Nesina 6.25mg Film-Coated Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Alogliptin benzoate

Available from:

Takeda Malaysia Sdn Bhd

INN (International Name):

Alogliptin benzoate

Units in package:

2 x 14tablet Tablets; 2 x 14tablet Tablets

Manufactured by:

Takeda Ireland Limited

Summary of Product characteristics

1
D3 Proposed Package Insert
1. NAME OF THE MEDICINAL PRODUCT
Nesina 6 .2 5mg Film-Coated Tablet
Nesina 12.5mg Film -Coated Tablet
Nesina 25mg Film -Coated Tablet
2. NAME AND STRENGTH OF ACTIVE SUBSTANCES
Nesina is available in three dosage strengths: 6.25mg, 12.5mg and 25mg, per tablet. Each tablet contains 8.5mg,
17mg or 34mg of alogliptin benzoate, which is equivalent to 6.25mg, 12.5mg and 25mg, respectively of alogliptin and
the following excipients:
Excipients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium
stearate, hypromellose 2910, titanium dioxide, ferric oxide (red or yellow) , polyethylene glycol 8000 and printing ink
gray F1.
3. PRODUCT DESCRIPTION
Nesina is supplied as tablets that are oval, biconvex, film-coated and are distinguished both by color and dose
specific imprinted markings on one side.
• 6.2 5mg tablet – light pink with imprinted “TAK” and “ ALG-6.25” on one side
• 12.5mg tablet – yellow with imprinted “ TAK” and “ALG-12.5” on one side
• 25mg tablet – light red with imprinted “TAK” and “ALG -25” on one side
4. INDICATION
Nesina is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus (T2 DM)
• as monotherapy as an adjunct to diet and exercise in patients for whom metformin is inappropriate due to
contraindications or intolerance
• in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycemic
control
• in combination with a sulfonylurea (SU) when diet and exercise plus a SU alone do not provide adequate
glycemic control
• in combination with pioglitazone when diet and exercise plus pioglitazone alone do not provide adequate
glycemic control
• in combinati on with pioglitazone and metformin when diet and exercise plus dual therapy with these agents do
not provide adequate glycemic control
• in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin
(with or wit hout met