AMFEXA Tablet Ref.[27655] Active ingredients: Dexamfetamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: MEDICE Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

Product name and form

Amfexa 5 mg Tablets.

Pharmaceutical Form

Tablets.

White, round, cloverleaf-shaped tablets of 8.4 mm diameter with a notched, cross-scored line on the top side and a cross-scored line embossed with “S” on each quarter on the rear side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 5 mg dexamfetamine sulfate.

Excipient with known effect:

Isomalt (E953) 147.5 mg per tablet

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dexamfetamine

Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

List of Excipients

Isomalt (E953)
Crospovidone
Magnesium stearate

Pack sizes and marketing

Boxes containing 20, 30, 50, or 100 tablets in PVC/PE/PVdC clear blisters heat sealed to aluminium foil.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDICE Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

Marketing authorization dates and numbers

PL 11243/0021

15/09/2014

Drugs

Drug Countries
AMFEXA Netherlands, United Kingdom

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