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HSA Approval

Trajenta Film-Coated Tablets 5mg

SIN14101P

Trajenta Film-Coated Tablets 5mg

Trajenta Film-Coated Tablets 5mg

February 8, 2012

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Regulatory Information

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**Dosage and Administration** **Adults** The recommended dose is 5 mg once daily. TRAJENTA can be taken with or without a meal at any time of the day. **Renal impairment** No dose adjustment is required for patients with renal impairment. **Hepatic Impairment** No dose adjustment is required for patients with hepatic impairment. **Elderly** No dose adjustment is necessary. Experience in patients older than > 75 years of age is limited. **Children and adolescents** TRAJENTA is not recommended for use in children below 18 years due to lack of data on safety and efficacy. **_Missed dose_** If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken at the same day.

ORAL

Medical Information

**Indications** TRAJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (see Clinical Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)

**Contraindications** Hypersensitivity to the active ingredient or any of the excipients.

A10BH05

linagliptin

Manufacturer Information

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

West-Ward Columbus Inc.

Dragenopharm Apotheker Püschl GmbH

Active Ingredients

Linagliptin

5.000mg

Linagliptin

Documents

Package Inserts

Package Insert.pdf

Approved: November 16, 2022

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