Prescribe a wider range of strengths with our extended range of Prednisolone Tablets


l 6 Different strengths of Prednisolone tablets - available now from Actavis l Prescribe our new strengths of 2.5mg, 10mg, 20mg and 30mg


l A wider range of strengths may result in a reduced pill burden for your patients l


An increased range of strengths offers more options when titrating your patients’ medication


Prescribing Information Prednisolone Please refer to the Summary of Product Characteristics (SPC) before prescribing. Presentation: Each tablet contains 2.5mg, 5mg, 10mg, 20mg, 25mg, 30mg Prednisolone. Indications: Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies unresponsive to conventional treatment. Arteritis/ collagenosis: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis. Blood disorders: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura. Cardiovascular disorders: post-myocardial infarction syndrome, rheumatic fever with severe carditis. Endocrine disorders: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia. Gastro-intestinal disorders: regional ileitis (Crohn’s disease), ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis. Hypercalcaemia: sarcoidosis, vitamin D excess. Infections (with appropriate chemotherapy): helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease. Muscular disorders: polymyositis, dermatomyositis. Neurological disorders: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy. Ocular disease: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease. Renal disorders: lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis, nephrotic syndrome. Respiratory disease: allergic pneumonitis, asthma, occupational asthma, pulmonary aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body, aspiration of stomach contents, pulmonary sarcoid, drug induced lung disease, adult respiratory distress syndrome, spasmodic croup, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy. Rheumatic disorders: rheumatoid arthritis, polymyalgia rheumatica, juvenile chronic arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease. Skin disorders: pemphigus vulgaris, exfoliative dermatitis, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum. Miscellaneous: sarcoidosis, hyperpyrexia, Behçets disease, immunosuppression in organ transplantation. Dosage and Administration: Lowest effective dose should be used for the minimum period. Children: Prednisolone should only be used when specifically indicated. Initial dose may vary from 5mg to 60mg daily depending on the disorder being treated. Divided daily dosage may be used. Initial dosage should be adjusted until the desired clinical response is achieved. The dose should be gradually reduced by 2.5–5 mg every second to fifth day (more rapidly at the higher initial dose levels) until lowest possible maintenance dose is reached. Preferably this should not exceed 10mg per day. Use of the lowest effective dose will tend to minimise side-effects. The incidence of side-effects increases with dose and duration of treatment. During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease. If there is lack of a satisfactory clinical response to Prednisolone Tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy. Use in children: appropriate fractions of the adult dose may be used. Dosage is usually determined by clinical response as in adults. Alternate day dosage is preferable. Method of Administration: Take following a meal to reduce the risk of gastric irritation. Contraindications: Hypersensitivity, systemic infections unless specific anti-infective therapy is employed, ocular herpes simplex. Contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Warnings and Precautions: Patients and/or carers should be warned that potentially severe


UK/PRE/0004/07-16(1) Date of Preparation: October 2016.


psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge in a few days or weeks of starting treatment. Most reactions recover after dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should be alert to possible psychiatric disturbances that may occur during or immediately after dose tapering/withdrawal of systematic steroids. Care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders including depressive or manic-depressive illness and previous steroid psychosis. Tumorigenicity: risk that malignancies in patients undergoing immunosuppression with these or other drugs will spread more rapidly. Calciphylaxis may occur very rarely. Caution and frequent monitoring is necessary in patients with tuberculosis, inflammatory bowel disease, hypertension, congestive heart failure, liver failure, hepatic disease, renal insufficiency, diabetes mellitus or a family history of diabetes, osteoporosis, menopausal and post-menopausal women, history of severe affective disorders particularly those with a previous history of steroid-induced psychoses, existing emotional instability or psychotic tendencies, epilepsy and/or seizure disorders, peptic ulceration, previous steroid myopathy, patients with myasthenia gravis receiving anticholinesterase therapy, patients with thromboembolic disorders, Duchenne’s muscular dystrophy. Adrenocortical insufficiency: pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary adrenal (HPA) suppression (secondary adrenocortical insufficiency). Acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly this may be minimised by gradual reduction of dosage. This may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. During prolonged therapy any intercurrent illness, trauma, or surgical procedure will require a temporary increase in dosage; patients should carry “Steroid treatment” cards. Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. Chickenpox may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Patients should avoid exposure to measles, and seek immediate medical advice if exposure occurs. Live vaccines should not be given to individuals on high doses of corticosteroids, due to impaired immune response. Live vaccines should be postponed until at least 3 months after stopping corticosteroid therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos, or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves. Establishment of secondary fungal and viral infections of the eye may also be enhanced in patients receiving glucocorticoids. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible perforation. Systemic glucocorticoid treatment can cause severe exacerbation of bullous exudative retinal detachment and lasting visual loss in some patients with idiopathic central serous chorioretinopathy. Glucocorticoids can produce or aggravate Cushing’s syndrome, and should be avoided in patients with Cushing’s disease. There is an enhanced effect of corticosteroids in patients with hypothyroidism. Psychic derangements may appear when corticosteroids including Prednisolone are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Raised intracranial


pressure with papilloedema (pseudotumour cerebri) associated with corticosteroid treatment has been reported in both children and adults. The onset usually occurs after treatment withdrawal. Use in the elderly: treatment of elderly patients, particularly if long term, should be undertaken with caution bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life threatening reactions. Paediatric population: corticosteroids cause growth retardation in infancy, childhood and adolescence, which may be reversible, therefore long-term administration of pharmacological doses should be avoided. If prolonged therapy is necessary, limit treatment to the minimum suppression of the HPA axis and growth retardation. Growth and development of infants and children should be closely monitored. Treatment should be administered where possible as a single dose on alternate days. Fertility, Pregnancy & Lactation: When administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids, but usually resolves spontaneously following birth and is rarely clinically important. Cataracts have also been rarely reported. Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with abnormal pregnancies may be treated as though they were in the non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring. Corticosteroids are excreted in small amounts in breast milk where they may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. Should be administered to nursing mothers only if the benefits of therapy are judged to outweigh the potential risks to the infant. Corticosteroids may alter the motility and number of spermatozoa in certain patients. Undesirable Effects: Common: irritability, depressed and labile mood, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, and aggravation of schizophrenia, behavioural disturbances, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia. Very rare: calciphylaxis. Unknown: recurrence of dormant tuberculosis, anaphylaxis, suppression of the HPA axis, manifestation of latent diabetes mellitus, raised intracranial pressure with papilloedema, aggravation of epilepsy, glaucoma, papilloedema, exophthalmos, chorioretinopathy, congestive heart failure, myocardial infarction, peptic ulceration with perforation and haemorrhage, acute pancreatitis, thromboembolism, osteoporosis. Pack Size and NHS Price(Generics): 2.5mg x 28 £0.68, 5mg x 28 £0.49, 10mg x 28 £2.72, 20mg x 28 £5.43, 25mg x 56 £75.00 & 30mg x 28 £8.15. Legal Category: POM. Further information is available from Actavis UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS. Marketing Authorisation Numbers: PL 24668/0296, PL 24668/0297, PL 24668/0298, PL 24668/0299, PL 24668/0300 & PL 24668/0301. Date of PI Preparation: 21/04/2016. UK/PRE/0001/04-16


Adverse events should be reported. Reporting forms and information can be found at


www.mhra.gov.uk/yellowcard Adverse events should also be reported to Actavis on 01271 385257.


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