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SPC, UK: HYDROCORTISONE Cream (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hydrocortisone Cream BP 0.5%.

Qualitative and quantitative composition

Contains 0.50% w/w Hydrocortisone Ph. Eur. Excipients with known effect: cetostearyl alcohol and chlorocresol. For the full list of excipients, see section 6.1.

Pharmaceutical form

A white cream.

Therapeutic indications

Hydrocortisone has topical anti-inflammatory activities of value in the treatment of various dermatological conditions including: Eczema- atopic, infantile, discoid or stasis Dermatitis- primary irritant, ...

Posology and method of administration

Posology Adults (including elderly) Gently apply a thin layer of cream to the affected area two or three times daily. Children and infants Gently apply a thin layer of cream to the affected area two or ...

Contraindications

Hypersensitivity to hydrocortisone or any of the other ingredients in the product. Untreated bacterial (e.g. impetigo), viral (e.g. herpes simplex), or fungal (e.g. candida or dermatophyte) infections. ...

Special warnings and precautions for use

The use of an occlusive dressing can considerably increase the degree of systemic absorption. If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially ...

Interaction with other medicinal products and other forms of interaction

No interactions have been reported for topical hydrocortisone.

Pregnancy and lactation

Pregnancy There is inadequate evidence of safety in human pregnancy. Topical administration of topical corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft ...

Effects on ability to drive and use machines

Hydrocortisone does not affect the ability to drive and use machines.

Undesirable effects

Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately. Epidermal thinning, telangectasia and striae may occur in areas ...

Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. In the ...

Pharmacodynamic properties

ATC Code: D07AA02 Pharmacotherapeutic group: Weak dermatological corticosteroid (group 1). Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory ...

Pharmacokinetic properties

Absorption Hydrocortisone is absorbed through skin, particularly in denuded areas. Distribution Corticosteroids are rapidly distributed to all body tissues. They cross the placenta to varying degrees and ...

Preclinical safety data

Not Applicable.

List of excipients

Also contains: Cetomacrogol Cetostearyl alcohol Chlorocresol Paraffin

Incompatibilities

None known.

Shelf life

Shelf life: a 24 month shelf life. After dilution or reconstitution: Not applicable. After first opening: Not applicable.

Special precautions for storage

Store below 25°C; do not freeze.

Nature and contents of container

The product containers are aluminium tubes with screw caps contained in cartons: Carton: White backed folding box board printed two colours on white. Tube: Manufactured from 99.5% pure aluminium; lacquered ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, North Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/0128

Date of first authorization / renewal of the authorization

12 July 1979 / 21 August 1997

Date of revision of the text

05/08/2019

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