Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Examples of hypogonadal disorder are:
Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.
In general, the dose should be adjusted according to the response of the individual patient.
The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.
It should be noted that smaller and less frequent doses may achieve the same response.
The safety and efficacy of Restandol Testocaps in children and adolescents has not been established. Pre-pubertal children treated with Restandol Testocaps should be treated with caution (see section 4.4).
Oral.
To ensure absorption, Restandol Testocaps must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.
The acute toxicity of testosterone is low.
High doses of Restandol Testocaps may cause gastrointestinal complaints due to the castor oil present in the capsule. Treatment consists of supportive measures.
3 years.
Store below 30°C; do not refrigerate or freeze; store in the original package and keep the blister in the outer carton.
A box of Restandol Testocaps contains either 3 or 6 sachets, each containing a blister with 10 capsules.
Any unused product or waste material should be disposed of in accordance with local requirements.
See also “Special precautions for storage” (section 6.4) and “Posology and method of administration” (section 4.2).
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