Pentasa Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Summary of the safety profile: The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash.
Hypersensitivity reactions and drug fever may occasionally occur, and severe cutaneous adverse reactions, including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and Toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see Precautions).
Prolonged-release tablet: (See Table 2.)

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Prolonged-release granules, Suppository and Rectal suspension: (See Table 3.)

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It is important to note that several of these disorders can also be attributed to the inflammatory bowel disease itself.
Suppository and Rectal suspension: Following rectal administration local reactions such as pruritus, rectal discomfort and urge may occur.

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mesalazine

Manufacturer:

Ferring

Distributor:

Zuellig Pharma