Source: Health Sciences Authority (SG) Revision Year: 2021 Publisher: <u>Product owner:</u> AmediusTec Ltd., 4 Loyang Way 1, Singapore 508708 <u>Manufacturer:</u> Dexcel Ltd., 1 Dexcel Street, Or-Akiva 3060000, Israel
Regadex.
| Pharmaceutical Form |
|---|
|
25 mg: Size 4, hard gelatin capsule, white cap and white body. “DP25” imprinted on body in black. 50 mg: Size 3, hard gelatin capsule, grey cap and white body. “DP50” imprinted on body in black. 75 mg: Size 4, hard gelatin capsule, brown cap and white body. “DP75” imprinted on body in black. 150 mg: Size 2, hard gelatin capsule, white cap and white body. “DP150” imprinted on body in black. 300 mg: Size 0, hard gelatin capsule, brown cap and white body. “DP300” imprinted on body in black. |
Each hard capsule contains 25 mg, 50 mg, 75 mg, 150 mg or 300 mg of pregabalin.
| Active Ingredient | Description | |
|---|---|---|
| Pregabalin |
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system. |
| List of Excipients |
|---|
|
For 25 mg: Capsule content: Strach, pregelatinized, Mannitol, Magnesium stearate Capsule shell: Gelatin, Titanium dioxide (E171) Black ink: Shellac, Propylene glycol (E1520), Strong ammonia solution (E527), Potassium Hydroxide, Black iron oxide (E172) For 50 mg: Capsule content: Strach, pregelatinized, Mannitol, Magnesium stearate Capsule shell: Gelatin, Titanium dioxide (E171) , Allura red AC (E129) and Brilliant blue FCF (E133) Black ink: Shellac, Propylene glycol (E1520), Strong ammonia solution (E527), Potassium Hydroxide, Black iron oxide (E172) For 75 mg: Capsule content: Strach, pregelatinized, Magnesium stearate Capsule shell: Gelatin, Titanium dioxide (E171), Red Iron oxide (E172), Yellow iron oxide (E172), Black iron oxide (E172) Black ink: Shellac, Propylene glycol (E1520), Strong ammonia solution (E527), Potassium Hydroxide, Black iron oxide (E172) For 150 mg: Capsule content: Strach, pregelatinized, Magnesium stearate Capsule shell: Gelatin, Titanium dioxide (E171) Black ink: Shellac, Propylene glycol (E1520), Strong ammonia solution (E527), Potassium Hydroxide, Black iron oxide (E172) For 300 mg: Capsule content: Strach, pregelatinized, Magnesium stearate Capsule shell: Gelatin, Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Black iron oxide (E172) Black ink: Shellac, Propylene glycol (E1520), Strong ammonia solution (E527), Potassium Hydroxide, Black iron oxide (E172) |
The hard capsules are packed in 7 capsules/ Alu-Alu blister x 8.
Product owner: AmediusTec Ltd., 4 Loyang Way 1, Singapore 508708
Manufacturer: Dexcel Ltd., 1 Dexcel Street, Or-Akiva 3060000, Israel
| Drug | Countries | |
|---|---|---|
| REGADEX | Singapore |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
