Prolonged Release Mesalazine Tablets Bp 500 Mg Tablet

What is Prolonged Release Mesalazine Tablets Bp 500 Mg Tablet?

Prolonged Release Mesalazine Tablets BP 500 mg contain mesalazine, also known as 5-aminosalicylic acid (5-ASA), in a prolonged-release oral tablet formulation. Mesalazine is an intestinal anti-inflammatory medicine primarily used in the management of ulcerative colitis and other approved inflammatory bowel conditions.

Uses / Indications

Prolonged Release Mesalazine 500 mg tablets may be used in the management of:

• Ulcerative colitis
• Mild to moderate active inflammatory bowel disease, where indicated
• Maintenance of remission in ulcerative colitis, where supported by the approved product information

The exact indication depends on the approved product specification and applicable prescribing information. Mesalazine prolonged-release tablets are classified as aminosalicylate preparations used for the treatment of ulcerative colitis.

Benefits

• Provides local anti-inflammatory activity in the intestinal tract.
• Helps reduce inflammation associated with susceptible inflammatory bowel conditions.
• Prolonged-release formulation is designed to provide controlled release of mesalazine over an extended period.
• Available as a 500 mg oral tablet.
• May be used for treatment or maintenance of remission according to the approved indication.

Side Effects

Common Side Effects

Possible adverse effects may include:

• Headache
• Abdominal pain or discomfort
• Nausea
• Diarrhoea
• Indigestion
• Skin rash
• Fever

Less Common or Serious Side Effects

Clinically important reactions may include:

• Hypersensitivity or allergic reactions
• Severe abdominal pain
• Severe skin reactions
• Changes in kidney function
• Liver-related abnormalities
• Pancreatitis
• Myocarditis or pericarditis
• Blood disorders

Medical attention should be sought if severe abdominal symptoms, allergic reactions, significant skin reactions, unusual bleeding, or other serious symptoms develop.

How Does It Work?

Mesalazine

Mesalazine is an aminosalicylate with predominantly local anti-inflammatory activity in the intestinal mucosa. Its mechanism is not fully understood, but it may reduce inflammatory processes involving arachidonic-acid metabolites and other inflammatory mediators.

Prolonged-Release Formulation

The prolonged-release formulation is designed to release mesalazine over several hours, allowing the active ingredient to become available at intestinal sites according to the formulation’s release characteristics.

Dosage Guidelines

The appropriate dose and treatment duration depend on the indication, disease severity, treatment response, formulation characteristics, age, kidney function and other clinical factors.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For prolonged-release tablets:

• Take exactly as prescribed.
• Swallow the tablet according to the approved product instructions.
• Do not crush, chew, split or otherwise alter the prolonged-release tablet unless specifically permitted by the approved product information.
• Maintain adequate fluid intake where appropriate.
• Renal function may need to be assessed before and during treatment.

When Not to Use

Mesalazine should generally not be used in patients with a known hypersensitivity to mesalazine, other salicylates, or any component of the formulation.

Medical advice is particularly important in patients with:

• Kidney impairment
• Liver impairment
• A history of blood disorders
• A history of hypersensitivity reactions to salicylates
• Gastrointestinal or cardiac conditions requiring clinical monitoring

Drug / Product Interactions

Clinically relevant interactions may occur with medicines that affect kidney function or with medicines used in inflammatory bowel disease.

Particular attention may be required with:

• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Nephrotoxic medicines
• Azathioprine
• 6-mercaptopurine
• Other medicines that may affect renal function or blood-cell counts

Patients taking multiple medicines should inform their healthcare professional before starting treatment.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Mesalazine overdose may require supportive medical management and monitoring, including assessment of renal function where clinically appropriate.

Missed Dose

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose unless specifically instructed by a healthcare professional.

Pregnancy

Mesalazine should be used during pregnancy only when clinically indicated and after appropriate medical assessment.

