Europe — EMA
Granupas
Granupas Aminosalicylic Acid is an oral anti‑inflammatory drug used for ulcerative colitis and Crohn's disease in the EU. Learn its uses, safety and interactions.
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What is Aminosalicylic Acid?
Granupas is a product that contains the active ingredient aminosalicylic acid. It is supplied in oral form and marketed in the European Union. The preparation is classified among aminosalicylic acids and is used as an anti‑inflammatory agent for gastrointestinal conditions. The product is intended for prescription use under medical supervision and is part of the ATC group A07EC01. No strength or dosage form is publicly listed.
What is Aminosalicylic Acid used for?
Granupas, containing aminosalicylic acid, is employed in the management of inflammatory bowel disease. Clinical practice in the EU includes its use for specific gastrointestinal conditions where inflammation is a primary concern.
- Ulcerative colitis, particularly mild to moderate disease activity. - Crohn's disease involving the colon or ileocolonic region. - Maintenance therapy to reduce relapse frequency after induction of remission. - Adjunctive treatment when other 5‑ASA agents are insufficient or not tolerated. - Pediatric patients with ulcerative colitis when approved by a specialist. - Patients requiring a non‑steroidal anti‑inflammatory option for intestinal inflammation.
What are the side effects of Aminosalicylic Acid?
The safety profile of aminosalicylic acid, the active component of Granupas, includes both frequent mild reactions and less common serious events that may require medical attention.
Common: - Nausea or upset stomach - Diarrhea or loose stools - Headache - Skin rash or mild itching
Serious: - Severe allergic reaction (anaphylaxis) with swelling, difficulty breathing - Hepatotoxicity indicated by jaundice or elevated liver enzymes - Blood dyscrasias such as neutropenia or agranulocytosis - Acute pancreatitis presenting with abdominal pain
What precautions apply to Aminosalicylic Acid?
When prescribing Granupas, clinicians consider several precautionary measures to minimize risk and ensure appropriate patient selection.
- Assess liver function before initiation and monitor periodically. - Evaluate renal function, especially in patients with pre‑existing kidney disease. - Use caution in individuals with a history of hypersensitivity to salicylates. - Avoid use during acute severe ulcerative colitis flare without specialist supervision. - Discuss potential risks with pregnant or breastfeeding women; data are limited. - Review concomitant use of other anti‑inflammatory or immunosuppressive agents. - Consider age‑related dosing adjustments for elderly patients.
What does Aminosalicylic Acid interact with?
Aminosalicylic acid can interact with other medicines, altering its effectiveness or increasing adverse effects.
Avoid: - Concurrent use with systemic corticosteroids at high doses, which may increase gastrointestinal toxicity. - Combination with other salicylate‑containing products, raising risk of salicylate toxicity.
Use with caution: - Anticoagulants such as warfarin, due to potential enhancement of bleeding risk. - Methotrexate, as aminosalicylic acid may affect hepatic metabolism. - Non‑steroidal anti‑inflammatory drugs (NSAIDs), which can exacerbate gastrointestinal irritation. - Live vaccines, because immunomodulatory effects might reduce vaccine efficacy.
Frequently asked questions
What is the active ingredient in Granupas and how does it work?+
For which conditions is Granupas typically prescribed in the European Union?+
Can Granupas be used in children with ulcerative colitis?+
What are the most frequently reported side effects of aminosalicylic acid?+
What serious adverse reactions require immediate medical attention?+
Should liver function be monitored while taking Granupas?+
Is it safe to combine Granupas with anticoagulant medications?+
Can Granupas be taken together with other salicylate‑containing drugs?+
What should patients know about using Granupas during pregnancy?+
Are there any dietary restrictions while on Granupas?+
How often should renal function be assessed while on Granupas?+
What is the ATC classification for aminosalicylic acid?+
Product details
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