Tantum verde orange-honey taste 3 mg lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

Aziende Chimiche Riunite Angelini Francesco

ATC code:

A01AD; A01AD02

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Dosage:

3 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other agents for local oral treatment; benzydamine

Authorization status:

Marketed

Authorization date:

2010-11-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tantum Verde orange-honey taste 3 mg lozenges
Benzydamine Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, or pharmacist have
told you.
-
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. See section 4.
-
You must talk to a doctor if you do not feel better or you feel worse
after 3 days.
WHAT IS IN THIS LEAFLET:
1. What Tantum Verde is and what it 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 IT IS USED FOR
Tantum Verde contains the active substance benzydamine, which is a
local anti-inflammatory agent.
It belongs to the group of agent for oral local treatment.
Tantum Verde is used in adults and children above 6 years of age, for
symptomatic local treatment
for the relief of pain and irritation of the mouth and throat.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE
DO NOT TAKE TANTUM VERDE :
-
If you are allergic to benzydamine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTION
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING TANTUM VERDE:
-
If you have a history of Asthma.
-
If you are allergic to acetylsalicylic acid or to other
anti-inflammatory painkillers called
NSAIDs.
-
If you have been told by your doctor that you have an intolerance to
some sugars, contact your
doctor before taking this medicine.
-
If after using the lozenges the pain in your mouth or throat gets
worse or does not improve

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2020
CRN009W5C
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tantum verde orange-honey taste 3 mg lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg of benzydamine hydrochloride equivalent to
2.68 mg of benzydamine.
Excipients with known effects: each lozenge contains 3073.53 mg of
Isomalt (E 953) and 0.017 mg of Sunset yellow (E 110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge.
Orange-yellow square-shaped lozenges, with a central cavity.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tantum Verde is indicated in adults and children over 6 years of age,
for symptomatic local treatment for the relief of pain and
irritation of mouth and throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Adults and children over 6 years of age: one lozenge 3 times a day.
The treatment must not exceed 7 days.
_Pediatric population_
Children 6-11 years of age:
The medicinal product should be administered under adult supervision.
Children below 6 years of age:
Due to the type of the pharmaceutical form, the administration should
be restricted to children of more than 6 years of age_._
_Method of administration_
For oropharingeal use.
Lozenge should be dissolved slowly in the mouth
Do not swallow. Do not chew.
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
Benzydamine use is not advisable in patient with hypersensitivity to
salicylic acid or other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma. Caution should
be exercised in these patients.
In a minority of patients, buccal/pharyngeal ulceration may be caused
by serious disease processes. Patients whose symptoms
worsen or do not improve within 3 days, or who appear feverish or have
other symptoms, must therefore seek the advice of
their doctor or dentist