Vit-B-Denk tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

thiamine (thiamine hydrochloride)(vitaminB1), pyridoxine (pyridoxine hydrochloride)(vitaminB6)

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

առկա չէ (A11DB)

INN (International Name):

thiamine (thiamine hydrochloride)(vitaminB1), pyridoxine (pyridoxine hydrochloride)(vitaminB6)

Dosage:

100mg+ 200mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) and (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-05-12

Patient Information leaflet

Version 7278/002
VIT-B-DENK
Film-coated tablet – oral use
Vitamins
Active substances: thiamine hydrochloride (vitamin B
1
), pyridoxine hydrochloride (vitamin B
6
)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE, BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Vit-B-Denk is and what it is used for
2.
What you need to know before you take Vit-B-Denk
3.
How to take Vit-B-Denk
4.
Possible side effects
5.
How to store Vit-B-Denk
6.
Contents of the pack and other information
1.
WHAT VIT-B-DENK IS AND WHAT IT IS USED FOR
Vit-B-Denk is a vitamin preparation.
Vit-B-Denk is used for the treatment of neurological system diseases,
which are caused by a proven
deficiency of vitamin B
1
and B
6
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIT-B-DENK
DO NOT TAKE VIT-B-DENK
if you are allergic to thiamine hydrochloride (vitamin B
1
), pyridoxine hydrochloride (vitamin B
6
),
soya, peanuts or any of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
In case of known hypersensitivity to vitamin B
1
, Vit-B-Denk should only be taken after careful risk-
benefit-considerations under medical control.
Tingling and pins and needles in the hands and feet (signs of
peripheral sensory neuropathy or
paraesthesia) have been observed in people taking daily doses above 50
mg pyridoxine hydrochloride
(vitamin B
6
) over long periods, as well as in people taking doses within the gram
range over short
periods. If you notice any tingling and pins and needles, pleas

Summary of Product characteristics

1
S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vit-B-Denk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: thiamine hydrochloride, pyridoxine hydrochloride
Each film-coated tablet contains 100 mg thiamine hydrochloride
(vitamin B
1
) and 200 mg pyridoxine
hydrochloride (vitamin B
6
).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, film-coated tablet, with the imprint “
VIT-B-DENK
” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Vit-B-Denk is used for the treatment of neurological system diseases
which are caused by a proven
deficiency of vitamine B
1
and B
6
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, the recommended daily dose is 1-2
Vit-B-Denk film-coated tablets
(corresponding to 100-200 mg thiamine hydrochloride and 200-400 mg
pyridoxine hydrochloride) per
day.
The film-coated tablets are swallowed with sufficient liquid. The
duration of treatment depends on the type
and severity of the illness.
After 4 weeks at the latest, the treating physician should decide
whether the administration of vitamin B
6
and vitamin B
1
in the high concentration present here is still indicated. It may be
necessary to switch to a
lower strength product to reduce the risk of neuropathy associated
with vitamin B
6
.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In case of known hypersensitivity to thiamine Vit-B-Denk should only
be administered orally under
medical control and strictest indication.
Peripheral sensory neuropathy have been reported for vitamin B
6
doses exceeding 50 mg per day over
a longer period of time, as well as for doses of 1 g or more if taken
in a short period of time. If signs of
paraesthesia (peripheral sensory neuropathy) are present, the dosage
should be reconsidered and
therapy with this medicinal product should be discontinued, if
necessary