Glycyron Tablets tablets coated

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, DL-methionine

Disponibbli minn:

Minophagen Pharmaceutical Co.

Kodiċi ATC:

A05B

INN (Isem Internazzjonali):

monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, DL-methionine

Dożaġġ:

35mg+ 25mg+ 25mg

Għamla farmaċewtika:

tablets coated

Unitajiet fil-pakkett:

(100/10x10/) in blister

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2016-06-08

Fuljett ta 'informazzjoni

Since hypokalaemia
(feelings of weakness,
muscular weakness, etc.)
might develop, adequate
measures should be taken
with careful observation
(including determination
of serum potassium level).
These diuretics enhance the
potassium excreting effect of
Glycyrrhizic acid contained
in this product, thus tending
to decrease serum
potassium.
Drug name
Clinical symptoms / measures
Mechanism / risk factor
Loop diuretics
Ethacrynic acid
Furosemide, etc.
Thiazide and similar
antihypertensive
diuretics
Trichlormethiazide
Chlortalidone, etc.
Body fluid / Electrolytes
Cardiovascular
Others
Abdominal pain, headache
Ingredients per tablet
Active ingredients
Inactive ingredients
Monoammonium Glycyrrhizinate
(as Glycyrrhizic Acid)
Glycine (JP)
Methionine
35mg
(25mg)
25mg
25mg
Identification
code
Color /
Dosage from
Appearance
Front Back Side
White/
Sugar-coated
tablets
Diameter 8.1 mm
Thickness 5.0 mm
0.1% to less than 5%
Increase in blood pressure
Decrease in serum potassium
4. ADVERSE REACTIONS
Adverse reactions were observed in 7 (6.5%) out of 107 cases in
the double-blind study
1)
conducted for the chronic liver diseases.
Notable ones were decrease in serum potassium in 2 cases
(1.9%), increase in blood pressure in 2 cases (1.9%) and abdomi-
nal pain in 2 cases (1.9%).
(1)Clinically significant adverse reactions
Pseudoaldosteronism (frequency unknown): There is a concern
about occurrence of pseudoaldosteronism such as hypokalae-
mia, increased blood pressure, sodium retention, fluid retention,
oedema, decrease in urinary amount, increased weight and
the
like,
patients
should
be
carefullyobserved
(including
determination of serum potassium level). In the event of any
abnormality, administration should be discontinued.
The symptoms of rhabdomyolysis such as weakness, lowered
muscle strength, myalgia, quadrispasm and quadriplegia may
occur. In the event of elevation of CK(CPK) or elevation of the
plasma and urine myoglobin level, administration should be
discontinued and appropriate measures should be taken.
(2)Other adverse rea

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
GLYCYRON
® TABLETS
Minophagen Pharmaceutical Co., Ltd.
2
1. NAME OF THE MEDICINAL PRODUCT
GLYCYRON
®
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the following active ingredients:
Monoammonium glycyrrhizinate
35 mg (25 mg as Glycyrrhizic acid)
Glycine
25 mg
DL-Methionine
25 mg
Each tablet contains: 29.7mg of Lactose Hydrate
For a full list of excipients, see
SECTION 6.1
3. PHARMACEUTICAL FORM
White, sugar-coated tablets for oral administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GLYCYRON
®
Tablets is indicated for the improvement of abnormal liver functions
in chronic
liver diseases, also for Eczema or dermatitis, infant strophulus and
alopecia areata, stomatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual dosage is 2 to 3 tablets in adults and 1 tablet in children,
administered orally after
meals three times a day. Dose may be adjusted according to the
patient’s age and symptoms.
4.3 CONTRAINDICATIONS
This product is contraindicated in the following patients:
(1) Patients in the final stage of liver cirrhosis whose serum
ammonium level tends to increase
Since the metabolite of
DL
-Methionine contained in this product inhibits urea biosynthesis,
ammoniua-decomposing ability any be decreased.
(2) Patients with aldosteronism, myopathy and hypopotassemia
There is a concern about aggravation of hypopotassemia, hypertension
or the like.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Careful administration
In the experience in the clinical use, incidence of the adverse
reactions such as hypopotassemia
tended to be higher in the elderly. Careful administration should be
taken while observing
patient’s conditions.
Important precautions
Since concomitant use with any other preparations containing
Glycyrrhizae Radix brings about
overlapping effect with glycyrrhizic acid contained in this product
and it liable to cause
pseudoaldosteronism, appropriate care should be taken.
Precautions concerning use
3
When dispensing the drug: Fo