JARDIANCE DUO 12.5 MG500 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

متاح من:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC رمز:

A10BD20

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

EMPAGLIFLOZIN 12.5 MG; METFORMIN HYDROCHLORIDE 500 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

المجال العلاجي:

METFORMIN AND EMPAGLIFLOZIN

الخصائص العلاجية:

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.

تاريخ الترخيص:

2017-09-27

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is to be supplied upon physician’s prescription only
JARDIANCE DUO
™ 5 MG / 500 MG
Each tablet contains
5
mg empagliflozin
and 500 mg metformin hydrochloride
(metformin HCl)
JARDIANCE DUO
™ 12.5 MG / 500 MG
Each tablet contains
5
12.
mg empagliflozin
and 500 mg metformin hydrochloride
(metformin HCl)
JARDIANCE DUO
™ 5 MG / 850 MG
Each tablet contains
5
mg empagliflozin
and 850 mg metformin hydrochloride
(metformin HCl)
JARDIANCE DUO
™ 12.5 MG / 850 MG
Each tablet contains 12.5 mg empagliflozin
and 850 mg metformin hydrochloride
(metformin HCl)
JARDIANCE DUO
™ 5 MG / 1000 MG
Each tablet contains
5
mg empagliflozin
and 1000 mg metformin hydrochloride
(metformin HCl)
JARDIANCE DUO
™ 12.5 MG / 1000 MG
Each tablet contains
5
12.
mg empagliflozin
and 1000 mg metformin hydrochloride
(metformin HCl)
FILM-COATED TABLETS
*Inactive ingredients and allergens in the 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 for your treatment. Do not pass it
on to others. It
may harm them, even if it seems to you that their medical condition is
similar.
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 a serious
side effect called lactic acidosis, which is manifested by
accumulation of lactic acid in
the blood and may cause death. Lactic acidosis is a medical emergency
and must be
treated in a hospital. Stop taking Jardiance Duo and consult your
physician right
away if you get any of the signs of lactic acidosis (see also section
2 - "Special
warnings related to the use of the medicine" and section 4 – "Side
effects").
1.
WHAT IS

خصائص المنتج

Jardiance Duo
Updated patient information
5/500, 5/850, 5/1000, 12.5/500, 12.5/850, 12.5/1000
Mar 2020
1
THE FORMAT OF THIS LEAFLET WAS DEFINED BY MOH AND ITS CONTENT CHECKED
AND APPROVED BY MOH IN NOVEMBER 2017 AND UPDATED ACCORDING TO MOH
GUIDELINES IN MAR 2020
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 (10.2), 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/500mg film-coated tablets
Jardiance duo
5mg/850mg film-coated tablets
Jardiance duo
5mg/1000mg film-coated