Chophytol solution oral

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Unduh Karakteristik produk (SPC)
08-10-2021

Bahan aktif:

cynara scolymus extract

Tersedia dari:

Laboratoires Rosa-Phytopharma

Kode ATC:

առկա չէ (A05AX)

INN (Nama Internasional):

cynara scolymus extract

Dosis:

200mg/ml

Bentuk farmasi:

solution oral

Unit dalam paket:

120ml glass bottle

Jenis Resep:

OTC

Status otorisasi:

Registered

Tanggal Otorisasi:

2021-10-08

Karakteristik produk

                                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.
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.
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,
TACHYCARDIA)
Disulframe, cefamandole, cefoperazone, ltamoxef (cephalosporin
antibiotics), chloramphenicol
(phenicol antibiotics), chlorpropamide, glibenclamide, glipizide,
tolbutamide (sulphonylurea
hypoglycaemic antidiabetic agents), griseofulv
                                
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