- Approval Id
- c7b86b51b6440c11
- Drug Approval Emc Name
- Cymex Cream
- Drug Name
- Cymex Cream
- Company Name
- Dexcel Pharma Ltd
- Company Address
- 7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
- Company Website
- http://www.dexcelpharma.com
- Company Telephone
- +44 (0)1327 312 266
- Company Medical Info Direct Line
- +44 (0) 1748 828 784
- Company Medical Info Email
- Dexcel@EU.ProPharmaGroup.com
- Atc Code
- D02AX
- Legal Category
- General Sales List
- Authorisation Holder
- Dexcel®-Pharma Ltd.
7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire NN11 8PB
United Kingdom
- Authorisation Number
- PL 14017/0309
- Authorisation Date
- 13th December 2007
- Instruction Authorisation Holder
- Dexcel®-Pharma Ltd.
7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire NN11 8PB
United Kingdom
- Instruction Authorisation Number
- PL 14017/0309
- Instruction Authorisation Date
- 13th December 2007
- Instruction Composition
- | | |
| --- | --- |
| 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.
- Instruction Dosage Form
- Emollient White Cream
- Instruction Clinical Particulars
- 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.
- Instruction Pharmacology
- 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.
- Instruction Pharmaceutical Particulars
- 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.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| 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
Emollient White Cream
## Clinical Particulars
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
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
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.
