AMILMETACRESOLO E 2,4 DICHLORENBENZOL ALKOHOL AKRAF Pastylka

Treść ulotki

1. What is TANTUM VERDEGOL ANTISEPTIC and what is it used for
2. What you need to know before taking TANTUM VERDEGOL ANTISETTICO
3. How to take TANTUM VERDEGOL ANTISETTICO
4. Possible side effects
5. How to store TANTUM VERDEGOL ANTISETTICO
6. Package Contents and Other Information

TANTUM VERDEGOL ANTISETTICO Lozenges lemon and honey flavour
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 effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet

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

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

TANTUM VERDEGOL ANTISEPTIC contains amylmetacresol and 2,4-dichlorobenzyl alcohol, both
mild antiseptics.
TANTUM VERDEGOL 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 in the mouth and
throat.
See 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 ANTISETTICO

This product is recommended for use in adults, children (from 6 years of age) and elderly patients.

Do not take TANTUM VERDEGOL ANTISETTICO if
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 VERDEGOL 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 if other symptoms appear, such as high fever, headache, nausea or vomiting and skin rash, because a bacterial infection (tonsillitis, pharyngitis) may be occurring, which needs to be treated differently.
TANTUM VERDEGOL ANTISETTICO should not be administered to children under 6 years of age.
Other medicines and TANTUM VERDEGOL ANTISETTICO
No clinically significant interactions are known.
Inform 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 VERDEGOL ANTISETTICO in patients with hepatic or renal insufficiency.

Pregnancy and breastfeeding
Pregnancy:
The safety of TANTUM VERDEGOL ANTISETTICO in pregnancy has not been established.
No data are available on the use of amylmetacresol and dichlorobenzyl alcohol as pharmacologically active substances during pregnancy. In the absence of documented experience, the use of TANTUM VERDEGOL ANTISETTICO is not recommended during pregnancy.
Breastfeeding:
The safety of TANTUM VERDEGOL ANTISETTICO during breastfeeding has not been established.
No data are available on the excretion of amylmetacresol and dichlorobenzyl alcohol into breast milk.
In the absence of documented experience, the use of TANTUM VERDEGOL 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 VERDEGOL ANTISETTICO does not or negligibly alters the ability to drive vehicles or use machines.

TANTUM VERDEGOL ANTISETTICO lemon and honey flavour contains:
Peppermint essential oil, quinoline yellow (E104), sodium saccharin (E954), tartaric acid (E334), sunset yellow colourant (E110), lemon essence, honey aroma, isomalt (E953), maltitol (E965)
This product contains the colourant Sunset Yellow, an excipient that can cause allergic reactions.
TANTUM VERDEGOL 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 VERDEGOL ANTISETTICO

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

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

If you take more TANTUM VERDEGOL ANTISETTICO 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 ANTISETTICO- Do not take a double dose to
make up for a missed dose.

• Continue the normal intake 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 effects
Rare (from ≥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 on the
basis of available data).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 VERDEGOL ANTISETTICO

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special 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 VERDEGOL ANTISETTICO contains

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

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

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

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. 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
Terapia SA
Strada Fabricii nr. 124, Cluj-Napoca
Romania
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

Netherlands:Kruidvat Amylmetacresol Plus Dichloorbenzylalcohol lozenges honey & lemon

Italy:TANTUM VERDEGOL ANTISETTICO

Romania: Faringosept Combo Honey and Lemon 0.6 mg/1.2 mg lozenges

Portugal: Mentocaína Mel e Limão