Summary of Product Characteristics (SmPC) - Diprobase ointment
1 NAME OF THE MEDICINAL PRODUCT
Diprobase Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
No pharmacologically active components.
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Diprobase Ointment is an emollient, moisturising and protective ointment for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Ointment is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.
4.2 Posology and method of administration
Adults and Children:
The ointment should be thinly applied to cover the affected area completely, massaging gently and thoroughly into the skin. Frequency of application should be established by the physician. Generally, Diprobase Ointment can be used as often as required.
4.3 Contraindications
Hypersensitivity to any of the components of the ointment is a contraindication to its use.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, pregnancy and lactation
None stated.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.
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
None stated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Diprobase Ointment contains no active ingredients and has no pharmacological action. The ingredients have an emollient action on dry or chapped skin.
5.2 Pharmacokinetic properties
Not applicable due to topical administration and direct action on the skin.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White soft paraffin and liquid paraffin
6.2 Incompatibilities
None known
6.3 Shelf life
60 months (tube presentations)
36 months (500gm plastic jar with screw cap)
6.4 Special precautions for storage
Store below 25ºC
6.5 Nature and contents of container
5, 50 and 100gm: Epoxy lined aluminium tubes with plastic caps.
500gm: White polypropylene jar closed with a white tamper-evident low density polyethylene screw cap.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Bayer plc
400 South Oak Way
Reading
RG2 6AD
8 MARKETING AUTHORISATION NUMBER(S)
PL 00010/0659
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/01/1986
10 DATE OF REVISION OF THE TEXT
11/09/2019