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JENTADUETO Film-coated tablet (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Jentadueto 2.5 mg/850 mg film-coated tablets. Jentadueto 2.5 mg/1,000 mg film-coated tablets.

2. Qualitative and quantitative composition

<u>Jentadueto 2.5 mg/850 mg film-coated tablets:</u> Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride. <u>Jentadueto 2.5 mg/1,000 mg film-coated tablets:</u> Each tablet ...

3. Pharmaceutical form

Film-coated tablet (tablet). <u>Jentadueto 2.5 mg/850 mg film-coated tablets:</u> Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with D2/850 on one side and the company logo ...

4.1. Therapeutic indications

Jentadueto is indicated in adults 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 ...

4.2. Posology and method of administration

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

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 Jentadueto should not be used in patients with type 1 diabetes. Hypoglycaemia When linagliptin was added to a sulphonylurea on a background of metformin, the incidence of hypoglycaemia was increased ...

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

No interaction studies have been performed. However, such studies have been conducted with the individual active substances, i.e. linagliptin and metformin. Co-administration of multiple doses of linagliptin ...

4.6. Fertility, pregnancy and lactation

Pregnancy The use of linagliptin has not been studied in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). A limited ...

4.7. Effects on ability to drive and use machines

Jentadueto has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when Jentadueto is used in combination with other antidiabetic ...

4.8. Undesirable effects

Summary of the safety profile The safety of linagliptin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 6800 patients with type 2 diabetes ...

4.9. Overdose

Linagliptin During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were not associated with a dose dependent increase ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, combinations of oral blood glucose lowering drugs <b>ATC code:</b> A10BD11 Jentadueto combines two antihyperglycaemic medicinal products with complementary ...

5.2. Pharmacokinetic properties

Bioequivalence studies in healthy subjects demonstrated that the Jentadueto (linagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of linagliptin and metformin ...

5.3. Preclinical safety data

Linagliptin plus metformin General toxicity studies in rats for up to 13 weeks were performed with the co-administration of linagliptin and metformin. The only observed interaction between linagliptin ...

6.1. List of excipients

<u>Tablet core:</u> Arginine Copovidone Magnesium stearate Maize starch Silica, colloidal anhydrous <u>Jentadueto 2.5 mg/850 mg film-coated tablets:</u> <em>Film coating:</em> Hypromellose Titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. <u>Blister:</u>Store in the original package in order to protect from moisture. <u>Bottle:</u> Keep the bottle tightly ...

6.5. Nature and contents of container

Pack sizes of 10 1, 14 1, 28 1, 30 1, 56 1, 60 1, 84 1, 90 1, 98 1, 100 1 and 120 1 film-coated tablets and multipacks containing 120 (2 packs of 60 1), 180 (2 packs of 90 1), 180 (3 packs ...

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

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

8. Marketing authorization number(s)

<u>Jentadueto 2.5 mg/850 mg film-coated tablets:</u> EU/1/12/780/001 (10 1 film-coated tablets) EU/1/12/780/002 (14 1 film-coated tablets) EU/1/12/780/003 (28 1 film-coated tablets) EU/1/12/780/004 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 20 July 2012 Date of latest renewal: 22 March 2017

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