Vildagliptin Denk 50mg Tablets

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

VILDAGLIPTIN

থেকে পাওয়া:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany

এটিসি কোড:

A10BH02

INN (আন্তর্জাতিক নাম):

VILDAGLIPTIN 50 mg

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

VILDAGLIPTIN 50 mg

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

DRUGS USED IN DIABETES

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2018-12-04

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN DENK 50 MG TABLETS
VILDAGLIPTIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
:
1.
What Vildagliptin Denk is and what it is used for
2.
What you need to know before you take Vildagliptin Denk
3.
How to take Vildagliptin Denk
4.
Possible side effects
5.
How to store Vildagliptin Denk
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN DENK IS AND WHAT IT IS USED FOR
The active substance of Vildagliptin Denk, vildagliptin, belongs to a
group of medicines
called “oral antidiabetics”.
Vildagliptin Denk is used to treat adult patients with type 2
diabetes. It is used when diabetes
cannot be controlled by diet and exercise alone. It helps to control
the level of sugar in the
blood. Your doctor will prescribe Vildagliptin Denk either alone or
together with certain
other antidiabetic medicines which you will already be taking, if
these have not proved
sufficiently effective to control diabetes.
Type 2 diabetes develops if the body does not make enough insulin or
if the insulin that the
body makes does not work as well as it should. It can also develop if
the body produces too
much glucagon.
Insulin is a substance which helps to lower the level of sugar in the
blood, especially after
meals. Glucagon is a substance which triggers the production of sugar
by the liver, causing
the blood sugar level to rise. The pancreas makes both of these
substances.
HOW VILDAGLIPTIN DENK WORKS
Vildagliptin Denk works by making the pancreas produce more ins

পণ্য বৈশিষ্ট্য

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SUMMARY OF PRODUCT CHARACTERISTICS
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1
.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin Denk 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg vildagliptin.
Excipient with known effect:
Each tablet contains 47 mg of lactose (anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off white round flat tablet (diameter: approximately 8.1 mm),
engraved with ΄VLD΄
on one side, plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin is indicated as an adjunct to diet and exercise to
improve glycaemic control in
adults with type 2 diabetes mellitus:
•
as monotherapy in patients in whom metformin is inappropriate due to
contraindica-
tions or intolerance.
•
in combination with other medicinal products for the treatment of
diabetes, including
insulin, when these do not provide adequate glycaemic control (see
sections 4.4, 4.5
and 5.1 for available data on different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
When used as monotherapy, in combination with metformin, in
combination with thiazoli-
dinedione, in combination with metformin and a sulphonylurea, or in
combination with insulin
(with or without metformin), the recommended daily dose of
vildagliptin is 100 mg, adminis-
tered as one dose of 50 mg in the morning and one dose of 50 mg in the
evening.
When used in dual combination with a sulphonylurea, the recommended
dose of vildagliptin
is 50 mg once daily administered in the morning. In this patient
population, vildagliptin 100
mg daily was no more effective than vildagliptin 50 mg once daily.
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When used in combination with a sulphonylurea, a lower dose of the
sulphonylurea may be
considered to reduce the risk of hypoglycaemia.
Doses higher than 100 mg are not recommended.
If a dose of Vildagliptin Denk is missed, it should be taken as soon
as the patient remembers.
A double dose should not be taken on the same day.
The safety and efficacy