PREDNISOLONE Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Prednisolone 10mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10 mg prednisolone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets. 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.
Therapeutic indications
Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies unresponsive to conventional treatment. Arteritis/collagenosis: ...
Posology and method of administration
Posology Adults and the elderly The lowest effective dose should be used for the minimum period. Children Prednisolone should only be used when specifically indicated, at the lowest dose possible and for ...
Contraindications
Prednisolone is contraindicated in: Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Systemic infections unless specific anti-infective therapy is employed. Ocular ...
Special warnings and precautions for use
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see Section 4.8). Symptoms typically emerge within a few days or weeks of ...
Interaction with other medicinal products and other forms of interaction
Vaccines: Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished. Antacids: The absorption of prednisolone may be ...
Fertility, pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however 88% of prednisolone is inactivated as it crosses the placenta. Administration of corticosteroids ...
Effects on ability to drive and use machines
The effect of Prednisolone on the ability to drive or use machinery has not been evaluated. There is no evidence to suggest that prednisolone may affect these abilities.
Undesirable effects
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, ...
Overdose
Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored. ...
Pharmacodynamic properties
Pharmacotherapeutic group: glucocorticoid steroid ATC code: H02AB06 Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement ...
Pharmacokinetic properties
Prednisolone is rapidly and apparently almost completely absorbed after oral administration; it reaches peak plasma concentrations after 1-3 hours. There is however wide inter-subject variation suggesting ...
Preclinical safety data
There are no non-clinical data of relevance to the prescriber that are not already covered in other sections of the SmPC.
List of excipients
Lactose monohydrate Pregelatinised starch Sodium starch glycolate, type A Iron oxide yellow (E172) Iron oxide red (E172) Glycerol dibehenate Magnesium stearate
Incompatibilities
None known.
Shelf life
24 months.
Special precautions for storage
Keep the blister packs in the outer carton in order to protect from light.
Nature and contents of container
Blisters of AL/PVC containing packs of 28 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Not available.
Marketing authorization holder
Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, N. Devon, EX32 8NS
Marketing authorization number(s)
PL 00142/0843
Date of first authorization / renewal of the authorization
01/04/2016
Date of revision of the text
14/02/2018
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