BETACAP SCALP APPLICATION - summary of medicine characteristics

Betacap Scalp Application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone (as valerate) 0.1% w/w

For excipients see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous solution.

Transparent, slightly gelled, emollient, scalp application.

4.

4.1 Therapeutic indications

For the topical treatment of dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis, which are unresponsive to less potent corticosteroids.

4.2 Posology and method of administration

For adults, including the elderly, and children over the age of one year, Betacap Scalp Application should be applied sparingly to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.

For the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 5 to 7 days.

4.3 Contraindications

Not to be used where there is bacterial, fungal or viral infection of the scalp.

Not to be used in cases of sensitivity to any of the ingredients.

Not to be used in children under the age of one year.

4.4 Special warnings and precautions for use

Keep away from the eyes.

Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally.

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Complications sometimes associated with the use of topical corticosteroids in psoriasis include the possibility of rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is important.

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.

Visual disturbance

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.

For external use only.

4.5 Interactions with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism and suppression of the HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.

Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

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 Google Play or Apple App Store.

4.9 Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation treatment with Betacap Scalp Application should be discontinued.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code

D07AC – Corticosteroids, potent (group III)

Betamethasone (as valerate) is a well-established example of a corticosteroid which is used in dermatological therapy in pharmacological doses for its anti-inflammatory and immuno-suppressive glucocorticoid properties. It suppresses the clinical manifestations of a wide range of inflammatory dermatoses and is frequently used at the concentration of 0.1% (as valerate). Betacap Scalp Application complies with the specification given in the monograph for Betamethasone Valerate Scalp Application BP. Betacap Scalp Application includes a coconut-oil related emollient ingredient to reduce the drying effect that a standard alcoholic vehicle may otherwise have on the scalp. The vehicle also contains isopropyl alcohol, which has antiseptic activity.

5.2 Pharmacokinetic properties

For clinical usage, the betamethasone valerate is presented as a slightly thickened evaporative solution which allows drug availability over the affected area, whilst reducing the propensity to spread onto uninvolved skin. In addition, after rapidly drying, the drug substance is thus deposited uniformly in a micronised crystalline form for efficient absorption into the skin. The lipid characteristics of the drug substance ensure that these micro-fine crystals rapidly dissolve in skin lipids to enhance molecular diffusion through the outer epidermal tissue and to encourage permeation into the deeper layers where it reverses the pathological processes responsible for the inflammation.

5.3 Preclinical safety data

6.  PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 7 Glycerol Cocoate (a water dispersible derivative of coconut oil)

Isopropyl Alcohol

Carbomer

Sodium Hydroxide

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from light. Return bottle to carton between use.

6.5 Nature and contents of container

30 ml and 100 ml polyethylene squeeze bottle with integral nozzle/applicator for convenient direct application to the scalp through the hair, and tamper-evident replaceable cap.

6.6 Instructions for use/handling

Not applicable.

Diomed Developments Limited T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

8. MARKETING AUTHORISATION NUMBER

PL 0173/0149

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE

AUTHORISATION

22 June 2004