Tantum Verde Smak miodovo-pomaranihovi

Package Leaflet: Information for the Patient

Tantum Verde Honey-Orange Flavor

3 mg, Hard Lozenges

Benzydamine Hydrochloride

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

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this package 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 package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Package Leaflet Contents:

• 1. What is Tantum Verde Honey-Orange Flavor and what is it used for
• 2. Important information before taking Tantum Verde Honey-Orange Flavor
• 3. How to take Tantum Verde Honey-Orange Flavor
• 4. Possible side effects
• 5. How to store Tantum Verde Honey-Orange Flavor
• 6. Package contents and other information

1. What is Tantum Verde Honey-Orange Flavor and what is it used for

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

2. Important information before taking Tantum Verde Honey-Orange Flavor

When not to take Tantum Verde Honey-Orange Flavor

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

Warnings and precautions

Before taking Tantum Verde Honey-Orange Flavor, discuss it with your doctor or pharmacist.

• It is not recommended to take 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 taking the medicine, consult a doctor, as mouth ulcers may be a sign of a more serious underlying condition in some patients.

Tantum Verde Honey-Orange 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 Honey-Orange 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 have a child, consult your doctor or pharmacist before taking this medicine.
Tantum Verde Honey-Orange Flavor should not be taken 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 Honey-Orange Flavorcontains isomalt, orange yellow (E

• 110) and orange flavor composition with citral, citronellol, d-limonene, geraniol, and linalool.

Isomalt

Isomalt is a type of sugar that 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.

Orange Yellow (E 110)

The medicine contains orange yellow and may cause allergic reactions.

Flavor Composition

The medicine contains an orange flavor composition with citral, citronellol, d-limonene, geraniol, and linalool, which may cause allergic reactions.

3. How to take Tantum Verde Honey-Orange Flavor

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dosage: 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 of age.
In children between 6 and 11 years of age, the medicine should be used under adult supervision.

Taking a higher dose of Tantum Verde Honey-Orange Flavor than recommended

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

Missing a dose of Tantum Verde Honey-Orange Flavor

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking 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 available data) include 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 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 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.
Side effects of unknown frequency(frequency cannot be estimated from 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 package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tantum Verde Honey-Orange Flavor

Keep the medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiration date stated on the box.
The expiration 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tantum Verde Honey-Orange Flavor contains

• The active substance of Tantum Verde Honey-Orange Flavor is benzydamine hydrochloride. One hard lozenge contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: isomalt (E 953), citric acid monohydrate, orange flavor PHL-013100 (contains, among others: citral, citronellol, d-limonene, geraniol, linalool), honey flavor 22 969 NF, levomenthol, acesulfame potassium, quinoline yellow (E 104), orange yellow (E 110).

What Tantum Verde Honey-Orange Flavor looks like and what the package contains

Biconvex lozenges of yellow-orange color.
Lozenges in PVC/PE/PVdC/Aluminum blisters or packaged individually in paraffin-coated paper, then in PE/paper/Aluminum pouches, all in a cardboard box.
Each package 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
phone: (22) 70 28 200
e-mail: [email protected]
Package leaflet for the blind and visually impaired available at the representative of the marketing authorization holder.

Date of package leaflet approval: