Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TESTOSTERONE UNDECANOATE
Organon (Ireland) Limited
40 Milligram
Capsules, Soft
2007-01-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Restandol Testocaps 40mg soft capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of testosterone undecanoate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule. (Short term capsule) Soft oval glossy capsule, transparent, orange in colour, with a yellow oily fill, with imprint ‘Org DV3’ in white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the replacement therapy of male hypogonadism associated with reduced levels of testosterone. In osteoporosis due to androgen deficiency in males. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated, and if other aetiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc.) and confirmed by 2 separate blood testosterone measurements. Dosage Adults: The initial dosage required will usually be 120 - 160 mg daily for two to three weeks. Subsequent dosage (40 - 120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy. Children: Safety and efficacy have not been adequately determined in children. To ensure absorption, Restandol Testocaps must be taken with a meal, if necessary with a little fluid and 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. In general, the dose should be adjusted according to the response of the individual patient. 4.3 CONTRAINDICATIONS o Use in pati Read the complete document