JANUVIA Film-coated tablet (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Januvia 25 mg film-coated tablets. Januvia 50 mg film-coated tablets. Januvia 100 mg film-coated tablets.

Qualitative and quantitative composition

Januvia 25 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin. Januvia 50 mg film-coated tablets: Each tablet contains sitagliptin ...

Pharmaceutical form

Film-coated tablet (tablet). Januvia 25 mg film-coated tablets: Round, pink film-coated tablet with 221 on one side. Januvia 50 mg film-coated tablets: Round, light beige film-coated tablet ...

Therapeutic indications

For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin ...

Posology and method of administration

Posology The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a PPARγ agonist, the dose of metformin and/or PPARγ agonist should be maintained, and Januvia administered ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).

Special warnings and precautions for use

General Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Acute pancreatitis Use of DPP-4 inhibitors has been associated with a risk of developing ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low. In vitro ...

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 (see section 5.3). The potential risk for humans is ...

Effects on ability to drive and use machines

Januvia 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. ...

Undesirable effects

Summary of the safety profile Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. Hypoglycaemia has been reported in combination with sulphonylurea (4.7% ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors ATC code: A10BH01 Mechanism of action Januvia is a member of a class of oral anti-hyperglycaemic ...

Pharmacokinetic properties

Absorption Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, ...

Preclinical safety data

Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level. Incisor teeth ...

List of excipients

Tablet core: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous (E341) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium stearyl fumarate Film coating: ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 1 film-coated tablets in perforated unit dose blisters. 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

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

Marketing authorization number(s)

Januvia 25 mg film-coated tablets: EU/1/07/383/001 EU/1/07/383/002 EU/1/07/383/003 EU/1/07/383/004 EU/1/07/383/005 EU/1/07/383/006 EU/1/07/383/019 EU/1/07/383/020 Januvia 50 mg film-coated tablets: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012

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