40995 Pamphlets Proctosedyl Oint(sanofi

S1
Proctosedyl Ointment
Composition
Each gram of ointment contains 5 mg of Hydrocortisone, 5 mg of Cinchocaine
Hydrochloride, 10 mg of Aesculin and 11.89 mg of Framycetin Sulphate.
Excipients: Wool fat (lanolin), liquid paraffin, white soft paraffin.
Pharmaceutical Form
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 hemorrhoids, and such hemorrhoidal
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:
Patients of untreated infections of viral, tuberculous or fungal origin.
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 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,
striate, 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).
Overdose
In the rare event of overdosage, supportive and symptomatic therapy is indicated.
Storag
Store below 25°C.
Expiry date
Do not use your medicine after the expiry date on the outer pack.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
Presentation
Box of 15 g ointment.
Produced by sanofi-aventis egypt s.a.e.
Under license of sanofi-aventis / France and its branch in Ireland
Brand name:
Artwork type:
Version number:
SAP identification no.:
Bar code:
Country:
Date:
Designer:
Dimensions:
Colours:
Proctosedyl ointment
Leaflet
S1
40995
860
Egypt
19.04.2008
Gamal Habib
200 x 110 mm
20/10/2009 16:06 - VISTAlink folder 287190 - Page 1/3
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40995 - Pamphlets Proctosedyl Oint(sanofi-avents
Plant:
Packaging material code:
Packaging material name:
CAIRO- EGYPT
40995
Pamphlets Proctosedyl Oint(sanofiavents
Second packaging material code:
VISTAlink folder number:
VISTAlink PDF version:
287190
3
This document has been digitally signed by the following people within the VISTAlink system,
following the sanofi-aventis group guidelines.
Reason
Market marketing validation
Market medical affairs validation
Market regulatory validation
Plant final technical validation
Plant quality validation
Plant ready to print
Signed by
Haitham Abdelhadi (Egypt
marketing department team)
Tamer Talaat (Egypt medical
affairs team)
Nermeen Nassar (Egypt
regulatory affairs team)
Gamal Habib (Cairo packaging
team)
Youssef Aziz (Cairo quality
assurance team)
Gamal Habib (Cairo packaging
team)
Date
18/08/2009 10:18:31
18/08/2009 10:38:18
19/08/2009 09:14:18
19/08/2009 14:03:48
20/10/2009 16:03:56
20/10/2009 16:06:24
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