Tantum Verde Smak miemtovi

Package Leaflet: Information for the Patient

Tantum Verde Mint Flavor

3 mg, Hard Lozenges

Benzydamine Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Tantum Verde Mint Flavor and what is it used for
• 2. Important information before using Tantum Verde Mint Flavor
• 3. How to use Tantum Verde Mint Flavor
• 4. Possible side effects
• 5. How to store Tantum Verde Mint Flavor
• 6. Package contents and other information

1. What is Tantum Verde Mint Flavor and what is it used for

Tantum Verde Mint Flavor contains the active substance benzydamine, which belongs to indole non-steroidal anti-inflammatory drugs (NSAIDs) for topical and systemic use. Benzydamine has anti-inflammatory, analgesic, and local anesthetic and antiseptic effects. The medicine is well absorbed locally, reaching high concentrations in inflamed tissues. The medicine is generally well tolerated and suitable for local treatment of inflammation symptoms. Suckable medicine. The medicine is used to treat discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat. If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before using Tantum Verde Mint Flavor

When not to use Tantum Verde Mint Flavor

• if the patient is allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).
• in patients with phenylketonuria, as the medicine contains aspartame, a source of phenylalanine.

Warnings and precautions

Before starting to use Tantum Verde Mint Flavor, the patient should discuss it with their doctor or pharmacist.

• The medicine is not recommended for use in patients with a known allergy to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• The medicine should be used with caution in patients who have had asthma, as it may cause shortness of breath.
• If the symptoms of inflammation in the mouth, such as ulcers, do not start to improve after 3 days of using the medicine, the patient should contact their doctor, as oral ulcers may be a sign of a more serious underlying disease in some patients.

Tantum Verde Mint Flavor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use. The interaction of Tantum Verde Mint Flavor with other medicines has not been studied.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Tantum Verde Mint Flavor should not be used during pregnancy or breastfeeding.

Driving and using machines

Local use of benzydamine in recommended doses does not affect the ability to drive or use machines. Tantum Verde Mint Flavor containsaspartame (E 951), isomalt (E 953), butylhydroxyanisole (E 320), and fragrances that may cause allergic reactions, such as benzyl alcohol (E 1519), citral, citronellol, d-limonene, eugenol, geraniol, linalol (contained in the mint and lemon flavor composition).

Aspartame (E 951)

The medicine contains 3.5 mg of aspartame in each hard lozenge. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

Isomalt (E 953)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Flavor compositions

The medicine contains flavor compositions with benzyl alcohol (E 1519), citral, citronellol, d-limonene, eugenol, geraniol, linalol, which may cause allergic reactions. The medicine contains 0.000175 mg of benzyl alcohol in each hard lozenge. Benzyl alcohol may cause allergic reactions and mild local irritation. Patients with liver or kidney diseases should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Butylhydroxyanisole (E 320)

The medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to use Tantum Verde Mint Flavor

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dosage is 1 lozenge 3 times a day. The lozenge should be sucked slowly. Do not swallow or chew. Do not exceed the recommended dose. Continuous treatment should not exceed 7 days.

Use in children and adolescents

Due to the pharmaceutical form, the medicine should not be used in children under 6 years of age. In children between 6 and 11 years of age, the medicine should be used under adult supervision. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Tantum Verde Mint Flavor than recommended

In case of accidental ingestion of too many lozenges, the patient should immediately contact their doctor, taking the medicine package with them. The doctor will take appropriate action. Very rare cases of overdose symptoms (excitation, convulsions, sweating, incoordination, tremors, vomiting) have been reported in children after ingestion of benzydamine-containing medicines in doses approximately 100 times higher than the dose contained in a single lozenge.

Missing a dose of Tantum Verde Mint Flavor

The patient should not take a double dose to make up for a missed dose. In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects with unknown frequency (frequency cannot be estimated from the available data) are allergic reactions, which can be severe.

The patient should immediately inform their doctor if they experience any of the following symptoms:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if it affects the whole body.

Uncommonside effects (occurring in less than 1 in 100 people): skin reactions due to hypersensitivity to light. Rareside effects (occurring in less than 1 in 1,000 people): burning or dryness in the mouth. If these symptoms occur, they can be reduced by slowly drinking a glass of water in small sips. Very rareside effects (occurring in less than 1 in 10,000 people): laryngospasm, angioedema. Side effects with unknown frequency(frequency cannot be estimated from the available data):

• premature closure of the ductus arteriosus in the fetus,
• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, chest pain or tightness, and (or) dizziness or fainting, severe skin itching or hives, swelling of the face, lips, tongue, and (or) throat; such a reaction can be life-threatening,
• oral numbness (local loss of sensitivity of the oral mucosa).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tantum Verde Mint Flavor

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C, in the original package. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tantum Verde Mint Flavor contains

• The active substance of the medicine is benzydamine hydrochloride. One hard lozenge contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: isomalt (E 953), levomenthol, aspartame (E 951), citric acid monohydrate, mint flavor composition PHL-008468 [contains, among others: benzyl alcohol (E 1519), citronellol, d-limonene, eugenol, geraniol, linalol], lemon flavor composition PHL-008469 [contains, among others: butylhydroxyanisole (E 320), benzyl alcohol (E 1519), citral, citronellol, d-limonene, geraniol, linalol], quinoline yellow (E 104), indigo carmine (E 132).

What Tantum Verde Mint Flavor looks like and what the package contains

Green, mint-flavored, biconvex hard lozenges. Lozenges in PVC/PE/PVdC/Aluminum blisters or packaged individually in paraffin-coated paper, then in aluminum-paper foil pouches, all in a cardboard box. Each package contains 20 or 30 hard lozenges.

Marketing authorization holder:

Angelini Pharma S.p.A.
Viale Amelia 70, 00181 Rome, Italy

Manufacturer:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona, Italy

Manufacturer:

PIERRE FABRE MEDICAMENT PRODUCTION
Site Diététique et Pharmacie
Zone Industrielle de la Coudette
32290 Aignan, France

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
phone: (22) 70 28 200
e-mail: [email protected]
The patient leaflet in a format suitable for the blind and visually impaired is available at the representative of the marketing authorization holder's office.

Date of last revision of the leaflet: March 2023