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SPC, UK: HYDROCORTISONE Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hydrocortisone 10 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg hydrocortisone. Excipient(s) with known effect: Contains lactose monohydrate (199.94 mg per tablet). For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. A white, round, biconvex tablet.

Therapeutic indications

Hydrocortisone Tablets are indicated for replacement therapy in congenital adrenal hyperplasia in children. Hydrocortisone Tablets are also used for the emergency treatment of severe bronchial asthma, ...

Posology and method of administration

Posology Replacement therapy Elderly Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age (see section 4.4). When long term treatment is to be discontinued, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with systemic infections (unless specific anti-infective therapy is employed). Patients vaccinated with ...

Special warnings and precautions for use

A patient information leaflet should be supplied with this product. Adrenal suppression Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal ...

Interaction with other medicinal products and other forms of interaction

Hydrocortisone interactions listed below have been reported after therapeutic doses of glucocorticoids. Potent CYP 3A4 inducers such as phenytoin, rifabutin, primidone, carbamazepine, aminoglutethimide, ...

Fertility, pregnancy and lactation

Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs; however, hydrocortisone readily crosses the placenta. Administration of corticosteroids to pregnant animals ...

Effects on ability to drive and use machines

Hydrocortisone may cause changes in vision and/or muscle weakness. If you have any of these symptoms you should not drive or operate machinery.

Undesirable effects

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration ...

Overdose

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Symptoms Overdosage may cause nausea and vomiting, sodium and water retention, hyperglycaemia ...

Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids ATC code: H02AB Pharmacodynamic effects Hydrocortisone is a glucocorticoid and the synthetic form of endogenously produced cortisol. Glucocorticoids are important ...

Pharmacokinetic properties

Absorption Hydrocortisone given by mouth is readily absorbed from the gastrointestinal tract. Distribution Hydrocortisone is extensively bound to plasma proteins. In plasma, cortisol is bound to corticosteroid-binding ...

Preclinical safety data

Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations). Animal studies have also shown that prenatal ...

List of excipients

Lactose monohydrate Pregelatinised starch Calcium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life Amber glass bottle: 2 years. PVC/aluminium foil blister pack: 1.5 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Amber glass bottle with HDPE/polypropylene cap containing 100 tablets. PVC/aluminium foil blister packs containing 30 tablets.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 20072/0238

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 September 2012

Date of revision of the text

17/07/2019

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