CETVIO Film-coated tablet Ref.[51088] Active ingredients: Paracetamol Tramadol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Teva Pharmaceuticals (Pty) Ltd, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090

Product name and form

CETVIO 37,5 mg/ 325 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Peach, capsule-shaped, film-coated, tablet, engraved “A325” on one side and “T37.5” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 37,5 mg tramadol hydrochloride and 325 mg paracetamol.

CETVIO is sugar free.

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:

Hydroxypropyl cellulose
Macrogol poly(vinyl alcohol) grafted copolymer
Magnesium stearate
Microcrystalline cellulose 101
Microcrystalline cellulose 102
Sodium starch glycolate, Type A
Starch, pregelatinised

Tablet coating:

Opadry II Beige 85F97409 consisting of:
Iron oxide yellow
Iron oxide red
Iron oxide black
Macrogol/PEG 3350
Polvinyl alcohol – Part. hydrolysed
Talc
Titanium dioxide

Pack sizes and marketing

CETVIO is packaged as follows:

PVC/Aluminium blister packs:

PVC Film Clear.

Foil Aluminium-Silver Plain.

The blister pack is packed into a carton box.

Pack sizes: 30 and 60.

Bottles:

White, round HDPE Bottles with polypropylene cap LNP HS LP-E/PV.

Pack sizes: 60 and 100.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals (Pty) Ltd, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090

Marketing authorization dates and numbers

47/2.9/0139

08 March 2022

Drugs

Drug Countries
CETVIO South Africa

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