sanofi-aventis

Proctosedyl Ointment

Each gram of ointment contains 5mg of Hydrocortisone, 5mg of Cinchocaine Hydrochloride, 10mg Aesculin and 10mg Framycetin Sulphate.

Excipients – Contains Wool Fat 10%w/w

For a full lsit of excipients, see section 6.1.

Ointment.

Yellow white, translucent, homogeneous, ointment.

In the local management of pain, pruritus and inflammation associated with internal or external haemorrhoids, and such haemorrhoidal complications as fissures, proctitis, perianal eczema, and post¹-operative states.

Dosage:

Application to external surface or by means of the cannula into the rectum, twice daily and after each bowel movement. Treatment should last for a week.

Administration:

Topical, Intrarectal and Perianal

1. Use in the presence of untreated infections of viral, tuberculous or fungal origin.

2. Use in patients hypersensitive to the active ingredient or any of the excipients.

1. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation.

2. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilation.

3. Prolonged use of an anti-infective may result in the development of super-infection due to organisms, including fungi, resistant to that anti-infective.

4. May cause local skin reactions (e.g. contact dermatitis).

None stated.

Animal studies have shown teratogenic effects. To date similar effects have not been shown to occur in man. This product should not be used in pregnancy or lactation unless considered essential by the physician.

Not applicable.

Itching, pain or rash may develop around the back passage.

In the rare event of overdosage, supportive and symptomatic therapy is indicated.

ATC Code: C05A.

A combination of a glucocorticoid, local anaesthetic and antibacterial.

None Stated.

Not applicable.

Wool fat (lanolin)

Liquid paraffin

White soft paraffin.

Not applicable.

Unopened - 3 years

In use shelf life - 4 weeks

Do not store above 25ºC.

Aluminium tubes internally lacquered with cannula treatment. Pack sizes are 15g and 30g. Each tube is accompanied by a cannula attachment.

Not all pack sizes are marketed.

No special requirements.

sanofi-aventis Ireland Ltd.,.

Citywest Business Campus

Dublin 24

PA 540/62/1

1^st April 1978/25^th November 2009.

September 2010