JARDIANCE DUO 12.5 MG850 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Beschikbaar vanaf:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC-code:

A10BD20

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

EMPAGLIFLOZIN 12.5 MG; METFORMIN HYDROCHLORIDE 850 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Therapeutisch gebied:

METFORMIN AND EMPAGLIFLOZIN

therapeutische indicaties:

Jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Autorisatie datum:

2020-12-31

Bijsluiter

-
Regulations (Preparations)
Patient leaflet in accordance with the Pharmacists'
1986
This medicine is dispensed with a physician’s prescription only
Jardiance Duo
®
5 mg / 850 mg
Each film-coated tablet contains
5
mg
empagliflozin and 850 mg metformin
hydrochloride (metformin HCl)
Jardiance Duo
®
12.5 mg / 850 mg
Each film-coated tablet contains 12.5 mg
empagliflozin and 850 mg metformin
hydrochloride (metformin HCl)
Jardiance Duo
®
5 mg / 1000 mg
Each film-coated tablet contains
5
mg
empagliflozin and 1000 mg metformin
hydrochloride (metformin HCl)
Jardiance Duo
®
12.5 mg / 1000 mg
Each film-coated tablet contains
5
12.
mg
empagliflozin and 1000 mg metformin
hydrochloride (metformin HCl)
Film-coated tablets
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, consult your physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
Jardiance Duo is not intended for patients with type 1 diabetes or for
patients with
diabetic ketoacidosis.
Important information:
Metformin, one of the ingredients in Jardiance Duo, may 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 a
hospital. Stop taking Jardiance 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?
Jardiance Duo is indicated, as an adjunct to diet and exercise, to
improve the control
of blood sugar levels in adults aged 18 and over with type 2 diabetes
mellitus whose
sugar levels are not controlled by treatment with metformin al

Productkenmerken

Jardiance Duo
Updated prescribing information
5/850, 5/1000, 12.5/850, 12.5/1000
July 2023
1
JARDIANCE DUO
PRESCRIBING INFORMATION
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 JARDIANCE DUO
and institute general supportive measures in a hospital setting.
Prompt hemodialysis is
recommended _[see Warnings and Precautions (8.1)]._
1
NAME OF THE MEDICINAL PRODUCT
Jardiance duo
5mg/850mg
Jardiance duo
5mg/1000mg
Jardiance duo
12.5mg/850mg
Jardiance duo
12.5mg/1000mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jardiance duo 5 mg/850 mg film-coated tablets
Each tablet contains 5 mg empagliflozin and 850 mg metformin
hydrochloride.
Jardiance duo 5 mg/1,000 mg fil