MEDOTRAMOL Film-coated tablet Ref.[50520] Active ingredients: Paracetamol Tramadol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Medotramol 37.5mg/325mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow coloured, film-coated, elongated tablets with “325” embossing on one side of the tablet.

Qualitative and quantitative composition

Each film-coated tablet contains 37.5mg tramadol hydrochloride and 325mg paracetamol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Paracetamol

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.
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:

Pregelatinised starch
Sodium starch glycolate
Microcrystalline cellulose
Magnesium stearate

Film-coating:

OPADRY yellow 15B82958 (hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), polysorbate 80).

Pack sizes and marketing

Medotramol is packed in PVC/PVDC Alu blisters.

Boxes of 10, 20, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

M.L.: 022288

Date of first authorization: 20/04/2016
Date of latest renewal: 24/08/2020

Drugs

Drug Countries
MEDOTRAMOL Cyprus
 
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