- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Adults and older peopleThe same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.
Paediatric populationLong term treatment should be avoided where possible.
InfantsTherapy should be limited if possible to a maximum of seven days.
Method of administrationFor cutaneous use on the scalp.Dosage: To be applied evenly and sparingly no more than twice daily
InfantsAlthough generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy. In such patients courses of treatment should not normally exceed 7 days.Keep away from eyes.
PregnancyThere are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Breast-feedingHydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Scalp Lotion no effects on the breast-fed newborns/infants are anticipated.
Tabulated list of adverse reactions
|System Organ Class||Rare>/10,000,<1/1000||Very rare</10,000||Not known|
|Immune system disorders||Hypersensitivity|
|Endocrine disorders||Adrenal suppression|
|Skin and subcutaneous tissue disorders||Skin atrophy, often irreversible, with thinning of the epidermis Telangiectasia Skin striae Pustular acne Perioral dermatitis Rebound effect Skin depigmentation Dermatitis and eczema, including contact dermatitis|
Reporting of suspected adverse reactionsReporting 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.
Product Information - Locoid Scalp Lotion change of ownership
Please note that following a Change of Ownership, LEO Pharma A/S are now Marketing Authorisation Holder for Locoid Scalp Lotion.
For a period of time you may still receive packs of Locoid Scalp Lotion in Astellas packaging, displaying an Astellas Marketing Authorisation number.
Please contact LEO Laboratories Limited for any queries related to this product.
Tel: +44(0) 1844 347 333
Leo Laboratories Limited
Horizon, Honey Lane, Hurley, Berkshire, SL6 6RJ, UK
+44 (0)1844 347 333