Zenoxone Hydrocortisone 1% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zenoxone Hydrocortisone 1% Cream Hydrocortisone 1% Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 1.0%w/w
BAN rINN: Hydrocortisone Trivial name: Cortisol
3. PHARMACEUTICAL FORM
Aqueous cream
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.
4.2 Posology and Method of Administration
To be applied topically.
Adults and elderly: To be applied sparingly once or twice daily for a maximum period of one week.
Children: To be applied as above. Do not use for children under 10 years of age without medical advice.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Zenoxone® should not be used on the eyes, face, the ano-genital region or on broken or infected skin such as; cold sores, athlete's foot, acne or chicken pox.
4.4 Special warnings and precautions for use
Do not use under an occlusive dressing.
Contains Hydrocortisone. Do not use on the eyes, face or ano-genital region, broken or infected skin. Do not use in pregnancy without medical advice. Do not use for children under 10 without medical advice. Stop treatment if symptoms of hypersensitivity occur. If the condition does not improve consult a doctor.
Hydrocortisone Cream contains Chlorocresol which may cause allergic reactions.
4.5 Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6 Pregnancy and lactation
This product should not be used without medical advice.
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 intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area.
4.7 Effects on Ability to Drive and Use Machines
None known.
4.8
Undesirable effects
Striae may occur especially in intertriginous areas.
Treatment with hydrocortisone is usually well tolerated but treatment should be stopped if symptoms of hypersensitivity occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No special procedures or antidote are likely to be needed.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hydrocortisone is a mild, topical corticosteroid. Hydrocortisone is an antiinflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of Hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its anti-inflammatory activity.
5.2 Pharmacokinetic properties
a) General characteristics: and b) Characteristics in patients:
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 to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk
Metabolism: Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.
Elimination: Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.
5.3 Preclinical safety data
Adverse effects of Hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic side effects.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
White Soft Paraffin BP Cetomacrogol Emulsifying Wax BP Liquid Paraffin BP Chlorocresol BP Purified Water BP
6.2 Incompatibilities
None known.
6.3 Shelf-Life
Three years.
6.4 Special Precautions for Storage
Store at a temperature not exceeding 25°C, do not freeze.
6.5 Nature and Content of Container
Internally-lacquered aluminium tube fitted with a polythene cap. Pack Size: 15g Pack Size: 10g
6.6 Instructions for Use, Handling and Disposal
Wash hands before and after applying hydrocortisone but if applying to the hands do not wash after application.
7. MARKETING AUTHORISATION HOLDER
TEVA UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
8. MARKETING AUTHORISATION NUMBER
PL 00289/0759
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/01/2006
10 DATE OF REVISION OF THE TEXT
03/07/2015