After long-term treatment, reduced placental and birth weight have been observed in animals. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy. It allows continued monitoring of the benefit/risk balance of the medicinal product. Once a daily dose equivalent to 7.5mg of prednisolone is reached, dose reduction should be slower to allow the HPA-axis to recover.Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Divided daily dosage may be used. Prednisolone is indicated in the management of all conditions deemed likely to benefit from short or long term glucocorticoid therapy. For further information with reference to dosage see section 4.4 Special warnings and precautions for use.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Systemic infections unless specific anti-infective therapy is employed.Patients with ocular herpes simplex due to the possibility of perforation.A patient information leaflet should be supplied with this product. Other preparations of this medicine may still be available. Patients should carry “steroid treatment” cards which give clear guidance on the precautions to be taken to minimise risk and provide details of prescriber, drug, dosage and duration of treatment.Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). It allows continued monitoring of the benefit/risk balance of the medicinal product. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules weight loss, and/or hypotension. The incidence of side-effects increases with dose and duration of treatment (see Section 4.4 'Special warnings and special precautions for use').
Corticosteroids may affect the effect of anticholinergics. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.Suppression of the hypothalamo-pituitary adrenal axis particularly in times of stress, as in trauma, surgery or illness, growth suppression in infancy, childhood and adolescence. Prednisolone is extensively bound to plasma proteins, although less so than hydrocortisone. Caution is required in patients with systemic sclerosis as an increased incidence of (possibly fatal) renal crisis in scleroderma, with hypertension and decreased urine output, has been observed with a daily prednisolone dose of 15 mg or more. Monitoring of the infant for adrenal suppression is advised.If insufficient sleep occurs, the likelihood of impaired alertness may be increased, patients should make sure they are not affected before driving or operating machinery.A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. The infections can be mild, but also difficult and in some cases fatal. neuromuscular blocking drugs (such as pancuronium) (see section 4.5).
The greatest risk has been reported in patients with diffuse systemic sclerosis. Salicylate levels in serum may increase upon discontinuation of corticosteroid therapy, which could lead to an increased risk of toxic effects of salicylate. These effects are believed to be due to the sudden change in glucocorticosteroid concentration rather than to low corticosteroid levels. Potassium-reducing diuretics (e.g., thiazides, furosemide, ethacrynic acid) and other drugs that reduce the amount of potassium such as amphotericin B, xanthines and beta2-agonists, may potentiate the potassium-lowering effect of glucocorticoids. For children aged 2-5 years use a dose of 20mg prednisolone.
Corticosteroids may affect the effect of anticholinergics. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.Suppression of the hypothalamo-pituitary adrenal axis particularly in times of stress, as in trauma, surgery or illness, growth suppression in infancy, childhood and adolescence. Prednisolone is extensively bound to plasma proteins, although less so than hydrocortisone. Caution is required in patients with systemic sclerosis as an increased incidence of (possibly fatal) renal crisis in scleroderma, with hypertension and decreased urine output, has been observed with a daily prednisolone dose of 15 mg or more. Monitoring of the infant for adrenal suppression is advised.If insufficient sleep occurs, the likelihood of impaired alertness may be increased, patients should make sure they are not affected before driving or operating machinery.A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. The infections can be mild, but also difficult and in some cases fatal. neuromuscular blocking drugs (such as pancuronium) (see section 4.5).
The greatest risk has been reported in patients with diffuse systemic sclerosis. Salicylate levels in serum may increase upon discontinuation of corticosteroid therapy, which could lead to an increased risk of toxic effects of salicylate. These effects are believed to be due to the sudden change in glucocorticosteroid concentration rather than to low corticosteroid levels. Potassium-reducing diuretics (e.g., thiazides, furosemide, ethacrynic acid) and other drugs that reduce the amount of potassium such as amphotericin B, xanthines and beta2-agonists, may potentiate the potassium-lowering effect of glucocorticoids. For children aged 2-5 years use a dose of 20mg prednisolone.