TANTUM 22,5 MG/15 ML Płyn do płukania ust

Treść ulotki

1. TANTUM VERDE GENGIVITE E STOMATITE 22,5 mg/15 ml + 7,5 mg/15 ml mouthwash
   1. What it is and what it is used for
   2. What you need to know before you take
   3. How to take
   4. Possible side effects
   5. How to store
   6. Contents of the pack and other information

TANTUM VERDE GENGIVITE E STOMATITE 22,5 mg/15 ml + 7,5 mg/15 ml mouthwash

Benzydamine hydrochloride / Cetylpyridinium chloride

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always 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.
• See a doctor if you do not feel better or if your symptoms worsen after 5-7 days of treatment.

Contents of this leaflet:

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

1. What it is and what it is used for

contains the active ingredients benzydamine hydrochloride (a non-steroidal anti-inflammatory drug) and cetylpyridinium chloride (an antiseptic).
It is used as an antiseptic, anti-inflammatory and analgesic in irritations of the mouth and gums, in gingivitis and stomatitis (such as for example, mouth ulcers, blisters in the mouth, inflammation from dentures). It is also indicated before and after tooth extractions.
Consult your doctor if you do not feel better or if you feel worse after 5-7 days of treatment.

2. What you need to know before you take

Do not take

• if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before taking
The use of , especially if prolonged, may lead to sensitization (allergic reactions). In this case, stop treatment and consult your doctor to start appropriate
therapy. See section 4 “Possible side effects”.

Other medicines and
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. Avoid the simultaneous use of other antiseptics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor for advice before taking this medicine.
During pregnancy and breastfeeding, it should only be used
under medical supervision.

Driving and operating machinery
The use of , at the recommended doses ,doesnot impair the ability to drive
vehicles or operate machinery.

contains hydrogenated castor oil polyoxyethylene and menta aroma
contains hydrogenated castor oil polyoxyethylene which may cause
localized skin reactions.
This medicine contains menta aroma which in turn contains benzyl alcohol, cinnamyl alcohol, citral,
citronellol, geraniol, isoeugenol, linalool, eugenol and D-Limonene. Benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and D-limonene may cause allergic
reactions.

3. How to take

Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 15 ml, 2-3 times a day.
Pour into the appropriate measuring cup up to the 15 ml mark.
Perform the rinses 2-3 times a day.
Caution: do not exceed the indicated doses without the advice of your doctor.
It can be used, if necessary, at any time of the
day.
Use for a maximum period of 5-7 days. For longer use, consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its
characteristics.

If you take more than you should
If you take an excessive amount of medicine or accidentally ingest large quantities, consult your doctor or pharmacist immediately.
With the local use of benzidamine hydrochloride and cetylpyridinium chloride, no cases of overdose have ever been reported.
In the event of benzidamine administered locally passing into the blood (systemic absorption), the toxic manifestations of overdose consist of: excitement, convulsions, sweating, ataxia
(progressive loss of muscle coordination), tremors and vomiting.
If you ingest significant amounts of cetylpyridinium chloride (more than ten packages of the product) you may
experience symptoms such as: nausea, vomiting, dyspnea (difficult breathing), cyanosis (insufficient oxygen in the blood), asphyxia (suffocation), decreased activity of the central nervous system, hypotension
(low blood pressure) and coma (state of loss of consciousness and vigilance).

If you forget to take
Do not take a double dose to make up for a missed dose.

If you stop taking
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 everybody gets them.
Side effects that may be observed during the intake of ,
whose frequency is unknown, are:
Benzidamine:

• slight feeling of numbness in the mouth. This effect is typically associated with the local anesthetic activity of benzidamine Cetylpyridinium:
• phenomena of drug intolerance which manifests with mild and transient burning or local irritation. These effects do not require changes to the treatment.

Reporting of side effects
If you experience any side effects, 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

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers
to the last day of that month.
The validity of the medicine after first opening of the bottle is 1 year.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the product contains

• the active ingredients are: benzydamine hydrochloride (100 ml of mouthwash contains 0.15 g of benzydamine hydrochloride equivalent to 0.134 g of benzydamine) and cetylpyridinium chloride (100 ml of mouthwash contains 0.05 g of cetylpyridinium chloride equivalent to 0.0425 g of cetylpyridinium)
• the other ingredients are: glycerol, ethanol (96%), saccharin, hydrogenated castor oil polyoxyl 35 castor oil, mint flavourmint aroma(see paragraph “contains hydrogenated castor oil polyoxyl 35 castor oil and mint aroma”), sodium bicarbonate, quinoline yellow (E 104), patent blue V (E 131), purified water.

Description of the appearance ofand contents of the pack
It is presented as a mouthwash in a 120 or 240 ml bottle with
a measuring cup.
Not all pack sizes may be available.

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

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

INDICATIONS
Inflammations affecting the gums, as well as the formation of bad breath, can sometimes
be related to the presence of bacterial plaque. Furthermore, the gums and mouth may be the site of
redness and pain caused by conservative dental therapies (e.g. cavity treatment), tooth extractions,
minor dental surgery.
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity, etc.,
can cause inflammation of the upper respiratory tract (mouth, nose) because they promote attack by
germs that can cause infections (pathogenic germs). To avoid worsening symptoms such as burning and pain, it is
useful to avoid some further irritating factors such as smoking, dry air, crowded places, etc.
All these situations can be overcome more quickly by also using a mouthwash that has
specific activity against inflammation, against pain and superficial anaesthetic and which simultaneously
has good efficacy against bacterial infections.