This information is intended for use by health professionals

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).

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.

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.

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

Pump dispenser 200 g and 500 g 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 and other handling

No special requirements for disposal.

7. Marketing authorisation holder

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

8. Marketing authorisation number(s)

PL 50567/0004

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

07 October 2019