Zerolatum Plus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zerolatum Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light liquid paraffin 51.66% w/w.
Benzalkonium chloride solution (50%w/v) 12.0% w/w equivalent to Benzalkonium chloride 6% w/w.
Irgasan PG 60 3.34%w/w equivalent to Triclosan 2.0%w/w For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
ATC Code: DO2A
For the prophylactic treatment of eczemas at risk from infection.
4.2 Posology and method of administration
Topical as a bath additive.
Zerolatum Plus should always be diluted with water. It is an effective cleanser and should not be used with soap.
Adults and children over one year:
In an eight inch bath add 40ml (3 capfuls)
Alternatively, in a four inch bath add 20ml (1 !4 capfuls).
Infants 6 - 12 months: Add 1ml (just sufficient to cover the bottom of the cap) and mix well with water.
Do not use for babies younger than six months.
4.3 Contraindications
Patients with a known hypersensitivity to any of the ingredients should not use the product.
4.4 Special warnings and precautions for use
Avoid contact of the undiluted product with the eyes. If the undiluted product comes into contact with the eye, reddening may occur. Eye irrigation should be performed for 15 minutes and then the eye examined under fluorescein stain. If there is persistent irritation or any uptake of fluorescein, the patient should be referred for ophthalmological opinion.
If this product comes into contact with dressings and clothes, it can be easily ignited with a naked flame. Patients are advised to avoid fire when using Zerolatum Plus.
The product should not be used with soap
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No restrictions on the use of the product in pregnancy and lactation are proposed.
4.7 Effects on ability to drive and use machines
None known.
Undesirable effects
4.8
None known.
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.
4.9 Overdose
The product is intended for topical use only. Accidental ingestion may cause gastrointestinal irritation with vomiting and diarrhoea. Vomiting may result in foam aspiration. In the case of accidental ingestion, give 1 to 2 glasses of milk or water to drink. If a large quantity of the product is ingested, the patient should be observed in hospital and the use of activated charcoal may be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Benzalkonium chloride and triclosan are anti-bacterial agents with proven efficacy against Staphylococcus aureus, the principal causative organism in infected eczemas.
Light liquid paraffin is an emollient widely used in the treatment of eczema.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Crodalan AWS (polysorbate 80, cetyl, stearyl and oleyl acetates and acetylated lanolin alcohol)
Isopropyl palmitate
Oleyl alcohol
Macrogol 4-lauryl ether (Laureth - 4)
Polypropylene glycol [ingredient of Irgasan PG60 (triclosan)]
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months (unopened).
6 months after first opening container.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
500ml White sloping shoulder High Density Polyethylene bottles with a 24mm polypropylene screw cap.
6.6
Special precautions for disposal
There are no special instructions for use or handling of Zerolatum Plus.
7 MARKETING AUTHORISATION HOLDER
Zeroderma Ltd
Linthwaite Laboratories
Linthwaite
Huddersfield
HD75QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 18962/0008.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/05/2007
10 DATE OF REVISION OF THE TEXT
23/12/2014