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 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 |
|---|
|
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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