Tantum Verde Mint Flavor (20 Tablets)

Tantum Verde Mint Flavor is intended as treatment of symptoms associated with inflammation of the mouth and throat (pain, redness, swelling).

Active substance: Benzydamini hydrochloridum

COMPOSITION

1 tablet contains 3 mg of benzydamine hydrochloride ( Benzydamini hydrochloridum), which corresponds to 2.68 mg of benzydamine.

For a full list of excipients, see section 6.1.

ACTION

Disinfecting; analgesic; anti-inflammatory

DOSAGE

Suck 1 lozenge 3 times a day.

Do not use more than the recommended dose. Continuous treatment should not exceed seven days. Due to its pharmaceutical form, Tantum Verde mint flavor should not be used in children under 6 years of age. In children under 12 years of age, the medicinal product should be used under adult supervision.

CONTRADICTIONS

The medicinal product is contraindicated in patients with hypersensitivity to the active substance or its excipients, and in patients with phenylketonuria (due to the content of aspartame).

Contents
Biconcave green lozenges with a mint flavor. The lozenges are individually packed in paraffin-coated paper, and then in packets of aluminum-paper foil, all in a cardboard box. 20 items – 2 packages of 10 items

Storage method
15°C-25°C
Manufacturer / Marketing Authorization Holder
ACRAF

WARNINGS

In some patients, ulcers in the mouth and throat may be just a symptom of another serious disease process. If symptoms persist after about 3 days of using the medicinal product, the patient should consult a physician.

The lozenges do not contain sugar, the sweetening agent is aspartame, see section 4.3.

The medicinal product is not recommended for use in patients:

• with hereditary fructose intolerance due to the content of isomalt,
• hypersensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

Benzydamine should be used with caution in patients with a history of asthma as there is a risk of bronchospasm.

Pregnancy and lactation
There are insufficient clinical data on the use of benzydamine in pregnant and lactating women. The degree of excretion of benzydamine in milk has not been studied. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo / fetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when using Tantum Verde mint flavor during pregnancy and breastfeeding.

Driving vehicles
Topical application of benzydamine in recommended doses does not influence the ability to drive vehicles and operate moving mechanisms.

Overdosage
So far, no symptoms of overdose with Tantum Verde mint flavor have been observed.

However, very rarely, symptoms of overdose (agitation, convulsions, sweating, ataxia, tremors, vomiting) have been reported in children after ingestion of benzidamine-containing medicinal products in doses approximately one hundred times higher than the dose contained in a single pill.

In the event of overdose, induce vomiting or perform gastric lavage. The patient should be monitored with symptomatic treatment, including maintenance of the body’s hydration.

Interactions with other drugs
There are no known interactions of Tantum Verde mint flavor with other drugs.

Side effects
The frequencies of adverse reactions are listed according to the MedDRA convention: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), not known (cannot be estimated from the available data).