1. Name Of The Medicinal Product
Proctosedyl Suppositories
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 may occur.
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 And Other Handling
None stated.
7. Marketing Authorisation Holder
sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
8. Marketing Authorisation Number(S)
PL 04425/0208
9. Date Of First Authorisation/Renewal Of The Authorisation
21 July 2005
10. Date Of Revision Of The Text
December 2006
Legal category
POM
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