Kindinorm A granules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

chamomilla dil. D12, valeriana dil. D6, kalium phosphoricum dil. D6, staphisagria dil. D12

Available from:

Dr. Gustav Klein GmbH & Co. KG

ATC code:

առկա չէ

INN (International Name):

chamomilla dil. D12, valeriana dil. D6, kalium phosphoricum dil. D6, staphisagria dil. D12

Dosage:

25mg+ 25mg+ 25mg+ 25mg

Pharmaceutical form:

granules

Units in package:

20g glass bottle

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-04-12

Summary of Product characteristics

SmPC – Kindinorm A, granules (QRD 4.0) v. 06 February
2017
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kindinorm A
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
In 10 g granules (size 5) are worked up:
Active substances:
Chamomilla dil. D12
0.025 g
Kalium phosphoricum dil. D6
0.025 g
Staphisagria dil. D12
0.025 g
Valeriana dil. D6
0.025 g
Excipient with known effect: sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Behavioral disorders in children and adolescents with attention and
concentration deficits, nervous
irritability, motoric overactivity, learning difficulties, sleep
disorders or conditions of general
weakness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Children aged 1 to 5 years:
2 granules 1 to 3 times per day
Children aged 6 to 11 years:
3 granules 1 to 3 times per day
Adolescents aged 12 years and older:
5 granules1 to 3 times per day
The frequency of intakes should be reduced as soon as complaints
improve.
Method of administration
Granules should be allowed to dissolve slowly in the mouth. For young
children, granules can be
dissolved in a little bit of water.
An interval of at least half an hour to meals should be kept.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Kindinorm A contains sucrose. Patients with rare hereditary problems
of fructose intolerance, glucose-
galactose malabsorption or sucrase-isomaltase insufficiency should not
take this medicinal product.
Kindinorm A should not be used in children under 1 year of age due to
the lack of data on safety and
efficacy.
3
A reassessment of the therapy is necessary
- if no improvement occurs within 8 weeks,
- if additional complaints arise.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Interactions with other medicinal products have not been observed. The
use of this homeopathic
medicinal product does not exclude the use of oth