Somnols®

INN: Zopiclonum

7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg of zopiclone.

Zopiclone is indicated for the short-term treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

PHARMACEUTICAL PARTICULARS

List of excipients
Core. Filler: calciumhydrogen phosphate, anhydrous. Lubricants: potato starch, magnesiumstearate, silicon dioxide. Disintegrator: sodium starch glycolate.

Composition of the film-coating: Opadry 33G28707 White.
Contentof Opadry 33G28707 White: hydroxypropylmethylcellulose (Hypromellose),titanium dioxide, lactose monohydrate, polyethylene glycol 300(Macrogol), triacetin.

Incompatibilities
None

Shelf life
3 years.

Special precautions for storage
Do not store above 25° C. Protect from light and moisture.
Do not use after the expiry date stated on the label.

Prescription drug.

Nature and contents of container
10film-coated tablets in a blister manufactured from an aluminum foil /PVC coated with PVDH film. 1 or 2 blisters per cardboard box.

Instructions for use and handling
None

MARKETING AUTHORISATION HOLDER JSC «Grindeks»; 53, Krustpils St., Riga, LV-1057 Latvia
Phone: 371 7083205
Fax: 371 7083505

MARKETING AUTHORISATION NUMBER LT 2000/7182/10

DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION 07.12.2000

DATE OF REVISION OF THE TEXT August 2005