Active ingredients: Benzydamine (Benzydamine hydrochloride), Cetylpyridinium (Cetylpyridinium chloride)
TANTUM VERDE MOUTH 22.5 mg / 15 ml + 7.5 mg / 15 ml mouthwash
Why is Tantum Verde Mouth used? What is it for?
Tantum Verde Bocca contains the active ingredients benzydamine hydrochloride (a non-steroidal anti-inflammatory) and cetylpyridinium chloride (an antiseptic).
Tantum Verde Bocca is used as an antiseptic, anti-inflammatory and pain reliever in irritations of the mouth and gums, in gingivitis and stomatitis. It is also indicated before and after tooth extractions.
Talk to your doctor if you do not feel better or if you feel worse after 5-7 days of treatment.
Contraindications When Tantum Verde Mouth should not be used
Do not take Tantum Verde Bocca if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Tantum Verde Mouth
Talk to your doctor or pharmacist before taking Tantum Verde Bocca.
The use of Tantum Verde Bocca, especially if prolonged, can 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".
For those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Interactions What medications or foods can modify the effect of Tantum Verde Mouth
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription.
Avoid the simultaneous use of other antiseptics.
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 for advice before taking this medicine.
During pregnancy and breastfeeding, Tantum Verde Bocca should only be used under medical supervision.
Driving and using machines
The use of Tantum Verde Bocca, at the recommended doses, does not affect the ability to drive or use machines.
Tantum Verde Bocca contains ethyl alcohol. The use of medicines containing alcohol which can cause positive anti-doping tests for those who play sports (see paragraph "For those who play sports").
Tantum Verde Bocca contains 40 polyoxyethylenated hydrogenated castor oil which may cause localized skin reactions.
NOTES ON HEALTH EDUCATION
Inflammations affecting the gums, as well as the formation of bad odors in the mouth, can sometimes be related to the presence of bacterial plaque. In addition, the gums and mouth can be the site of redness and pain caused by conservative dental therapies (eg treatment of caries), dental extractions, minor surgical interventions on the teeth.
Some environmental conditions, such as lowering or sudden changes in temperature, raising the level of humidity, etc., can cause inflammation of the upper respiratory tract (mouth, nose), because they favor the attack by germs that can cause infections (germs pathogens). In order not to aggravate symptoms such as burning and pain, it is useful to avoid some further irritating factors such as smoke, dry air, crowded places, etc.
All these situations can be overcome more quickly using a mouthwash that has specific activity against inflammation, against pain and superficial anesthetics and at the same time has a good efficacy against bacterial infections.
Dose, Method and Time of Administration How to use Tantum verde Mouth: Dosage
Always take 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 15ml, 2-3 times a day.
Pour into the special measuring cup Tantum Verde Bocca up to the 15 ml mark.
Rinse 2-3 times a day.
Warning: do not exceed the indicated doses without the advice of your doctor.
Tantum Verde Bocca can be used, if necessary, at any time of the day.
Use Tantum Verde Bocca for a maximum period of 5-7 days. For a longer use consult your doctor. Contact your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
If you forget to take Tantum Verde Bocca
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tantum Verde Bocca
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 an overdose of Tantum Verde Mouth
In case you accidentally swallow / take an overdose of Tantum Verde Bocca, notify your doctor immediately or go to the nearest hospital.
With the local use of benzydamine hydrochloride and cetylpyridinium chloride overdose has never occurred.
In the case of the passage of locally administered benzydamine into the blood (systemic absorption), the toxic manifestations of overdose consist of: excitement, convulsions, sweating, ataxia (progressive loss of muscle coordination), tremors and vomiting.
If you ingest large quantities of cetylpyridinium chloride (more than ten packs of product) you may experience symptoms such as: nausea, vomiting, dyspnoea (labored breathing), cyanosis (insufficient amount of oxygen in the blood), asphyxia (suffocation), decreased activity central nervous system, hypotension (low blood pressure) and coma (loss of consciousness and alertness).
Side Effects What are the side effects of Tantum Verde Mouth
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may be observed while taking Tantum Verde Bocca, the frequency of which is not known:
- slight numbness in the mouth. This effect is typically associated with the local anesthetic activity of benzydamine
- phenomena of drug intolerance that manifest themselves with slight and transient burning or local irritation. These effects are associated with cetylpyridinium activity and do not require treatment changes.
Compliance with the instructions contained in this leaflet reduces the risk of side effects.
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.
Store in the original package to protect from light and moisture.
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.
The shelf life of the medicine after first opening the bottle is 1 year.
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 Tantum Verde Bocca contains
The active ingredients are: benzydamine hydrochloride (100 ml of mouthwash contain 0.15 g of benzydamine hydrochloride equal to 0.134 g of benzydamine) and cetylpyridinium chloride (100 ml of mouthwash contain 0.05 g of cetylpyridinium chloride equal to 0.0425 g of cetylpyridinium).
The other ingredients are: glycerol, ethanol (96%) (see section "Tantum Verde Bocca contains ethyl alcohol"), saccharin, hydrogenated castor oil 40, polyoxyethylene, sodium bicarbonate, mint flavor, quinoline yellow (E 104), patent blue V (E 131), purified water.
Description of the appearance of Tantum Verde Mouth and contents of the package
Tantum Verde Bocca is presented as a mouthwash in a 120 or 240 ml bottle with a measuring cup.
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 -
TANTUM OROSAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Mouthwash: 100 ml contain:
Benzydamine hydrochloride g 0.15 (equal to benzydamine g 0.134)
Cetylpyridinium chloride g 0.05 (equal to cetylpyridinium g 0.0425)
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM -
Mouthwash
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Antiseptic, anti-inflammatory and analgesic treatment for irritations of the mouth, gums and throat; in gingivitis, stomatitis and pharyngitis.
