cal safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential. Effects in animals (affecting the thyroid gland in rodents) were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
In male rats, decreased fertility was observed from exposures which were approximately twice the exposure at the maximum recommended human dose. The observed effect was reversible.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule content
Starch, pregelatinised (maize)
Mannitol (E421)
Magnesium stearate
Sodium laurilsulfate
Capsule shell
Gelatin
Titanium dioxide (E171)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
6.5 Nature and contents of container
The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in carton packs.
Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Recordati Ireland Ltd.
Raheens East
Ringaskiddy Co. Cork
Ireland
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/09/608/008
EU/1/09/608/009
EU/1/09/608/010
EU/1/09/608/011
EU/1/09/608/012
EU/1/09/608/013
EU/1/09/608/014
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/01/2010
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
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