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Summary of Product Characteristics Prednisolone, DK/H/2488/001-006, March 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT /…/ 2.5 mg tablets /…/ 5 mg tablets /…/ 10 mg tablets /…/ 20 mg tablets /…/ 25 mg tablets /…/ 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg prednisolone. Each tablet contains 5 mg prednisolone. Each tablet contains 10 mg prednisolone. Each tablet contains 20 mg prednisolone. Each tablet contains 25 mg prednisolone. Each tablet contains 30 mg prednisolone. Excipient with known effect: Each 2.5 mg tablet contains 89.2 mg of lactose monohydrate Each 5 mg tablet contains 87.2 mg of lactose monohydrate Each 10 mg tablet contains 81.7 mg of lactose monohydrate Each 20 mg tablet contains 163.4 mg of lactose monohydrate Each 25 mg tablet contains 159.4 mg of lactose monohydrate Each 30 mg tablet contains 153.4 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 2.5mg tablet Yellow, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A610” on one side and “2.5” on the other. 5mg tablet White, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A620” on one side and “5” on the other. 10mg tablet Red, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A630” on one side and “10” on the other. 20mg tablet Red, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A640” on one side and “20” on the other. 1 Prednisolone, DK/H/2488/001-006, March 2021 25mg tablet White, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A650” on one side and “25” on the other. 30mg tablet Yellow, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A670” on one side and “30” on the other. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prednisolone is indicated to treat conditions where the anti-inflammatory and immunosuppressive effects of prednisolone are desired. 4.2 Posology and method of administration Individual Generally the dosage depends on the nature and severity of the disease. The dose should begin with a dose that provides the desired control of the disease. Then the dose should be reduced to the lowest dose that provides adequate control of the disease. Discontinuation must always be considered depending on the indication and disease activity. Following long-term treatment (for adult’s typically over 3 weeks duration) the discontinuation should be done gradually over weeks or months depending on the dose and duration of treatment. Gradual discontinuation should also be considered after short-term treatment with higher doses or in patients with risk factors for adrenocortical insufficiency. The gradual discontinuation should be individually adjusted, but the majority of adult patients can tolerate dose reductions of 2.5 mg every third to seventh day to a dose equal to 5-10 mg/day. Adults Inflammatory diseases: The daily oral dose is typically between 5 and 60 mg depending on the nature of the disease and severity. Replacement therapy Recommended start dose is 5 mg in the morning and half the morning dose in the evening. Paediatric population It is important that the maintenance dose in children is gradually reduced to the lowest dose, which gives adequate control of the disease and a minimum of side effects due to the risk of growth inhibition (see section 4.4 and 4.8). Elderly No special dose adjustment is required in the elderly. Persistent use of corticosteroids in elderly people can lead to an increased risk for a number of manifest and latent diseases. (See section 4.4 and 4.8). Impaired hepatic function: Dose adjustment may be necessary, since patients with impaired hepatic function have a greater risk for adverse events due to reduced plasma protein binding in hypoalbuminaemia. Renal insufficiency: No specific dose adjustment is necessary. 2 Prednisolone, DK/H/2488/001-006, March 2021 Method of administration /…/ should be swallowed with water. /…/ can be taken before or after a meal. 4.3 Contraindications /…/ is contraindicated in: Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Systemic fungal infections In general no contraindications apply in conditions where the use of glucocorticoids may be life-saving. 4.4 Special warnings and precautions for use Because complications of corticosteroid treatment are dose-dependent; the dose, treatment duration and risk/benefit must be assessed for each patient. The lowest possible dose of corticosteroid that can control the condition being treated must be used, and when dose reduction is possible, this must be undertaken gradually (see section 4.2). Anti-inflammatory/Immunosuppressive effects/Infection Corticosteroids may mask the signs of infection, and new infections may occur during treatment. Corticosteroids suppress the immune system, and identification of an infection may be difficult. Patients in long-term glucocorticoid treatment must not be immunized with live vaccines. Corticosteroids in high doses may interfere with active immunisation. However, immunisation procedures may be performed on patients taking corticosteroids at low doses, e.g. for Addison's disease. Patients taking corticosteroids at doses that suppress the immune system should be informed that they must avoid exposure to chickenpox or measles. If they are exposed, they must seek medical advice. This is particularly important with respect to children. In cases of active tuberculosis, corticosteroid treatment should be limited to cases of fulminant or disseminated tuberculosis in which the corticosteroid is used as part of the appropriate tuberculosis treatment. If corticosteroids are indicated in patients with latent tuberculosis or in tuberculin-reactive patients, these patients must be monitored carefully as recurrence of the disease may occur. In the event of long-term corticosteroid treatment, patients should receive prophylactic anti-tuberculosis treatment. If rifampicin is used in anti-tuberculosis programmes, consideration must be given to the increased effect of rifampicin on the metabolic clearance of corticosteroids in the liver. It may therefore be necessary to increase the dose of corticosteroid. Adrenal Suppression Drug-induced secondary adrenal insufficiency may occur as a result of rapid discontinuation after long-term treatment with corticosteroids. It may be necessary to monitor the patient for up to one year after long-term or high-dose treatment discontinuation with corticosteroids. Symptoms of withdrawal include fever, myalgia, arthralgia, headache and poor general health. These may be reduced by gradually discontinuing treatment (see section 4.2). These symptoms may persist for months after treatment has stopped. Corticosteroid treatment should therefore be resumed if the patient is subjected to stress during this period. If the patient is already taking corticosteroids it may be necessary to increase the dose. Salt and/or a mineralocorticoid should be considered, as mineralocorticoid secretion may be reduced. Intercurrent illness and stress During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily reintroduced. 3 Prednisolone, DK/H/2488/001-006, March 2021 Diabetes Treatment with corticosteroids may increase insulin resistance, leading to a risk of development of diabetes in patients with impaired glucose tolerance. Similarly, this may result in an increased need for insulin or oral anti-diabetic drugs in patients being treated for diabetes mellitus. About 20% of patients treated with high dose steroids develop "steroid diabetes"; this is reversible when treatment is discontinued. Gastrointestinal perforation Corticosteroids should be used with caution in patients with non-specific ulcerative colitis, diverticulitis or ileitis due to the risk of perforation. The anti-inflammatory properties of corticosteroids may mask signs of gastrointestinal perforation and delay the diagnosis with the risk of fatal consequences. Fluid retention /…/ should be used with caution in patients with hypertension or cardiac insufficiency. Moderate and high doses of corticosteroids may cause elevated blood pressure, salt and fluid retention as well as increased excretion of potassium. The probability of this is lower when using synthetic derivatives, but not when they are used at high doses. Low-salt and potassium-rich diets may be considered. Psychiatric reactions Psychological effects may occur after treatment with corticosteroids. Existing emotional instability or psychotic tendencies may be exacerbated by corticosteroids. Osteoporosis Depending on the duration of treatment and the dose used, a negative effect on calcium metabolism must be expected. Prophylaxis for osteoporosis is therefore recommended and is particularly important if other risk factors are present. Prophylaxis is based on adequate calcium and vitamin D intake as well as exercise. In the event of pre-existing osteoporosis, supplementary treatment should be considered. Eye disorders Prolonged use of corticosteroids may result in subcapsular cataracts (particularly in children), increased risk of ocular infection, and glaucoma with a risk of damage to the optic nerve. Corticosteroids should be used with caution in patients with ocular herpes simplex due to the risk of corneal
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