Active ingredients: Benzydamine (Benzydamine hydrochloride)
TANTUM VERDE 0.15% mouthwash
Tantum Verde package inserts are available for pack sizes:- TANTUM VERDE 0.15% mouthwash
- TANTUM VERDE 0.30% solution for oral mucosa
- TANTUM VERDE 0.15% solution for oral mucosa
Why is Tantum Verde used? What is it for?
Tantum Verde collutorio is a non-steroidal anti-inflammatory drug with analgesic properties, ie a medicine that acts against pain and inflammation of the throat, mouth and gums. Tantum Verde collutorio also has disinfectant properties and a moderate surface anesthetic action.
Tantum Verde collutorio is used for the treatment of symptoms of inflammation and irritation, also associated with pain, of the gums, mouth and throat (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy ( e.g. caries treatment or tooth extraction).
Contraindications When Tantum Verde should not be used
Do not use Tantum Verde
- if you are allergic to benzydamine 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
Talk to your doctor or pharmacist before taking Tantum Verde. In a limited number of patients, internal lesions of the mouth and throat may be a sign of more serious illness.
In particular, tell your doctor:
- if you are allergic to acetylsalicylic acid or other anti-inflammatory drugs;
- if you have suffered from breathing problems in the past, such as asthma.
The use of Tantum Verde mouthwash, especially if prolonged, can give rise to sensitization phenomena (allergic phenomena) See paragraph 4 "Possible side effects". In this case, stop the treatment and contact your doctor
For those who carry out sporting activities
Tantum Verde contains ethyl alcohol, which can determine the positivity of doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.
Interactions Which drugs or foods can modify the effect of Tantum Verde
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 using this medicine. If you are pregnant or breast-feeding, use Tantum Verde only after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Driving and using machines
The use of Tantum Verde mouthwash, at the recommended doses, does not alter the driving ability or the use of machinery.
Tantum Verde contains parahydroxybenzoates which can cause allergic reactions (including delayed).
Dose, Method and Time of Administration How to use Tantum Verde: Posology
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.
How many
The recommended dose is 15ml, 2-3 times a day.
Warning: do not exceed the indicated doses without medical advice.
How long
Only use Tantum Verde for short periods of treatment. If you feel no better after 3 days of treatment, consult your doctor or dentist as needed.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
You can take Tantum Verde in pure form (without diluting it with water) or diluted:
- Pour into the Tantum Verde measuring cup up to the 15 ml mark (pure use)
- If you take it diluted, pour the water into the measuring cup that already contains Tantum Verde until it reaches the 30 ml mark (diluted with water)
- Rinse or gargle (do not swallow).
Overdose What to do if you have taken too much Tantum Verde
If you use more Tantum Verde than you should
In case you accidentally swallow / take too much Tantum Verde mouthwash, notify your doctor immediately or go to the nearest hospital.
If you forget to use Tantum Verde
Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Tantum Verde
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Tantum Verde the following undesirable effects may occur:
uncommon (may affect up to 1 in 100 people):
- photosensitivity (sensitivity of the skin to light);
rare (may affect up to 1 in 1000 people):
- hypersensitivity reactions (allergic reaction)
- burning and dry mouth.
very rare (may affect up to 1 in 10,000 people):
- laryngospasm (difficulty in breathing)
- angioedema (sudden swelling of the mouth / throat and mucous membranes causing difficulty in swallowing and / or breathing)
not known (frequency cannot be estimated from the available data):
- anaphylactic reactions (severe allergic reactions).
If you experience any of the side effects listed above while taking Tantum Verde, STOP the treatment and 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.
This medicine does not require any special storage conditions.
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.
Composition and pharmaceutical form
What Tantum Verde contains
- the active ingredient is: benzydamine hydrochloride (100 ml of mouthwash contain 0.15 g of benzydamine hydrochloride equal to 0.134 g of benzydamine)
- the other components are: glycerol, ethanol (96 per cent), saccharin, methyl parahydroxybenzoate (see paragraph "Tantum Verde contains parahydroxybenzoates"), sodium bicarbonate, mint flavor, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.
Description of what Tantum Verde looks like and contents of the pack
Tantum Verde 0.15% is presented as a mouthwash in a glass bottle of 120 or 240 ml 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
GREEN TANTUM 0.15% MOUTHWASH
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml contain:
active principle: benzydamine hydrochloride 0.15 g (equal to 0.134 g of benzydamine).
