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SPC, UK: HYDROCORTISONE 1% w/w Ointment (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hydrocortisone 1% w/w Ointment.

Qualitative and quantitative composition

Each 1 gram of the ointment contains 10 mg of Hydrocortisone (i.e. 1% w/w). Excipient with known effect: Each 1 gram of the ointment contains 100 mg (10% w/w) of wool fat. For the full list of excipients, ...

Pharmaceutical form

Ointment for cutaneous use only.

Therapeutic indications

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.

Posology and method of administration

Posology Use sparingly over a small area once/twice a day for a maximum period of one week. If the condition has not improved, or worsens, consult your doctor. This product should not be recommended for ...

Contraindications

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin. Hypersensitivity to the active substance or to any of the excipients listed in section ...

Special warnings and precautions for use

Remarks on indications There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes. ...

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

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

Effects on ability to drive and use machines

None known.

Undesirable effects

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Striae may occur especially in intertriginous areas. Reporting ...

Overdose

Not applicable.

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, weak (group 1) ATC code: D07AA02 Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of ...

Pharmacokinetic properties

Absorption Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas, or under occlusive dressings. Distribution Corticosteroids are rapidly distributed ...

Preclinical safety data

Adverse effects of Hydrocortisone are due to its effect on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic ...

List of excipients

Wool fat Liquid paraffin White soft paraffin

Incompatibilities

None known.

Shelf life

Shelf life: 60 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex end seal band in the crimp seal and a white plastic cap for reclosure after piercing membrane. Pack Sizes: ...

Special precautions for disposal and other handling

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

Marketing authorization holder

Pinewood Laboratories Limited, Trading as Pinewood Healthcare, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization number(s)

PL 04917/0020

Date of first authorization / renewal of the authorization

11<sup>th</sup> November 1997

Date of revision of the text

21/06/2018

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