Disclaimer

pramoxine/hydrocortisone aerosol foam - rectal, Proctofoam-HC (cont.)

SIDE EFFECTS: Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: rectal bleeding, change in skin appearance (e.g., color, thickness), skin redness/tenderness/pus or other signs of infection.Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to hydrocortisone; or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, eye problems, infections (especially rectal sores/infections), liver disease, stomach/intestinal problems.Though very unlikely, it is possible that the hydrocortisone in this medication will be absorbed into your bloodstream. This may have undesirable effects that may require additional corticosteroid treatment. Children and those using this drug for an extended time may be at higher risk, especially if they also have serious medical problems such as severe infections, injuries, or surgeries. This precaution applies for up to 1 year after stopping use of this drug.Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst /urination, unusual weakness, unusual weight loss, dizziness.Consult your doctor or pharmacist for more details, and inform them that you use (or have used) this medication.Caution is advised when using this drug in children. Do not use this product over a large area or use tight-fitting diapers/plastic pants unless directed by your doctor.During pregnancy, this medication should be used only when clearly needed. It should not be used for long periods of time or in large amounts. Discuss the risks and benefits with your doctor.It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.



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