Excipients: methyl parahydroxybenzoate.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Mouthwash.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.
04.2 Posology and method of administration
Pour into the measuring cup 15 ml of Tantum Verde mouthwash to be used, 2-3 times a day, in pure or diluted form (in this case add 15 ml of water to the measuring cup).
Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity to benzydamine or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case, interrupt the treatment and consult the doctor to institute suitable therapy.
In a limited number of patients, oropharyngeal ulcerations can be a sign of more serious pathologies. Therefore, if symptoms persist for more than three days, the patient should contact their doctor or dentist as needed.
The use of benzydamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or to other NSAIDs.
Tantum Verde mouthwash should be administered with caution in subjects who have had episodes of bronchial asthma in the past, as bronchospasm phenomena may occur in this type of patient.
Tantum Verde mouthwash contains parahydroxybenzoates which can cause allergic reactions (even delayed).
For those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
04.5 Interactions with other medicinal products and other forms of interaction
Interaction studies with other drugs have not been conducted.
04.6 Pregnancy and lactation
There are no data on the use of benzydamine in pregnancy or during lactation. The excretion of the product in breast milk has not been studied.
Animal studies with regard to effects in pregnancy and lactation are insufficient (see section 5.3) and therefore the potential risk for humans cannot be assessed.
During pregnancy and breastfeeding Tantum Verde should not be used.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive or use machines.
04.8 Undesirable effects
Within each frequency class, undesirable effects are reported in descending order of severity.
The following scales of values were used: very common (≥1 / 10); common (≥1 / 100,
Gastrointestinal disorders
Rare: burning and dry mouth.
Disorders of the immune system
Rare: hypersensitivity reactions.
Not known: anaphylactic reactions.
Respiratory, thoracic, mediastinal disorders
Very rare: laryngospasm.
Skin and subcutaneous tissue disorders
Uncommon: photosensitivity.
Very rare: angioedema.
04.9 Overdose
Symptoms of overdose in children, such as excitation, convulsions, sweating, ataxia, tremor and vomiting, have been reported very rarely after oral administration of benzydamine at a dosage approximately 100 times that of the 3 mg tablets. In case of acute overdose, only symptomatic treatment can be carried out; empty the stomach by inducing vomiting or gastric lavage and keep the patient under observation by giving supportive treatment and maintaining adequate hydration.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: stomatologicals; other substances for local oral treatment.
ATC: A01AD02
Clinical studies show that benzydamine is effective in treating irritative processes localized in the mouth and pharynx. In addition, benzydamine possesses a local anesthetic effect of medium intensity.
05.2 Pharmacokinetic properties
Absorption through the oropharyngeal mucosa is demonstrated by measurable quantities of benzydamine in human serum, however insufficient to produce systemic effects.
The drug is mainly excreted via the urine, mainly in the form of inactive metabolites and conjugation products.
When applied topically, benzydamine reaches effective concentrations in inflamed tissues as it has the ability to penetrate through the lining epithelia.
05.3 Preclinical safety data
Embryonic and peri-post natal toxicity were investigated in reproductive toxicity studies in rats and rabbits at plasma concentrations much higher (up to 40 times) than those observed following oral administration of a single therapeutic dose. No teratogenic effects were observed in these studies. The available kinetic data do not allow to establish the clinical relevance of the reproductive toxicity studies. However, due to their incompleteness, preclinical studies cannot provide the physician with additional information compared to that already present in the CPR.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Glycerol, ethanol (96 percent), saccharin, methyl parahydroxybenzoate, sodium bicarbonate, mint flavor, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.
06.2 Incompatibility
There are no known chemical-physical incompatibilities of benzydamine towards other compounds.
06.3 Period of validity
4 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Colorless glass bottle of 120 and 240 ml with measuring cup with measuring notches at 15 and 30 ml.
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 MARKETING AUTHORIZATION HOLDER
Joint Chemical Companies Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome.
08.0 MARKETING AUTHORIZATION NUMBER
Tantum Verde mouthwash 120 ml, AIC n. 022088052
Tantum Verde mouthwash 240 ml, AIC n. 022088076
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1/3/1971 - 1/6/2010
10.0 DATE OF REVISION OF THE TEXT
October 2010