Metaz Lotion is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis and
seborrhoeic dermatitis of the scalp.

Adults, including elderly patients and Children : A few drops of Metaz Lotion should be applied to affected scalp
sites, once daily; massage gently and thoroughly until the medication disappears.
Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic
regimen and duration of treatment should be no more than 5 days.

Metaz Lotion is contraindicated in skin atrophy, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum) parasitical and fungal (e.g. candida or dermatophyte) infections of the scalp. Metaz should not be used on wounds or on skin which is ulcerated. Metaz Lotion should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the excipients listed in section 6.1.

If irritation or sensitisation develop with the use of Metaz, treatment should be withdrawn and appropriate therapy
instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable
response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitary-adrenal (HPA) axis
suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of
Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of
topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under
occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may
also occur with topical corticosteroids, especially in infants and children.
Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to
body mass ratios. As the safety and efficacy of Metaz in paediatric patients below 2 years of age have not been
established, its use in this age group is not recommended.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin. If used in
childhood, occlusion should not be used and courses should be limited to 5 days. Long term continuous therapy should
be avoided in all patients irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following
development of tolerance, risk of centralised 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. As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment
with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with
intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue
treatment on an intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and
can also delay the healing.
Metaz Lotion contains propylene glycol which may cause skin irritation.
Care must be taken to keep the preparation away from the eyes. Metaz topical preparations are not for ophthalmic use,
including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular)
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 of visual disturbances 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.
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.

None known.

Pregnancy
During pregnancy treatment with Metaz should be performed only on the physician's order. Then however, the
application on large body surface areas or over a prolonged period should be avoided. 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 are no adequate and well-controlled studies with Metaz in pregnant women and therefore the risk of such effects
to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth
may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a
very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Metaz should be used in
pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in breast milk. Metaz should be administered to nursing mothers only after careful consideration of
the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast-feeding should be
discontinued.

None known.

Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: skin dryness, irritation,
dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitaryadrenal
axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body
weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.
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:

To report any side effect(s): National Pharmacovigilance Center (NPC) o SFDA Call Center: 19999. o E-mail: npc.drug@sfda.gov.sa o Website: https://ade.sfda.gov.sa/

 

Excessive prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in
secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is
indicated.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of
application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral
ingestion.

Pharmacotherapeutic group: Mometasone, ATC code: D07AC13
Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal
predictive models.
In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and
about 8 times as potent after five applications.
In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced
epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate
0.1% ointment is minimal, approximately 0.7% of the applied dose in man, the majority of which is excreted within 72
hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in
plasma and excreta. Minimal absorption would be anticipated with the lotion formulation.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.

Labrasol;Hexylene Glycol; Hydroxypropyl cellulose; Methyl Paraben; Propyl Paraben; Propylene Glycol, Hydrochloric acid and purified water.

None known.

36 months

Do not store above 30°C.

Discard bottle after one month of opening

30ml white LDPE bottles with LDPE dropper and white Polypropylene cap.

Not applicable