Tantum verde

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Tantum Verde
1.5 mg/ml, oral and throat spray
Benzydamini hydrochloridum
Please read this leaflet carefully 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
physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a physician.

Contents of the leaflet:

1. What Tantum Verde is and what it is 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. Contents of the pack and other information

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

Tantum Verde oral and throat spray contains the active substance
benzydamine, an indole-like non-steroidal anti-inflammatory drug (NSAID) intended for
local and general use.
Benzydamine has anti-inflammatory and analgesic properties and acts locally as a local anesthetic and antiseptic. The drug is well absorbed locally, achieving high concentrations in tissues affected by inflammation. The medicine is generally well tolerated and is suitable for local treatment of inflammatory symptoms.
This medicine is intended for application to the mucous membranes of the mouth and throat.
It is used to treat symptoms (pain, redness, swelling) associated with inflammatory conditions of the oral cavity and throat, such as bacterial and viral infections, mucositis following radiotherapy, postoperative conditions in otorhinolaryngology and dentistry, and after intubation.
If there is no improvement after 7 days, or if the patient feels worse, consult a physician.

2. Important information before using Tantum Verde

When not to use Tantum Verde

• if the patient is allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Tantum Verde, consult your doctor or pharmacist.
The use, especially prolonged, of locally acting medicines may cause an allergic reaction.
In such a case, discontinue the medicine and consult a doctor, who will recommend appropriate management.

Tantum Verde and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Tantum Verde and other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

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

Methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).

Ethanol
This medicine contains 13.6 mg of alcohol (ethanol) per single dose of 0.17 ml of solution, which corresponds 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 produce noticeable effects.

Mint flavouring
The medicine contains mint flavouring with benzyl alcohol (E 1519), cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, and d-limonene, which may cause allergic reactions.
Each dose (0.17 ml) contains 0.024 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions and mild local irritation.
Administration of benzyl alcohol to young children is associated with the risk of serious adverse effects, including breathing disorders (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without medical advice.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it 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. If in doubt, consult a doctor or pharmacist.
Tantum Verde should be sprayed onto the mucous membranes of the mouth and throat.
Recommended dosage:
Children and adolescents
Children under 6 years of age: 1 dose (spray actuation) per 4 kg body weight, 2 to 6 times daily.
Regardless of body weight, do not exceed 4 doses per single administration.
Children aged 6 to 12 years: 4 doses, 2 to 6 times daily.
Children over 12 years of age: 4 to 8 doses, 2 to 6 times daily.
Adults
4 to 8 doses (spray actuations) 2 to 6 times daily.
Each dose contains 0.17 ml of solution.
Do not exceed the recommended dose. Continuous treatment should not last longer than 7 days; any extension of treatment should be decided by a doctor.

Instructions for use:

1. Lift the nozzle.
2. Place the nozzle in the mouth and direct the spray outlet towards the inflamed area in the oral cavity or throat.
3. Press the knurled surface of the pump firmly with a finger until the dose is delivered. Repeat this action the required number of times.

Note: When using the medicine for the first time, press the pump several times to prime it and ensure proper spray function.
If the effect of the medicine seems too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Tantum Verde
Overdose is unlikely due to the low concentration of the active substance and the local route of administration.
No cases of overdose have been observed so far.
If a higher than recommended dose has been used or if a large amount of the medicine has been accidentally swallowed, seek immediate advice from a doctor or pharmacist.
Missed dose of Tantum Verde
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare (less than 1 in 10,000 people) and frequency not known (cannot be estimated based on
available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, intense itching of the skin or raised skin rashes, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening,
• burning sensation of the oral mucosa, dryness in the mouth, nausea and vomiting, sensory disturbances, numbness, dizziness, and headaches, skin rash.

Local symptoms are related to the pharmacodynamic action of benzydamine, which, among other effects, exhibits local anesthetic activity.
Local adverse reactions are usually transient, resolve spontaneously, and rarely require additional treatment.
Benzydamine used locally is absorbed into the bloodstream to a small extent; therefore, systemic adverse reactions occur very rarely.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Tantum Verde

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Use within 6 months after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tantum Verde contains

• The active substance is benzidamine hydrochloride. 100 ml of solution contains 0.15 g of benzidamine hydrochloride.
• The other ingredients are: glycerol, ethanol 96%, methyl 4-hydroxybenzoate (E 218), mint flavouring composition (containing, among others, benzyl alcohol (E 1519), cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, d-limonene), saccharin, sodium bicarbonate, polysorbate 20, purified water.

What Tantum Verde looks like and contents of the pack
A clear, colourless solution with a mint flavour.
HDPE container with a dosing pump and a foldable dosing nozzle (cannula), in a cardboard box.
1 container – 30 ml
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Lithuania, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Lithuania, country of export: LT/1/01/0257/005
Parallel import authorisation number: 442/19