PROCTOSEDYL SUPPOSITORY

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIBUCAINE HYDROCHLORIDE; ESCULIN; FRAMYCETIN SULFATE; HYDROCORTISONE

Available from:

APTALIS PHARMA CANADA ULC

ATC code:

C05AA01

INN (International Name):

HYDROCORTISONE

Dosage:

5MG; 10MG; 10MG; 5MG

Pharmaceutical form:

SUPPOSITORY

Composition:

DIBUCAINE HYDROCHLORIDE 5MG; ESCULIN 10MG; FRAMYCETIN SULFATE 10MG; HYDROCORTISONE 5MG

Administration route:

RECTAL

Units in package:

12/24

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0404592002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-05-27

Summary of Product characteristics

PRESCRIBING INFORMATION
PROCTOSEDYL
®
(Hydrocortisone BP - Framycetin sulfate BP -
Cinchocaine hydrochloride BP - Aesculin)
Anorectal Therapy
APTALIS PHARMA CANADA INC.
Version Date:
597 Laurier Blvd.
April 26, 2012
Mont-St-Hilaire, Quebec
Canada J3H 6C4
Control Number: 154596
PROCTOSEDYL
®
Anorectal Therapy
Prescribing Information
_________________________________________________________________________________
Aptalis Pharma Canada Inc.
2
February 23, 2012
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.
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
_________________________________________________________________________________
Aptalis Pharma Canada Inc.
3
February 23, 2012
The safe use of topical corticosteroids during pregnancy has not been
fully established.
Therefore, during pregnancy, they should not be used unnecessarily on
extended areas, in
large amounts or for prolonge