Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients in the capsule content:
Sugar sphere (sucrose, maize starch)
Methacrylic acid-ethylacrylate-copolymer (1:1)
Talc
Triethyl citrate
Poly(vinyl alcohol)
Macrogol 3350
Polysorbate 80
Sodium hydroxide
Sodium laurilsulfate
Simeticone emulsion
Silica colloidal anhydrous
Methylcellulose
Sorbic acid
Indigo carmine lacquer
Purified water
 in the capsule shell:
Gelatin
Titanium dioxide (E 171)
Sodium laurilsulfate additional in the capsule shell of MEDIKINET MR 10 mg and 20 mg:
Erythrosine (E 127)
Patent blue V (E 131)
 additional in the capsule shell of MEDIKINET MR 30 mg and 40 mg:
Erythrosine (E 127)
Black iron oxide (E 172)
Indigo carmine (E 132)

6.2   Incompatibilities
Not applicable.
6.3   Shelf life
3 years.
6.4   Special precautions for storage
Do not store above 25 °C.
Store in the original package in order to protect from moisture.
6.5   Nature and contents of the container
Boxes of 28 or 30 modified-release capsules, hard in PVC/PVdC clear blisters heat sealed to aluminium foil.

Not all pack sizes may be marketed.

6.6   Instructions for use/handling
No special requirements.