What Esomeprazol Mylan contains
The active substance is esomeprazole. Each gastro-resistant tablet contains either 20mg or 40mg of esomeprazole (as esomeprazole magnesium).
The other ingredients are:
- Core: Sugar spheres (sucrose and maize starch), Crospovidone (Type B) (E1202), Hydroxypropylcellulose (E463), Sodium lauryl sulphate
- Sub Coating 1: Mannitol (E421)
- Sub Coating 2: Povidone K30 (E1201), Talc (E553b), Macrogol 6000
- Enteric Coating: Methacrylic acid-ethyl acrylate co polymer (1:1) Dispersion 30%, Triethyl citrate (E1505), Glycerol monostearate (E471), Polysorbate 80 (E433), Talc (E553b), Titanium dioxide (E171)
- Lubrication: Talc (E553b)
- Blending and Compression: Cellulose microcrystalline (E460), Mannitol (E421), Crospovidone (Type A) (E1202), Macrogol 6000, Sodium stearyl fumarate.
- Opadry Clear Coating consisting of Hypromellose (E464), Macrogol 400, Macrogol 8000.
- For 20mg only: Opadry Pink Coating consisting of: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Sodium lauryl sulphate, Iron oxide red (E172) , Iron oxide yellow (E172), Iron oxide black (E172).
- For 40mg only: Opadry Brown Coating consisting of: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Sodium lauryl sulphate, Iron oxide red (E172) , Iron oxide yellow (E172).
What Esomeprazol Mylan looks like and contents of the pack
Esomeprazol Mylan 20mg gastro-resistant tablets are light pink, film-coated, oblong, biconvex tablets debossed with “M” on one side of the tablet and “EM3” on the other side.
Esomeprazol Mylan 40mg gastro-resistant tablets are pink, film-coated, oblong, biconvex tablets debossed with “M” on one side of the tablet and “EM4” on the other side.
Esomeprazol Mylan is available in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 gastro- resistant tablets.
Esomeprazol Mylan is available in high-density polyethylene bottles containing 14, 28, 56, 98, 100, 200 or 500 gastro-resistant tablets.
Not all pack sizes may be marketed.
Dit middel is ingeschreven in het register onder nummer RVG 108973 (20 mg) en RVG 108974 (40 mg).
Houder van de vergunning voor het in de handel brengen en fabrikant Houder van de vergunning
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire EN6 1TL,Verenigd Koninkrijk.
Fabrikanten:
McDermott Laboratories Ltd. T/A Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ierland.
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire EN6 1TL,Verenigd Koninkrijk.
This medicinal product is authorised in the Member States of the EEA under the following names:
France Esomeprazole Qualimed 20mg & 40mg Comprimé gastro-résistant The Netherlands Esomeprazol Generics 20mg & 40 mg maagsapresistente tabletten
Deze bijsluiter is voor het laatst goedgekeurd in mei 2012.