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

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

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 the patient information leaflet or as directed by a doctor or pharmacist.
In case of doubt, you should consult a 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 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 after 7 days there is no improvement 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. Package contents and other information

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

Tantum Verde Forte contains the active substance - benzydamine, from the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine is characterized by strong anti-inflammatory and analgesic effects, and also has local anesthetic and antiseptic effects. Thanks to the fact that the medicine is very well absorbed locally and reaches high concentrations in the tissues affected by the inflammatory process, the symptoms quickly subside. The medicine is well tolerated and is suitable for local treatment of inflammatory symptoms.
The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammation of the oral cavity and throat, i.e. in bacterial and viral infections, laryngitis, inflammation of the mucous membranes after radiotherapy, in post-operative conditions in laryngology and stomatology, as well as 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, you should discuss it with your doctor or pharmacist.
Using, especially long-term, locally acting medicines, may cause an allergic reaction, in which case the medicine should be discontinued and you should consult a doctor, who will recommend appropriate action.

Tantum Verde Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There are no known interactions between Tantum Verde Forte and other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether you can use the medicine while pregnant or breastfeeding.

Driving and using machines

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

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

The medicine may cause allergic reactions (possible late reactions).
The medicine may cause skin reactions.

3. How to use Tantum Verde Forte

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
The medicine is intended for use by adults, especially those who cannot rinse their mouths.
The medicine should be used from 2 to 6 times a day, in 2-4 doses.
Each dose contains 0.17 ml of solution.
Do not use a larger dose than recommended.
The medicine is intended for short-term use. Continuous treatment should not exceed 7 days. If symptoms recur or worsen, you should consult a doctor.

Instructions for use:

• 1. Lift 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 of medicine is released. Repeat this action the appropriate number of times.

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

Using a larger dose of Tantum Verde Forte than recommended

In case of using a larger dose than recommended or accidental ingestion of a large amount of medicine, you should immediately contact a doctor or pharmacist. You should bring this leaflet with you.

Missing a dose of Tantum Verde Forte

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.
Uncommon(less than 1 in 100 people, but more than 1 in 1,000 people): skin damage due to hypersensitivity 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 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, and which may potentially 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 you experience any side effects, including any side effects not listed in the leaflet, you should inform 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 Forte

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storage.
Shelf life after first opening: 6 months.
Do not use this medicine 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. 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 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 package contains

Tantum Verde Forte is a mint-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 folding dosing nozzle (nozzle), in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, in 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:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, in the country of export, marketing authorization number:LT/1/01/0257/006
Parallel import authorization number:64/18
Date of leaflet approval: 20.10.2022
[Information about the trademark]