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ROCALTROL Soft capsules (2014)

Active ingredients: Calcitriol

Product Name and Form

Rocaltrol 0.25 microgram Capsules.

Rocaltrol 0.5 microgram Capsules.

Pharmaceutical form

Soft capsules.

0.25 microgram: One length brown-orange to red-orange opaque and the other white to grey-yellow or grey-orange opaque.

0.5 microgram: Both lengths brown-orange to red-orange opaque.

Qualitative and Quantitative Composition

Each capsule contains either 0.25 or 0.5 microgram of calcitriol.

For excipients, see 6.1.

Chemical substance
Description
Calcitriol

Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. In physiological amounts it augments the intestinal absorption of calcium and phosphate and plays a significant part in the regulation of bone mineralisation.

List of excipients

Content:

Butylhydroxyanisole
Butylhydroxytoluene
Medium-chain triglycerides

Shell:

Gelatin
Glycerol
Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch)
Titanium dioxide E171
Iron oxide red E172
Iron oxide yellow E172

Pack sizes and Marketing

PVC opaque blisters containing 100 capsules (5 strips of 20 capsules).

Marketing authorization holder
Authorization dates

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

13 January 2003

Marketing authorization number:

Rocaltrol 0.25 microgram Capsules: PL 00031/0122

Rocaltrol 0.5 microgram Capsules: PL 00031/0123