SPC, UK: ONE-ALPHA Capsules (2017)

Product Name and Form

One-Alpha 1 microgram soft capsules.

One-Alpha 0.25 microgram soft capsules.

One-Alpha 0.5 microgram soft capsules.

Pharmaceutical form

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.

Qualitative and Quantitative Composition

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.

List of excipients

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

Pack sizes and Marketing

PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.

Marketing authorization holder
Authorization dates

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

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

Marketing authorization number:

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