Tantum Verde lozenges with lemon flavor, 0.003 N40

Dosage form

Lemon flavored lozenges Manufacturer

Aziende Chimike Riunite Angelini Francesco A.C.R.A., Italy

Structure

For one lozenge:

The active ingredient is benzydamine hydrochloride - 3 mg.

Auxiliary ingredients:

isomaltose 3183 mg,

racementol 4 mg,

aspartame 3.5 mg,

lemon acid,

monohydrate 2 mg,

mint flavor 5 mg,

lemon flavoring 1.5 mg,

dye quinoline yellow (E104) 0.035 mg,

dye indigo carmine (E132) 0.015 mg.

pharmachologic effect

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug

ATX code: Рђ01AD02

Pharmacological properties

Pharmacodynamics

Benzydamine is a non-steroidal anti-inflammatory drug that belongs to the indazole group.

It has anti-inflammatory and local anesthetic effect, has an antiseptic effect against a wide range of microorganisms.

The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through membranes with subsequent damage to cellular structures, disruption of metabolic processes and cell lysosomes.

Has antifungal action against Candida albicans.

It causes structural modifications of the cell wall of fungi and their metabolic chains, thus interfering with their reproduction, which was the basis for the use of benzydamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics

When applied topically, the drug is well absorbed through the mucous membranes and penetrates into the inflamed tissues, it is found in the blood plasma in an amount insufficient to obtain systemic effects.

Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.

Indications

Symptomatic therapy of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiology):

- gingivitis, glossitis, stomatitis (including after radiation and chemotherapy)

-pharyngitis, laryngitis, tonsillitis

- candidiasis of the oral mucosa (as part of combination therapy)

-calculous inflammation of the salivary glands

-after surgery and trauma (tonsillectomy, jaw fractures)

-after the treatment and tooth extraction

- periodontal disease

In case of infectious and inflammatory diseases requiring systemic treatment, it is necessary to use TantumВ® Verde as part of a combination therapy.

Application during pregnancy and lactation

TantumВ® Verde should not be used during pregnancy and during breastfeeding.

Contraindications

Hypersensitivity to benzydamine or other components of the drug

intolerance to fructose

children under 6 years old

phenylketonuria

Carefully

Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including a history).

Side effects

The classification of the incidence of side effects of the World Health Organization (WHO):

very often - 1/10

often - from?

1/100 to < 1/10

infrequently - from? 1/1000 to < 1/100

rarely - from 1/10000 to < 1/1000

very rarely - < 1/10000

frequency unknown - cannot be estimated from the available data.

In each group, adverse effects are presented in order of decreasing severity.

Local reactions: rarely - dry mouth, burning sensation in the mouth

frequency unknown - feeling of numbness in the mouth.

Allergic reactions: infrequently - photosensitivity

rarely - hypersensitivity reactions.

skin rash, itchy skin

very rarely - angioedema, laryngospasm

frequency unknown - anaphylactic reactions.

If any of the side effects indicated in the instructions are aggravated, or any other side effects not indicated in the instructions are noted, you should immediately inform your doctor about it.

Interaction

Interaction studies with other medicinal products have not been conducted.

How to take, course of administration and dosage

Locally, after eating.

Adults (including elderly patients) and children over 6 years of age: 1 lozenge 3 times a day.

Keep the tablets in the mouth until they are completely dissolved.

Do not swallow.

Do not chew.

Do not exceed the recommended dose.

For children from 6 to 12 years old, the use of the drug is performed under the supervision of an adult.

The duration of treatment should not exceed 7 days.

If after treatment within 7 days there is no improvement or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of administration and in the doses indicated in the instructions.

If necessary, please consult your doctor before using the medicinal product.

Overdose

Currently, no cases of overdose of TantumВ® Verde have been reported.

Symptoms: when using the drug in accordance with the instructions for use, an overdose is unlikely.

If the drug is accidentally swallowed, the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

Treatment: symptomatic

emptying the stomach by causing vomiting or flushing the stomach using a gastric tube (under medical supervision)

provide medical supervision, supportive therapy and necessary hydration.

No antidote known.

Special instructions

When using the drug TantumВ® Verde, hypersensitivity reactions may develop.

In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.

In a limited number of patients, the presence of sores in the throat and mouth may indicate a more serious pathology.

If symptoms persist for more than 3 days, a doctor should be consulted.

The use of TantumВ® Verde is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

The drug TantumВ® Verde should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm while taking the drug.

The drug contains isomaltose and, therefore, is not recommended in patients with hereditary fructose intolerance.

The use of the drug in children is possible only under the supervision of an adult to avoid swallowing the tablet.

Influence on the ability to drive vehicles, mechanisms

Does not affect the ability to drive vehicles and work with mechanisms.

Storage conditions

At a temperature not exceeding 25 В° C, in a dark place.

Keep out of the reach of children.

Shelf life

4 years.

Active substance

Benzydamine

Terms of dispensing from pharmacies

Without recipe

Dosage form

lozenges

Appointment

For adults, Children over 6 years old

Indications

Pharyngitis, Angina, Stomatitis, Inflammation in the mouth, Laryngitis, Inflammation of the gums, Tonsillitis

Dosage

3mg

INN / Active ingredient

benzydamine

Storage conditions and periods

In a dark place, at a temperature not exceeding 25 degrees.

Specifications

Category

Sore throat

Scope of the drug

Ear, Throat, Nose

Release form

Tablet

Manufacturer country

Switzerland

Package quantity, pcs

40

Vacation conditions

Without recipe

Brand name

Tantum

The amount of the dosage form in the primary package

1 PC.

Primary packaging type

Paper

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

A01AD02 Benzidamine

Dosage form

Lozenges [lemon]

Expiration date in days

1460

Package weight, g

one hundred

Information on technical characteristics, delivery set, country of manufacture