PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TANTUM VERDEGOL ANTISEPTIC Lemon and Honey Flavour Lozenges

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

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

TANTUM VERDEGOL ANTISETTICO contains amidochlorophenol and 2,4-dichlorobenzyl alcohol, both mild antiseptics.
TANTUM VERDEGOL ANTISETTICO is used to relieve the symptoms of sore throat. By dissolving the tablet in the mouth, the active ingredients are allowed to act directly on the affected area, providing lubrication and 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 VERDEGOL ANTISEPTIC

This product is recommended for use in adults, children (from 6 years of age onwards), and elderly patients.
Do not take TANTUM VERDEGOL ANTISEPTIC if
you are allergic (hypersensitive) to amylmetacresol, 2,4-dichlorobenzyl alcohol, or to any of the other
components of this medicinal product (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 lozenges, young children are at risk of choking following ingestion of TANTUM VERDEGOL ANTISEPTIC.
Prolonged use of this medicinal product 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 if new symptoms appear, such as high fever, headache, nausea or vomiting, or skin rash, as this may indicate a bacterial infection (e.g. pharyngitis, tonsillitis) requiring different treatment.
TANTUM VERDEGOL ANTISEPTIC must not be administered to children under 6 years of age.
Other medicines and TANTUM VERDEGOL ANTISEPTIC
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 VERDEGOL ANTISEPTIC in patients with hepatic or renal insufficiency.
Pregnancy and breastfeeding
Pregnancy:
The safety of TANTUM VERDEGOL ANTISEPTIC during pregnancy has not been established.
There are no available data on the use of amylmetacresol and dichlorobenzyl alcohol in pregnancy as pharmacologically active substances. In the absence of documented experience, the use of TANTUM VERDEGOL ANTISEPTIC is not recommended during pregnancy.
Breastfeeding:
The safety of TANTUM VERDEGOL ANTISEPTIC during breastfeeding has not been established.
There are no available data on the excretion of amylmetacresol and dichlorobenzyl alcohol in human milk.
In the absence of documented experience, the use of TANTUM VERDEGOL ANTISEPTIC is not recommended during breastfeeding.
Fertility:
There are no available data on the effects of amylmetacresol and dichlorobenzyl alcohol on fertility.
Driving and using machines
TANTUM VERDEGOL ANTISEPTIC does not affect or affects negligibly the ability to drive vehicles or operate machinery.
TANTUM VERDEGOL ANTISEPTIC lemon and honey flavour contains:
Peppermint essential oil, quinoline yellow (E104), sodium saccharin (E954), tartaric acid (E334), sunset yellow dye (E110), lemon essence, honey flavour, isomalt (E953), maltitol (E965).
This product contains sunset yellow, an excipient which may cause allergic reactions.
TANTUM VERDEGOL ANTISEPTIC contains liquid maltitol and isomalt.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product.

3. How to take TANTUM VERDEGOL ANTISEPTIC

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 one tablet and the next.
TANTUM VERDEGOL ANTISEPTIC must be slowly dissolved in the mouth. Do not swallow, chew or bite TANTUM VERDEGOL ANTISEPTIC.

If you take more TANTUM VERDEGOL ANTISEPTIC than you should:
If you exceed the recommended dosage, you may experience gastrointestinal disturbances. Stop taking this product and consult your doctor or pharmacist.

If you forget to take TANTUM VERDEGOL ANTISEPTIC: Do not take a double dose to make up for the forgotten dose.

Continue taking the product as normally scheduled.

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 experiences 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 (from ≥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, painful 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 the 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 through the national reporting system at the following 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 VERDEGOL ANTISEPTIC

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 medicines 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 VERDEGOL ANTISETTICO contains

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

TANTUM VERDEGOL ANTISETTICO Lemon and Honey Flavour Lozenges:
Peppermint essential oil
Quinoline Yellow (E104)
Sodium saccharin (E954)
Tartaric acid (E334)
Sunset Yellow FCF (E110)
Lemon essence
Honey flavour
Isomalt (E953)
Maltitol (E965)

Description of the appearance of TANTUM VERDEGOL ANTISETTICO and contents of the pack
PVC-PVdC/aluminium blister packs.
Each package contains 6, 8, 10, 12, 16, 20, 24, 30, 36, 40, or 48 lozenges.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 Rome
Italy

Manufacturer
LOZY’S PHARMACEUTICALS, S.L
Campus Empresarial 31795 Lekaroz (Navarra)
SPAIN
MAE Holding B.V.
Stationsweg 4, 5211 TW 's-Hertogenbosch
THE NETHERLANDS
Terapia SA
Strada Fabricii nr. 124, Cluj-Napoca
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Kruidvat Amylmetacresol Plus Dichloorbenzylalcohol zuigtabletten honing & citroen
Italy: TANTUM VERDEGOL ANTISETTICO
Romania: Faringosept Combo Miere şi Lămâie 0,6 mg/1,2 mg pastile
Portugal: Mentocaína Mel e Limão