SINUCLEAR TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

COMMON SORREL HERB; ELDER FLOWER; GENTIAN ROOT; PRIMULA FLOWER WITH CALYX; VERBENA HERB

متاح من:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

الشكل الصيدلاني:

COATED TABLETS

تركيب:

COMMON SORREL HERB 36 MG; GENTIAN ROOT 12 MG; PRIMULA FLOWER WITH CALYX 36 MG; ELDER FLOWER 36 MG; VERBENA HERB 36 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

BIONORICA SE, GERMANY

الخصائص العلاجية:

Provides relief of symptoms in the nose and its sinuses in connection with common cold, in adults and children older than 12 years.

تاريخ الترخيص:

2022-04-30

خصائص المنتج

Page 1 of 5
_ _
This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved
on May 2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sinuclear
Coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active pharmaceutical ingredients:
1 coated tablet contains:
Verbena herb, powdered 36 mg; Gentian root, powdered 12 mg; Common
Sorrel herb, powdered
36 mg; Elder flower, powdered 36 mg; Primula flower with calyx,
powdered 36 mg.
Excipients:
Glucose syrup
2.750 mg
Lactose monohydrate
48.490 mg
Sucrose
123.816 mg
Sorbitol
0.444 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
The coated tablets are green, round, biconvex with a smooth surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Provides relief of symptoms in the nose and its sinuses in connection
with common cold,
in adults and children older than 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless prescribed otherwise, adults and adolescents from 12 years of
age take 1 coated tablet 3
times a day.
Coated tablets to be taken unchewed – preferably with some liquid.
Crushing/halving: do not crush or halve the coated tablet.
Unless prescribed otherwise, the duration of administration is 7 –
14 days. Also observe the
instructions under 4.4 ”Special warnings and precautions for use”.
Page 2 of 5
4.3
CONTRAINDICATIONS
Sinuclear must not be taken in case of known hypersensitivity to one
of the pharmaceutical
ingredients or to any of the excipients of Sinuclear.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There are no sufficient investigations on the use of Sinuclear in
children under the age of 12 years.
Therefore, Sinuclear should not be used in children under the age of
12 years.
Patients with the rare hereditary problems of fructose intolerance,
galactose intolerance
e.g.
galacotosaemia, the Lapp lactase deficiency, glucose-galactose
malabsorption or sucrose-
isomaltase insufficiency should not take Sinuclear.
In the