Tantum Verde Dental 0,5% toothpaste

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 0.5 g

Pharmaceutical form:

TOOTHPASTE

Composition:

BENZYDAMINE HYDROCHLORIDE 0.5 g

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-03-15

Patient Information leaflet

 
1

_BEFORE_
_ _
_USE _
READ CAREFULLY ALL THE INFORMATION CONTAINED ON THE 
PACKAGE INSERT 

This is a SELF-MEDICATION drug you can use to treat mild, 
transient disorders that can be easily recognised and solved 
without consulting a physician. You can purchase this 
medication without prescription. However, it should be taken 
correctly to ensure its efficacy and minimise undesirable 
effects. For more information and advice, please consult the 
pharmacist. See a physician if the disorder does not go away 
after a short treatment period. 

TANTUM VERDE DENTAL 0.5% TOOTHPASTE 
BENZYDAMINE HYDROCHLORIDE 
COMPOSITION 
100 g contains: 
Active ingredients: benzydamine hydrochloride 0.5 g 
(equivalent to benzydamine 0.447 g).   
Excipients: Calcium phosphate dibasic dehydrate; Glycerol; 
Sodium Carmellose; Sodium laurisulphate; Anhydrous colloidal 
silica; Sodium saccharine; Methyl p-hydroxybenzoate; Propyl 
p-hydroxybenzoate; Mint flavour; Quinoline yellow (E104); 
Blue patent V (E131); Purified water q.s.  

2
PHARMACEUTICAL FORM 
Tantum Verde Dental is marketed in the form of toothpaste for 
oral use. 
Each packaging contains a 75 ml tube. 

WHAT IT IS 
Tantum Verde Dental 0,5% toothpaste is a non-steroidal anti-
inflammatory with analgesic properties, active against pain 
involved in mouth and gum inflammation. 

MARKETING AUTHORIZATION HOLDER 
Aziende Chimiche Riunite Angelini Francesco- ACRAF S.p.A. 
Viale Amelia 70, 00181 Rome 

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

WHY IT IS USED 
Tantum Verde Dental 0,5% toothpaste is used for the 
antiinflammatory and analgesic treatment of mouth and gum 
irritations. 

WHEN IT SHOULD NOT TO BE USED 
Hypersensitivity towards the active ingredient or any of the 
excipients.  

3
WHEN IT CAN BE TAKEN ONLY AFTER CONSULTING THE PHYSICIAN'S 
OPINION 
Pregnancy and lactation (refer to “_What to do during _
_pregnancy and lactatio

Summary of Product characteristics

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
NAME OF THE MEDICINAL PRODUCT 
Tantum Verde Dental 0,5% toothpaste 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION  
100 ml of toothpaste contains: 
Active ingredient: Benzydamine hydrochloride 0.5 g
(equivalent to benzydamine 0.447 g). 
For the excipients, see 6.1. 

3.  
PHARMACEUTICAL FORM 
toothpaste. 

4.  
CLINICAL PARTICULARS 

4.1   THERAPEUTIC INDICATIONS  
Antiinflammatory and analgesic treatment of mouth and
gum irritations. 
4.2   POSOLOGY AND METHOD OF ADMINISTRATION 
Spread Tantum Verde Dental on toothbrush, accurately massage
gums and teeth and rinse the 
oral cavity while keeping the toothpaste in mouth.   
Repeat the application three times a day, after meals.  
Do not exceed the recommended dose. 
4.3   CONTRAINDICATIONS 
Hypersensitivity towards the active ingredient or any of
the excipients.  
4.4   SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE 
The product does not require any special precaution for use. 
The product contains parahydroxybenzoates, which may cause
(usually delayed) allergic 
reactions.  
4.5   INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION

No interactions with other pharmaceutical products have been
observed. 
4.6   PREGNANCY AND LACTATION 
There are no contraindications for the topical use of
benzydamine in pregnancy or lactation. 

Page 2 of 3 
4.7   EFFECTS ON ABILITY TO DRIVE AND USE MACHINES.  
The topical use of benzydamine, at the recommended doses,
does not affect the ability to 
drive and use machines.  
4.8   UNDESIRABLE EFFECTS 
The treatment with Tantum Verde Dental 0,5%
toothpaste may lead to sensitisation 
phenomena. In this case, discontinue the treatment and set up an
appropriate therapy.   
4.9   OVERDOSE 
No cases of overdosing have been reported. 

5.  
PHARMACOLOGICAL PROPERTIES 
5.1