TRAJENTA DUO 2.5 MG 1000 MG

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Saatavilla:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC-koodi:

A10BA02

Lääkemuoto:

FILM COATED TABLETS

Koostumus:

LINAGLIPTIN 2.5 MG; METFORMIN HYDROCHLORIDE 1000 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Terapeuttinen ryhmä:

METFORMIN

Terapeuttinen alue:

METFORMIN

Käyttöaiheet:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. TRAJENTA-DUO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. TRAJENTA-DUO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRAJENTA-DUO.

Valtuutus päivämäärä:

2018-06-30

Pakkausseloste

Trajenta Duo 2.5/500 mg, 2.5/850 mg, 2.5/1000 mg
Patient information
Film-coated tablets
September 2023
2
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) – 1986
This medicine is dispensed with a physician’s prescription only
Trajenta Duo
®
2.5 mg/500 mg
Trajenta Duo
®
2.5 mg/850 mg
Trajenta Duo
®
2.5 mg/1000 mg
Film-coated tablets
Each Trajenta Duo 2.5
mg/500 mg film-coated tablet
contains:
Each Trajenta Duo 2.5
mg/850 mg film-coated tablet
contains:
Each Trajenta Duo 2.5
mg/1000 mg film-coated
tablet contains:
2.5 mg linagliptin,
500 mg metformin
hydrochloride
2.5 mg linagliptin,
850 mg metformin
hydrochloride
2.5 mg linagliptin,
1000 mg metformin
hydrochloride
Inactive ingredients and allergens in this medicine – see section 6
‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, contact your physician
or pharmacist. This medicine has been prescribed to treat your
illness. Do not pass it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
Important information:
Metformin, one of the ingredients in Trajenta Duo, can cause a rare
but serious side effect
called lactic acidosis (a build-up of lactic acid in the blood) which
may cause death. Lactic
acidosis is a medical emergency and must be treated in hospital. Stop
taking Trajenta Duo
and contact your physician right away or go to the nearest hospital
emergency room if you
experience symptoms of lactic acidosis (see also section 4 - ‘Side
effects’).
1.
What is this medicine intended for?
Trajenta Duo is intended, in addition to diet and physical exercise,
to improve control of
blood sugar levels in adults with type 2 diabetes mellitus for whom
combined treatment with
two active ingredients, linagliptin and metformin hydrochloride, is
appropriate.
Limitations of use: Trajenta Duo should not be used for the treatment
of type 1 diabetes

Valmisteyhteenveto

Trajenta duo
Prescribing Information
File coated tablets 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1,000mg
September 2023
PRESCRIBING INFORMATION
1 NAME OF THE MEDICINAL PRODUCT
TRAJENTA DUO 2.5 mg/500 mg
TRAJENTA DUO 2.5 mg/850 mg
TRAJENTA DUO 2.5 mg/1,000 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Linagliptin 2.5 mg and 500/850/1000 mg Metformin
HCl.
For the full list of excipients, see section “Description”.
3 PHARMACEUTICAL FORM
Film coated tablets.
WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis have
resulted in death,
hypothermia, hypotension, and resistant bradyarrhythmias. The onset of
metformin-
associated lactic acidosis is often subtle, accompanied only by
nonspecific symptoms such as
malaise, myalgias, respiratory distress, somnolence, and abdominal
pain. Metformin-
associated lactic acidosis was characterized by elevated blood lactate
levels (>5 mmol/Liter),
anion gap acidosis (without evidence of ketonuria or ketonemia), an
increased
lactate/pyruvate ratio; and metformin plasma levels generally >5
mcg/mL
[see Warnings
and Precautions (8.1)].
Risk factors for metformin-associated lactic acidosis include renal
impairment, concomitant
use of certain drugs (e.g., carbonic anhydrase inhibitors such as
topiramate), age 65 years
old or greater, having a radiological study with contrast, surgery and
other procedures,
hypoxic states (e.g., acute congestive heart failure), excessive
alcohol intake, and hepatic
impairment.
Steps to reduce the risk of and manage metformin-associated lactic
acidosis in these high
risk groups are provided in the full prescribing information
[see Dosage and Administration
(5.2), Contraindications (7), Warnings and Precautions (8.1), Drug
Interactions (10), and
Use in Specific Populations (11.6, 11.7)].
If metformin-associated lactic acidosis is suspected, immediately
discontinue Trajenta Duo
and institute general supportive measures in a hospital setting.
Prompt hemodialysis is
recommended
[see Warnings and Precautions (8.1)].