Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Tablet Core
Lactose monohydrate
Cellulose, Microcrystalline 102
Croscarmellose Sodium
Hypromellose 2910
Povidone K-29/32
Sodium Laurilsulfate
Magnesium stearate
Silica, Colloidal Anhydrous

Tablet Coating
Rosetemib S.K. 5 mg/10 mg - Opadry Yellow 02F220026 consisting of:
HPMC 2910/Hypromellose (E464)
Titanium dioxide (E171, CI 77891)
Macrogol/PEG (E1521 MW 4000)
Iron oxide yellow (E172, VI 77492)
Talc (E553b)
Iron oxide red (E172, CI 77492)
Purified water

Rosetemib S.K 10 mg/10 mg - Opadry Beige 02F270003 consisting of:
HPMC 2910/Hypromellose (E464)
Iron oxide yellow (E172, VI 77492)
Titanium dioxide (E171, CI 77891)
Iron oxide yellow (E172, VI 77492)
Macrogol/PEG (E1521 MW 4000)
Talc (E553b)
Purified water


Rosetemib S.K 20 mg/10 mg - VIVACOAT PC-2P-308 consisting of:
HPMC 2910/Hypromellose (E464)
Titanium dioxide (E171, CI 77891)
Talc (E553b)
Polyetheylen glycol (PEG) (E1521, MW 4000)
Iron oxide yellow (E172, VI 77492)
Purified water

Rosetemib S.K 40 mg/10 mg - Opadry White OY-L-28900 consisting of:
Lactose monohydrate
HPMC 2910/Hypromellose (E464)
Titanium dioxide (E171, CI 77891)
Macrogol/PEG (E1521 MW 4000)
Purified water

6.2     Incompatibilities
Not applicable

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4     Special precautions for storage

This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from light and moisture.
It is recommended to store at room temperature

6.5     Nature and contents of container

OPA/Al/PVC//Al blisters packed into carton boxes.

Pack sizes of 30 film-coated tablets.
6.6     Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.