Linagliptin Viatris

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Linagliptin

Tersedia dari:

Viatris Limited

Kode ATC:

A10BH05

INN (Nama Internasional):

Linagliptin

Bentuk farmasi:

Film-coated tablet

Area terapi:

linagliptin

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2024-02-09

Selebaran informasi

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINAGLIPTIN VIATRIS 5 MG FILM-COATED TABLETS
linagliptin
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
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Linagliptin Viatris is and what it is used for
2.
What you need to know before you take Linagliptin Viatris
3.
How to take Linagliptin Viatris
4.
Possible side effects
5.
How to store Linagliptin Viatris
6.
Contents of the pack and other information
1.
WHAT LINAGLIPTIN VIATRIS IS AND WHAT IT IS USED FOR
Linagliptin Viatris contains the active substance linagliptin which
belongs to a group of medicines
called “oral anti-diabetics”. Oral anti-diabetics are used to
treat high blood sugar levels. They work by
helping the body reduce the level of sugar in your blood.
Linagliptin Viatris is used for ‘type 2 diabetes’ in adults, if
the disease cannot be adequately controlled
with one oral anti-diabetic medicine (metformin or sulphonylureas) or
diet and exercise alone.
Linagliptin Viatris may be used together with other anti-diabetic
medicines e.g., metformin,
sulphonylureas (e.g., glimepiride, glipizide), empagliflozin, or
insulin.
It is important to keep following the advice about diet and exercise
that you have been given by your
doctor or nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINAGLIPTIN VIATRIS
DO NOT TAKE LINAGLIPTIN VIATRIS
-
if you are allergic to linagliptin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse be

Karakteristik produk

Health Products Regulatory Authority
09 February 2024
CRN00D9VW
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linagliptin Viatris 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg linagliptin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
A pink film-coated, round, biconvex tablet, debossed with "M" on one
side of the tablet and "LI" on the other side with a
diameter of approximately 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Linagliptin Viatris is indicated in adults with type 2 diabetes
mellitus as an adjunct to diet and exercise to improve glycaemic
control as:
Monotherapy

when metformin is inappropriate due to intolerance or contraindicated
due to renal impairment.
Combination therapy

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
The dose of linagliptin is 5 mg once daily. When linagliptin is added
to metformin, the dose of metformin should be
maintained, and linagliptin administered concomitantly.
When linagliptin is used in combination with a sulphonylurea or with
insulin, a lower dose of the sulphonylurea or insulin, may
be considered to reduce the risk of hypoglycaemia (see section 4.4).
_ _
Special populations
_Renal impairment_
For patients with renal impairment, no dose adjustment for linagliptin
is required.
_Hepatic impairment_
Pharmacokinetic studies suggest that no dose adjustment is required
for patients with hepatic impairment but clinical
experience in such patients is lacking.
_Elderly_
No dose adjustment is necessary based on age.
_Paediatric population_
A clinical trial did not establish efficacy in paediatric patients 10
to 17 years of age (see section 4.8, 5.1 and 5.2). Therefore,
treatment of children and ado