UDvia Suspension

Patient Information Leaflet: Information for the User
Prescribing Information

UDvia-450 SR

UDvia-125 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 Suspension are and what they are used for?
  • What you need to know before you take UDvia Suspension?
  • How to take UDvia Suspension?
  • Possible side effects
  • How to store UDvia Suspension?
  • Contents of the pack and other information

1. What UDvia Suspension are and what they are used for?

UDvia Suspension 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 Suspension are used for:

  • Treatment of chronic cholestatic liver diseases
  • Primary biliary cholangitis (PBC) 
  • Dissolution of cholesterol gallstones 
  • Liver disorders associated with cystic fibrosis

2. What you need to know before you take UDvia Suspension?

Do not take UDvia Suspension 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 Suspension 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 for gallstones should use non-hormonal contraception

Children

  • Can be used in children, including infants, as prescribed 
  • Dose is based on body weight 
  • Use a measuring device or oral syringe for accurate dosing

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 works or be affected by it.

UDvia Suspension 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 Suspension?

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

Dosage depends on your condition and body weight

General guidelines:

  • Primary biliary cholangitis (PBC):
      • Approx. 14 mg/kg/day
      • Initially given in divided doses, later may be given once daily 
  • Gallstone dissolution:
      • Approx. 10 mg/kg/day
      • Usually taken once daily at bedtime
  • Children (cystic fibrosis):
      • 20–30 mg/kg/day in divided doses

Your doctor will decide the exact dose.

How to take

  • Swallow Suspension whole with water
  • Take regularly as prescribed

If you take more UDvia Suspension 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 Suspension

  • 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 Suspension

  • 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 Suspension contain:

  • Ursodeoxycholic acid 125 mg 
  • Other ingredients:
    • Flavoured sorbitol base

What UDvia Suspension look like and contents of the pack

  • Oral suspension 
  • Available in 60 mL and 100 mL bottles 

Marketing Authorization Holder

Zorvia Healthcare Limited
Thane West, Maharashtra, India

This leaflet was issued on:

23rd March 2026

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