Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
MAKLODOL 50 MG (Film-coated tablet).
| Pharmaceutical Form |
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Film-coated tablet. MAKLODOL 50 MG film-coated tablet: White to off-white, capsule shaped, biconvex, film coated tablets debossed with “ML 4” on one side and plain on other side. |
MAKLODOL 50 MG Film-coated tablet.
Each film-coated tablet contains tramadol hydrochloride 50 mg. Contains sugar (Lactose monohydrate 125.30 mg).
Excipients: For a full list of excipients, see section 6.1.
| Active Ingredient |
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Tramadol is a centrally acting opioid analgesic. It is a non selective pure agonist at μ-, δ- and κ-opioid receptors with a higher affinity for the μ-receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. |
| List of Excipients |
|---|
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Colloidal silicon dioxide and coating agent containing Hypromellose 6 cPs Contains sugar (lactose). |
Container Pack:
Tablets are packed in a round white opaque plastic container (HDPE) and are closed with a white child resistant closure, packed in an outer carton. Pack sizes include 100 tablets
Blister Pack:
Clear, transparent PVC 250 μm as the forming material and silver coloured, plain 25 μm aluminium foil/6 – 8 gsm HSL in a pre-printed outer carton.
Not all packs and pack sizes are necessarily marketed.
Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
MAKLODOL 50 MG: 52/2.9/0750.749
MAKLODOL 50 MG: 15 FEBRUARY 2022
| Drug | Countries | |
|---|---|---|
| MAKLODOL | South Africa |
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