GALVUS 50 MG TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VILDAGLIPTIN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

VILDAGLIPTIN

Unit dalam pakej:

7Tablet Tablets; 28Tablet Tablets; 56 Tablet Tablets

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
GALVUS
®
VILDAGLIPTIN 50 MG TABLETS
WHAT IS IN THIS LEAFLET
1.
WHAT GALVUS IS USED FOR
2.
HOW GALVUS WORKS
3.
BEFORE YOU TAKE GALVUS
4.
HOW TO USE GALVUS
5.
WHILE USING GALVUS
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
GALVUS
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT GALVUS IS USED FOR
Each Galvus tablet contains 50 mg
of the active substance
vildagliptin.
Galvus is a medicine used to treat
patients with type 2 diabetes
whose condition cannot be
controlled by diet and exercise
alone. It helps to control the level
of sugar in the blood. Such
medicines are known as oral
antidiabetics.
Type 2 diabetes develops if the
body does not produce enough
insulin or if the insulin that your
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 that helps to
lower the level of sugar in your
blood, especially after meals.
Glucagon is a substance that
triggers the production of sugar by
the liver, causing the blood sugar
level to rise. The pancreas makes
both of these substances.
HOW GALVUS WORKS
Galvus works by making the
pancreas produce more insulin and
less glucagon. Galvus helps to
control the blood sugar level.
Your doctor will prescribe Galvus
either alone or in combination with
other antidiabetics depending on
your condition.
It is important that you continue to
follow the diet and/or exercise
recommended to you while you are
on treatment with Galvus.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
BEFORE YOU TAKE GALVUS
Follow all instructions given to
you by your doctor or pharmacist
carefully, even if they differ from
the information contained in this
leaflet.
_When you must not use it: _
•
If you are allergic
(hypersensitive) to vildagliptin
or any of the other ingredients
of Galvus.
_PREGNANT WOMEN _
Tell your doctor if you are
pregnant, if you think you might
be pregn

Ciri produk

Novartis
Page 2
Malaysia Package Insert
04-May-2022
Galvus
2
1.
NAME OF THE MEDICINAL PRODUCT
Galvus 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 47.82 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to light yellowish, round (8 mm diameter), flat-faced with
bevelled-edges, unscored tablet. One
side is debossed with “NVR”, and the other side with “FB”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galvus is indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with
type 2 diabetes mellitus:
•
as monotherapy
•
as combination therapy -
•
Initial combination with metformin when diabetes is not adequately
controlled by diet
and exercise alone
•
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.
Novartis
Page 3
Malaysia Package Insert
04-May-2022
Galvus
3
When used as initial combination therapy with metformin, the
recommended dose of Galvus is 50 m