Linagliptine Viatris 5 mg, filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

LINAGLIPTINE 5 mg/stuk

INN (Mezinárodní Name):

LINAGLIPTINE 5 mg/stuk

Léková forma:

Filmomhulde tablet

Složení:

CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Podání:

Oraal gebruik

Datum autorizace:

1900-01-01

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINAGLIPTINE VIATRIS 5 MG, FILMOMHULDE TABLETTEN
linagliptine
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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] 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.
[Invented name] 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.
[Invented name] 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 [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]
-
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 [Invented name]
if you:
-
have type 1 diab

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linagliptine Viatris 5 mg, filmomhulde tabletten
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
[Invented name] 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