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HSA Approval

LACIPIL TABLET 4 mg

SIN07934P

LACIPIL TABLET 4 mg

LACIPIL TABLET 4 mg

November 25, 1994

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

**Dosage and Administration** The initial dosage is 2 mg once daily. It should be taken at the same time each day, preferably in the morning, with or without food. The treatment of hypertension should be adapted to the severity of the condition, and according to individual response. The dose may be increased to 4 mg and if necessary to 6 mg, after adequate time has been allowed for the full pharmacological effect to occur. In practice this should not be less than three to four weeks, unless the clinical condition requires a more rapid upward titration. Treatment may be continued indefinitely. - **Hepatic impairment** No dose modification is required in patients with mild or moderate hepatic impairment. Insufficient data are available to make a recommendation for patients with severe hepatic impairment (see Warnings and Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Renal impairment** As lacidipine is not excreted by the kidneys the dose does not require modification in patients with renal impairment. - **Children** No experience has been gained with lacidipine in children. - **Elderly** No dose modification is required.

ORAL

Medical Information

**Indications** As a treatment of hypertension either alone or in combination with other antihypertensive agents, e.g. beta-blockers, diuretics and ACE inhibitors.

**Contraindications** - Hypersensitivity to any component of the preparation. - As with other dihydropyridines, _LACIPIL_ is contraindicated in patients with severe aortic stenosis.

C08CA09

lacidipine

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXO WELLCOME SA

Active Ingredients

LACIDIPINE

4 mg

Lacidipine

Documents

Package Inserts

Lacipil Tablet PI.pdf

Approved: January 4, 2017

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LACIPIL TABLET 4 mg - HSA Approval | MedPath