Dalmevin 50 mg Tablett

국가: 스웨덴

언어: 스웨덴어

출처: Läkemedelsverket (Medical Products Agency)

유효 성분:

vildagliptin

제공처:

Medochemie Ltd

ATC 코드:

A10BH02

INN (International Name):

vildagliptin

복용량:

50 mg

약제 형태:

Tablett

구성:

vildagliptin 50 mg Aktiv substans; laktos (vattenfri) Hjälpämne

처방전 유형:

Receptbelagt

제품 요약:

Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 112 tabletter; Blister, 180 tabletter; Blister, 336 tabletter

승인 상태:

Godkänd

승인 날짜:

2017-07-20

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DALMEVIN 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, pharmacist or
diabetes nurse.
-
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 Dalmevin is and what it is used for
2.
What you need to know before you take Dalmevin
3.
How to take Dalmevin
4.
Possible side effects
5.
How to store Dalmevin
6.
Contents of the pack and other information
1.
WHAT DALMEVIN IS AND WHAT IT IS USED FOR
The active substance of Dalmevin, vildagliptin, belongs to a group of
medicines called “oral
antidiabetics”.
Dalmevin 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 Dalmevin 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 DALMEVIN WORKS
Dalmevin works by making the pancreas produce more insulin and less
glucagon. This helps to
control the blood sugar level. This medicine

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dalmevin 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: each tablet contains 48 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to light yellowish, round flat bevel edged uncoated tablet plain
on both sides with diameter 8mm.
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 is missed, it should be taken as soon as the
patient remembers. A double dose
should not be taken on the same day.
2
The safety and efficacy of vildagliptin as triple oral therapy in
combination with metformin and a
thiazolidinedione ha