MESALAMINE
As listed in the register: MESALAMINE
800 mg · tablet (delayed-release)
- Prescription only
- Digestion, stomach, diabetes and nutrition
- Active substance
- Mesalazine
- Made by
- Tillotts Pharma Ag
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (APRISO). It describes the substance, not this exact product.
The mechanism of action of mesalamine (5-ASA) is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells.
Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites.
Therefore, mesalamine and its metabolite are not expected to inhibit the metabolism of other drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.
Of the approximately 32% of the dose absorbed, about 2% of the dose was excreted unchanged in the urine, compared with about 30% of the dose excreted as N-Ac-5-ASA.
Food Effects The effect of a high fat meal intake on absorption of mesalamine granules (the same granules contained in APRISO capsules) was evaluated in 30 healthy subjects.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-27
Safety of the active substance
From the US prescribing label for the same active substance (APRISO). It describes the substance, not this exact product.
- APRISO is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of APRISO capsules [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 ), Description ( 11 )].
- Known or suspected hypersensitivity to salicylates, aminosalicylates, or any component of APRISO capsules.
The most common reactions reported in at least 3% of APRISO-treated patients and at a greater rate than placebo are shown in Table 1 below.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States6 matching products
Netherlands1 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Tillotts Pharma Ag |
|---|---|
| Active substance | Mesalazine |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 800 mg |
| Form | tablet (delayed-release) |
| Classification | A07EC02 · Digestion, stomach, diabetes and nutrition |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Approved |
| Marketed | No — authorised but not currently marketed, according to the register |
| DIN | 02552426 |
| DPD drug code | 104108 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.