Chophytol solution oral

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Preuzimanje Svojstava lijeka (SPC)
03-11-2022

Aktivni sastojci:

cynara scolymus extract

Dostupno od:

Laboratoires MAYOLY SPINDLER

ATC koda:

առկա չէ (A05AX)

INN (International ime):

cynara scolymus extract

Doziranje:

200mg/ml

Farmaceutski oblik:

solution oral

Jedinice u paketu:

120ml glass bottle

Tip recepta:

OTC

Status autorizacije:

Registered

Datum autorizacije:

2022-11-03

Svojstava lijeka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1)
NAME OF THE MEDICINAL PRODUCT
CHOPHYTOL 20 PER CENT, oral solution
2)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Soft aqueous artichoke extract:
………………………………………….. 20 g
_ _
_ _
_ _
_ _
_ _
_For 100 ml of oral solution _
Alcoholic degree = 5.1
0
(V/V).
Each teaspoon contains 0.20 g of absolute alcohol.
Excipient with known effect: glycerol (0.015 g/ml), methyl
parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216).
For a full list of excipients, see section 6.1
3)
PHARMACEUTICAL FORM
Oral solution.
Dark brown opaque solution with a slight greenish precipitate.
4)
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Traditionally indicated to improve the renal and digestive elimination
functions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR ADULTS ONLY.
Oral use.
Swallow 1 teaspoon with water before the 3 main meals or when symptoms
occur. The
duration of treatment is 2-3 weeks.
4.3
CONTRAINDICATIONS
Hypersensitivity to the components of the drug, cholelithiasis, sever
hepatic deficiency,
acute diseases of the liver, kidneys, biliary and urinary tract.
Age under 18 years. Pregnancy and lactation. Alcoholism.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
Do not administer in case of bile tract obstruction and severe
hepato-cellular insufficiency.
Take into account the content of alcohol (0.20 g by teaspoon) and
avoid intake of alcoholic
beverages.
Due to the presence of ethanol (alcohol), this drug is unsafe in
alcoholic subjects and should
not be used in pregnant or breastfeeding women, children and high-risk
groups such as
patients with hepatic insufficiency or epilepsy.
This medicine contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate,
which may cause allergic reactions (possibly delayed).
4.5
INTERACTIONS WITH OTHER PRODUCTS AND OTHER FORMS OF INTERACTION.
CONCOMITANT USE TO BE TAKEN INTO ACCOUNT
Due to the alcohol content (0.20 g/teaspoon):
+ MEDICINAL PRODUCTS INDUCING ANTABUSE REACTION WITH ALCOHOL (WARMTH,
BLUSH,
VOMITING,
                                
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