Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Maize starch
Citric acid, anhydrous
Croscarmellose sodium
Gelatine
Magnesium stearate
Mannitol (E421)

Euthyrox tablets contain sodium:
Each Euthyrox 25 mcg tablet contains up to 18 mcg sodium.
Each Euthyrox 50 mcg tablet contains up to 19 mcg sodium.
Each Euthyrox 100 mcg tablet contains up to 21 mcg sodium.

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 25° C. Keep container in the outer carton, in order to protect from light.

6.5   Nature and contents of container
Blister pack:
PVC base film with aluminium cover foil.

Pack sizes:
-      Euthyrox 25 mcg: cartons of 50, 100 tablets
-      Euthyrox 50 mcg: cartons of 30, 50, 100 tablets
-      Euthyrox 100 mcg: cartons of 30, 50, 100 tablets

Not all pack sizes may be marketed.
6.6   Special precautions for disposal

No special requirements.


7.    MARKETING AUTHORISATION HOLDER

Merck Serono Ltd.
Hakishon 18 St.
Yavne 81220

8.    MARKETING AUTHORISATION NUMBER(S)

Euthyrox 25 mcg: 170-16-37022-99
Euthyrox 50 mcg: 147-50-33604-00
Euthyrox 100 mcg: 147-51-33605-00