Chophytol tablets coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Prenos Lastnosti izdelka (SPC)
03-11-2022

Aktivna sestavina:

cynara scolymus extract

Dostopno od:

Laboratoires GALENIQUES VERNIN

Koda artikla:

առկա չէ (A05AX)

INN (mednarodno ime):

cynara scolymus extract

Odmerek:

200mg

Farmacevtska oblika:

tablets coated

Enote v paketu:

(60/2x30/) in blister, (180/6x30/) in blister

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2022-11-03

Lastnosti izdelka

                                SmPC CHOPHYTOL, coated tablet
SUMMARY OF PRODUCT CHARACTERISTICS
1) NAME OF THE MEDICINAL PRODUCT
CHOPHYTOL®
2) QUALITATIVE AND QUANTITATIVE COMPOSITION
Artichoke (dry aqueous extract of leaves) on maltodextrin
200.000 mg
For a coated tablet.
Excipient with known effect: each tablet contains sucrose (0.08 g),
methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216).
For a full list of excipients, see section 6.1.
3) PHARMACEUTICAL FORM
Coated tablet.
_DESCRIPTION _
Round biconvex tablets with brown coating.
4) CLINICAL PARTICULARS
_4.1. THERAPEUTIC INDICATIONS _
Traditionally indicated to improve the renal and digestive elimination
functions:
- digestion recovery
- improvement in kidneys excretory function
_4.2. POSOLOGY AND METHOD OF ADMINISTRATION _
Oral use.
For adults only. 1–2 tablets three times a day with water before the
meal or when symptoms occur.
Treatment course duration is 2–3 weeks.
_4.3. CONTRAINDICATIONS _
-
hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
cholelithiasis
-
severe hepatic failure
-
acute diseases of liver, kidneys, bile duct and urinary tract
-
patients
with
hereditary
fructose
intolerance,
glucose-galactose
malabsorption
or
sucrose-
isomaltase deficiency
-
children under age of 18
-
pregnancy and lactation
_4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Do not administer in case of bile tract obstruction and severe
hepato-cellular insufficiency.
In case of diarrhea or abdominal pains, the treatment must be stopped.
SmPC CHOPHYTOL, coated tablet
This medicinal product contains sucrose. Patient with problems of
fructose intolerance, glucose-
galactose malabsorption syndrome or sucrase-isomaltase insufficiency
should not take this medicine.
This medicine contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate , which may
cause allergic reactions (possibly delayed).
_4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION _
No data present with regard to interaction with other medicinal
pro
                                
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