Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Tablets: microcrystalline cellulose), carmellose sodium (low substitued), magnesium stearate, colloidal silica (anhydrous).

Each tablet contains approximately 0.46 mg sodium.

CR tablets: cellulose microcrystalline, croscarmellose sodium, polyacrylate dispersion 30%, ethylcellulose aqueos dispertion, talc, silica colloidal anhydrous, magnesium stearate.
Coating: hypromellose, talc, titanium dioxide, castor oil - polyoxyl 40 hydrogenated, iron oxide red, iron oxide yellow.

Each CR 200 mg tablet contains approximately 2.3 mg sodium.
Each CR 400 mg tablet contains approximately 4.6 mg sodium.

Syrup: sorbitol liquid (sorbitol 70% non crystallising), propylene glycol, dispersible cellulose (microcrystalline cellulose and sodium carboxymethylcellulose), hydroxyethylcellulose methyl parahydroxybenzoate, polyethylene glycol 400 stearate (macrogol stearate), sorbic acid, saccharin sodium, propyl parahydroxybenzoate, caramel aroma 52929 A, purified water.
For further information, see section 4.4


TEG API JUL23 V7                                                REF: New Zealand May 2023 6.2   Incompatibilities

None known.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage

Tablets:       Store below 25°C and protect from moisture.
CR tablets:    Store below 25°C and protect from moisture.
Syrup:         Store below 30°C and protect from light.
After first opening of the bottle, store below 25oC and use within 3 months and no later than the expiry date of the preparation.

Tegretol must be kept out of the reach and sight of children.

6.5   Nature and contents of container
Tegretol 200 mg tablets: PVC/PE/PVDC blisters containing 50 and 500 tablets Tegretol CR 200 mg tablets: PVC/PE/PVDC blisters containing 50 slow release tablets Tegretol CR 400 mg tablets: PVC/PE/PVDC blisters containing 30 slow release tablets Tegretol syrup 2%: glass type III bottle 250mL
Pack sizes: Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

There are no specific instructions for use/handling.
7.    Registration Holder and Importer:

Novartis Israel Ltd., P.O.B 7126, Tel Aviv.