PROCTOSEDYL OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESCULIN; HYDROCORTISONE; DIBUCAINE HYDROCHLORIDE; FRAMYCETIN SULFATE

Available from:

APTALIS PHARMA CANADA ULC

ATC code:

C05AA01

INN (International Name):

HYDROCORTISONE

Dosage:

1%; 0.5%; 0.5%; 1%

Pharmaceutical form:

OINTMENT

Composition:

ESCULIN 1%; HYDROCORTISONE 0.5%; DIBUCAINE HYDROCHLORIDE 0.5%; FRAMYCETIN SULFATE 1%

Administration route:

RECTAL

Units in package:

15G/30G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0404592001; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-09-11

Summary of Product characteristics

PRESCRIBING INFORMATION
Including Patient Medication Information
PROCTOSEDYL
®
(Hydrocortisone BP - Framycetin sulfate BP -
Cinchocaine hydrochloride BP - Aesculin)
Anorectal Therapy
APTALIS PHARMA CANADA ULC
Version Date:
85 Enterprise Blvd., Suite 500
August 10, 2018
Markham, Ontario
Canada L6G 0B5
216051
PROCTOSEDYL
®
Anorectal Therapy
Prescribing Information
_________________________________________________________________________________
Aptalis Pharma Canada ULC
2
August 10, 2018
PRESCRIBING INFORMATION
NAME OF DRUG
PROCTOSEDYL
®
(Hydrocortisone BP - Framycetin sulfate BP -
Cinchocaine hydrochloride BP - Aesculin)
THERAPEUTIC CLASSIFICATION
Anorectal Therapy
INDICATIONS:
The reduction of swelling, pain and inflammation of hemorrhoids and
other rectal lesions. The
management of acute and chronic nonspecific proctitis, acute internal
hemorrhoids, cryptitis,
fissures and incomplete fistulas, internal and external pruritus ani.
May be used in pre- and
postoperative hemorrhoidectomy and repair of fissures.
PROCTOSEDYL contains an antibacterial ingredient, framycetin. To
reduce the development
of drug-resistant bacteria and maintain the effectiveness of
framycetin, PROCTOSEDYL
should only be used for the authorized indication and clinical use.
CONTRAINDICATIONS:
Hydrocortisone must not be used in the presence of tuberculosis,
fungal and viral infections.
Sensitivity to any of the components.
PRECAUTIONS:
Discontinue use if sensitization occurs. Hydrocortisone should not be
used until an adequate
proctologic examination is completed and a diagnosis made. Other
specific measures against
infections, allergy, and other causal factors must not be neglected.
The possibility, however
rare, that prolonged use of this preparation might produce systemic
corticosteroid effects,
should be borne in mind. Patients should be advised to inform
subsequent physicians of the
previous use of hydrocortisone.
PROCTOSEDYL
®
Anorectal Therapy
Prescribing Information
___________________________________________________________________