Tantum verde forte

Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Tantum Verde Forte
3 mg/ml, oral and throat spray
Benzydamini hydrochloridum
Please read the leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used according to the instructions provided in the 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 doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Leaflet contents:

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

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

Tantum Verde Forte contains the active substance benzydamine, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has strong anti-inflammatory and analgesic properties and acts locally as an anesthetic and antiseptic. Due to its excellent local absorption and high concentration achieved in inflamed tissues, symptoms rapidly subside. The medicine is well tolerated and is suitable for local treatment of inflammatory symptoms.
Tantum Verde Forte is indicated for the treatment of symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat, such as bacterial and viral infections, laryngitis, mucosal inflammation following radiotherapy, postoperative conditions in otorhinolaryngology and dentistry, 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Tantum Verde Forte, consult a doctor or pharmacist.
Prolonged use, especially long-term, of locally acting medicines may cause allergic reactions. In such cases, discontinue use of the medicine and consult a doctor, who will recommend appropriate management.

Tantum Verde Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
No interactions between Tantum Verde Forte and other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether the use of the medicine is justified in pregnant or breastfeeding women.

Driving vehicles and operating machinery
Tantum Verde Forte has no effect on the ability to drive vehicles or operate machinery.

Tantum Verde Forte contains methyl parahydroxybenzoate (E 218), hydrogenated castor oil, and mint flavour.
Methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).
Hydrogenated castor oil
This medicine may cause skin reactions.
Mint flavour
The mint flavour contains benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalool, which may cause allergic reactions.

3. How to use Tantum Verde Forte

This medicine should always be used exactly as described in the patient information leaflet or according to the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for use by adults, particularly for those who cannot gargle.
Use the medicine 2 to 6 times a day, with 2–4 doses each time. Each dose contains 0.17 ml of solution.
Do not exceed the recommended dose.
This medicine is intended for short-term use only. Continuous treatment should not exceed 7 days. If symptoms recur or worsen, consult a doctor.
Instructions for use:

1.

Raise the cannula.

2. Place the cannula into the mouth and direct its outlet towards the inflamed area in the oral cavity or throat.
3. Press firmly with your finger on the knurled surface of the pump 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 fill it and achieve proper spray function.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Tantum Verde Forte
If a larger than recommended dose is used or if a large amount of the medicine is accidentally swallowed,
contact your doctor or pharmacist immediately. Bring this leaflet with you.
Missed dose of Tantum Verde Forte
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 everybody will experience them.
Uncommon (less frequent than in 1 out of 100 people, but more frequent than in 1 out of 1,000 people): skin damage due to photosensitivity (phototoxic reactions).
Rare (less frequent than in 1 out of 1,000 people, but more frequent than in 1 out of 10,000 people): burning or dryness in the oral cavity.
Very rare (less frequent than in 1 out of 10,000 people): laryngospasm, angioedema.
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 skin itching or raised skin rash, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening.
• nausea, vomiting, oral hypoaesthesia, dizziness, headache.

Local symptoms are related to the pharmacodynamic action of benzydamine, which, among other effects, exhibits local anaesthetic properties.
Local adverse reactions are usually transient, resolve spontaneously, and rarely require additional treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 helps to provide more information on the safety of the medicine.

5. How to store Tantum Verde Forte

Keep the medicine out of sight and reach of children.
No special storage instructions are required.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tantum Verde Forte contains

• The active substance is benzidamine hydrochloride. 100 ml of solution contains 0.3 g of benzidamine hydrochloride.
• Other components are: glycerol, 96% ethanol, hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate (E 218), peppermint flavour, purified water.

What Tantum Verde Forte looks like and contents of the pack
Tantum Verde Forte is a mint-flavoured solution for spraying into the mouth and throat.
The medicinal product is packed in an HDPE bottle containing 15 ml of solution, equipped with a dosing pump and a folding dosing nozzle (cannula). The bottle is placed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, country of export:
Angelini Pharma Österreich GmbH
Brigittenauer Lände 50-54
1200 Vienna
Austria
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco
A.C.R.A.F. S.p.A
Via Vecchia del Pinocchio 22
60131 Ancona
Italy
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland
Marketing Authorization number in Lithuania, country of export:
LT/1/01/0257/006
Parallel import authorization number: 231/25