PROCTOSEDYL oint.

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

SANOFI AVENTIS-FRANCE

Pharmaceutical form:

topical ointment

Units in package:

15 gram

Manufactured by:

SANOFI AVENTIS-EGYPT

Authorization date:

2006-05-30

Patient Information leaflet

22/08/2013 15:39 - VISTAlink folder 1057190 - Page 1/2
COMPOSITION:
Each gram of Proctosedyl ointment contains :
5mg of Hydrocortisone,
5mg of Cinchocaine Hydrochloride,
10mg of Aesculin and 11.89 mg of Framycetin Sulphate equivalent to 10
mg Framycetin base .
_Excipients:_ Wool fat (lanolin), liquid paraffin, white soft
paraffin.
PHARMACEUTICAL FORM
Ointment. Yellow white, translucent, homogeneous ointment.
PHARMACODYNAMIC PROPERTIES
A combination of glucocorticoid, local anesthetic and antibacterial.
PHARMACOKINETICS
Not applicable.
THERAPEUTIC INDICATIONS
Your medicine is used 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 post-operative states.
POSOLOGY AND METHOD OF ADMINISTRATION
Apply the ointment in small quantities with the finger on the painful
or pruritic areas, morning and evening and after each stool. For deep
application attach cannula to tube, insert to full extent and squeeze
tube gently from lower end whilst withdrawing.
Treatment should last for a week.
CONTRAINDICATIONS
_Can't be used in:_
Use in the presence of untreated infections of viral, tuberculous or
fungal origin.
Use in patients hypersensitive to the active ingredients or any of the
excipients.
UNDESIRABLE EFFECTS
Like all medicines Proctosedyl Ointment may cause some problems,
although these are rare such as Itching, pain or rash that may develop
around the back passage.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
You should mention to your doctor or pharmacist any other medicines
that you are taking, including any that you have bought without a
prescription.
PREGNANCY AND LACTATION
Animal studies have shown teratogenic effects. To date similar effects
have not been shown to occur in human. This product should not be
used in pregnancy or lactation unless considered essential by the
physician.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1- Continuous treatment for lon