SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Unguentum M

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

There is no specific active ingredient.

3 PHARMACEUTICAL FORM

Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Unguentum M has emollient properties and is recommended for the symptomatic treatment of dermatitis, nappy rash, ichthyosis, eczema, protection of raw and abraded skin areas, pruritus and related skin conditions where dry scaly skin is a problem, and as a pre-bathing emollient for dry/eczematous skin, to alleviate drying effects.

Unguentum M is to be used as a diluent for various topical corticosteriod formulations in those instances where a lower strength preparation is considered desirable by the physician and as a general base for extemporaneous dispensing.

4.2 Posology and method of administration

A thin application of the cream should be gently massaged into the skin three times daily or at appropriate intervals.

When used as a protective cream Unguentum M should be applied sparingly to the affected areas of the skin before, or immediately after, exposure to a potentially harmful factor.

4.3 Contraindications

Unguentum M should not be used:

-    if hypersensitivity to any of the ingredients is known

-    near the eyes and on mucous membranes

4.4 Special warnings and precautions for use

Sorbic acid and Cetostearyl alcohol may cause local skin reactions, (e.g. contact dermatitis)

Propylene glycol may cause skin reactions.

Ingestion of Unguentum M should be avoided.

Fire Hazard with paraffin-based emollients

Emulsifying ointment or 50% Liquid Paraffin and 50% White Soft Paraffin Ointment in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when these preparations are applied to large areas of the body, and clothing or dressings become soaked with the ointment. Patients should be told to keep away from fire or flames and not to smoke when using these preparations. The risk of fire should be considered when using large quantities of any paraffin-based emollient.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

No evidence of any harmful effect on the use of Unguentum M in pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None.

4.8    Undesirable effects

Rarely (1 in 10 out of 10,000 persons treated) skin irritation such as burning sensations and reddening or allergic contact dermatitis may occur.

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, Website: www.mhra.gov.uk/yellowcard.

4.9    Overdose

None.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Unguentum M is an ambiphilic topical preparation with emollient properties which maintains the high lipid content of an ointment but also has the water miscible characteristics of a cream. The high lipid content reduces water loss from the skin and therefore has a hydrating effect which permits the recovery from dermatitis, eczema, and dry or scaly skin conditions. Unguentum M also contains sorbic acid which has an antibacterial effect.

5.2 Pharmacokinetic properties

Unguentum M is for topical use only and contains no specific active ingredient. There are no pharmacokinetic data for this product.

Preclinical safety data

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water White soft paraffin Cetostearyl alcohol Polysorbate 40 Propylene glycol Glycerol monostearate 40 - 50 Liquid paraffin Medium-chain triglycerides Sorbic acid

Colloidal anhydrous silica Sodium hydroxide

6.2 Incompatibilities

None.

6.3 Shelf life

Aluminium tubes:5 years Plastic containers: 3 years

6.4 Special precautions for storage

None.

6.5    Nature and contents of container

Aluminium tubes. Content: 10g, 15g, 30g, 50g, 60g, 80g and 100g. Plastic jars. Content: 500g.

Plastic pump dispensers. Content: 200ml.

6.6    Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Almirall Hermal GmbH Scholtzstrasse 3 D-21465 Reinbek Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 33016/0014

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/09/2005

09/09/2016