis, where there is a lack of restored bile flow following surgery or by an artificial bile duct (portoenterostomy).

Precautions & Warnings of Actibile 75 Tablet:

While taking Actibile 75 Tablet, your doctor may require regular liver function tests every four weeks for the first three months of treatment. Afterwards, periodical tests should be done to detect any potential deterioration in hepatic function.

Dosage adjustment of Actibile 75 Tablet is required during the initial treatment period if you are having pre-existing treatment for PBC. For patients undergoing dissolution of gallstones, follow-up ultrasounds or X-rays are typically required every six months to monitor the stone dissolution process.

In cases of intestinal stenosis or stasis, caution must be exercised, as it may cause obstruction. Women taking Actibile 75 Tablet to dissolve gallstones should only use non-hormonal contraceptives because hormonal contraceptives may induce gallstone formation.

Furthermore, inform your doctor if you have any pre-existing medical conditions before taking Actibile 75 Tablet.

Side Effects of Actibile 75 Tablet:

While Actibile 75 Tablet is generally well-tolerated, some patients may experience adverse reactions as the body adapts to the medication. The most frequently reported side effects are gastrointestinal in nature, specifically diarrhea or soft, loose stools.

Although rare, certain serious side effects require immediate medical intervention. These include deterioration of liver function or the progression of liver cirrhosis symptoms. Additionally, patients may experience the calcification of gallstones, which makes them unresponsive to UDCA therapy, or severe right-sided upper abdominal pain (biliary colic). Hypersensitivity reactions, such as urticaria (nettle rash), may also occur. If any of these severe symptoms persist, clinical supervision should be taken immediately to prevent further complications.

Safety Related Concerns of Actibile 75 Tablet:

• Pregnancy

Actibile 75 Tablet is not recommended during pregnancy unless clearly needed and prescribed by your doctor. If you are pregnant or planning to become pregnant, talk to your doctor before taking this medication to weigh the benefits against potential risks to the developing baby.

• Breastfeeding

It is better to avoid the use of the Actibile 75 Tablet while breastfeeding, since it is unknown whether the active ingredients of this medicine could pass into the breast milk and affect the breastfed child. Therefore, consulting with your doctor before taking Actibile 75 is crucial.

• Alcohol

It is advisable to avoid excessive alcohol intake while taking Actibile 75 Tablet, as it can strain the liver and worsen the underlying condition, counteracting the hepatoprotective benefits of the treatment.

• Food Interactions

The interaction between specific food items and the Actibile 75 Tablet is not listed, but taking it with food is recommended for improved gastrointestinal tolerance. To maximize the therapeutic efficacy of the treatment, patients should avoid certain types of food, which may hinder the absorption of the medicine or put extra stress on the liver.

Limiting the intake of saturated fats, fried foods, and highly processed sugars is essential, as these can elevate biliary cholesterol saturation and hinder the dissolution of gallstones. Additionally, avoiding spicy or oily items can help mitigate common symptoms of biliary distress and support overall hepatobiliary health.

• Drug Interactions

Actibile 75 Tablet can interact with other medications, either by changing their effectiveness or increasing the risk of toxicity. Bile acid sequestrants like cholestyramine and colestipol, as well as antacids that contain aluminum hydroxide, can attach to Ursodeoxycholic Acid in the gastrointestinal tract, which significantly reduces its absorption. Hence, they should be administered at least two hours apart from Actibile 75.

This medication may also reduce the intestinal absorption and overall effectiveness of certain antibiotics, such as ciprofloxacin and dapsone, as well as the antihypertensive agent nitrendipine. Conversely, it might increase the absorption of the immunosuppressant cyclosporine, necessitating careful monitoring of blood levels.

Lastly, patients should be informed that medications like hormonal oral contraceptives, clofibrate, and some statins, such as rosuvastatin, might promote gallstone formation, potentially counteract the stone-dissolving benefits of the treatment.

• Using Machinery & Driving

Actibile 75 Tablet generally does not affect the ability to drive or operate machinery. However, if you experience symptoms such as dizziness or headache, avoid these activities until you feel better and seek medical advice if needed.

Storage of Actibile 75 Tablet:

Store below 30°C in dry place. Protect from light and moisture. Keep out of reach of children. Avoid using it after the expiry date, printed on the packaging. Dispose of expired or unused medication properly; do not throw it away casually.

Additional Information:

• To maximize the therapeutic benefits of Actibile 75 Tablet, patients should adopt specific lifestyle and dietary modifications. Maintaining a stable, healthy weight is critical, as rapid weight loss can actually trigger gallstone formation.
• Follow a low-fat, high-fiber diet. Avoid fried foods and excessive dairy.
• Drink plenty of water to help maintain bile consistency.
• Do not suddenly stop your medication unless your doctor specifically tells you to.
• Do not share your medicine with other persons, even if they also have similar symptoms.

Frequently Asked Questions (FAQs):

Q. What is the use of Actibile 75 Tablet?

A. Actibile 75 Tablet is used for the treatment of Primary Biliary Cholangitis (PBC), a chronic liver disease where the bile ducts are progressively damaged. It is also used to dissolve radiolucent (non-calcified) cholesterol gallstones in patients who are unable to undergo any surgical procedure. Additionally, it is prescribed to manage hepatobiliary disorders associated with cystic fibrosis in pediatric patients aged 6 to 18 years.

Q. How long does Actibile 75 Tablet take to work on gallstones?

A. It typically, depending on the size and cholesterol content of the gallstones. Because the rate of dissolution varies per individual, regular diagnostic imaging (ultrasounds or X-rays) every six months is mandatory to monitor therapeutic progress and adjust the treatment plan if necessary.

Q. Can Actibile 75 Tablet dissolve all types of gallstones?

A. No, Actibile 75 Tablet is exclusively effective against radiolucent cholesterol-rich gallstones. It is not indicated for the treatment of calcified (calcium-containing) stones, as these compositions do not respond to Ursodeoxycholic Acid therapy. Before initiating treatment, diagnostic imaging is required to confirm that the stones are non-calcified and that the gallbladder remains functional.

Q. Can I stop taking Actibile 75 Tablet once the symptoms go away?

A. No, you must complete the course as prescribed by your doctor, even if symptoms improve. Symptomatic relief often occurs before the gallstones are completely eliminated. Discontinuing treatment prematurely may leave residual cholesterol crystals behind, which can lead to the recurrence of stones or a return of biliary symptoms. Stopping the medication should only be done after the confirmation of your doctor.

Q. Can Actibile 75 Tablet be used in children?

A. Yes, Actibile 75 Tablet can be given to children above 6 years, but it must only be used under the strict supervision of a healthcare provider. Dosing for children is prescribed according to the child's weight for conditions like cystic fibrosis-related liver issues.

Reference:

1. URSO 250® (Ursodiol) Tablet. Prescribing Information. Last Revised: January 2023. Accessed on: 1st April 2026. Click Here

2. Ursodeoxycholic acid 250 mg capsules, hard ursodeoxycholic acid. Package leaflet: Information for the user. Last Revised: July 2021. Accessed on: 1st April 2026. Click Here

3. APO-Ursodeoxycholic Acid Capsules. Consumer Medicine Information (CMI) summary. Last Revised: March 2025. Accessed on: 1st April 2026. Click Here

4. Udihep® (Ursodeoxycholic Acid Tablets BP, 150 mg). Last Revised: February 2024. Accessed on: 1st April 2026. Click Here