Active ingredients: Alfacalcidol
One-Alpha 1 microgram soft capsules.
One-Alpha 0.25 microgram soft capsules.
One-Alpha 0.5 microgram soft capsules.
One-Alpha 1 microgram soft capsules: Brown, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.
One-Alpha 0.25 microgram soft capsules: Cream-coloured, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.
One-Alpha 0.5 microgram soft capsules: Reddish, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.
Each capsule contains 1 microgram of alfacalcidol.
Each capsule contains 0.25 micrograms of alfacalcidol.
Each capsule contains 0.5 micrograms of alfacalcidol.
Excipient with known effect: Sesame oil.
For the full list of excipients, see section 6.1.
Alfacalcidol is Vitamin D-hormone analog (an active metabolite of Vitamin D), which performs important functions in regulation of the calcium balance and the bone metabolism and is activated by the enzyme 25-hydroxylase (converted rapidly in the liver to 1,25-dihydroxyvitamin D) for systemic and in osteoblasts for local D-hormone actions.
One-Alpha1 microgram soft capsules:
Sesame oil
All-rac-α-tocopherol
Gelatine
Glycerol
Potassium sorbate
Black iron oxide
Red iron oxide
One-Alpha0.25 microgram soft capsules:
Sesame oil
All-rac-α-tocopherol
Gelatin
Glycerol
Potassium sorbate
Titanium dioxide
One-Alpha0.5 microgram soft capsules:
Sesame oil
All-rac-α-tocopherol
Gelatin
Glycerol
Potassium sorbate
Red iron oxide
Titanium dioxide
PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.
LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
One-Alpha 1 microgram soft capsules: PL 00043/0050
One-Alpha 0.25 microgram soft capsules: PL 00043/0052
One-Alpha 0.5 microgram soft capsules: PL 00043/0206
Date of first authorisation:
One-Alpha 1 microgram soft capsules: 26 January 1978
One-Alpha 0.25 microgram soft capsules: 25 January 1978
One-Alpha 0.5 microgram soft capsules: 22 September 1999
Date of latest renewal:
One-Alpha 1 microgram soft capsules: 7 February 2004
One-Alpha 0.25 microgram soft capsules: 8 November 2006
One-Alpha 0.5 microgram soft capsules: 21 September 2004