Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville 7551
LENIZAK film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Almost white to slightly yellow, oblong, film-coated tablets with a break-mark on one side and a debossed “M” on the other side. The dimension of the film-coated tablet is approximately 14 mm in length and 6 mm in width. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each tablet contains 75 mg tramadol hydrochloride and 25 mg dexketoprofen.
Sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexketoprofen |
Dexketoprofen belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of Dexketoprofen is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators such as kinins, causing an indirect action which would be additional to the direct action. |
|
| 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 |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Polyvinyl alcohol |
Film-coated tablets are provided in blister packs, in three alternative materials:
PA/Aluminium/PVC//Aluminium blister
PVC/PE/PVDC//Aluminium blister
PVC/PVDC//Aluminium blister
Pack sizes: 2, 4, 10, 15, 20, 30, 50, 100 film-coated tablets/pack or multipacks containing 500 (5 packs of 100) film-coated tablets/pack.
Not all pack sizes may be marketed.
LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville 7551
54/2.8/0539.538
18 May 2021
| Drug | Countries | |
|---|---|---|
| LENIZAK | South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
