Vagisil - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Lidocaine

VAGISIL 2% Cream

Why is Vagisil used? What is it for?

VAGISIL cream is an anesthetic for local use with anti-itching activity.

Contraindications When Vagisil should not be used

In cases of hypersensitivity to the components of the product or other closely related substances from a chemical point of view.

In pediatric age.

During pregnancy and breastfeeding.

Precautions for use What you need to know before taking Vagisil

The efficacy and safety of lidocaine depend on a correct dosage. Therefore it is necessary to use the quantity of product sufficient to obtain the desired effect.

Pay attention in the elderly and in seriously ill patients.

Interactions Which drugs or foods may change the effect of Vagisil

Propanolol prolongs the plasma half-life of lidocaine.

Cimetidine can raise the plasma levels of lidocaine.

Warnings It is important to know that:

After a short period of treatment with no appreciable results or in case of suspected fungal infection, consult your doctor. Patients allergic to anesthetics derived from para-aminobenzoic acid (procaine, tetracaine, benzocaine, etc.) show cross-reactivity towards lidocaine. In elderly and seriously ill patients use only in case of absolute necessity and under direct medical supervision.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena, in which case it is necessary to interrupt the treatment and, if necessary, to institute a suitable therapy.

The cream should not be applied near the eyes.

Do not use in case of lesions of the mucous membranes, a condition in which it is necessary to consult a doctor.

Dose, Method and Time of Administration How to use Vagisil: Posology

Apply a thin layer of VAGISIL cream on the area to be treated: the application can be repeated up to 3 or 4 times a day, if necessary.

Warning: do not exceed the indicated doses without medical advice.

Warning: use only for short periods of treatment.

Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.

Overdose What to do if you have taken too much Vagisil

The correct use of VAGISIL cream does not pose any particular problems: in case of application of an excessive dose it is sufficient to eliminate the excess of product.

In case of accidental ingestion of VAGISIL, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Vagisil

Only extremely improper use of the product can give undesirable systemic effects. The occurrence, albeit in rare cases, of allergic reactions is possible.

Compliance with the instructions contained in the package leaflet reduces the risk of side effects which are generally transient. However, when they occur, it is advisable to consult your doctor or pharmacist.

It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet

Expiry and Retention

Warning: do not use the medicine after the expiry date indicated on the package.

Keep this medicine out of the reach and sight of children.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

COMPOSITION

100 g of cream contain

Lidocaine base 2.0 g

Excipients

Purified water, Stearic acid, Glycerin, Glycerin monostearate, Castor oil sulfonate, Triethanolamine, Diethylene glycol and monoethylether, Isopropyl alcohol, Rose scent, Chlorothymol, Zinc oxide, Sodium dioctyl sulfosuccinate.

HOW VAGISIL PRESENTS ITSELF

it comes in the form of a cream. The contents of the package are a 20 g tube of cream for cutaneous use.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Vagisil can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VAGISIL 2% CREAM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g of cream

Active principles:

Lidocaine base 2.0 g

03.0 PHARMACEUTICAL FORM

Cream for skin use.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Vulvar and perianal itching.

04.2 Posology and method of administration

The use of the product is intended for adult patients.

Apply VAGISIL cream in a thin layer on the area to be treated: the application can be repeated up to 3 or 4 times a day, if necessary.

Use only for short periods of treatment

04.3 Contraindications

Hypersensitivity to lidocaine, or to other components of the product and closely related substances from a chemical point of view.

Pediatric age.

Pregnancy and breastfeeding.

04.4 Special warnings and appropriate precautions for use

As with any local anesthetic, any reactions and complications are more easily avoided by using the lowest effective dosages.

Pay attention in the elderly and in seriously ill patients.

Do not use in case of mucosal lesions condition in which it is necessary to consult a doctor.

The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena, in which case it is necessary to interrupt the treatment and, if necessary, to institute suitable therapy.

After a short period of treatment, with no appreciable results or in case of suspected fungal infection, consult your doctor.

04.5 Interactions with other medicinal products and other forms of interaction

Propanol prolongs the plasma half-life of lidocaine. Cimetidine may increase the plasma levels of lidocaine.

04.6 Pregnancy and breastfeeding

Preclinical studies conducted on rats and rabbits did not highlight any risks for the fetus. However, since no clinical data are available in pregnant women, the use of the product is to be considered contraindicated in this situation.

04.7 Effects on ability to drive and use machines

Nobody.

04.8 Undesirable effects

Only extremely improper use of the product can give undesirable systemic effects.

The appearance of allergic reactions is possible, albeit in rare cases.

Patients allergic to anesthetics derived from paraminobenzoic acid (procaine, tetracaine, benzocaine, etc.) show cross-reactivity towards lidocaine.

04.9 Overdose

Symptoms of overdose are characterized by neuroexcitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and by cardiovascular changes with hypotension and bradycardia.

Treatment is symptomatic. Seizures can be controlled by administering short-acting barbiturates or benzodiazepines.

The side effects reported above and the symptoms of overdose attributable to lidocaine, have never occurred with the correct use of VAGISIL, respecting therapeutic indications and posology.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

VAGISIL contains lidocaine, a local surface anesthetic: this action is obtained by blocking the sensitive nerve endings of the skin and mucous membranes.

05.2 Pharmacokinetic properties

Lidocaine can be absorbed through the mucosa.

Lidocaine is metabolised in the liver to form various metabolites, including monoethylglycinxylidide and glycinxylidide, which are eliminated by the kidney.

The apparent volume of distribution is about 1.3 l / kg, the plasma protein binding is 40/80%, the plasma half-life is about 100 min.

05.3 Preclinical safety data

Acute toxicity:

LD 50 in the mouse: s.c. 278 mg / kg i.v. 27 mg / kg

LD 50 in the rat: s.c. 469 mg / kg i.p. 167 mg / kg

Epicutaneous treatment with 10% ointment for 6 days a week for 4 weeks did not cause any systemic toxic effect or histological alterations of the skin.

Prolonged use may cause sensitization.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Purified water, Stearic acid, Glycerin, Glycerin monostearate, Castor oil sulfonate, Triethanolamine, Diethylene glycol and monoethylether, Isopropyl alcohol, Rose scent, Chlorothymol, Zinc oxide, Sodium dioctyl sulfosuccinate.

06.2 Incompatibility

Lidocaine hydrochloride causes the precipitation of amphotericin.

In solution, lidocaine hydrochloride (2 g / l) forms a precipitate when mixed with sodium methohexitone (2 g / l) and a crystalline precipitate with sodium sulfadiazine (4 g / l).

06.3 Period of validity

60 months in intact packaging.

06.4 Special precautions for storage

No special precautions.

06.5 Nature of the immediate packaging and contents of the package

Aluminum tube internally coated with epoxy resin. High density polyethylene cap.

20 g tube

06.6 Instructions for use and handling

None in particular

07.0 MARKETING AUTHORIZATION HOLDER

Combe International Ltd - Ground Floor Cedar Court, Guilford Road, Leatherhead

Surrey KT22 9RX - UK

Importer and distributor:

COMBE Italia Srl - Via Procaccini n ° 41 - 20154 MILAN

08.0 MARKETING AUTHORIZATION NUMBER

VAGISIL 2% Cream - tube g. 20 AIC 028700033

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Vagisil Cream 20 g tube - 00.2009

10.0 DATE OF REVISION OF THE TEXT

11.2012

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

none:  antinutrients food-additives cereals-and-derivatives