Chophytol tablets coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

cynara scolymus extract

Tersedia dari:

Laboratoires Rosa-Phytopharma

Kode ATC:

առկա չէ (A05AX)

INN (Nama Internasional):

cynara scolymus extract

Dosis:

200mg

Bentuk farmasi:

tablets coated

Unit dalam paket:

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

Jenis Resep:

OTC

Status otorisasi:

Registered

Tanggal Otorisasi:

2019-12-12

Karakteristik produk

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),
ethyl parahydroxybenzoate (E214).
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 parahydroxybenozate and 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
products and other forms of interaction.
_4.6.