Tantum Verde P 3mg Lozenges, mint taste

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

BENZYDAMINE HYDROCHLORIDE

Disponible des:

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

Codi ATC:

R02AX03

Designació comuna internacional (DCI):

BENZYDAMINE HYDROCHLORIDE 3 mg

formulario farmacéutico:

LOZENGE

Composición:

BENZYDAMINE HYDROCHLORIDE 3 mg

tipo de receta:

OTC

Área terapéutica:

THROAT PREPARATIONS

Estat d'Autorització:

Authorised

Data d'autorització:

2006-03-15

Informació per a l'usuari

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TANTUM VERDE P 3 MG LOZENGES, MINT TASTE
Benzydamine Hydrochloride
WHAT IS IN THIS LEAFLET
1.
What Tantum Verde P is and what is used for
2.
What you need to know before you take Tantum Verde P
3.
How to take Tantum Verde P
4.
Possible side effects
5.
How to store Tantum Verde P
6.
Contents of the pack and other information
1.
WHAT TANTUM VERDE P IS AND WHAT IS USED FOR
Tantum Verde P contains benzydamine, which 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P
DO NOT TAKE TANTUM VERDE P:
-
If you are allergic to benzydamine hydrochloride or any of the other
ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist before taking Tantum Verde P
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 has
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 or
nurse. 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 3 days
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-
If you suffer from a condition known as phenylketonuria.
-
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 within 3 days, or you appear feverish or have other symptoms,
you should speak
to your doctor or dentist.
OTHER M

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tantum Verde P 3 mg Lozenges, mint taste.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to
2.68 mg benzydamine).
Excipients: each lozenge contains 3183 mg Isomalt (E 953), 3,5 mg
Aspartame (E 951).
Tantum Verde mint taste contains fragrances with Benzyl Alcohol,
Citronellol, d- Limonene,
Eugenol, Geraniol, Linalool, Citral, Butylated hydroxyanisole.
For the full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Lozenge.
Green square-shaped lozenges, with a central cavity.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tantum Verde P is indicated in adults and children over 6 years of
age, for
symptomatic
treatment for the relief of pain and irritation of mouth and throat.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over six years of age: one lozenge 3 times a day.
The treatment must not exceed 7 days.
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.
Oropharingeal use.
Lozenge should be dissolved slowly in the mouth. Do not swallow.
Do not chew.
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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 patients 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 do not improve within three days,
or who appear feverish
or have other symptoms, must therefore seek the advice of their doctor
or dentist as appropriate.
The medici