Sunday, December 25, 2022

Prednisolone 10mg Tablets Summary of Product Characteristics SmPC emc

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• patients repeatedly taking doses in the evening. Prednisolone should only be used when specifically indicated, at the lowest dose possible and for the shortest possible time. The tablets are foil strip packed and supplied in cartons of 30 tablets.

In animal studies, corticosteroids have been shown to give rise to various types of malformations (palate gap, skeletal malformations, see section 5.3). Estrogens increase the concentration of transcortin. The effect of glucocorticoids that bind to transcortin can be enhanced and dose adjustments may be needed if estrogens are added or removed from a stable treatment regimen. Glucocorticoids increase blood sugar levels. Patients with diabetes mellitus receiving concomitant insulin and / or oral hypoglycaemic agents may need to adjust the dose of such treatment.

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In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5mg prednisolone or equivalent) for greater than three weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses.

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