Package leaflet: Information for the user

Tantum Verde
1.5 mg/ml, oral and throat rinse solution
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor 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 you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents:

What Tantum Verde is and what it is used for
Important information before using Tantum Verde
How to use Tantum Verde
Possible side effects
How to store Tantum Verde
Contents of the pack and other information

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

Tantum Verde oral and throat rinse solution contains the active substance benzydamine, which belongs to the group of indole-like non-steroidal anti-inflammatory drugs (NSAIDs) for topical 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 drug is generally well tolerated and is suitable for topical treatment of inflammatory symptoms.
This medicine is intended for use on the mucous membranes of the mouth and throat.
It is used to treat symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat, such as bacterial and viral infections, mucosal inflammation following radiotherapy, postoperative conditions in otorhinolaryngology and dentistry, and after intubation.
If there is no improvement after 7 days or if you feel worse, consult your doctor.

2. Important information before using Tantum Verde

When not to use Tantum Verde

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

Warnings and precautions
Before starting to use Tantum Verde, consult a doctor or pharmacist.
Prolonged, especially long-term, use of locally acting medicines may cause an allergic reaction.
In such a case, discontinue use of the medicine and consult a doctor who will recommend appropriate management.
Accidental swallowing of small amounts of Tantum Verde solution does not pose a health risk.

Tantum Verde with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Tantum Verde during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, the lowest possible dose should be used for the shortest possible duration.
The doctor will decide whether the medicine can be used by breastfeeding women.

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

Tantum Verde contains: methyl parahydroxybenzoate (E 218), ethanol, benzyl alcohol (E 1519), flavouring composition, polysorbate 20 (E 432), and sodium.

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

Ethanol
This medicine contains 1200 mg of alcohol (ethanol) in a single 15 ml dose, equivalent to 80 mg/ml of solution (8% w/w). The amount of alcohol in a single dose of this medicine is equivalent to less than 31 ml of beer or 13 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents, and its effect in children is likely to be negligible. It may cause some effects in younger children, such as drowsiness.
The alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, he or she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, he or she should consult a doctor or pharmacist before using this medicine.

Flavouring composition
The medicine contains a flavouring composition containing benzyl alcohol (E 1519), cinnamyl alcohol, citral, citronellal, geraniol, isoeugenol, linalool, eugenol, and d-limonene, which may cause allergic reactions.
The medicine contains 2.1 mg of benzyl alcohol in each dose (15 ml). Benzyl alcohol may cause allergic reactions and mild local irritation.
Pregnant or breastfeeding women should consult a doctor before using the 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 the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Polysorbate 20 (E 432)
Polysorbates may cause allergic reactions.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose; therefore, the medicine is considered "sodium-free".

3. How to use Tantum Verde

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dosage is to rinse the mouth and throat 2 to 3 times daily.
Each time, use approximately 15 ml of Tantum Verde solution, either undiluted or diluted with a small amount of water, and rinse the mouth and throat for 20 to 30 seconds.
Do not exceed the recommended dose. Continuous treatment should not last longer than 7 days; any decision on extending treatment should be made by a doctor.
The use of Tantum Verde solution is not recommended in individuals who have difficulty performing proper mouth and throat rinsing.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Use of more Tantum Verde than recommended
Overdose is unlikely due to the low concentration of the active substance in the medicine and its local route of administration.
Nevertheless, if a very large amount of Tantum Verde solution is accidentally swallowed (e.g., by children), symptoms such as vomiting, abdominal pain, restlessness, anxiety, seizures, ataxia, fever, tachycardia, and potentially respiratory center paralysis may occur.
In case of exceeding the recommended dose or accidental ingestion of a large amount of the medicine, contact a doctor or pharmacist immediately.

Missed dose of Tantum Verde
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning 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 (may affect up to 1 in 10,000 patients) and frequency not known (frequency cannot be estimated from the 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, severe itching of the skin or raised skin rash, 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 headache, skin rash.

Local symptoms are related to the pharmacodynamic action of benzydamine, which, among other effects, has local anaesthetic properties.
Local adverse reactions are usually transient, resolve spontaneously, and rarely require additional treatment.
Benzydamine, when applied locally, is absorbed into the systemic circulation in minimal amounts; therefore, systemic adverse reactions occur very rarely.
Diluting the medicine usually eliminates these symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps to provide more information on the safe use of the medicine.

5. How to store Tantum Verde

Keep the medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tantum Verde contains

The active substance is benzidamine hydrochloride. 1 ml of solution contains 1.5 mg of benzidamine hydrochloride.
Other ingredients are: glycerol (E 422), ethanol 96%, methyl parahydroxybenzoate (E 218), mint flavouring compound (containing, among others, benzyl alcohol (E 1519), cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, d-limonene), saccharin, sodium hydrogen carbonate, polysorbate 20 (E 432), quinoline yellow 70% (E104), patent blue V 85% (E131), purified water.

What Tantum Verde looks like and contents of the pack
Clear green solution with a mint flavour.
Bottle made of colourless glass with a polypropylene screw cap and a polypropylene dosing container graduated at 15 ml and 30 ml, in a cardboard box.
1 bottle – 120 ml
1 bottle – 240 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation Holder
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw, Poland
tel. (22) 70 28 200
e-mail: [email protected]
representative of the Marketing Authorisation Holder.