The metabolism of omeprazole in patients with liver dysfunction is impaired, resulting in an increased AUC. Omeprazole has not shown any tendency to accumulate with once daily dosing.

Impaired renal function

The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.

Elderly

The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).

Paediatric patients

During treatment with the recommended doses to children from the age of 1 year, similar plasma concentrations were obtained as compared to adults. In children younger than 6 months, clearance of omeprazole is low due to low capacity to metabolise omeprazole.

5.3 Preclinical safety data

 Gastric ECL-cell hyperplasia and carcinoids have been observed in life-long studies in rats treated with omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. Similar findings have been made after treatment with H2-receptor antagonists, proton pump inhibitors and after partial fundectomy. Thus, these changes are not from a direct effect of any individual active substance.

In mutagenicity studies (in-vitro and in-vivo) no findings of clinical relevance occurred.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Capsule contents:

Hypromellose

Lactose monohydrate

Crospovidone

Glycerol dibehenate

Titanium dioxide

Anhydrous silica

Talc

Triethyl citrate

Methacrylic acid-ethyl acrylate copolymer (1:1)*

Capsule shells**:

Titanium dioxide (E 171)

Water

Gelatin

* contains up to 0.7% sodium laurilsulfate and 2.3% polysorbate 80.

** contains up to 2000 ppm sodium laurilsulfate.

6.2 Incompatibilities

 Not applicable

6.3 Shelf life

 24 months

6.4 Special precautions for storage

 Do not store above 25°C.

Store in the original container. Keep the container tightly closed.

6.5 Nature and contents of container

 White high density polyethylene bottle with a white polypropylene screw cap containing a desiccant.

Original pack containing 7 gastro-resistant capsules (tablet container)

Original pack containing 14 gastro-resistant capsules (tablet container)

Original pack containing 28 gastro-resistant capsules (tablet container)

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

 No special requirements.

7. MARKETING AUTHORISATION HOLDER

 Astellas Pharma Co. Ltd.,

25 The Courtyard,

Kilcarbery Business Park,

Clondalkin,

Dublin 22,

Ireland.

8. MARKETING AUTHORISATION NUMBER(S)

 PA 1241/1/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 28th April 2006

10. DATE OF REVISION OF THE TEXT

 February 2011