Source: Registered Drug Product Database (NG) Publisher: Importer: MOREHOPE PHARMA NIGERIA LIMITED, NO. 1 OMOLABAKEADEOTI STREET, AJAO ESTATE, ISOLO, LAGOS STATE, NIGERIA Manufacturing Site: MCW HEALTHCARE PVT LTD., 286, 287-A, 287-B, SECTOR-E, INDUSTRIAL AREA SANWAR ROAD, INDORE, INDIA
SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets.
| Pharmaceutical Form |
|---|
|
Green coloured, oval shape, uncoated tablet having break line on one side of each tablet. |
Each uncoated tablet contains:
Paracetamol BP (325 mg)
Diclofenac Sodium BP (50 mg)
Colour: Approved colour used. (In House) (- )
Excipients (In House) (- QS)
Batch Size: 7,50,000 Tablets
| Sr. No. | Ingredients | Specification | Label Claim (In mg) | % Overages | Qty / Batch in (Kg) | Reason for inclusion |
|---|---|---|---|---|---|---|
| Mixing Material | ||||||
| 1. | Paracetamol | BP | 325 | 375.000 | Medicament | |
| 2. | Diclofenac Sodium | BP | 50 | 37.500 | Medicament | |
| 3. | Maize Starch | BP | 115.000 | Diluent, Disintegrating Agent or Binder | ||
| 4. | Dibasic Calcium Phosphate | BP | 85.000 | Filler and Diluent | ||
| Paste Material | ||||||
| 5. | Maize Starch | BP | 22.500 | Diluent, Disintegrating Agent or Binder | ||
| 6. | P.V.P.K-30 | BP | 6.250 | Binder | ||
| 7. | Methyl Paraben | BP | 0.825 | Preservative | ||
| 8. | Propyl Paraben | BP | 0.080 | Preservative | ||
| 9. | Col Brilliant Blue Supra | BP | 0.440 | Colorant | ||
| 10. | Colour Tartrazine Supra | BP | 0.095 | Colorant | ||
| 11. | Purified Water | BP | 150.000 | Solvent | ||
| Lubrication | ||||||
| 12. | Purified Talcum | BP | 12.460 | Lubricant | ||
| 13. | Magnesium Stearate | BP | 6.620 | Lubricant | ||
| 14. | Sodium Starch Glycolate | BP | 6.180 | Lubricant | ||
| 15. | Sodium Lauryl Sulphate | BP | 2.540 | Lubricant | ||
| Active Ingredient |
|---|
|
Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms. |
|
Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain. |
| List of Excipients |
|---|
|
Maize starch |
1X10 Tablets.
Importer:
MOREHOPE PHARMA NIGERIA LIMITED, NO. 1 OMOLABAKEADEOTI STREET, AJAO ESTATE, ISOLO, LAGOS STATE, NIGERIA
Manufacturing Site:
MCW HEALTHCARE PVT LTD., 286, 287-A, 287-B, SECTOR-E, INDUSTRIAL AREA SANWAR ROAD, INDORE, INDIA
NAFDAC Registration Number B4-9193
| Drug | Countries | |
|---|---|---|
| SOCOMOL | Nigeria |
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