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SPC, UK: MOMETASONE FUROATE Cream (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mometasone Furoate 1mg/g Cream.

Qualitative and quantitative composition

1 g of cream contains 1 mg of mometasone furoate (0.1% w/w mometasone furoate). Excipients with known effect: 70 mg propylene glycol monopalmitostearate per gram of cream (7.0% w/w). 41.1 mg–44.7 mg stearyl ...

Pharmaceutical form

Cream. White or almost white cream with no visible particles or phase separation.

Therapeutic indications

Mometasone Furoate 1mg/g Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis. This medicinal product ...

Posology and method of administration

Posology Adults, including elderly patients, adolescents and children aged 6 years and over A thin film of Mometasone Furoate 1mg/g Cream should be applied to the affected areas of skin once daily. One ...

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to other corticosteroids. Mometasone Furoate 1mg/g Cream is contraindicated in facial rosacea, acne vulgaris, ...

Special warnings and precautions for use

If irritation or sensitisation develop with the use of Mometasone Furoate 1mg/g Cream, treatment should be withdrawn and appropriate therapy instituted. Should an infection develop, use of an appropriate ...

Interaction with other medicinal products and other forms of interaction

None stated.

Pregnancy and lactation

Pregnancy During pregnancy and lactation treatment with Mometasone Furoate should be performed only on the physicians order. Then however, the application on large body surface areas or over a prolonged ...

Effects on ability to drive and use machines

None stated.

Undesirable effects

Table 1. Treatment-related adverse reactions reported with Mometasone Furoate by body system and frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); ...

Overdose

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible. If HPA axis suppression ...

Pharmacodynamic properties

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 ...

Pharmacokinetic properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 1mg/g is minimal, approximately 0.4% of the applied dose in man, the majority of ...

Preclinical safety data

There are no findings of relevance to the prescriber other than those mentioned elsewhere in the SPC.

List of excipients

Hexylene glycol Stearyl alcohol & macrogol cetostearyl ether White beeswax Propylene glycol monopalmitostearate Titanium dioxide (E171) Aluminium starch octenylsuccinate Dilute phosphoric acid White soft ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years. In-use shelf life: 3 months.

Special precautions for storage

Store below 30°C.

Nature and contents of container

Collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a polypropylene cap. Pack sizes: 30g, 60g or 100g. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Auden Mckenzie (Pharma Division) Ltd, McKenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

Marketing authorization number(s)

PL 17507/0111

Date of first authorization / renewal of the authorization

Date of first authorisation: 20<sup>th</sup> June 2012 Date of latest renewal: 25<sup>th</sup> May 2017

Date of revision of the text

01/08/2019

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