EUCREAS Film-coated tablet (2022)

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Περιεχόμενα

1. Name of the medicinal product

Eucreas 50 mg/850 mg film-coated tablets. Eucreas 50 mg/1000 mg film-coated tablets.

2. Qualitative and quantitative composition

Eucreas 50 mg/850 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). Eucreas 50 mg/1000 ...

3. Pharmaceutical form

Film-coated tablet. Eucreas 50 mg/850 mg film-coated tablets: Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with NVR on one side and SEH on the other side. Eucreas 50 mg/1000 ...

4.1. Therapeutic indications

Eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. ...

4.2. Posology and method of administration

Posology Adults with normal renal function (GFR ≥90 ml/min) The dose of antihyperglycaemic therapy with Eucreas should be individualised on the basis of the patients current regimen, effectiveness and ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe ...

4.4. Special warnings and precautions for use

General Eucreas is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes. Lactic acidosis Lactic acidosis, a very rare but serious metabolic ...

4.5. Interaction with other medicinal products and other forms of interaction

There have been no formal interaction studies for Eucreas. The following statements reflect the information available on the individual active substances. Vildagliptin Vildagliptin has a low potential ...

4.6. Pregnancy and lactation

Pregnancy There are no adequate data from the use of Eucreas in pregnant women. For vildagliptin studies in animals have shown reproductive toxicity at high doses. For metformin, studies in animals have ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines.

4.8. Undesirable effects

Summary of the safety profile Safety data were obtained from a total of 6 197 patients exposed to vildagliptin/metformin in randomised placebo-controlled trials. Of these patients, 3 698 patients received ...

4.9. Overdose

No data are available with regard to overdose of Eucreas. Vildagliptin Information regarding overdose with vildagliptin is limited. Symptoms Information on the likely symptoms of overdose with vildagliptin ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs ATC code: A10BD08 Mechanism of action Eucreas combines two antihyperglycaemic agents with ...

5.2. Pharmacokinetic properties

Eucreas Absorption Bioequivalence has been demonstrated between Eucreas at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride ...

5.3. Preclinical safety data

Animal studies of up to 13-week duration have been conducted with the combined substances in Eucreas. No new toxicities associated with the combination were identified. The following data are findings ...

6.1. List of excipients

Tablet core: Hydroxypropylcellulose Magnesium stearate Film-coating: Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000 Talc

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

PA/alu/PVC/alu: 2 years. PCTFE/PVC/alu: 18 months. PVC/PE/PVDC/alu: 18 months.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package (blister) in order to protect from moisture.

6.5. Nature and contents of container

Aluminium/Aluminium (PA/alu/PVC/alu) blister: Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

8. Marketing authorization number(s)

Eucreas 50 mg/850 mg film-coated tablets: EU/1/07/425/001–006 EU/1/07/425/013–015 EU/1/07/425/019–024 EU/1/07/425/031–033 EU/1/07/425/037–045 Eucreas 50 mg/1000 mg film-coated tablets: EU/1/07/425/007–012 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14 November 2007 Date of latest renewal: 23 July 2012

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