Proctosedyl Suppositories

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cinchocaine Hydrochloride (micro) BP 5mg Hydrocortisone (micro) EP 5mg

3 PHARMACEUTICAL FORM

Smooth off-white suppositories.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

The local anaesthetic Cinchocaine relieves pain and relaxes sphincteric spasm. Pruritis and inflammation are relieved by Hydrocortisone which also decreases serous discharge. Proctosedyl is, therefore, useful for the short term relief (not more than 7 days) of pain, irritation and pruritis associated with haemorrhoids, pruritis ani.

4.2 Posology and method of administration

Adults (including the elderly) and children:

A suppository is inserted morning and evening, and after each stool. The ointment may be used concurrently with the suppositories.

4.3 Contraindications

Known hypersensitivity to any of the ingredients. Not for use in the presence of infections.

4.4 Special warnings and precautions for use

As with all preparations containing topical steroids, the possibility of systemic absorption should be considered. In particular, long-term continuous therapy should be avoided in infants. Adrenal suppression can occur even without occlusion.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation

In pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for long periods.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

In persons sensitive to any of the ingredients, anal irritation or skin rash may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cinchocaine is a local anaesthetic of the amide type.

Hydrocortisone is a glucocorticoid with anti-inflammatory and other properties.

5.2 Pharmacokinetic properties

The literature states that absorption of Hydrocortisone does occur through the skin, particularly denuded skin. However, this absorption is not of a clinical significance as Hydrocortisone topically has only rarely been associated with side effects resulting from pituitary adrenal suppression.

Cinchocaine is little absorbed through the intact skin, but absorbed through mucous membranes. Like other local anaesthetics of the amide type, Cinchocaine is metabolised in the liver.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hard fat

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

18 months.

6.4 Special precautions for storage

Store at 2°C - 8°C.

6.5 Nature and contents of container

Each suppository is contained in a pocket formed from white PVC/PE laminate in packs of 12.

6.6 Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GUI 4YS

or trading as:-

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

8 MARKETING AUTHORISATION NUMBER

PL 04425/0208

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 17/08/2010

10 DATE OF REVISION OF THE TEXT

04/08/2016