VAGISIL MEDICATED CREME - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Vagisil Medicated Creme.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3.   PHARMACEUTICAL FORM

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

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

8.   MARKETING AUTHORISATION NUMBER

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

07/11/2005