MILDISON LIPOCREAM CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Mildison Lipocream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Mildison Lipocream contains 1% w/w hydrocortisone.

Excipient(s) with known effect:

Cetostearyl alcohol (6 % w/w)

Benzyl Alcohol (0.75 % w/w)

Propyl parahydroxybenzoate (E216) (0.05 % w/w)

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cream.

The product is a white or practically white smooth cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Mildison Lipocream is indicated in adults, children and infants. It is indicated in eczema and dermatitis of all types including atopic eczema, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.

4.2 Posology and method of administration

For cutaneous use.

Posology

Adults, children and older people:

Apply a small quantity only sufficient to cover the affected area two or three times a day. Due to the formulation of the base the product may be used both for dry scaly lesions and for moist or weeping lesions.

Children and infants: Long term treatment should be avoided. Courses should be limited to seven days where possible.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.

4.4 Special warnings and precautions for use

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

This medicine also contains 7.5 mg of benzyl alcohol in each gram which is equivalent to 0.75% w/w.

Benzyl alcohol may cause allergic reactions and mild local irritation.

Keep away from the eyes.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.

Mildison Lipocream 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.

Infants

Although generally regarded as safe even for long term administration in adults there is a potential for overdosage in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients courses of treatment should not normally exceed seven days.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, Pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of hydrocortisone in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3).

Breast-feeding

Hydrocortisone/me­tabolites are excreted in human milk, but at therapeutic doses of Mildison no effects on the breast-fed newborns/infants are anticipated.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Local atrophic changes may occur, particularly in skin folds, intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Systemic absorption from such sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated. Napkins may act as occlusive dressings.

Not known (cannot be estimated from the available data)

Eye disorders: Vision, blurred (see also section 4.4).

Skin and subcutaneous tissue disorders (Not known (cannot be estimated from the available data): Skin atrophy, often irreversible, with thinning of the epidermis, telangiectasia, purpura and skin striae. Pustular acne, perioral dermatitis, skin depigmentation, contact dermatitis and rebound effect (withdrawal reactions) -redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4).

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions which can be delayed.

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

Excessive use, especially under occlusive dressings or over a long period of time, may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02

The active ingredient, hydrocortisone, is a well-established corticosteroid with the pharmacological actions of a corticosteroid classified as mildly potent.

5.2 Pharmacokinetic properties

In human in-vivo studies the potency of this formulation has been demonstrated as being of the same order as other widely available formulations of hydrocortisone 1%.

5.3 Preclinical safety data

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. Theoretically, there is the possibility that if maternal systemic absorption occurred the infant’s adrenal function could be affected.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl alcohol

Macrogol Cetostearyl Ether

Light Liquid paraffin

White soft paraffin

Benzyl alcohol

Propyl parahydroxybenzoate (E216)

Sodium citrate anhydrous

Citric acid anhydrous

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25oC

6.5 Nature and contents of container

Collapsible membrane-necked internally coated aluminium tubes with a polyethylene screw cap containing 10 g, 15 g, 30 g, or 100 g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

8 MARKETING AUTHORISATION NUMBER(S)

PL 50567/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

Date of first authorisation: 23 September 1987

Date of latest renewal: 21 December 2004.