PENTASA 1 GM 28 SUPP

702.00 EGP

Mesalazine is the active moiety of sulphasalazine in the treatment of ulcerative colitis. It acts locally on the gut wall in inflammatory bowel disease, although its precise mechanism of action is not clear.

Increased leucocyte migration, abnormal cytokine production, increased production of arachidonic acid metabolites, particularly leukotriene B4 and increased free radical formation in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease. Mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leucocyte chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. It is currently unknown which, if any of these mechanisms play a predominant role in the clinical efficacy of mesalazine.

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PENTASA 1 GM 28 SUPP

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1. PENTASA 1 GM 28 SUPP

1.1. ACTIVE INGREDIENT OF PENTASA

1.2. Mechanism of Action of Pentasa

1.2.1. Therapeutic indications

1.2.2. Posology and method of administration

1.2.2.1. Contraindications of Pentasa

1.2.2.2. Special Population

PENTASA Mesalazine treats ulcerative colitis affecting the distal colon and rectum.

ACTIVE INGREDIENT OF PENTASA

Mesalazine

Mechanism of Action of Pentasa

Therapeutic indications

PENTASA Mesalazine Enema treats ulcerative colitis affecting the distal colon and rectum.

Posology and method of administration

Adults: The recommended dosage is one supp at bedtime.

Children: Not recommended.

PENTASA Mesalazine suppository are for rectal administration

Contraindications of Pentasa

patients with known hypersensitivity to salicylates or any of the excipients.
patients with severe liver and/or renal impairment

Special Population

Fertility, pregnancy and lactation

PENTASA should be used with caution during pregnancy and lactation and only if the potential benefit outweighs the possible risks in the opinion of the physician.

Pregnancy

Mesalazine cross the placental barrier. There is no adequate data on the use of PENTASA in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available.

In one single case after long-term use of a high dose of mesalazine (2-4 g, orally) during pregnancy, renal failure is one of the outcomes.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.

Pentasa causes Blood disorders (leucopenia, thrombocytopenia, anaemia) in new-borns of mothers who take pentasa.

PENTASA should only be used during pregnancy if the potential benefit outweighs the possible risk.

Breast-feeding

N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine is excreted in breast milk. The mesalazine concentration in breast milk is lower than in maternal blood, whereas the metabolite, acetyl mesalazine appears in similar or increased concentrations. There is limited experience of the use of oral mesalazine in lactating women available to date. No controlled studies with PENTASA during breast-feeding. Hypersensitivity reactions such as diarrhoea in the infant are very serious. Therefore, use PENTASA only during breast-feeding, if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, discontinue breast-feeding should.