Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa, Tel: 0860-PHARMA (742 762) / +2721 707 7000
TAMOLTRA (37,5 mg/325 mg) film coated tablet.
TAMOLTRA FORTE (75 mg/650 mg) film coated tablet.
| Pharmaceutical Form |
|---|
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Film coated tablet. TAMOLTRA: Slightly yellow-brown, oval, convex film coated tablets. TAMOLTRA FORTE: Slightly orange, oval, biconvex film coated tablets widely scored on both sides. |
TAMOLTRA: Each film coated tablet contains tramadol hydrochloride 37,5 mg and paracetamol 325 mg.
TAMOLTRA FORTE: Each film coated tablet contains tramadol hydrochloride 75 mg and paracetamol 650 mg.
Sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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. |
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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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Tablet core: Magnesium stearate TAMOLTRA Film coating: Opadry Yellow 15B82958 composition: Hypromellose TAMOLTRA FORTE Film coating: Red iron oxide, E172 Opadry Yellow 15B82958 composition: Hypromellose |
TAMOLTRA is available in blister packs consisting of PVC/PVDC, white film and aluminium foil, with 20, 30 or 60 tablets packed in an outer carton.
TAMOLTRA FORTE is available in blister packs consisting of PVC/PVDC, white film and aluminium foil, with 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets packed in an outer carton.
Not all pack sizes may be marketed.
Pharma Dynamics (Pty) Ltd, 1st Floor Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa, Tel: 0860-PHARMA (742 762) / +2721 707 7000
TAMOLTRA: A46/2.9/0976
TAMOLTRA FORTE: A47/2.9/0926
TAMOLTRA: 27 July 2017
TAMOLTRA FORTE: 03 May 2022
| Drug | Countries | |
|---|---|---|
| TAMOLTRA | South Africa |
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