Tantum verde
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Tantum Verde
1.5 mg/ml, oral and throat spray
Benzydamini hydrochloridum
Please read the entire 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 for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
- If there is no improvement after 7 days, or if the patient feels worse, consult a physician.
Table of contents of the leaflet:
- What is Tantum Verde 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 is Tantum Verde and what it is used for
Tantum Verde, an oral and throat spray, contains the active substance benzydamine, which belongs to the group of indole non-steroidal anti-inflammatory drugs (NSAIDs) intended for local and general use.
Benzydamine has anti-inflammatory and analgesic properties and acts locally as an 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.
The 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, mucosal inflammation 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, please consult your doctor or pharmacist.
The use, especially prolonged, of topically 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.
Tantum Verde and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
No interactions between Tantum Verde and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your 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, a flavouring mixture, 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 0.17 ml dose, 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 cause noticeable effects.
Flavouring mixture
The medicine contains a mint flavouring mixture 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 a risk of serious adverse reactions, 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 advice or consultation with a pharmacist.
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 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) per 4 kg of body weight, 2 to 6 times daily.
Regardless of body weight, do not exceed 4 doses at one time.
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 (sprays) 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 decision on extending treatment should be made by a doctor.
Instructions for use:
- Raise the cannula.
- Place the cannula in the mouth and direct its outlet towards the inflamed area in the oral cavity or throat.
- Press the knurled surface of the pump firmly with your finger until a dose of the medicine is released. Repeat this action the required number of times.
Note: When using the medicine for the first time, press the pump several times to prime the device and ensure proper spray function.
If the effect of the medicine seems too strong or too weak, consult a doctor.
Use of more than the 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 dose higher than recommended is used, or if a large amount of the medicine is accidentally swallowed, 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 (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, severe skin itching 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, dry mouth, nausea and vomiting, sensory disturbances, numbness, dizziness and headache, 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 used locally, is absorbed into the systemic circulation in small amounts; 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.
5. How to store Tantum Verde
Keep this medicine out of 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.
Shelf life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the package and other information
What Tantum Verde contains
- The active substance is benzidamine hydrochloride. 100 ml of solution contains 0.15 g of benzidamine hydrochloride.
- Other ingredients are: glycerol, ethanol 96%, methyl parahydroxybenzoate (E 218), peppermint flavouring composition, 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 bottle with a dosing pump in a cardboard box.
1 bottle - 30 ml
For more detailed information, please contact the responsible entity or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/01/0257/005
Parallel Import Authorisation Number: 31/19