Summary of Product Characteristics (SmPC) - Symba Skin Toner 2%
1 NAME OF THE MEDICINAL PRODUCT
Symba Skin Toner Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroquinone 2% w/w
3 PHARMACEUTICAL FORM
Topical Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For Topical Administration
For reducing hyperpigmentation of skin, such as persistent freckles and brown marks (lentigines) and irregular pigmentation of negroid skin.
4.2 Posology and method of administration
Adults and Elderly: Apply twice daily after washing, until pigmentation has been reduced (depending on skin type, for 6-16 weeks). Then twice weekly.
Children: Not for use on children, unless under the direction of a physician.
4.3 Contraindications
Known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Not suitable for red marks.
Do not use on broken skin or near eyes.
For external use only.
Keep medicines away from children.
Discontinue if eczema or irritation occurs, or if darkening reoocurs during treatment.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, Pregnancy and lactation
No undesirable effects known during pregnancy or lactation but contact between treated skin and infants is to be avoided.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Irritation and subsequent hypersensitivity have been observed but are rare for creams at less than 5% Hydroquione. Ochronosis and pigmented colloid milium have been reported following extended use of stronger creams in a high sunshine climate(South Africa). Such severe effects are preceded by redarkening of the skin and follow continual administration.
4.9 Overdose
None known as regards topical application. If accidently ingested, treat symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hydroquinone interferes with the production of new melanocytes and hence the bleaching effect on pigmented skin progresses slowly and evenly.
5.2 Pharmacokinetic properties
Effects on pigmented skin are normally observed by 6 weeks from initiation of the hydroquinone treatment. The time varies according to skin type.
5.3 Preclinical safety data
No additional information to that already included elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium lauryl sulphate (Ph. Eur.), propylene glycol (Ph. Eur.), disodium edetate (Ph. Eur), ascorbic acid (Ph. Eur.), sodium metabisulphite (Ph. Eur.), glyceryl monostearate (Ph. Eur.), isopropyl myristate (Ph. Eur.), cetyl esters wax (NF), cetostearyl alcohol (Ph. Eur.), propyl parahydroxybenzoate (Ph. Eur.), potable water.
6.2 Incompatibilities
None
6.3 Shelf life
36 months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Epoxy-resin lined, collapsible, aluminium tubes with polyethylene closure, containing 50g cream.
6.6 Special precautions for disposal
Wash hands after use
7 MARKETING AUTHORISATION HOLDER
Avianta Pharma Limited, Unit H, Ashbourne Drive, Leamington Spa,
England,
CV31 3SS,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 49226/0023
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/06/1984 / 07/02/2001
10 DATE OF REVISION OF THE TEXT
06/11/2025