Tantum Verde Forte

Leaflet attached to the packaging: patient information

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

Tantum Verde Forte

3 mg/ml, spray for oral and throat use

Benzydamine hydrochloride

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

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
If advice or additional information is needed, a pharmacist should be consulted.

• This leaflet should be kept in case it needs to be read again.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Tantum Verde Forte contains the active substance benzydamine, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has strong anti-inflammatory and analgesic effects and acts locally as an anesthetic and antiseptic. Due to its good local absorption and high concentration in inflamed tissues, symptoms quickly subside. The medicine is well-tolerated and suitable for local treatment of inflammatory symptoms.
The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammation of the mouth and throat, such as bacterial and viral infections, laryngitis, inflammation of the mucous membranes after radiotherapy, post-operative conditions in laryngology and stomatology, and after intubation.

2. Important information before using Tantum Verde Forte

When not to use Tantum Verde Forte

If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Tantum Verde Forte, the patient should discuss it with their doctor or pharmacist.
Using, especially long-term, locally acting medicines may cause an allergic reaction; in such a case, the medicine should be discontinued and the patient should consult a doctor who will recommend appropriate action.

Tantum Verde Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions of Tantum Verde Forte with other medicines are known.

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.
The doctor will decide whether the medicine can be used in pregnant or breastfeeding women.

Driving and using machines

The medicine does not affect the ability to drive or operate machines.

Tantum Verde Forte contains methyl parahydroxybenzoate (E 218), hydrogenated castor oil, and peppermint flavor.

Methyl parahydroxybenzoate (E 218)
The medicine may cause allergic reactions (possible late reactions).
Hydrogenated castor oil
The medicine may cause skin reactions.
Peppermint flavor
Peppermint flavor contains benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalool, which may cause allergic reactions.

3. How to use Tantum Verde Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for use in adults, especially those who cannot rinse their mouth.
The medicine should be used 2 to 6 times a day, 2-4 doses at a time. Each dose contains 0.17 ml of solution.
A higher dose than recommended should not be used.
The medicine is intended for short-term use. Continuous treatment should not exceed 7 days. If symptoms recur or worsen, the patient should consult their doctor.
Instructions for use:

1.

Raise the nozzle.

2.

Place the nozzle in the mouth and direct its outlet towards the area of inflammation in the mouth or throat.

3.

Press the ridged surface of the pump firmly with your finger until the dose is released. Repeat this action the appropriate number of times.

Note: When using the medicine for the first time, press the button several times to fill the pump and achieve proper spraying.
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 Forte than recommended

In case of using a higher dose than recommended or accidental ingestion of a large amount of the medicine, the patient should immediately contact their doctor or pharmacist. They should take this leaflet with them.

Missing a dose of Tantum Verde Forte

A double dose should not be used to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tantum Verde Forte can cause side effects, although not everybody gets them.
Uncommon(less than 1 in 100 people, but more than 1 in 1,000 people): skin damage due to increased sensitivity to light (phototoxic reactions).
Rare(less than 1 in 1,000 people, but more than 1 in 10,000 people): burning or dryness in the mouth.
Very rare(less than 1 in 10,000 people): laryngospasm, angioedema.
Frequency not known(cannot be estimated from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, and which may be life-threatening.
• nausea, vomiting, numbness in the mouth, dizziness, headaches.

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.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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, more information can be gathered on the safety of the medicine.

5. How to store Tantum Verde Forte

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Shelf life after first opening – 6 months.
The medicine should not be used after the expiry date stated on the packaging. 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. Contents of the packaging and other information

What Tantum Verde Forte contains

• The active substance of the medicine is benzydamine hydrochloride. 100 ml of solution contains 0.3 g of benzydamine hydrochloride.
• The other ingredients are: glycerol, ethanol 96%, hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate (E 218), peppermint flavor, purified water.

What Tantum Verde Forte looks like and what the packaging contains

Tantum Verde Forte is a peppermint-flavored solution for spraying in the mouth and throat.
The packaging of the medicine is an HDPE bottle containing 15 ml of solution, equipped with a dosing pump with a foldable dosing nozzle (nozzle). The bottle is in a cardboard box.
For more detailed information, the patient 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:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorization number in Lithuania, the country of export:

LT/1/01/0257/006

Parallel import authorization number: 231/25

Date of leaflet approval: 01.07.2025

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