Active ingredients: Benzydamine (Benzydamine hydrochloride)
GINETANTUM 0.1% vaginal solution
Ginetantum package inserts are available for pack sizes:- GINETANTUM 0.1% vaginal solution
- GINETANTUM 500 mg granules for cutaneous solution for external genitalia, GINETANTUM 500 mg / 10 ml concentrate for cutaneous solution for external genitalia
Why is Ginetantum used? What is it for?
Ginetantum contains the active ingredient benzydamine hydrochloride, a non-steroidal anti-inflammatory.
Ginetantum is used for:
- the local treatment of inflammation of the vulva and vagina (eg vulvovaginitis) of any origin and nature, characterized by small vaginal discharge, itching, irritation, burning and pain,
- l "intimate hygiene in the period after childbirth (puerperium).
If you do not see appreciable results after 7 days of treatment, please contact your doctor.
Contraindications When Ginetantum should not be used
Do not take Ginetantum
- if you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to substances similar to benzydamine.
Precautions for use What you need to know before taking Ginetantum
Talk to your doctor or pharmacist before taking Ginetantum.
In case of vaginal bleeding and / or whitish discharge from the vagina (leukorrhea) do not use Ginetantum without first consulting your doctor.
The use of Ginetantum, especially if prolonged, could give rise to sensitization phenomena (allergic reactions). In this case, stop the treatment and consult your doctor to start a suitable therapy (see section 4 "Possible side effects").
Ginetantum should only be used for vaginal douching and should not be swallowed (see section "If you take more Ginetantum than you should").
Interactions Which drugs or foods can modify the effect of Ginetantum
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No negative interactions were observed between Ginetantum and other drugs commonly used in relevant therapy.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Ginetantum can be used in pregnancy or while breastfeeding.
Driving and using machines
The use of Ginetantum does not affect the ability to drive or use machines.
Ginetantum contains belzalkonium chloride which is irritating and can cause local skin reactions.
Dose, Method and Time of Administration How to use Ginetantum: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1-2 vaginal irrigations per day, for seven consecutive days.
Warning: do not exceed the indicated doses without the advice of your doctor.
The solution can be used at room temperature. If you want to warm the solution, expose the closed bottle to a jet of hot water for a few minutes.
- To open the bottle, hold the knurled ring firmly and twist the cap to break the security seal.
- Pull the cannula out until you hear it click, as shown in the figure below. The cannula remains attached to the bottle and therefore only the complete extraction allows the liquid to escape.
- Gently introduce the cannula into the vagina and squeeze the bottle until it is empty. Emptying can be gradual and adjusted as needed, as a special valve prevents the solution from flowing back into the bottle. Irrigate while lying down if possible. The liquid is kept in the vagina for a few minutes.
Do not use Ginetantum for more than 7 days.
Contact your doctor if the disorder persists beyond seven days, occurs repeatedly or if you notice any recent changes in its characteristics.
If you forget to take Ginetantum
Do not use a double dose to make up for a forgotten dose.
If you stop taking Ginetantum
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Ginetantum
Ginetantum should only be used for vaginal douching. No cases of overdose have been reported with the correct use of the medicinal product.
Ginetantum should not be ingested. In case you accidentally swallow a dose of Ginetantum, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Ginetantum
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Skin irritation may be observed occasionally while taking Ginetantum, especially with prolonged use. In this case, contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Ginetantum contains
- the active ingredient is: benzydamine hydrochloride (100 ml of solution contain 100 mg of benzydamine hydrochloride equal to 89.46 mg of benzydamine)
- the other ingredients are: benzalkonium chloride (see paragraph Ginetantum contains benzalkonium chloride), edetate disodium, base rose perfume and purified water.
Description of what Ginetantum looks like and contents of the pack
Ginetantum is presented in the form of a solution for vaginal use, in bottles of 140 ml equipped with a cannula.
Each pack contains 1 or 5 bottles of 140 ml.
Not all pack sizes may be marketed.
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.
01.0 NAME OF THE MEDICINAL PRODUCT -
GINETANTUM 0.1% VAGINAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml contain:
Active ingredient: benzydamine hydrochloride 100 mg (equal to 89.46 mg of benzydamine).
Excipients: contains benzalkonium chloride
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Vaginal solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Vulvovaginitis of any origin and nature, characterized by small vaginal discharge, itching, irritation, burning and vulvar pain. Intimate hygiene during the puerperium.
04.2 Posology and method of administration -
1-2 vaginal irrigations per day for seven consecutive days.
The solution can be used at room temperature. If you want to warm it, just expose the closed bottle to a jet of hot water for a few minutes.
04.3 Contraindications -
Ginetantum must not be used in subjects who have demonstrated hypersensitivity to the active substance or to any of the excipients or to closely related substances from a chemical point of view.
04.4 Special warnings and appropriate precautions for use -
The use, especially if prolonged, of topical products could give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and adopt suitable therapeutic measures.
Ask the patient to contact the doctor before use in case of vaginal bleeding and / or leucorrhoea.
04.5 Interactions with other medicinal products and other forms of interaction -
No negative interactions were observed with other drugs commonly used in the relevant therapy.
04.6 Pregnancy and breastfeeding -
There are no contraindications to the topical use of benzydamine during pregnancy or breastfeeding.
04.7 Effects on ability to drive and use machines -
Ginetantum does not affect the ability to drive or use machines.
04.8 Undesirable effects -
Occasionally, especially with prolonged use of the product, skin irritations may occur.
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Therapeutic drug category: anti-inflammatory preparations for vaginal administration.
ATC code: G02CC03.
Benzydamine is a non-steroidal anti-inflammatory drug with analgesic and anti-exudative properties. In topical use it also manifests surface antiseptic and anesthetic activity.
05.2 "Pharmacokinetic properties -
Spectrofluorimetric investigations have shown that the benzydamine contained in the vaginal solution is fixed to the vaginal epithelium and is concentrated in it to the extent of 9.7 ± 6.24 mcg / g of fresh tissue. The gradual absorption through the mucosa produces very low blood levels. and insufficient to express systemic pharmacological effects. Excretion occurs predominantly in the urine and mostly in the form of inactive metabolites or conjugation products.
05.3 Preclinical safety data -
Benzydamine has a very poor toxicity and is linked more to pharmacodynamic disorders than to anatomo-pathological alterations. The margin between LD50 and single oral therapeutic dose is 1000: 1. Benzydamine does not exert gastrologic or teratogenic effects and does not interfere with normal embryonic development.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Benzalkonium chloride, edetate disodium, basic rose perfume, purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
4 years.
06.4 Special precautions for storage -
This medicinal product does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package -
Carton containing 1 or 5 transparent polyethylene bottles of 140 ml fitted with white polyethylene cannula with semitransparent polypropylene closure cap.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Joint Chemical Companies Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, 70 - 00181 ROME.
08.0 MARKETING AUTHORIZATION NUMBER -
Ginetantum 0.1% vaginal solution, 1 bottle 140 ml: AIC n. 023399037
Ginetantum 0.1% vaginal solution, 5 bottles 140 ml: AIC n. 023399049
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
21.05.1979/01.06.2010
10.0 DATE OF REVISION OF THE TEXT -
September 2012
