Summary of medicine characteristics - BOOTS DERMA CARE HYDROCORTISONE 1% OINTMENT, HYDROCORTISONE OINTMENT, ALMUS HYDROCORTISONE 1% OINTMENT, BOOTS DERMA CARE 1% W/W OINTMENT
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTHydrocortisone Ointment
Boots Derma Care Hydrocortisone 1% Ointment
Almus Hydrocortisone 1% Ointment
Boots Derma Care 1% w/w Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient %w/w
Hydrocortisone Ph Eur 1.0
3. PHARMACEUTICAL FORM
Ointment
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
For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.
Children under 10 years of age: Not recommended except under medical supervision.
For topical application.
4.3 Contraindications
The product should not be used if allergic to any of the ingredients or on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot.
4.4 Special warnings and precautions for use
Medical advice should be sought if the condition does not improve.
Visual impairment:
Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Long term continuous or inappropriate 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 advice is recommended in these cases or other treatment options should be considered.
4.5 Interactions with other medicaments and other forms of interaction
No clinically significant interactions known.
4.6 Fertility, pregnancy and lactation
This product should not be used in pregnancy without medical advice. There is no information about effects during lactation.
4.7 Effects on ability to drive and to use machines
No adverse effects known.
4.8 Undesirable effects
Hydrocortisone Ointment 1% is usually well tolerated but if hypersensitivity occurs discontinue use.
Eye disorders:
Frequency not known: blurred vision (see also section 4.4)
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
No special precautions or antidotes are likely to be needed.
5.1. Pharmacodynamic Properties
Hydrocortisone is a corticosteroid which has antiinflammatory 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, eyelid, face and scalp than from the forearm, knee, elbow, palm and sole.
5.3. Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
White soft paraffin.
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
36 months.
6.4. Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and contents of container
6.6 Special precautions for disposal
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Trading as: BCM
8. MARKETING AUTHORISATION NUMBER(S)
PL 00014/0364.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION14 April 1987 / 17 June 1997