Lipobase
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipobase.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lipobase contains no active ingredient.
Excipient(s) with known effect: cetostearyl alcohol; methyl parahydroxybenzoate. For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A white cream for topical administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Lipobase is indicated in adults and children. For use where it is desired by the physician to reduce gradually the topical dosage of Locoid Lipocream. It may also be used where a continuously alternating application of the active product and the base is required e.g. in prophylactic therapy. Application of the Lipobase is also recommended where it is felt by the physician that the use of a bland emollient base is preferable to the cessation of therapy with the active product. Lipobase may also be used as a diluent for the active product in those cases where dilution is regarded as necessary by the prescriber. Lipobase may also be used other than in conjunction with a topical corticosteroid for its emollient action, and for the treatment of mild skin lesions such as pruritus or dry, scaly skin, where topical corticosteroid is not warranted.
4.2 Posology and method of administration
For adults, children and older people: Lipobase may be used either by replacing an application of the active product or alternating the application of the active product and the base, gradually diminishing the application of the active product until therapy ceases, or by the application of the product for its emollient action.
4.3 Contraindications
Hypersensitivity to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Lipobase can be used during pregnancy or if you are breast-feeding.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
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
None stated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Soft paraffin and fat products, ATC code D02AC The product acts topically as an emollient cream.
5.2 Pharmacokinetic properties
Topical administration with no pharmacologically active constituents.
5.3 Preclinical safety data
No relevant preclinical safety data has been generated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetostearyl alcohol Macrogol cetostearyl ether Light liquid paraffin White soft paraffin Methyl parahydroxybenzoate Sodium citrate, anhydrous Citric acid, anhydrous Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
Aluminium tube 30g, 50g, 100g and 200g packs: 3 years. Pump dispenser 200g and 500g packs: 2 years
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
Collapsible aluminium tube with plastic screw cap containing 30 g, 50 g, 100 g or 200 g; and pump dispenser containing 200 g or 500 g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00166/0125
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 February 1985 Date of latest renewal: 23 March 2009
10 DATE OF REVISION OF THE TEXT
19/03/2015