hyprolose,

hypromellose,

iron oxide (20 mg & 40 mg tablets: reddish-brown; 20 mg tablets: yellow) (E 172), magnesium stearate,

methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent,

cellulose microcrystalline,

synthetic paraffin,

macrogol,

polysorbate 80,

crospovidone,

sodium stearyl fumarate,

sugar spheres (sucrose and maize starch),

talc,

titanium dioxide (E 171),

triethyl citrate.

6.2 Incompatibilities

 Not applicable.

6.3 Shelf life

 3 years.

2 years in climate zones III-IV.

6.4 Special precautions for storage

 Do not store above 30°C.

Keep the container tightly closed (bottle) in order to protect from moisture. Store in the original package (blister) in order to protect from moisture.

6.5 Nature and contents of container

 - Polyethylene bottle with a tamper proof, polypropylene screw cap equipped with a desiccant capsule.

- Aluminium blister package.

20 mg, 40 mg: Bottles of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140 (5x28) tablets.

20 mg, 40 mg: Blister packs in wallet and/or carton of 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1, 56, 60, 90, 98, 100x1, 140 tablets.

6.6 Special precautions for disposal and other handling

 Administration through gastric tube

1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 mL water and approximately 5 mL air. For some tubes, dispersion in 50 mL water is needed to prevent the pellets from clogging the tube.

2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.

3. Hold the syringe with the tip up and check that the tip has not clogged.

4. Attach the syringe to the tube whilst maintaining the above position.

5. Shake the syringe and position it with the tip pointing down. Immediately inject 5–10 mL into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip).

6. Turn the syringe with the tip down and immediately inject another 5–10 mL into the tube. Repeat this procedure until the syringe is empty.

7. Fill the syringe with 25 mL of water and 5 mL of air and repeat step 5 if necessary to wash down any sediment left in the syringe. For some tubes, 50 mL water is needed.

7. MARKETING AUTHORISATION HOLDER

 AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU, UK.

8. MARKETING AUTHORISATION NUMBER(S)

 PA 970/27/2

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 27 July 2000 / 10 March 2005

Date of latest renewal: 10 March 2010

10. DATE OF REVISION OF THE TEXT

 30 September 2011