Milgamma tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

benfotiamine, pyridoxine (pyridoxine hydrochloride)

Available from:

Mauermann-Arzneimittel KG Heinrich-Knote-Strasse 2

ATC code:

առկա չէ (A11DB)

INN (International Name):

benfotiamine, pyridoxine (pyridoxine hydrochloride)

Dosage:

100mg+ 100mg

Pharmaceutical form:

tablets coated

Units in package:

(30/2x15/) in blister, (60/4x15/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-10-12

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Milgamma
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 coated tablet contains 100 mg benfotiamine (lipoid-soluble vitamin B
1
derivative) and 100 mg
pyridoxine hydrochloride (Vitamin B
6
).
Excipient with known effect: each coated tablet contains 92.399 mg
saccharose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
White
,
round biconvex coated tablets with smooth surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Systemically neurological diseases caused by a proven deficiency of
vitamins B
1
and B
6
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Children and adolescents _
There are no adequate studies on the use of benfotiamine and
pyridoxine in the dosage of
Milgamma_ _in children and adolescents below 18 years of age.
Therefore, Milgamma_ _should
not be used in children and adolescents below 18 years of age.
_ _
_Adults _
Unless otherwise prescribed adults should take 1 coated tablet
Milgamma
daily. In acute conditions
the dose can be increased after consultation with the physician up to
1 coated tablet
Milgamma
3x daily.
Elderly: Normal Dosage regimens are recommended in the elderly. On the
basis of the available data
no restrictions on the use of Benfotiamine 100 mg, Pyridoxine 100 mg,
coated tablets in elderly at the
recommended dosage are required.
_Duration of treatment _
After 4 weeks the physician should decide whether the increased dosage
of Vitamin B
6
and B
1
(3x 1
coated tablet daily) is still necessary. Where appropriate, the dosage
should be decreased to 1 coated
tablet
Milgamma
daily to reduce the risk of neuropathies associated with Vitamin B
6
.
The duration of administration is determined by the therapeutic
response. Milgamma is
initially taken over a period of at least 4 weeks in cases of vitamin
B1/B6 deficiency and over
a period of at least 4-6 weeks in cases of diabetic and alcoholic
polyneuropathy and in cases
of supportive treatment of painful nerve disorders, respectively.
Thereafter maint