UDvia-450 SR

Patient Information Leaflet: Information for the User
Prescribing Information

UDvia-450 SR

UDvia-450 SR

Read all this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

  • What UDvia-450 SR Tablets are and what they are used for?
  • What you need to know before you take UDvia-450 SR Tablets?
  • How to take UDvia-450 SR Tablets?
  • Possible side effects
  • How to store UDvia-450 SR Tablets?
  • Contents of the pack and other information

1. What UDvia-450 SR Tablets are and what they are used for?

UDvia-450 SR Tablets contain ursodeoxycholic acid, a naturally occurring bile acid.

It works by:

  • Reducing cholesterol in bile
  • Helping dissolve cholesterol gallstones
  • Improving bile flow and reducing liver inflammation

UDvia-450 SR Tablets are used for:

  • Dissolution of cholesterol gallstones
  • Prevention of gallstone formation
  • Treatment of chronic liver diseases such as:
    • Primary biliary cholangitis
    • Primary sclerosing cholangitis
    • Cystic fibrosis–related liver disease
    • Intrahepatic cholestasis (including in pregnancy)

2. What you need to know before you take UDvia-450 SR Tablets?

Do not take UDvia-450 SR Tablets if you:

  • are allergic to ursodeoxycholic acid or any of the ingredients
  • have acute inflammation of the gallbladder or bile ducts
  • have blockage in the bile ducts
  • have calcified gallstones
  • have frequent biliary colic (severe gallstone pain)
  • have non-functioning gallbladder
  • have active stomach or duodenal ulcers

Warnings and precautions

Talk to your doctor before taking UDvia-450 SR Tablets if:

  • you have liver problems
  • you have gallstones
  • you develop persistent diarrhea
  • you are being treated for primary biliary cholangitis

Monitoring during treatment:

  • Your doctor may regularly check liver function tests (LFTs)
  • Ultrasound may be done to monitor gallstone dissolution

Special precautions

  • Treatment should always be under medical supervision
  • If diarrhea occurs, inform your doctor
  • Women taking UDvia-450 SR for gallstones should use non-hormonal contraception

Children

  • Can be used in children only if prescribed by a doctor
  • Special care required in certain liver co Other medicines and UDvia-450 SR Tablets

Tell your doctor if you are taking:

  • antacids containing aluminium
  • cholesterol-lowering drugs (e.g., clofibrate)
  • ciclosporin
  • ciprofloxacin
  • nitrendipine or statins
  • These medicines may affect how UDvia-450 SR works or be affected by it.

UDvia-450 SR with food and drink

  • Take with or after food as advised by your doctor

Pregnancy and breast-feeding

  • If you are pregnant or planning pregnancy, consult your doctor before use
  • Limited data available in pregnancy
  • May be used only if clearly necessary
  • Breastfeeding is generally considered safe, but consult your doctor

Driving and using machines

UDvia-450 SR has no or minimal effect on driving or operating machinery

3. How to take UDvia-450 SR Tablets?

Always take this medicine exactly as your doctor has told you.

Dosage depends on your condition and body weight

General guidelines:

  • Gallstones: 8–10 mg/kg/day in divided doses
  • Primary biliary cholangitis: 12–16 mg/kg/day
  • Children (cystic fibrosis): 20–30 mg/kg/day

Your doctor will decide the exact dose.

How to take

  • Swallow tablets whole with water
  • Take regularly as prescribed

If you take more UDvia-450 SR than you should

  • Overdose may cause diarrhea
  • Contact your doctor immediately

If you forget a dose

  • Do not take a double dose
  • Take the next dose at the usual time

If you stop taking UDvia-450 SR

  • Do not stop treatment without consulting your doctor
  • Long-term treatment may be required

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects:

  • Diarrhea
  • Soft or pasty stools

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. You can also report side effects via email: medico@zorvia.com

How to store UDvia-450 SR Tablets

  • Keep out of the sight and reach of children
  • Store below 30°C
  • Protect from light
  • Do not use after the expiry date

5. Contents of the pack and other information

What UDvia-450 SR Tablets contain:

  • Ursodeoxycholic acid 450mg

Other ingredients: As listed on the pack

What UDvia-450 SR Tablets look like and contents of the pack

  • Available in strips of 10 tablets

Marketing Authorization Holder

Zorvia Healthcare Limited
Thane West, Maharashtra, India

This leaflet was issued on:

23rd March 2026

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