Breastfeeding

Mesalazine and its metabolites may be present in breast milk. The potential benefits and risks of treatment during breastfeeding should be discussed with a qualified healthcare professional.

Children

Use in children should follow the age-specific recommendations of the approved product information. Suitability of the particular prolonged-release formulation should be established before use.

Elderly Patients

Older patients may require particular attention to renal function and other age-related risk factors during treatment.

Renal Impairment

Renal function should be assessed before treatment and monitored as clinically appropriate. Mesalazine treatment may require particular caution in patients with impaired kidney function.

General Instructions

• Take the medicine exactly according to the prescribed schedule.
• Swallow the prolonged-release tablet according to the approved product instructions.
• Do not crush or chew the tablet unless specifically permitted.
• Maintain adequate fluid intake where appropriate.
• Do not alter the prescribed dose without professional advice.
• Follow the approved product information and healthcare professional’s instructions.
• Do not share prescription medicines with other people.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Adequate fluid intake may be appropriate during treatment, particularly where recommended by the healthcare professional. Dietary management should be individualised according to the underlying gastrointestinal condition.

Comparison with Other Treatments

Mesalazine is an aminosalicylate that acts primarily at the intestinal mucosa. Other treatments for inflammatory bowel disease may include corticosteroids, immunomodulators, biologic medicines or other targeted therapies.

Treatment selection depends on the type and severity of disease, treatment goals, previous therapy, tolerability and the approved indication. Different mesalazine formulations may also have different release characteristics and sites of drug availability.

Precautions & Warnings

• Confirm any history of hypersensitivity to mesalazine or other salicylates.
• Assess renal function before treatment and periodically when clinically appropriate.
• Use cautiously in patients with kidney or liver impairment.
• Monitor patients with a history of blood disorders as clinically appropriate.
• Seek medical attention for severe abdominal pain, significant skin reactions or allergic symptoms.
• Patients taking nephrotoxic medicines or immunomodulators should inform their healthcare professional.
• Use during pregnancy or breastfeeding should be based on appropriate professional assessment.
• Follow the approved product information for administration of the prolonged-release formulation.

Can I Use It With Other Medicines?

Generally Compatible With

Mesalazine may be prescribed with other medicines when clinically appropriate. Compatibility depends on the patient’s complete medication profile and medical condition.

Use With Caution / Avoid

Particular caution may be required when mesalazine is used with:

• NSAIDs
• Nephrotoxic medicines
• Azathioprine
• 6-mercaptopurine
• Other medicines that may affect renal function or blood-cell counts

Patients should inform their healthcare professional about all prescription medicines, non-prescription medicines and other products they use.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What is Prolonged Release Mesalazine 500 mg used for?

Prolonged-release mesalazine is an aminosalicylate used primarily in the management of ulcerative colitis and other approved inflammatory bowel conditions.

2. What is the active ingredient in these tablets?

The active ingredient is mesalazine 500 mg, also known as 5-aminosalicylic acid or 5-ASA.

3. How does Mesalazine work?

Mesalazine has a predominantly local anti-inflammatory action in the intestinal mucosa. Its precise mechanism is not fully established.

4. What does prolonged release mean?

A prolonged-release formulation is designed to release mesalazine over an extended period rather than releasing the entire drug immediately. The specific release characteristics depend on the formulation.

5. Can Mesalazine affect the kidneys?

Kidney-related adverse effects can occur, so renal function may need to be assessed before and during treatment, particularly in patients with relevant risk factors.

6. Can Mesalazine be taken with other medicines?

Mesalazine can be used with other medicines when clinically appropriate, but caution may be required with NSAIDs, nephrotoxic medicines, azathioprine and 6-mercaptopurine.

7. What should I do if I miss a dose?

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. Do not double the next dose unless specifically advised by a healthcare professional.

8. How should Prolonged Release Mesalazine Tablets be stored?

Store according to the conditions stated on the approved product label and package insert, and keep the medicine out of reach of children.