Tantum Verde Forte

Leaflet attached to the packaging: information for the patient

Tantum Verde Forte

3 mg/ml spray for oral and throat use

Benzydamine hydrochloride

Read the 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 doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Tantum Verde Forte and what is it 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 packaging and other information

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

Tantum Verde Forte contains the active substance benzydamine, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine is characterized by its strong anti-inflammatory and analgesic effects, and it also has local anesthetic and antiseptic properties. Thanks to its good local absorption and high concentration in inflamed tissues, symptoms quickly subside. The medicine is well-tolerated and suitable for local treatment of inflammatory symptoms.
The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammation of the oral cavity and throat, such as bacterial and viral infections, pharyngitis, inflammation of the mucous membranes after radiotherapy, post-operative conditions in laryngology and stomatology, and after intubation.
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Tantum Verde Forte

When not to use Tantum Verde Forte

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 Forte, the patient should discuss it with their doctor or pharmacist.
Using, especially long-term, locally acting medicines may cause an allergic reaction, in which case the medicine should be discontinued and the patient should consult their doctor, who will recommend appropriate action.

Tantum Verde Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions between Tantum Verde Forte and other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Tantum Verde Forte should not be used during pregnancy or breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery.

Tantum Verde Forte contains methyl parahydroxybenzoate (E 218), hydrogenated castor oil, ethanol 96%, and a flavoring composition, as well as sodium.

Methyl parahydroxybenzoate (E 218)

The medicine may cause allergic reactions (possible late reactions).

Hydrogenated castor oil

The medicine may cause skin reactions. The medicine may cause nausea and diarrhea.

96% ethanol

This medicine contains 13.6 mg of alcohol (96% ethanol) in each single dose of 0.17 ml solution, which is equivalent to 80 mg/ml (8% w/w). 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 have noticeable effects.

Flavoring composition

The medicine contains a flavoring composition with benzyl alcohol (E 1519), citronellol, d-limonene, eugenol, geraniol, linalool, which may cause allergic reactions.
The medicine contains 0.017 µg (micrograms) of benzyl alcohol in each dose (0.17 ml). Benzyl alcohol may cause allergic reactions and mild local irritation.
Patient with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

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, the patient should consult their doctor or pharmacist.
The medicine is intended for use by adults, especially those who cannot rinse their mouths.
The medicine should be used from 2 to 6 times a day, in doses of 2-4.
Each dose contains 0.17 ml of solution.
A higher dose than recommended should not be used.
The medicine is intended for short-term use. Continuous treatment should not exceed 7 days. If symptoms recur or worsen, the patient should consult their doctor.

Instructions for use:

• 1. Lift the nozzle.
• 2. Place the nozzle in the mouth and direct its outlet to the area of inflammation in the oral cavity or throat.
• 3. Press the ribbed surface of the pump firmly with your finger until the dose of medicine is released. Repeat this action the appropriate number of times.

Note: When using the medicine for the first time, press the button several times to fill the pump and obtain the correct spray.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Tantum Verde Forte than recommended

In case of using a higher dose than recommended or accidental ingestion of a large amount of medicine, the patient should immediately consult their doctor or pharmacist. They should bring this leaflet with them.

Missing a dose of Tantum Verde Forte

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tantum Verde Forte can cause side effects, although not everybody gets them.
Uncommon(may affect up to 1 in 100 people): skin damage due to hypersensitivity to light (phototoxic reactions).
Rare(may affect up to 1 in 1,000 people): burning or dryness in the mouth.
Very rare(may affect up to 1 in 10,000 people): laryngospasm, angioedema.
Frequency not known(cannot be estimated from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), whose symptoms may include difficulty breathing, pain or tightness in the chest and (or) dizziness, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, and which may potentially be life-threatening.
• nausea, vomiting, numbness in the mouth, dizziness, headaches.

Local symptoms are related to the pharmacodynamic effect of benzydamine, which, among other things, has a local anesthetic effect.
Local side effects are usually transient, resolve on their own, and rarely require additional treatment.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Tantum Verde Forte

The medicine should be stored out of sight and reach of children.
No special precautions for storage are necessary.
The medicine should not be used after the expiry date stated on the carton and label (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tantum Verde Forte contains

• The active substance of the medicine is benzydamine hydrochloride. 1 ml of solution contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: glycerol (E 422), ethanol 96%, hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate (E 218), peppermint flavoring composition PHL-008468 (contains, among others: benzyl alcohol (E 1519), citronellol, d-limonene, eugenol, geraniol, linalool), purified water.

What Tantum Verde Forte looks like and what the pack contains

Tantum Verde Forte is a peppermint-flavored solution for spraying in the mouth and throat.
The packaging of the medicine is a polyethylene bottle containing 15 ml of solution, equipped with a dosing pump with a folding dosing nozzle (nozzle). The bottle is in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 702 82 00
e-mail: angelini@angelini.pl
The patient leaflet in a format suitable for the blind and visually impaired is available at the representative's office of the marketing authorization holder

Date of the last update of the leaflet: