PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TANTUM VERDE ANTISETTIC mint flavour tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

What TANTUM VERDE ANTISETTIC is and what it is used for
What you need to know before taking TANTUM VERDE ANTISETTIC
How to take TANTUM VERDE ANTISETTIC
Possible side effects
How to store TANTUM VERDE ANTISETTIC
Contents of the pack and other information

1. What TANTUM VERDE ANTISETTICO is and what it is used for

TANTUM VERDE ANTISETTICO contains amylmetacresol and 2,4-dichlorobenzyl alcohol, both mild antiseptics.
TANTUM VERDE ANTISETTICO is used to relieve sore throat symptoms. By dissolving the lozenge in the mouth, the active substances are allowed to act on the affected area, also exerting a lubricating effect and providing relief. This helps to alleviate pain and discomfort in the mouth and throat.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before taking TANTUM VERDE ANTISETTICO

This product is recommended for use in adults, children (from 6 years of age onwards), and elderly patients.
Do not take TANTUM VERDE ANTISETTICO if
you are allergic (hypersensitive) to amylmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other
components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist if you have or are currently experiencing other throat disorders.
Due to the size of the tablets, young children are at risk of choking when taking TANTUM VERDE ANTISETTICO.
Prolonged use of this medicine is not recommended.
Sore throat is generally a mild condition that does not last longer than one week. Consult your doctor if symptoms persist for more than 3 days, worsen, or new symptoms appear, such as high fever, headache, nausea or vomiting, or skin rash, as a bacterial infection (e.g. angina, tonsillitis) may be present, requiring different treatment.
TANTUM VERDE ANTISETTICO must not be administered to children under 6 years of age.
Other medicines and TANTUM VERDE ANTISETTICO
There are no clinically significant interactions known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Patients with impaired renal and/or hepatic function:
There are no available data on the use of TANTUM VERDE ANTISETTICO in patients with hepatic or renal insufficiency.
Pregnancy and breastfeeding
Pregnancy:
The safety of TANTUM VERDE ANTISETTICO during pregnancy has not been established.
There are no data available on the use of amylmetacresol and dichlorobenzyl alcohol during pregnancy as pharmacologically active substances. In the absence of documented experience, the use of TANTUM VERDE ANTISETTICO is not recommended during pregnancy.
Breastfeeding:
The safety of TANTUM VERDE ANTISETTICO during breastfeeding has not been established.
There are no data on the excretion of amylmetacresol and dichlorobenzyl alcohol in breast milk.
Due to lack of documented experience, the use of TANTUM VERDE ANTISETTICO is not recommended during breastfeeding.
Fertility:
There are no data available on the effects of amylmetacresol and dichlorobenzyl alcohol on fertility.
Driving and using machines
TANTUM VERDE ANTISETTICO does not affect or affects negligibly the ability to drive vehicles or use machinery.
TANTUM VERDE ANTISETTICO mint flavour contains:
Peppermint essential oil, anise essential oil, levomenthol, indigotine (E132), quinoline yellow (E104), sodium saccharin (E954), tartaric acid (E334), isomalt (E953), maltitol (E965).
TANTUM VERDE ANTISETTICO contains liquid maltitol and isomalt.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take TANTUM VERDE ANTISETTICO

Use in adults: 1 tablet every 2 or 3 hours as needed, up to a maximum of 8 tablets in 24 hours.
Children from 6 years of age onwards: maximum of 4 tablets in 24 hours, with a minimum interval of 2 hours between each tablet.
TANTUM VERDE ANTISETTICO must be slowly dissolved in the mouth. Do not swallow, chew or bite TANTUM VERDE ANTISETTICO.
If you take more TANTUM VERDE ANTISETTICO than you should
If you exceed the recommended dosage, you may experience gastrointestinal disturbances. Stop taking the product and consult your doctor or pharmacist.
If you forget to take TANTUM VERDE ANTISETTICO

Do not take a double dose to make up for a forgotten dose.
Continue taking the product as normally prescribed. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you are hypersensitive to this product, stop taking it and consult your doctor or pharmacist.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist immediately.

Rare (≥1/10,000 to ≤1/1,000): hypersensitivity reactions, including skin rash, burning sensation, itching, and swelling of the mouth or throat.

Cases of urticaria, angioedema, dyspnea, sore tongue (glossodynia), and gastrointestinal disorders such as dyspepsia and nausea have been reported; the frequency of these adverse reactions is unknown (cannot be estimated based on available data).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TANTUM VERDE ANTISETTICO

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TANTUM VERDE ANTISETTIC contains

The active substances are amylmetacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
The other components are:

TANTUM VERDE ANTISETTIC mint-flavoured tablets:
Peppermint essential oil
Anise essential oil
Levomenthol
Indigotine (E132)
Quinoline Yellow (E104)
Sodium saccharin (E954)
Tartaric acid (E334)
Isomalt (E953)
Maltitol (E965)

Description of the appearance of TANTUM VERDE ANTISETTIC and pack sizes
PVC-PVdC/aluminium blisters.
Each package contains 6, 8, 10, 12, 16, 20, 24, 30, 36, 40 or 48 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Angelini Pharma S.p.A.
Viale Amelia 70, 00181 Rome, Italy

Manufacturers
LOZY’S PHARMACEUTICALS, S.L
Campus Empresarial 31795 Lekaroz (Navarra)
SPAIN

MAE Holding B.V.
Stationsweg 4, 5211 TW 's-Hertogenbosch
THE NETHERLANDS

INFARMADE, S.L.
C/ Torre de los Herberos, 35
P.I. “Carretera de la Isla”, Dos Hermanas, 41703 (Sevilla)
SPAIN

Terapia SA
Strada Fabricii nr. 124, Cluj-Napoca
Romania

This medicinal product is authorized in the European Economic Area Member States under the following names:
Netherlands: Kruidvat Amylmetacresol Plus Dichloorbenzylalcohol mint Zuigtabletten
Italy: TANTUM VERDE ANTISETTIC
Romania: Faringosept Combo Mentă 0.6 mg/1.2 mg pastille
Portugal: Mentocaína Menta