Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc.
at 1-866-210-5948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS Do not insert any part of the aerosol container directly into the anus.
Avoid contact with the eyes.
Contents of the container are under pressure.
Do not burn or puncture the aerosol container.
Do not store at temperatures above 120°F (49°C).
Like all medications, Proctofoam Hc can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: