GRANUPAS Gastro-resistant granules

Active ingredients: 4-Aminosalicylic acid

Product name and form

GRANUPAS 4 g gastro-resistant granules.

Pharmaceutical Form

Gastro-resistant granules.

The granules are small off white/light brown coloured approximately 1.5 mm diameter.

Qualitative and quantitative composition

Each sachet contains 4 g of para-aminosalicylic acid.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis. It inhibits the onset of bacterial resistance to streptomycin and isoniazid.

List of Excipients

Silica, colloidal hydrated
Dibutyl sebacate
Methacrylic acid – Ethyl acrylate copolymer (1:1) Dispersion 30 per cent
Hypromellose
Cellulose, microcrystalline
Talc

Pack sizes and marketing

Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.

Pack size of 30 sachets. A calibrated measuring spoon is provided.

Marketing authorization holder

Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands

Marketing authorization dates and numbers

EU/1/13/896/001

Date of first authorisation: 07 April 2014