HYDROCORTONE Tablet Ref.[50009] Active ingredients: Hydrocortisone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Product name and form

Hydrocortone 10 mg Tablets.

Pharmaceutical Form

Tablet.

White, oval-shaped tablets quartersected on one side and imprinted with ‘HYD 10’ on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 10 mg Hydrocortisone.

Excipient: Contains 191.1mg Lactose Monohydrate per tablet.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Hydrocortisone

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates.

List of Excipients

Lactose monohydrate
Magnesium stearate
Maize starch

Pack sizes and marketing

Blister packs of opaque PVC lidded with aluminium foil containing 30 tablets, presented in an outer carton.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Marketing authorization dates and numbers

PA1986/054/001

Date of first authorisation: 1 April 1978
Date of last renewal: 1 April 2008

Drugs

Drug Countries
HYDROCORTONE Ireland, Lithuania

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