Vagisil Medicated Creme
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vagisil Medicated Creme.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine PhEur 2%w/w
For a full list of excipients see Section 6.1
3. PHARMACEUTICAL FORM Emulsion Cream, in a decorated metal tube.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For symptomatic treatment of peri-anal or vulvae pruritus.
4.2 Posology and method of administration
Vagisil cream is applied topically.
Apply to the affected area. Repeat as needed three or four times daily. Not suitable for children under 12 years of age.
4.3 Contraindications
Known sensitivity to any of the ingredients.
Special warnings and precautions for use
4.4
Not for use on extensive body areas or on the eyes.
If symptoms persist for more than one week, discontinue use and consult your doctor.
Not suitable for children under 12 years of age.
As with all medicines, keep out of reach of children.
As with all medicines, do not use in pregnancy without first consulting a doctor.
4.5 Interactions with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
There are insufficient data on pregnant animals and humans but no problems have occurred in clinical use.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
May rarely cause sensitivity. If this occurs, treatment should be stopped and advice sought.
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 www.yellowcard.mhra. gov .uk
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No preclinical findings of relevance have been reported.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stearic acid
Self-emulsifying Glyceryl Monostearate
Glycerol
Triethanolamine
Zinc oxide
Sulfonated castor oil
Isopropyl alcohol
Chlorothymol
Fragrance
Docusate sodium
Diethylene Glycol Monoethyl Ether
Purified Water.
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
No special precautions.
6.5 Nature and contents of container
20 g and 30 g aluminium tubes with a foil covered nozzle and white high density polyethylene cap.
Not all pack sizes may be marketed.
6.6 Instruction for use, handling and disposal
Vagisil cream is applied topically.
7 MARKETING AUTHORISATION HOLDER
Combe International Ltd,
Cedar Court Guildford Road Leatherhead Surrey
KT22 9RX
MARKETING AUTHORISATION NUMBER
8.
PL 03157/0013.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/11/2005
10 DATE OF REVISION OF THE TEXT
23/02/2015