Also indicated before and after tooth extractions.
04.2 Posology and method of administration -
Rinse with 15 ml of mouthwash, 2-3 times a day, using the special measuring cup.
The product can be used, if necessary, at any time of the day.
Use for a maximum period of 5-7 days. For a longer use consult a doctor.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients.
04.4 Special warnings and appropriate precautions for use -
The use, especially if prolonged of topical preparations, could give rise to sensitization phenomena. In this case, stop the treatment and consult the doctor to institute suitable therapy.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
No interactions of benzydamine and cetylpyridinium with other commonly used drugs have been observed. However, the simultaneous use of other antiseptics should be avoided.
04.6 Pregnancy and breastfeeding -
There are no contraindications to the topical use of benzydamine and cetylpyridinium during pregnancy or while breastfeeding.
04.7 Effects on ability to drive and use machines -
The topical use of benzydamine and cetylpyridinium, at the recommended doses, does not alter the driving ability or the use of other machinery.
04.8 Undesirable effects -
No undesirable effects have been highlighted following the use of topical benzydamine, other than a slight sense of numbness in the mouth, typically associated with its local anesthetic activity.
With cetylpyridinium it is possible to observe, in some cases, intolerance phenomena that manifest themselves with slight and transient burning or local irritation that do not require changes to the treatment
04.9 Overdose -
With the topical use of benzydamine and cetylpyridinium, overdosing phenomena have never occurred.
Toxic manifestations of systemic benzydamine overdose consist of excitation, convulsions, sweating, ataxia, tremors and vomiting. Since there is no specific antidote, the treatment of acute benzydamine intoxication is purely symptomatic.
Symptoms resulting from the ingestion of significant quantities of quaternary ammonium compounds include nausea, vomiting, dyspnoea, cyanosis, asphyxia, CNS depression, hypotension and coma. However, such toxic doses of cetylpyridinium chlorine cannot be achieved even with the intake of a number more than 10 product packs. Treatment of cetylpyridinium overdose is symptomatic.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Benzydamine chloride is a non-steroidal chemical structure molecule with anti-inflammatory and analgesic properties. In topical use it also manifests disinfectant properties and surface anesthetic action. The mechanism of action seems to be attributable to the inhibition of prostaglandin synthesis. The activity of benzydamine in topical use is due to the ability to penetrate through the epithelia coating and to reach effective concentrations in inflamed tissues Benzydamine is mainly used for the treatment of diseases of the oropharyngeal cavity.
Cetylpyridinium is a cationic disinfectant from the group of quaternary ammonium salts; it is active against gram positive bacteria and less active against gram negative and therefore has an excellent antiseptic and bactericidal activity. Cetylpyridinium chloride also has antifungal properties. Due to its disinfectant activity and the absence of toxic effects, at therapeutic concentrations, the compound is widely used in self-medication specialties.
The antiseptic efficacy of the benzydamine + cetylpyridinium combination has been confirmed in some in vitro tests on bacteria and fungi.
05.2 "Pharmacokinetic properties -
Of the two active ingredients, cetylpyridinium and benzydamine, only benzydamine is absorbed. Therefore, cetylpyridinium does not give rise, on a systemic level, to pharmacokinetic interactions with benzydamine.
Absorption of benzydamine through the oropharyngeal mucosa is demonstrated by measurable quantities of benzydamine in human serum, however insufficient to produce systemic effects.
The drug is excreted in the urine, mainly in the form of inactive metabolites and conjugation products.
05.3 Preclinical safety data -
Benzydamine has a very poor toxicity however linked to pharmacodynamic effects without corresponding histo-pathological alterations.
The margin between LD50 and single oral therapeutic dose is 1000: 1.
Benzydamine does not exert gastrologic effects; the drug has no teratogenic effects and does not interfere with normal embryonic development.
Also for cetylpyridinium, safety studies conducted in animals indicate good tolerability even after systemic administration. Mild irritation was found after topical ocular applications, but at concentrations higher than those used for mouthwash.
The use of cetylpyridinium as a mouthwash does not alter the composition of the normal oral flora.
The benzydamine + cetylpyridinium association, TANTUM OROSAN mouthwash, was well tolerated in healthy volunteers as it did not cause local and systemic toxic effects.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Glycerol; 96 percent ethanol; Saccharin; 40 polyoxyethylene hydrogenated castor oil; Sodium bicarbonate; Mint flavor; Quinoline yellow dye (E 104); Patent V Blue Dye (E 131); Purified water.
06.2 Incompatibility "-
The benzydamine solution does not show incompatibility with other drugs or substances of relevant use.
06.3 Period of validity "-
Expiry of the unopened package correctly stored: 3 years
The validity of the product after the first opening of the bottle is 1 year.
06.4 Special precautions for storage -
Store in the original container and outer carton.
Sensitive to light and humidity
06.5 Nature of the immediate packaging and contents of the package -
Colorless glass bottles of 120 and 240 ml, closed with a polypropylene screw cap with polyethylene undercap with attached dosing cup
06.6 Instructions for use and handling -
Pour 15 ml of TANTUM OROSAN mouthwash into the measuring cup.
Unused product and waste derived from this medicine must be disposed of in accordance with local legal requirements
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 -
TANTUM OROSAN 22.5mg / 15ml + 7.5mg / 15ml mouthwash, 120 ml bottle A.I.C. n ° 035355027
TANTUM OROSAN 22.5mg / 15ml + 7.5mg / 15ml mouthwash, 240ml bottle A.I.C. n ° 035355015
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
07/10/2004
10.0 DATE OF REVISION OF THE TEXT -
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