TANTUM VERDE ANTISETTIKO Леденцы

Содержание инструкции

1. TANTUM VERDE ANTISETTICO mint flavored lozenges
   1. What is TANTUM VERDE ANTISEPTIC and what is it used for
   2. What you need to know before taking TANTUM VERDE ANTISETTICO
   3. How to take TANTUM VERDE ANTISETTICO
   4. Possible side effects
   5. How to store TANTUM VERDE ANTISETTICO
   6. Package contents and other information

TANTUM VERDE ANTISETTICO mint flavored lozenges

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet

• 1. What TANTUM VERDE ANTISETTICO is and what it is used for
• 2. What you need to know before you take TANTUM VERDE ANTISETTICO
• 3. How to take TANTUM VERDE ANTISETTICO
• 4. Possible side effects
• 5. How to store TANTUM VERDE ANTISETTICO
• 6. Contents of the pack and other information

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

TANTUM VERDE ANTISEPTIC contains amylmetacresol and 2,4-dichlorobenzyl alcohol, both mild
antiseptics.
TANTUM VERDE ANTISEPTIC is used to relieve the symptoms of sore throat. By dissolving the lozenge
in the mouth, the active ingredients are allowed to act in the painful area, also exerting a lubricating action and
offering relief. This helps to alleviate pain and discomfort at the level of 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) and elderly patients.

Do not take TANTUM VERDE ANTISETTICOif
you are allergic (hypersensitive) to amylmetacresol, 2,4-dichlorobenzyl alcohol or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist if you suffer from or are suffering from other throat disorders.
Due to the size of the lozenges, small children are at risk of choking after
ingesting TANTUM VERDE ANTISETTICO.
Prolonged use of this medicine is not recommended.
Generally, sore throat is a mild condition that does not last more than a week. Consult your doctor if
symptoms persist for more than 3 days, worsen or other symptoms appear, such as high fever,
headache, nausea or vomiting and skin rash, because a bacterial infection
(sore throat, tonsillitis) may be occurring, which needs to be treated differently.
TANTUM VERDE ANTISETTICO must not be given to children under 6 years of age.
Other medicines and TANTUM VERDE ANTISETTICO
No clinically significant interactions are known.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Patients with impaired renal and/or hepatic function:
No data are available on the use of TANTUM VERDE ANTISETTICO in patients with hepatic or renal
insufficiency.

Pregnancy and breastfeeding
Pregnancy:
The safety of TANTUM VERDE ANTISETTICO in pregnancy has not been established.
No data are available on the use of amylmetacresol and dichlorobenzyl alcohol in 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.
No data are available on the excretion of amylmetacresol and dichlorobenzyl alcohol in breast milk.
In the absence of documented experience, the use of TANTUM VERDE ANTISETTICO is not recommended during
breastfeeding.
Fertility:
No data are available on the effects of amylmetacresol and dichlorobenzyl alcohol on fertility.

Driving and using machines
TANTUM VERDE ANTISETTICO does not alter or negligibly alters the ability to drive vehicles or
use machines.

TANTUM VERDE ANTISETTICOmint flavour contains:
Peppermint essential oil, anise essential oil, levomenthol, indigotine dye (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, contact your doctor before taking this
medicine.

3. How to take TANTUM VERDE ANTISETTICO

Use in adults:1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Children 6 years and older:maximum 4 lozenges in 24 hours, with a minimum interval of 2 hours between one lozenge
and the next.
TANTUM VERDE ANTISETTICO must be dissolved slowly in the mouth. Do not swallow, chew or
bite TANTUM VERDE ANTISETTICO.

If you take more TANTUM VERDE ANTISETTICOthan 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 VERDE ANTISETTICO

• Do not take a double dose to make up for a missed dose.
• Continue the normal administration of the product. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience hypersensitivity to this product, stop taking it and consult your doctor or
pharmacist. If any of the side effects get worse, or if you notice any other side effects
Rare (≥1/10,000 to ≤1/1,000): hypersensitivity reactions, including skin rash, burning, itching and swelling of the
mouth or throat.
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 defined based on
available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 the medicine out of sight and reach of children.
• This medicine does not require any particular storage conditions.
• Do not use beyond the expiry date indicated on the packaging. The expiry date refers to the last day of the month indicated.
• Do not dispose of any medicine in 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 ANTISETTICO contains

• The active ingredients are amylmetacresol 0.6 mg and dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are:

TANTUM VERDE ANTISETTICO mint-flavored lozenges:
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 ANTISETTICOand package contents
PVC-PVdC/aluminum blisters.
Each pack contains 6, 8, 10, 12, 16, 20, 24, 30, 36, 40, 48 lozenges.
Not all pack sizes may be marketed.

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

Manufacturer
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 (Seville)
SPAIN
Terapia SA
Strada Fabricii nr. 124, Cluj-Napoca
Romania
This medicinal product is authorized in the Member States of the European Economic Area with the following
names:

Netherlands:Kruidvat Amylmetacresol Plus Dichloorbenzylalcohol mint Zuigtabletten

Italy:TANTUM VERDE ANTISETTICO

Romania: Faringosept Combo Mentă 0.6 mg/1.2 mg lozenges

Portugal: Mentocaína Menta