- Approval Id
- 47d73768b1929e2d
- Drug Approval Emc Name
- Hydrocortisone ointment 1% w/w
- Drug Name
- Hydrocortisone ointment 1% w/w
- Company Name
- Sovereign Medical
- Company Address
- Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR
- Company Telephone
- +44 (0)1268 535 200
- Company Medical Info Direct Line
- +44 (0) 1748 827 299
- Company Medical Info Email
- medinfo@waymade.co.uk
- Company Medical Info Fax
- +44 (0)1268 535 299
- Atc Code
- D07AA02
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Waymade plc t/a Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
- Authorisation Number
- PL 06464/0699
- Authorisation Date
- 11 January 1999
- Instruction Authorisation Holder
- Waymade plc t/a Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
- Instruction Authorisation Number
- PL 06464/0699
- Instruction Authorisation Date
- 11 January 1999
- Instruction Composition
- Hydrocortisone EP 1% w/w
- Instruction Dosage Form
- A smooth, white to off-white ointment
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Hydrocortisone Ointment is indicated for the treatment of eczema and dermatitis of all types, including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.4.2 Posology and method of administration
Adults and children: To be applied sparingly to the affected skin two or three times daily after gently cleansing the area. Courses of treatment in children should generally be limited to not more than seven to ten days.4.3 Contraindications
Hydrocortisone Ointment is contra-indicated in patients with bacterial, viral or fungal infections of the skin. Urticaria, rosacea, ulcers and local infection are also contra-indications.4.4 Special warnings and precautions for use
Prolonged use in infants and children and on the face should be avoided.
Hydrocortisone Ointment is for symptomatic relief and is not curative. For this reason, there is a possibility of rebound of symptoms.
Hydrocortisone Ointment is not recommended for pruritis.
Topical corticosteroids may be hazardous in patients with psoriasis and should therefore be avoided.
Long term use in patients with diabetes or tuberculosis is not recommended.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
The label will state mild steroid.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.4.5 Interaction with other medicinal products and other forms of interaction
No known interactions.4.6 Pregnancy and lactation
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. Thus, there may be a very small risk of such effects in the human foetus.
No problems have been documented for neonates when Hydrocortisone Ointment is used by nursing mothers.4.7 Effects on ability to drive and use machines
No adverse effects known.4.8 Undesirable effects
Side effects are rare but the following local effects have been reported frequently: spread of infection, irreversible striae atrophicae, thinning of the skin, changes in hair growth, acne, oily skin and mild depigmentation.
Serious systemic effects of pituitary suppression and hypercorticism may occur if significant systemic absorption occurs. This is likely if applied frequently or over prolonged periods or over a large areas or over moist and /or denuded areas or if an occlusive dressing is present. Systemic absorption is more likely when used over intertriginous areas. Children are particularly at risk and in these patients, Hydrocortisone Ointment should only be used twice daily for a maximum of ten days over a body surface area not exceeding 10% and without an occlusive dressing.
Vision, blurred (see also section 4.4) (uncommon)
Skin and Subcutaneous Tissue Disorders
Not known (cannot be estimated from available data): Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Following oral ingestion, symptoms may include nausea, vomiting and diarrhoea.
Treatment need only be symptomatic.
No special procedures or antidotes are likely to be needed.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group I), ATC code: D07AA02
Hydrocortisone is a corticosteroid which has anti-inflammatory activity.5.2 Pharmacokinetic properties
Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelids, face and scalp than from the forearm, knee, elbow, palm and sole.5.3 Preclinical safety data
Not applicable.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
White soft paraffin6.2 Incompatibilities
No major incompatibilities known6.3 Shelf life
36 months6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
An internally lacquered, collapsible aluminium tube with an unlined polypropylene screw cap in a cardboard carton. Each tube contains either
15 g, 30 g or 50 g of ointment.6.6 Special precautions for disposal and other handling
None
- Instruction Content
- ## Composition
Hydrocortisone EP 1% w/w
## Pharmaceutical Form
A smooth, white to off-white ointment
## Clinical Particulars
4.1 Therapeutic indications
Hydrocortisone Ointment is indicated for the treatment of eczema and dermatitis of all types, including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.4.2 Posology and method of administration
Adults and children: To be applied sparingly to the affected skin two or three times daily after gently cleansing the area. Courses of treatment in children should generally be limited to not more than seven to ten days.4.3 Contraindications
Hydrocortisone Ointment is contra-indicated in patients with bacterial, viral or fungal infections of the skin. Urticaria, rosacea, ulcers and local infection are also contra-indications.4.4 Special warnings and precautions for use
Prolonged use in infants and children and on the face should be avoided.
Hydrocortisone Ointment is for symptomatic relief and is not curative. For this reason, there is a possibility of rebound of symptoms.
Hydrocortisone Ointment is not recommended for pruritis.
Topical corticosteroids may be hazardous in patients with psoriasis and should therefore be avoided.
Long term use in patients with diabetes or tuberculosis is not recommended.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
The label will state mild steroid.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.4.5 Interaction with other medicinal products and other forms of interaction
No known interactions.4.6 Pregnancy and lactation
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. Thus, there may be a very small risk of such effects in the human foetus.
No problems have been documented for neonates when Hydrocortisone Ointment is used by nursing mothers.4.7 Effects on ability to drive and use machines
No adverse effects known.4.8 Undesirable effects
Side effects are rare but the following local effects have been reported frequently: spread of infection, irreversible striae atrophicae, thinning of the skin, changes in hair growth, acne, oily skin and mild depigmentation.
Serious systemic effects of pituitary suppression and hypercorticism may occur if significant systemic absorption occurs. This is likely if applied frequently or over prolonged periods or over a large areas or over moist and /or denuded areas or if an occlusive dressing is present. Systemic absorption is more likely when used over intertriginous areas. Children are particularly at risk and in these patients, Hydrocortisone Ointment should only be used twice daily for a maximum of ten days over a body surface area not exceeding 10% and without an occlusive dressing.
Vision, blurred (see also section 4.4) (uncommon)
Skin and Subcutaneous Tissue Disorders
Not known (cannot be estimated from available data): Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Following oral ingestion, symptoms may include nausea, vomiting and diarrhoea.
Treatment need only be symptomatic.
No special procedures or antidotes are likely to be needed.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group I), ATC code: D07AA02
Hydrocortisone is a corticosteroid which has anti-inflammatory activity.5.2 Pharmacokinetic properties
Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelids, face and scalp than from the forearm, knee, elbow, palm and sole.5.3 Preclinical safety data
Not applicable.
## Pharmaceutical Particulars
6.1 List of excipients
White soft paraffin6.2 Incompatibilities
No major incompatibilities known6.3 Shelf life
36 months6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
An internally lacquered, collapsible aluminium tube with an unlined polypropylene screw cap in a cardboard carton. Each tube contains either
15 g, 30 g or 50 g of ointment.6.6 Special precautions for disposal and other handling
None
