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ANGELINI PHARMA ITALIA SpA

Tantum Verde 0, 15% 120 ml mouthwash

Tantum Verde 0, 15% 120 ml mouthwash

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Tantum Verde 0.15% mouthwash 120 ml is an anti-inflammatory mouthwash based on benzydamine hydrochloride , indicated for the symptomatic treatment of sore throat , gingivitis , stomatitis and pharyngitis . It provides rapid relief from pain and inflammation of the oropharynx , even after dental procedures, leaving a pleasant sensation of freshness thanks to the mint aroma.

NET WEIGHT OF THE PRODUCT

EAN

022088052

MINSAN

022088052

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Tantum Verde 0.15% 120 ml mouthwash is an anti-inflammatory mouthwash based on benzydamine hydrochloride , specifically formulated to offer effective symptomatic treatment against irritative-inflammatory conditions of the oropharyngeal cavity , such as gingivitis , stomatitis and pharyngitis . Thanks to its targeted action, this product is ideal for those seeking rapid relief from sore throat , inflammation of the mouth and irritated gums , even following conservative or extractive dental treatments.

The active ingredient benzydamine hydrochloride, present in a concentration of 0.15% , acts locally by reducing pain, swelling and redness, promoting an immediate sensation of well-being. The 120 ml format with a practical bottle is designed for daily use and for self-medication in case of sore throat and oral irritation . The presence of refreshing aromas, such as mint, makes use pleasant and gives a lasting sensation of freshness.

Tantum Verde mouthwash is the ideal solution for those who want to take care of the health of their mouth and throat, effectively combating the symptoms of inflammation and pain. Its formulation is suitable for adults and children, offering reliable support in managing the most common oral problems. Choose Tantum Verde for complete oral well-being and targeted treatment of oral cavity conditions.


ACTIVE INGREDIENTS

Active ingredients contained in Tantum Verde 0.15% 120 ml mouthwash - What is the active ingredient in Tantum Verde 0.15% 120 ml mouthwash?

100 ml contain: active ingredient: benzydamine hydrochloride 0.15 g (equivalent to 0.134 g of benzydamine). Excipient with known effect : methyl parahydroxybenzoate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tantum Verde 0.15% 120ml mouthwash - What does Tantum Verde 0.15% 120ml mouthwash contain?

Glycerol, ethanol (96%), saccharin, methyl parahydroxybenzoate , sodium bicarbonate, mint flavour, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.

DIRECTIONS

Therapeutic indications Tantum Verde 0.15% 120 ml mouthwash - Why is Tantum Verde 0.15% 120 ml mouthwash used? What is it used for?

Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Tantum Verde 0.15% 120ml mouthwash - When should Tantum Verde 0.15% 120ml mouthwash not be used?

Hypersensitivity to benzydamine or to any of the excipients listed in section 6.1.

DOSAGE

Quantity and method of taking Tantum Verde 0.15% 120 ml mouthwash - How to take Tantum Verde 0.15% 120 ml mouthwash?

Pour 15 ml of Tantum Verde mouthwash into the measuring cup and use 2–3 times a day, pure or diluted (in this case add 15 ml of water to the measuring cup). Do not exceed the recommended doses.

CONSERVATION

Storage Tantum Verde 0.15% 120 ml mouthwash - How to store Tantum Verde 0.15% 120 ml mouthwash?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Tantum Verde 0.15% 120 ml mouthwash - It is important to know that Tantum Verde 0.15% 120 ml mouthwash:

Use of the product, especially if prolonged, may give rise to sensitization phenomena. In this case, discontinue treatment and consult your doctor to establish appropriate therapy. In a limited number of patients, oropharyngeal ulcerations may be a sign of more serious pathologies. Therefore, if the symptoms persist for more than three days, the patient should contact his or her doctor or dentist as needed. The use of benzydamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. Tantum Verde mouthwash should be administered with caution to 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 that may cause allergic reactions (even delayed). For those who practice sports: the use of medicines containing ethyl alcohol may cause positive results in anti-doping tests in relation to the limits of alcohol concentration indicated by some sports federations.

INTERACTIONS

Interactions Tantum Verde 0.15% 120 ml mouthwash - Which medicines or foods can modify the effect of Tantum Verde 0.15% 120 ml mouthwash?

No interaction studies have been performed.

SIDE EFFECTS

Like all medicines, Tantum Verde 0.15% 120ml mouthwash can cause side effects - What are the side effects of Tantum Verde 0.15% 120ml mouthwash?

The table below lists adverse reactions classified by system organ class according to MedDRA. The adverse reactions are listed using the following frequency scales: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare ≥ 1/10,000, < 1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
CLASSIFICATION BY SYSTEMS AND ORGANS FREQUENCY: SIDE EFFECTS
Immune system disorders Rare : hypersensitivity reaction
Not known : anaphylactic reaction
Respiratory, thoracic, mediastinal pathologies Very rare : laryngospasm
Gastrointestinal disorders Uncommon : burning mouth, dry mouth.
Skin and subcutaneous tissue disorders Uncommon : photosensitivity
Very rare : angioedema
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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 the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Tantum Verde 0.15% 120ml mouthwash - What are the risks of Tantum Verde 0.15% 120ml mouthwash in case of 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 the event of acute overdose, only symptomatic treatment is possible; empty the stomach by inducing vomiting or gastric lavage and keep the patient under observation by giving supportive treatment and maintaining adequate hydration.

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 Tantum Verde 0.15% 120 ml mouthwash.

There are no data on the use of benzydamine during pregnancy or breastfeeding. The excretion of the product in breast milk has not been studied. Studies conducted in animals with reference to the effects on pregnancy and breastfeeding are insufficient (see paragraph 5.3) and therefore the potential risk for humans cannot be evaluated. During pregnancy and breastfeeding Tantum Verde should not be used.

DRIVING AND USE OF MACHINERY

Taking Tantum Verde 0.15% 120 ml mouthwash before driving or using machines - Does Tantum Verde 0.15% 120 ml mouthwash affect driving or using machines?

Tantum Verde does not alter the ability to drive vehicles or use machinery.
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