HYDREA Capsule, hard Ref.[116210] Active ingredients: Hydroxycarbamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2025  Publisher: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Product name and form

Hydrea 500 mg Hard Capsules.

Pharmaceutical Form

Capsule, hard.

Size 0 hard gelatin capsule with an opaque pink body and an opaque green cap, containing a white homogeneous powder. Printed with 'CHP 500' in black ink.

Qualitative and quantitative composition

Each capsule contains 500 mg of Hydroxycarbamide.

Excipients with known effect: Contains Lactose Monohydrate 42.2 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients. In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.

List of Excipients

Citric acid, anhydrous
Lactose monohydrate
Magnesium stearate
Sodium phosphate

Gelatin capsules contain:

Erythrosine (E127)
Indigotine (E132)
Yellow iron oxide
Titanium dioxide (E71)
Opacode S-1-277002

Pack sizes and marketing

Carton containing 100 capsules in blisters consisting of PVC/ PCTFE/PVDC and sealed aluminium foil with PVC/PVDC backing.

Marketing authorization holder

Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Marketing authorization dates and numbers

PL 45043/0113

29/05/1986 / 16/12/2002

Drugs

Drug Countries
HYDREA Australia, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Romania, Tunisia, Turkey, United Kingdom, United States

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