ZYDOL Soluble tablet Ref.[27761] Active ingredients: Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Grünenthal Ltd., 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, England, HP14 3FE, UK

Product name and form

ZYDOL 50mg Soluble Tablets.

Pharmaceutical Form

White to near white, round, flat tablets with bevelled edges, characteristic peppermint odour, engraved with ‘T4’ on one side, manufacturer’s logo on the other.

Qualitative and quantitative composition

Each ZYDOL soluble tablet contains 50 mg tramadol hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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

ZYDOL soluble tablets contain:

Microcrystalline cellulose
Maize starch
Saccharin sodium
Aniseed flavour
Peppermint flavour
Colloidal anhydrous silica
Magnesium stearate

Pack sizes and marketing

Aluminium/Polypropylene foil blisters.

Pack sizes of 10, 20 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Grünenthal Ltd., 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, England, HP14 3FE, UK

Marketing authorization dates and numbers

PL 21727/0006

14 February 2002

Drugs

Drug Countries
ZYDOL Australia, Ireland, United Kingdom

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