Lipobase

Lipobase.

Lipobase contains no active ingredient.

Excipient(s) with known effect: cetostearyl alcohol; methyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

Cream.

A white cream for topical administration.

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.

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.

Hypersensitivity to any of the excipients listed in section 6.1.

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).

Lipobase contains paraffin. 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.

No interaction studies have been performed.

Lipobase can be used during pregnancy or if you are breast-feeding.

None stated.

None stated.

None stated.

Pharmacotherapeutic group: Soft paraffin and fat products, ATC code D02AC

The product acts topically as an emollient cream.

Topical administration with no pharmacologically active constituents.

No relevant preclinical safety data has been generated.

Cetostearyl alcohol

Macrogol cetostearyl ether

Light liquid paraffin

White soft paraffin

Methyl parahydroxybenzoate

Sodium citrate, anhydrous

Citric acid, anhydrous

Purified water

None stated.

Aluminium tube 30 g, 50 g, 100 g and 200 g packs: 3 years.

Pump dispenser 200 g and 500 g packs: 2 years.

Do not store above 25°C.

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.

No special requirements for disposal.

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

PL 50567/0004

Date of first authorisation: 19 February 1985

Date of latest renewal: 23 March 2009

07 October 2019