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Pentasa

Pentasa Adverse Reactions

mesalazine

Manufacturer:

Ferring

Distributor:

Metro Drug
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 Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: 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 treament (see Precautions).
It is important to note that several of these disorders can also be attributed to the inflammatory bowel disease itself.
Tablet: See Table 2. 1 g: Following rectal administration local reactions such as pruritus, rectal discomfort and urge may occur. (See Table 2.)

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Granules: The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash. (See Table 3.)

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Suppository/Rectal Suspension: Following rectal administration local reactions such as pruritus, rectal discomfort and urge may occur. (See Table 4.)

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