Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Core
Lactose, anhydrous
Crospovidone
Povidone (K-30)
Maize starch
Silica, colloidal anhydrous
Magnesium stearate
The film-coated tablet coating of Myfortic 180 consist of Hypromellose phthalate; Titanium dioxide (CI 77891, E-171); Iron oxide yellow (CI 77492, E-172); indigotine (Indigo carmine) (F,D & C Blue, E132).

The film-coated tablet coating of Myfortic 360 consist of Hypromellose phthalate; Titanium dioxide (CI 77891, E-171); Iron oxide yellow (CI 77492, E-172); Iron oxide red (CI 77491, E-172).

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
Do not store above 30°C.

Store in the original package in order to protect from moisture.

6.5   Nature and contents of container
The tablets are packed in polyamide/aluminium/PVC/aluminium blister packs in quantity of 120 tables per carton.

6.6    Special precautions for disposal and other handling

In order to retain the integrity of the enteric coating, Myfortic tablets should not be crushed (see section 4.2).

Mycophenolic acid has demonstrated teratogenic effects (see section 4.6). Where crushing of Myfortic tablets is necessary, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane.

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



MYF API March23 V3                                                                                REF UK SmPC March23 Any unused product or waste material should be disposed of in accordance with local requirements.

7. REGISTRATION HOLDER and IMPORTER:

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