BRONCHICLEAR TABLETS

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

PRIMULA ROOT DRY EXTRACT (6-7:1); EXTRACTING AGENT : ETHANOL 47.4 % (V/V); THYME HERB DRY EXTRACT (6-10:1); EXTRACTING AGENT: ETHANOL 70.0 % (V/V)

Доступна з:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

Код атс:

R05CA10

Фармацевтична форма:

FILM COATED TABLETS

Склад:

PRIMULA ROOT DRY EXTRACT (6-7:1); EXTRACTING AGENT : ETHANOL 47.4 % (V/V) 60 MG; THYME HERB DRY EXTRACT (6-10:1); EXTRACTING AGENT: ETHANOL 70.0 % (V/V) 160 MG

Адміністрація маршрут:

PER OS

Тип рецепту:

Not required

Виробник:

BIONORICA SE, GERMANY

Терапевтична области:

COMBINATIONS

Терапевтичні свідчення:

For the relief of symptoms in acute bronchitis with coughs and colds associated with viscous mucus in children from 12 years of age, adolescents and adults.

Дата Авторизація:

2022-10-31

інформаційний буклет

gbpz-bro-ft-1911101-il.indd 4-5
05.01.18 11:03
gbpz-bro-ft-1911101-il.indd 4-5
05.01.18 11:03

Характеристики продукта

Page 1 of 6
This leaflet format has been determined by the Ministry of Health and
the content thereof has
been checked and approved on October 2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bronchiclear
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
60 mg of dry extract of primula root (6-7 : 1); extracting agent:
ethanol 47.4% (V/V)
160 mg of dry extract of thyme herb (6-10 : 1); extracting agent:
ethanol 70% (V/V).
Excipients:
Glycose syrup
34 mg
Lactose monohydrate
50 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Green, round, biconvex film-coated tablets with semi-matte surface
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms in acute bronchitis with coughs and colds
associated with
viscous mucus in children from 12 years of age, adolescents and
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adolescents, children from the age of 12 years and adults take 1
film-coated tablet 3 times
a day. The film-coated tablets should be swallowed unchewed, with
sufficient liquid
(preferably a glass of water) before meals.
Do not chew, split or crush the film-coated tablet.
The duration of treatment depends on the course of the disease. In
each case, please note
the information given in the first paragraph under “Special warnings
and precautions for
use" and the information under “Undesirable effects".
Page 2 of 6
4.3
CONTRAINDICATIONS
Bronchiclear must not be used in case of known hypersensitivity to the
active substances
or other labiates (_Lamiaceae_), birch, mugwort, celeriac or to any of
the excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If complaints persist for longer than 10 days or if shortness of
breath, fever and purulent or
bloody expectoration occur, a doctor should be consulted immediately.
Caution should be exercised in patients with gastritis or gastric
ulcer. In such patients
Bronchiclear should be taken after meals wi