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JARDIANCE Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Jardiance 10 mg film-coated tablets. Jardiance 25 mg film-coated tablets.

Qualitative and quantitative composition

Jardiance 10 mg film-coated tablets: Each tablet contains 10 mg empagliflozin. Excipients with known effect: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous. Each tablet ...

Pharmaceutical form

Film-coated tablet (tablet). Jardiance 10 mg film-coated tablets: Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed with S10 on one side and the Boehringer Ingelheim logo on the other ...

Therapeutic indications

Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: As monotherapy when metformin is considered inappropriate ...

Posology and method of administration

Posology The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes. In patients tolerating ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Diabetic ketoacidosis Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including empagliflozin. In a ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Diuretics Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4). Insulin and ...

Pregnancy and lactation

Pregnancy There are no data from the use of empagliflozin in pregnant women. Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate ...

Effects on ability to drive and use machines

Jardiance has minor influence on the ability to drive and use machines. Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Jardiance ...

Undesirable effects

Summary of the safety profile A total of 15,582 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin, of which 10,004 patients received empagliflozin, ...

Overdose

Symptoms In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins ATC code: A10BK03 Mechanism of action Empagliflozin is a reversible, highly potent (IC<sub>50</sub> ...

Pharmacokinetic properties

Absorption The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes. After oral administration, empagliflozin was rapidly absorbed ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development. In long term toxicity studies in rodents ...

List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Film coating: Hypromellose Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/aluminium perforated unit dose blisters. Pack sizes of 7 1, 10 1, 14 1, 28 1, 30 1, 60 1, 70 1, 90 1, and 100 1 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization number(s)

Jardiance 10 mg film-coated tablets: EU/1/14/930/010 EU/1/14/930/011 EU/1/14/930/012 EU/1/14/930/013 EU/1/14/930/014 EU/1/14/930/015 EU/1/14/930/016 EU/1/14/930/017 EU/1/14/930/018 Jardiance 25 mg film-coated ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 May 2014 Date of latest renewal: 14 February 2019

Πηγαίο έγγραφο

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