Vagisil Medicated Creme
SUMMARY 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 pruritus vulvae.
Vagisil Medicated Creme is indicated in adults and children aged over 12 years
4.2 Posology and method of administration
Posology
Apply to the affected area. Repeat as needed three or four times daily. Paediatric Population
Not suitable for children under 12 years of age Method of Administration
Vagisil Medicated Creme is applied topically
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy:
The safety of this medicinal product for use in human pregnancy has not been established. The product is, therefore, not recommended during pregnancy, unless considered essential by the physician.
Lactation:
Lidocaine enters the mother's milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.
4.7 Effects on ability to drive and use machines
Vagisil Medicated Creme has no influence on the ability to drive and use machines.
4.8 Undesirable effects
May cause sensitivity. If this occurs, treatment should be stopped and advice sought.
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: >1/10
Common: >1/100 to <1/10
Uncommon: >1/1,000 to <1/100
Rare: >1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
|
System Organ Class |
Undesirable Effect |
Frequency |
|
Immune system disorders or skin and subcutaneous tissue disorders |
Sensitivity |
Not 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 www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdose with Vagisil Medicated Creme is unlikely, but signs of systemic toxicity would be consistent with those of lidocaine and may include blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain or irregular heartbeat.
Accidental ingestion may result in anaesthesia of the upper respiratory tract, nausea, vomiting and abdominal discomfort. Ingestion of very large quantities could result in CNS and cardiovascular toxicity. Treatment should be symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Local anaesthetic ATC code: D04AB
Lidocaine has a local anaesthetic action, relieving pain and discomfort in the affected areas. Local anaesthetics inhibit conduction of nerve impulses from sensory nerves. The action results from an alteration of cell membrane permeability to ions. Lidocaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses which can result in local anaesthesia.
5.2 Pharmacokinetic properties
2% Lidocaine is the active ingredient of the Vagisil Creme formulation. It is readily absorbed from mucous membranes and through damaged skin. The rate and extent of lidocaine absorption depends upon the specific site of application, duration of exposure and mode of application. Absorption through intact skin is considered poor.
5.3 Preclinical safety data
A literature search on non-clinical data reveal no special hazard for humans based on conventional studies of safety and toxicity. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine. The mutagenic potential of lidocaine has been determined in the in vitro Ames Bacterial Reverse Mutation Assay, the in vitro chromosome aberration assay using Syrian hamster ovary cells, and the in vivo rat micronucleus assay. Lidocaine was negative in all three assays.
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
8. MARKETING AUTHORISATION NUMBER
PL 03157/0013.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/11/2005
10 DATE OF REVISION OF THE TEXT
22/12/2015