Tantum Verde

Leaflet attached to the packaging: patient information

Tantum Verde

1.5 mg/ml, spray for oral and throat use

Benzydamine hydrochloride

Please read carefully 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 a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this 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 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, which belongs to the group of indole non-steroidal anti-inflammatory drugs (NSAIDs) for local and general use.
Benzydamine has anti-inflammatory, analgesic, and local anesthetic and antiseptic effects. The medicine is well absorbed locally, reaching high concentrations in the inflamed tissues. The medicine is generally well tolerated and suitable for local treatment of inflammation symptoms.
The medicine is for use on the mucous membranes of the mouth and throat.
The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammation of the mouth and throat, such as bacterial and viral infections, mucositis after radiotherapy, post-operative conditions in laryngology and stomatology, and after intubation.
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Tantum Verde

When not to use Tantum Verde

Warnings and precautions

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

Tantum Verde and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
No interactions of Tantum Verde 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.

Driving and using machines

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

Tantum Verde contains methyl parahydroxybenzoate (E 218), ethanol, flavoring, polysorbate 20 (E 432), and sodium.

Methyl parahydroxybenzoate (E 218)

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

Etanol

This medicine contains 13.6 mg of alcohol (ethanol) in each single dose of 0.17 ml solution, which is equivalent to 80 mg/ml (8% w/w). 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.

Flavoring

The medicine contains a mint flavoring with benzyl alcohol (E 1519), cinnamaldehyde, citral, geraniol, citronellol, isoeugenol, linalool, and eugenol, 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 serious 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 their 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 their 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).

Polysorbate 20 (E 432)

Polysorbates may cause allergic reactions.

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 patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Tantum Verde should be sprayed onto the mucous membranes of the mouth and throat.
The recommended dose is:

Children and adolescents

Children under 6 years: 1 dose of the medicine (1 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: 4 doses of the medicine, 2 to 6 times a day.
Children over 12 years: 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 exceed 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 towards the area of inflammation in the mouth or throat.
• 3. Press the knurled 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 pump button should be pressed several times to fill the pump and obtain the correct spray.
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 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 reported so far.
In case of using a higher dose than recommended or accidental ingestion of a large amount of the medicine, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Tantum Verde

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare(may affect up to 1 in 10,000 people) and frequency not known(frequency 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 be life-threatening,
• burning sensation of the mucous membranes of the mouth, dryness of the mouth, nausea, and vomiting, disturbances 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, when used locally, is absorbed into the circulation in small amounts, and therefore, general side effects occur very rarely.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to 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 precautions for storage.
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 containers. The patient should ask their 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. 1 ml of solution contains 1.5 mg of benzydamine hydrochloride.
• The other ingredients are: glycerol (E 422), ethanol 96%, methyl parahydroxybenzoate (E 218), mint flavoring GARGARISME 052503T (contains, among others: benzyl alcohol (E 1519), cinnamaldehyde, citral, geraniol, citronellol, isoeugenol, d-limonene, linalool, eugenol), saccharin, sodium bicarbonate, polysorbate 20 (E 432), purified water.

What Tantum Verde looks like and what the package contains

Clear, colorless solution with a mint flavor.
Multi-dose polyethylene container with a dosing pump and a foldable dosing nozzle (canula), in a cardboard box.
1 container – 30 ml

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: [email protected]
The patient leaflet in a version suitable for the blind and partially sighted is available at the representative's office of the marketing authorization holder.

Date of last update of the leaflet: