Tantum Verde lozenges

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

benzydamine (benzydamine hydrochloride)

متاح من:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

ATC رمز:

R02AX03

INN (الاسم الدولي):

benzydamine (benzydamine hydrochloride)

جرعة:

3mg

الشكل الصيدلاني:

lozenges

الوحدات في الحزمة:

(20/2x10/), in pack

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2020-12-26

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
Tantum Verde, 3 mg lozenges, mint taste.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains:
Active substance: 3 mg of benzydamine hydrochloride equivalent to 2.68
mg benzydamine.
Excipients with known effects: each lozenge contains 3183 mg of
Isomalt (E 953) and 3.5 mg
of Aspartame (E 951).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lozenge.
Green square-shaped lozenges, with a central cavity.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and irritation of the oral cavity and
throat
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 6 years of age: one lozenge 3 times a day.
Treatment duration must not exceed 7 days.
_Paediatric 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 the 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 as
appropriate.
This medicinal product contains:
- ASPARTAME: aspartame is hydrolysed in the gastrointestinal tract
when orally ingested. One
of the major hy