This information is intended for use by health professionals

1. Name of the medicinal product

Unguentum M

2. Qualitative and quantitative composition

There is no specific active ingredient.

Excipients with known effect:

Sorbic acid (E200) – 2 mg/g

Cetosterearyl alcohol – 90 mg/g

Propylene glycol (E1520) – 50 mg/g

Buthylhydroxytoluene (E321) contained in white soft paraffin

For full list of excipients, see section 6.1.

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

Posology

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 listed in section 6.1 is known.

- near the eyes and on mucous membranes.

4.4 Special warnings and precautions for use

Sorbic acid (E200) and Cetostearyl alcohol may cause local skin reactions, (e.g. contact dermatitis)

Propylene glycol (E1520) may cause skin reactions.

White soft paraffin contains buthylhydroxytoluene (E321) and may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

Ingestion of Unguentum M should be avoided.

Fire Hazard with emollients

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.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Fertility, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 phamacokinetic data for this product.

5.3 Preclinical safety data

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6. Pharmaceutical particulars
6.1 List of excipients

Purified water, white soft paraffin (contains buthylhydroxytoluene (E321)), cetostearyl alcohol, polysorbate 40, propylene glycol (E1520), glycerol monostearate 40 – 55, liquid paraffin, medium-chain triglycerides, sorbic acid (E200), colloidal anhydrous silica, sodium hydroxide.

6.2 Incompatibilities

None.

6.3 Shelf life

Aluminium tubes: 5 years

Plastic containers: 3 years

After first opening, use within 6 months.

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 and other handling

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

10. Date of revision of the text

20 August 2019