Tantum Verde 0,15 % Mouthwash

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy

ATC code:

A01AD02

INN (International Name):

BENZYDAMINE HYDROCHLORIDE 0.15 g

Pharmaceutical form:

OROMUCOSAL SOLUTION

Composition:

BENZYDAMINE HYDROCHLORIDE 0.15 g

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-03-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TANTUM VERDE 0.15% MOUTHWASH
Benzydamine hydrochloride
WHAT IS IN THIS LEAFLET:
1.
What Tantum Verde is and what is used for
2.
What you need to know before you take Tantum Verde
3.
How to take Tantum Verde
4.
Possible side effects
5.
How to store Tantum Verde
6.
Contents of the pack and other information
1.
WHAT TANTUM VERDE IS AND WHAT IS USED FOR
Tantum
Verde
mouthwash
is
an
anti-inflammatory
non
steroid
analgesic
used
for
the
symptomatic
treatment
of
irritative-inflammatory
processes
even
when
associated
with
oropharyngeal
pain
(eg.
gingivitis,
stomatitis,
pharyngitis),
also
as
a
consequence
of
conservative dental therapy or extraction. Tantum Verde mouthwash also
acts as a disinfectant
and as a superficial anaesthetic.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE
DO NOT TAKE TANTUM VERDE
If you are allergic to benzydamine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription, for you to treat a
mild illness without a
doctor’s help.
Nevertheless. You still need to use Tantum Verde, carefully to get the
best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet.
-
You must talk to a doctor if you don’t feel better or if you feel
worse after few days
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WARNINGS AND PRECAUTIONS
No special handling precautions
_. _
OTHER MEDICINES AND TANTUM VERDE
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any
other medicines.
TANTUM VERDE WITH FOOD AND DRINK
Food and drink have no influence.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tantum Verde 0,15 % Mouthwash
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mL contain:
Active ingredient: 0.15 g benzydamine hydrochloride (equivalent to g
0.134 benzydamine)
Excipients with known effect:: 0,1 g Methyl p-hydroxybenzoate (E218)
and 8 g ethanol
(96%) and mint fragrance with allergenes
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Mouthwash
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment for pain and irritations of the oropharynx tract
(gingivitis, stomatitis,
pharyngitis), also as a consequence of dental therapy be it extracting
or preserving nature.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Empty in the cup 15 mL of Tantum Verde mouthwash for 2-3 times daily,
to be
used undiluted or diluted (in this case adding in the cup 15 mL of
water).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of product, especially when prolonged, may cause
sensitization. In this case interrupt
treatment and consult your doctor in order to establish an appropriate
therapy.
In a limited numbers of patients, oropharyngeal ulcers may be a sign
of more serious
pathologies. If symptoms should persist for more than three days,
therefore, the patient must
consult his physician or dentist according to his needs.
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The use of benzydamine is not recommended in cases of hypersensitivity
to salicylic acid or
other NSAIDs.
Tantum Verde mouthwash should be used with caution in patients who
have previously had
episodes of bronchial asthma, as in these patients may intervene
bronchospasm.
Tantum Verde contains p-hydroxybenzoate which can cause allergic
reactions (possibly
delayed).
This medicine contains 1200 mg of alcohol (ethanol) in each single
recommended dose of
15 mL which is equivalent to 80 mg/mL. The amount in each single
recommended dose
of 15 mL of this medicine is e