Tantum verde forte

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Tantum Verde Forte
Ben zy damini hydrochloridum
3 mg/ml, oral and throat spray
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used according to the instructions in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Table of contents of the leaflet:

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 pack 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 a local anesthetic and antiseptic. Due to its excellent local absorption and high concentration in inflamed tissues, symptoms quickly subside. The medicine is well tolerated and is suitable for local treatment of inflammatory symptoms.
The medicine is used for symptomatic treatment (pain, redness, swelling) associated with inflammatory conditions of the oral cavity 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
Do not use this medicine 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 your doctor or pharmacist.
Prolonged, especially long-term, use of locally acting medicines may cause allergic reactions. In such a case, discontinue use and consult your doctor for 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 you plan to use.
No interactions between Tantum Verde Forte and other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether this medicine can be used during pregnancy or breastfeeding.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

Tantum Verde Forte contains methyl parahydroxybenzoate (E 218) and hydrogenated castor oil.
This medicine may cause allergic reactions (including delayed-type reactions).
This medicine may cause skin reactions.

3. How to use Tantum Verde Forte

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.
The medicine is intended for use by adults, particularly those who are unable to gargle.
Use the medicine 2 to 6 times daily, administering 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 last longer than 7 days. If symptoms recur or worsen, consult a doctor.

Instructions for use:

1. Lift the cannula.
2. Place the cannula in the mouth and direct its outlet towards the inflamed area in the oral cavity or throat.
3. Press firmly on the knurled surface of the pump with a finger until the medicine dose is released. Repeat this action as many times as needed.

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 feels too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Tantum Verde Forte
If a dose higher than recommended is used or if a large amount of the medicine is accidentally swallowed, seek immediate medical advice from a doctor or pharmacist. Bring this leaflet with you.
Missed dose of Tantum Verde Forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not very common (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 sensation or dryness in the mouth.
Very rare (less frequent than in 1 out of 10,000 people): laryngospasm, angioedema.
Frequency unknown (cannot be estimated from available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, chest pain or tightness and (or) dizziness/fainting, severe skin itching or raised skin rashes, swelling of the face, lips, tongue and (or) throat, and which may potentially be life-threatening.
• nausea, vomiting, oral hypoaesthesia, dizziness, headache.

Local side effects are related to the pharmacodynamic action of benzydamine, which among other effects exhibits local anaesthetic activity.
Local adverse effects are usually transient, resolve spontaneously, and rarely require additional treatment.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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 side effects helps to provide more information on the safety of the medicine.
5. How to store Tantum Verde Forte
Keep the medicine out of the sight and reach of children.
No special storage conditions 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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, ethanol 96%, hydrogenated castor oil, sodium saccharin, methyl 4-hydroxybenzoate (E 218), peppermint flavouring composition, 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 packaged in an HDPE bottle containing 15 ml of solution, equipped with a dosing pump and a foldable dosing nozzle (cannula), 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:
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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Lithuania, country of export: LT/1/01/0257/006
Parallel import authorisation number: 64/18