Cymex Cream
Marketing Authorization Holder: Dexcel®-Pharma Ltd. 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB United Kingdom
General Sales List
D02AX
PL 14017/0309
Summary of Product Characteristics
Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.
Composition
Active and inactive ingredients
| | | | --- | --- | | Urea PhEur | 1.0% w/w | | Cetrimide PhEur | 0.5% w/w | | Dimeticone 350 PhEur | 9.0% w/w | | Chlorocresol PhEur | 0.1% w/w | For a full list of excipients, see section 6.1.
Pharmaceutical Form
Dosage form and administration route
Emollient White Cream
Clinical Particulars
Therapeutic indications and usage
4.1 Therapeutic indications For the application to cold sores and cracked lips.4.2 Posology and method of administration There are no special hazards associated with the use of cetrimide in specific patient groups. No special precautions or modified dosage requirements are, therefore, indicated for its use in infants, the elderly or during pregnancy or lactation. No hazardous drug interactions are considered likely. Adults, elderly and children: apply sparingly every hour for the relief of cold sores and cracked lips. Topical application.4.3 Contraindications Hypersensitivity to urea, cetrimide, dimeticone, chlorocresol or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use Cymex Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Keep out of the sight and reach of children. For external use only. If symptoms persist consult your doctor.4.5 Interaction with other medicinal products and other forms of interaction None known.4.6 Pregnancy and lactation Consult a doctor before use if pregnant or breast-feeding.4.7 Effects on ability to drive and use machines Not applicable.4.8 Undesirable effects None. 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/yellowcard4.9 Overdose Features Symptoms are unlikely to arise after ingestion of this product. It is possible that nausea and vomiting or diarrhoea may occur. Management Gut decontamination or other specific management is unlikely to be required. Treat symptomatically. A small glass of milk or water may be helpful.
Pharmacological Properties
Pharmacodynamics and pharmacokinetics
5.1 Pharmacodynamic properties ATC Code DO 2A X Urea has keratolytic properties, Cetrimide is a quaternary ammonium disinfectant, Chlorocresol is a mild disinfectant while Dimeticone 350 acts as a water repellent.5.2 Pharmacokinetic properties Not applicable.5.3 Preclinical safety data No particular remarks.
Pharmaceutical Particulars
Storage and handling information
6.1 List of excipients Deionised Water Liquid paraffin BP Cetosteryl Alcohol BP6.2 Incompatibilities Not applicable.6.3 Shelf life 36 months6.4 Special precautions for storage Store below 25ºC.6.5 Nature and contents of container 5 g White Aluminium tubes with Elongated nozzles and HDPE caps. Internally lacquered.6.6 Special precautions for disposal and other handling See 4.2 Posology and Method of Administration.