RESTANDOL TESTOCAPS Capsule Ref.[7120] Active ingredients: Testosterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

Restandol Testocaps 40 mg capsule.

Pharmaceutical Form

Capsule.

Soft oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.

Qualitative and quantitative composition

Each capsule contains 40.0mg Testosterone Undecanoate which is equivalent to 25.3 mg testosterone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Testosterone

Testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), is responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

List of Excipients

Capsule contents

Each capsule contains:

Castor oil
Propylene glycol laurate (E477)

Capsule shell:

Glycerin
Sunset Yellow (E110)
Gelatin

Printing ink:

Opacode WB white

Auxiliary substances:

Medium-chain triglycerides
Lecithin

Pack sizes and marketing

A box of Restandol Testocaps contains either 3 or 6 sachets, each containing a blister with 10 capsules.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0595

14/1/81 / 8/11/2004

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