PHYSEPTONE MIXTURE Oral solution Ref.[9784] Active ingredients: Methadone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

Product name and form

Methadone Mixture DTF 1mg/ml.

Physeptone Mixture.

Pharmaceutical Form

A clear bright yellowish green oral solution.

Qualitative and quantitative composition

Each ml contains methadone hydrochloride 1mg.

Excipients with known effect:

Sunset yellow (E110) 0.008mg/ml, tartrazine (E102) 0.07mg/ml, demineralised liquid sucrose 441.5mg/ml.

Contains less than 1mmol/ml sodium per maximum daily dose, i.e. essentially 'sodium-free.'

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methadone

Methadone is a synthetic opioid analgesic similar to morphine although less sedative. It acts on the CNS system and smooth muscles via the peripheral nervous system.

List of Excipients

Demineralised liquid sucrose
Glycerol (E422)
Green S (E142)
Tartrazine (E102)
Sunset yellow (E110)
Hydrochloric acid (E507)
Sodium benzoate (E211)
Sodium hydroxide (pH adjustment)
Purified water

Pack sizes and marketing

Amber glass Winchester bottle with a tamper evident child proof lined cap. 500, 100, 50 and 30ml pack sizes are available. Or HDPE plastic bottle with lined cap. The plastic bottles come in four different sizes; the 1L and 500ml bottles are sealed with a tamper evident and child resistant cap whereas the 2.5 and 5 L bottles are sealed with a tamper evident cap or tamper evidence is provided with a tamper evident sticker.

The product is not supplied with a patient leaflet but patient leaflets are available to the prescriber and dispenser in a tear off pad format.

The material for the construction of the closures is a HDPE with an EP wad.

Not all pack sizes may be marketed.

Marketing authorization holder

T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

Marketing authorization dates and numbers

PL 01883/0018

Date of first authorisation: 20 January 1983

Drugs

Drug Countries
PHYSEPTONE Australia, United Kingdom

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