Tantum Verde Smak eukaliptusovi

Package Leaflet: Information for the Patient

Tantum Verde Eucalyptus 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 as described in the 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is Tantum Verde Eucalyptus Flavor and what is it used for
• 2. Important information before using Tantum Verde Eucalyptus Flavor
• 3. How to use Tantum Verde Eucalyptus Flavor
• 4. Possible side effects
• 5. How to store Tantum Verde Eucalyptus Flavor
• 6. Contents of the pack and other information

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

Tantum Verde Eucalyptus Flavor contains the active substance benzydamine, which belongs to nonsteroidal anti-inflammatory drugs (NSAIDs). Benzydamine has anti-inflammatory, analgesic, local anesthetic, and antiseptic properties. Tantum Verde Eucalyptus Flavor is a lozenge used to treat symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat in adults and children over 6 years old. If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before using Tantum Verde Eucalyptus Flavor

When not to use Tantum Verde Eucalyptus Flavor

• If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Tantum Verde Eucalyptus Flavor, discuss it with your doctor or pharmacist.

• It is not recommended to use the medicine if you are allergic to acetylsalicylic acid (aspirin) or other nonsteroidal 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 symptoms of inflammation in the mouth, such as ulcers, do not start to improve after 3 days of using the medicine, consult a doctor, as mouth ulcers can be a sign of a more serious disease in some patients.

Tantum Verde Eucalyptus Flavor and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The interaction of Tantum Verde Eucalyptus Flavor with other medicines has not been studied.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Tantum Verde Eucalyptus 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 operate machinery. Tantum Verde Eucalyptus Flavor contains isomalt(a type of sugar), which should be taken into account in patients with congenital intolerance to certain sugars (e.g., fructose). If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking the medicine.

3. How to use Tantum Verde Eucalyptus Flavor

Always use this medicine as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The recommended dosage is 1 lozenge 3 times a day. Suck the lozenge slowly. Do not swallow or chew. Do not take more than the recommended dose. Continuous treatment should not exceed 7 days.

Use in children and adolescents

Due to the pharmaceutical form of the medicine, it should not be used in children under 6 years old. In children between 6 and 11 years old, the medicine should be used under adult supervision.

Overdose of Tantum Verde Eucalyptus Flavor

In case of accidental ingestion of too many lozenges, go to a doctor immediately, taking the package of the medicine with you. The doctor will take appropriate action. Very rare reports of overdose symptoms (excitement, convulsions, sweating, incoordination, tremors, vomiting) have been made in children after ingestion of benzydamine-containing medicines in doses about 100 times higher than the dose contained in a single lozenge.

Missed dose of Tantum Verde Eucalyptus Flavor

Do not take a double dose to make up for a missed dose. If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Tell your doctor immediately if you experience any of the following symptoms:

• Sudden swelling of the mouth or throat,
• Difficulty breathing,
• Rash or itching, especially if it covers 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 1000 people): burning or dryness in the mouth. If you experience these symptoms, you can reduce them 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 of unknown frequency(frequency cannot be estimated from the available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Tantum Verde Eucalyptus Flavor

Keep the medicine out of sight and reach of children. BlisterStore the medicine at a temperature not exceeding 30°C, in the original packaging to protect it from light and moisture. PackStore the medicine at a temperature not exceeding 25°C, in the original packaging. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tantum Verde Eucalyptus Flavor contains

• The active substance of Tantum Verde Eucalyptus Flavor is benzydamine hydrochloride. One hard lozenge contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: isomalt (E 593), eucalyptus oil, citric acid monohydrate, acesulfame potassium, levomenthol, quinoline yellow (E 104), indigo carmine (E 132).

What Tantum Verde Eucalyptus Flavor looks like and contents of the pack

Dark green, biconvex lozenges. Lozenges in a PVC/PE/PVdC/Aluminum blister pack, in a cardboard box or packaged individually in paraffin-coated paper, then in PE/paper/Aluminum pouches, all in a cardboard box. Each pack contains 20 or 30 hard lozenges.

Marketing authorization holder and manufacturer

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

Representative of the marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 70 28 200
e-mail: angelini@angelini.pl
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 approval of the leaflet: