Vildagliptin Krka 50 mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
04-09-2023
Summary of Product characteristics
(SPC)
01-11-2023
Active ingredient:
Vildagliptin
Available from:
KRKA, d.d., Novo mesto
ATC code:
A10BH; A10BH02
INN (International Name):
Vildagliptin
Dosage:
50 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Dipeptidyl peptidase 4 (DPP-4) inhibitors; vildagliptin
Authorization status:
Not marketed
Authorization date:
2018-01-12
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VILDAGLIPTIN KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Vildagliptin Krka
3.
How to take Vildagliptin Krka
4.
Possible side effects
5.
How to store Vildagliptin Krka
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN KRKA IS AND WHAT IT IS USED FOR
The active substance of Vildagliptin Krka, vildagliptin, belongs to a
group of medicines called “oral
antidiabetics”.
Vildagliptin Krka 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 Krka 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 KRKA WORKS
Vildagliptin Krka works by making the pancreas produce more i
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
01 November 2023
CRN00CVGZ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vildagliptin Krka 50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg vildagliptin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, round tablets with bevelled edges, 8 mm in
diameter, thickness 3.2 – 5.0 mm.
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
contraindications 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 thiazolidinedione, 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, administered 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.
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 Krka 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 of vildagliptin as triple oral therapy in
combination with metformin and a thiaz
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