JANUMET Film-coated tablet (2023)

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Περιεχόμενα

1. Name of the medicinal product

Janumet 50 mg/850 mg film-coated tablets. Janumet 50 mg/1,000 mg film-coated tablets.

2. Qualitative and quantitative composition

Janumet 50 mg/850 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. Janumet 50 mg/1,000 ...

3. Pharmaceutical form

Film-coated tablet (tablet). Janumet 50 mg/850 mg film-coated tablets: Capsule-shaped, pink film-coated tablet with 515 debossed on one side. Janumet 50 mg/1,000 mg film-coated tablets: Capsule-shaped, ...

4.1. Therapeutic indications

For adult patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose ...

4.2. Posology and method of administration

Posology The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patients current regimen, effectiveness, and tolerability while not exceeding the maximum recommended ...

4.3. Contraindications

Janumet is contraindicated in patients with: hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8); any type of acute metabolic acidosis ...

4.4. Special warnings and precautions for use

General Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. Acute pancreatitis Use of DPP-4 inhibitors has been associated with ...

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

Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of sitagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses of sitagliptin (see section 5.3). A limited amount ...

4.7. Effects on ability to drive and use machines

Janumet has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported ...

4.8. Undesirable effects

Summary of the safety profile There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated ...

4.9. Overdose

During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered. Minimal increases in QTc, not considered to be clinically relevant, were observed in one ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose lowering drugs ATC code: A10BD07 Janumet combines two antihyperglycaemic medicinal products with complementary mechanisms ...

5.2. Pharmacokinetic properties

Janumet A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate ...

5.3. Preclinical safety data

No animal studies have been conducted with Janumet. In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed ...

6.1. List of excipients

Tablet core: Microcrystalline cellulose (E460) Povidone K29/32 (E1201) Sodium lauryl sulfate Sodium stearyl fumarate Film coating: Poly(vinyl alcohol) Macrogol 3350 Talc (E553b) Titanium ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets. Pack ...

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

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

8. Marketing authorization number(s)

Janumet 50 mg/850 mg film-coated tablets: EU/1/08/455/001 EU/1/08/455/002 EU/1/08/455/003 EU/1/08/455/004 EU/1/08/455/005 EU/1/08/455/006 EU/1/08/455/007 EU/1/08/455/015 EU/1/08/455/017 EU/1/08/455/019 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 16 July 2008 Date of latest renewal: 13 March 2013

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