TRAMACET Film coated tablet Ref.[10453] Active ingredients: Paracetamol Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex UB11 1BD, United Kingdom

Product name and form

TRAMACET 37.5mg/325mg Film coated tablets.

Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pale yellow film-coated tablet, marked with the manufacturer’s logo on one side and ‘T5’ on the other side.

Qualitative and quantitative composition

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

Excipients: One film coated tablet contains 1.878 mg lactose (=1.784 mg lactose).

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 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:

Powdered cellulose
Pregelatinised starch
Sodium starch glycolate (Type A)
Maize starch
Magnesium stearate

Film-coating:

Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Macrogol 6000
Yellow iron oxide (E172)
Propylene glycol
Talc

Pack sizes and marketing

Tramadol hydrochloride/Paracetamol tablets are packed in paper/PET/aluminium-PVC blisters.

Box of 2 tablets, of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets.

Not all packaging sizes may be marketed.

Marketing authorization holder

Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex UB11 1BD, United Kingdom

Marketing authorization dates and numbers

PL 21727/0039

Date of first authorisation: 25 September 2003
Date of last renewal: 22/06/2007

Drugs

Drug Countries
TRAMACET Ecuador, Hong Kong, Mexico, United Kingdom, South Africa

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