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
DOLTREX 50 MG 50 mg (Film-coated tablet).
| Pharmaceutical Form |
|---|
|
Film-coated tablet. DOLTREX 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. |
DOLTREX 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 | Description | |
|---|---|---|
| Tramadol |
Tramadol, a cyclohexanol derivative, 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 contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. |
| List of Excipients |
|---|
|
Colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and coating agent containing hypromellose 6 cPs, polyethylene glycol 400, polysorbate 80 and titanium dioxide. 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
DOLTREX 50 MG: 52/2.9/0749
DOLTREX 50 MG: 15 FEBRUARY 2022
| Drug | Countries | |
|---|---|---|
| DOLTREX | South Africa |
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