Trajenta

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

linagliptin

Saatavilla:

Boehringer Ingelheim International GmbH

ATC-koodi:

A10BH05

INN (Kansainvälinen yleisnimi):

linagliptin

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-08-23

Pakkausseloste

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAJENTA 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 Trajenta is and what it is used for
2.
What you need to know before you take Trajenta
3.
How to take Trajenta
4.
Possible side effects
5.
How to store Trajenta
6.
Contents of the pack and other information.
1.
WHAT TRAJENTA IS AND WHAT IT IS USED FOR
Trajenta 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.
Trajenta 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. Trajenta 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 TRAJENTA
DO NOT TAKE TRAJENTA
-
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 before taking Trajenta if
you:

have type 1 diabetes (your body does not produce any insulin) or
diabetic ketoacidosis

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trajenta 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of linagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
8 mm diameter round, light red film-coated tablet debossed with
“D5” on one side and the Boehringer
Ingelheim logo on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trajenta 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 adolescents with
linagliptin is not recommended.
Linagliptin has not been studied in paediatric patients und