ination half-life is around 4 hours. Aceclofenac is highly protein- bound (>99%). Aceclofenac circulates mainly as unchanged drug. 4'- Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.
No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.
5.3 Preclinical safety data
The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No unexpected findings were recorded.
Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.
Aceclofenac was not found to be carcinogenic in either the mouse or rat.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some fetuses.
6. Pharmaceutical particulars
6.1 List of excipients
The excipients used in Preservex film-coated tablets 100 mg are those commonly recommended for use in pharmaceutical preparations. These are microcrystalline cellulose, sodium croscarmellose, povidone, glyceryl palmitostearate and the film coat, containing partially substituted hydroxypropyl methylcellulose, microcrystalline cellulose, polyoxyethylene 40 stearate and titanium dioxide (E171).
6.2 Incompatibilities
None known.
6.3 Shelf life
The shelf-life for this product shall not exceed three years from the date of manufacture.
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
The immediate container for Preservex film-coated tablets 100 mg is a laminated aluminium/aluminium foil pack. Each foil strip contains either 10 or 14 tablets. One, two, four or six foil strips will be provided with a patient information leaflet inside a carton.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Almirall S.A.
General Mitre 151
08022 Barcelona
Spain
8. Marketing authorisation number(s)
PL 16973/0001
9. Date of first authorisation/renewal of the authorisation
Date of first authorization: 15 September 1997
Date of latest renewal : 09 March 2009
10. Date of revision of the text
06/2018
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