Tantum Verde

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tantum Verde

1.5 mg/ml,spray for oral and throat use
Benzydamine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

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

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

Tantum Verde, a spray for oral and throat use, contains the active substance - benzydamine, belonging to indole non-steroidal anti-inflammatory drugs (NSAIDs) for local and general use.
Benzydamine is characterized by its anti-inflammatory and analgesic effects, and it also has a local anesthetic and disinfectant effect. The medicine is well absorbed locally, reaching high concentrations in the tissues affected by the inflammatory process. The medicine is generally well tolerated and is suitable for local treatment of inflammatory symptoms.
The medicine is for use on the mucous membrane of the mouth and throat.
The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammation of the mouth and throat, i.e. in bacterial and viral infections, inflammation of the mucous membranes after radiotherapy, in post-operative conditions in laryngology and stomatology, as well as after intubation.
If after 7 days there is no improvement or the patient feels worse, you should contact a doctor.

2. Important information before using Tantum Verde

When not to use Tantum Verde

Warnings and precautions

Before starting to use Tantum Verde, you should discuss it with your doctor or pharmacist.
Using, especially long-term, locally acting medicines, may cause an allergic reaction. In such a case, you should stop using the medicine and consult a doctor, who will recommend the appropriate procedure.

Tantum Verde and other medicines

You should tell your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
No interactions of Tantum Verde with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

The medicine does not affect your ability to drive or use machines.

Tantum Verde contains methyl parahydroxybenzoate (E 218), ethanol, a mint flavor, and sodium.

Methyl parahydroxybenzoate (E 218)

The medicine may cause allergic reactions (late-type reactions are possible).

Ethanol

This medicine contains 13.6 mg of alcohol (ethanol) in a single dose of 0.17 ml of solution, which is equivalent to 80 mg/ml. The amount of alcohol in a single dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Mint flavor

The medicine contains a mint flavor with benzyl alcohol (E 1519), cinnamal, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, d-limonene, which may cause allergic reactions.
The medicine contains 0.024 mg of benzyl alcohol in each dose (0.17 ml). Benzyl alcohol may cause allergic reactions and mild local irritation.
Administering benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Tantum Verde

This medicine should always be used exactly as described in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
Tantum Verde should be sprayed onto the mucous membrane of the mouth and throat.
The recommended dose is:

Children and adolescents

Children under 6 years of age: 1 dose of the medicine (spray) per 4 kg of body weight, 2 to 6 times a day.
Regardless of body weight, do not exceed 4 doses at a time.
Children from 6 to 12 years of age: 4 doses of the medicine, 2 to 6 times a day.
Children over 12 years of age: 4 to 8 doses of the medicine, 2 to 6 times a day.

Adults

4 to 8 doses (sprays) of the medicine, 2 to 6 times a day.
Each dose of the medicine contains 0.17 ml of solution.
Do not use a higher dose than recommended. Continuous treatment should not be longer than 7 days, and any extension should be decided by a doctor.

Instructions for use:

• 1. Lift the nozzle.
• 2. Place the nozzle in the mouth and direct its outlet to the area of inflammation in the mouth or throat.
• 3. Press the ridged surface of the pump firmly with your finger until the dose of the medicine is released. Repeat this action the appropriate number of times.

Note: When using the medicine for the first time, the pump button should be pressed several times to fill the pump and obtain the correct spray.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Using a higher dose of Tantum Verde than recommended

Overdose of the medicine is unlikely due to the low concentration of the active substance in the medicine and the local route of administration.
No cases of overdose have been observed so far.
If you use a higher dose than recommended or accidentally swallow a large amount of the medicine, you should contact a doctor or pharmacist immediately.

Missing a dose of Tantum Verde

You should not use a double dose to make up for a missed dose.

If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare(less than 1 in 10,000 people) and frequency not known(cannot be estimated from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), whose symptoms may include 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, and which may potentially be life-threatening,
• burning sensation of the mucous membrane of the mouth, dryness of the mouth, nausea, and vomiting, disorders of sensation, numbness, dizziness, and headaches, rash.

Local symptoms are related to the pharmacodynamic effect of benzydamine, which, among other things, has a local anesthetic effect.
Local side effects are usually transient, resolve on their own, and rarely require additional treatment.
Benzydamine used locally is absorbed into the circulation in small amounts, so general side effects occur very rarely.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tantum Verde

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 contains

• The active substance of the medicine is benzydamine hydrochloride. 100 ml of solution contains 0.15 g of benzydamine hydrochloride.
• The other ingredients are: glycerol, ethanol 96%, methyl parahydroxybenzoate (E 218), mint flavor, saccharin, sodium bicarbonate, polysorbate 20, purified water.

What Tantum Verde looks like and what the package contains

Clear, colorless solution with a mint flavor.
HDPE bottle with a dosing pump in a cardboard box.
1 bottle - 30 ml
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Angelini Pharma Österreich GmbH
Brigittenauer Lände 50-54
1200 Vienna
Austria

Manufacturer:

A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, export country marketing authorization number:LT/1/01/0257/005
Parallel import authorization number:31/19

Date of leaflet approval: 23.01.2024

[Information about the trademark]