SPC, UK: OMEPRAZOLE Gastro-resistant capsules (2018)

Product Name and Form

Omeprazole 10mg Gastro-resistant Capsules.

Pharmaceutical form

Gastro-resistant capsules, hard.

Hard gelatine capsules of size 3, Opaque yellow cap and body containing white to off-white spherical pellets.

Qualitative and Quantitative Composition

Each capsule contains 10mg omeprazole.

Excipient with known effect: Contains sucrose, see section 4.4.

Each 10mg omeprazole capsule contains 51 to 58mg of sucrose.

For the full list of excipients, see section 6.1.

List of excipients

Sugar spheres (consisting of corn starch and sucrose)
Sodium lauryl sulfate
Disodium phosphate
Mannitol
Hypromellose
Polyethylene glycol 6000
Talc
Polysorbate 80
Titanium dioxide
Eudragit L30-D55 (poly(methacrylic acid, ethyl acrylate))

Capsules consist of gelatin and contain the colours quinoline yellow (E104) and titanium dioxide (E171).

Pack sizes and Marketing

OPA/Aluminium/PVC: Aluminium blister; OPA/Aluminium/PVC: PET/Aluminium blister:

Pack sizes: 7’s, 10’s, 14’s, 15’s, 20’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s

HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant:

Pack size: 30, 90

Marketing authorization holder
Authorization dates

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

22.03.2002

Marketing authorization number:

PL 00142/0516