LENIZAK Film-coated tablet Ref.[51186] Active ingredients: Dexketoprofen Tramadol

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

Product name and form

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.

Qualitative and quantitative composition

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 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

Tablet core:

Microcrystalline cellulose
Maize starch, pregelatinised
Croscarmellose sodium
Sodium stearyl fumarate
Silica colloidal, anhydrous

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol/PEG 3350
Talc

Pack sizes and marketing

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.

Marketing authorization holder

LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville 7551

Marketing authorization dates and numbers

54/2.8/0539.538

18 May 2021

Drugs

Drug Countries
LENIZAK South Africa

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