Hydrocortisone/pramoxine (Into the rectum)

Proctofoam-HC, Zypram

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Cream, Foam

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine is for use only on your skin in or around your anus. Do not get any medicine in your eyes, nose, or mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after you use this medicine.
• Foam
  • Do not use the aerosol container to put the medicine directly into your rectum. Always use the applicator that came with the medicine.
  • Connect the applicator to the cap of the aerosol container. Shake the container for 5 to 10 seconds just before using.
  • After you fill the applicator, gently insert it into the anus. Push the plunger to release the medicine.
  • To use this medicine on the skin around your anus, place a small amount on a tissue and gently wipe your skin.
  • Do not use near heat or open flame, or while smoking. Do not puncture, break, or burn the aerosol can.
  • Wash the applicator with warm, soapy water after use.
  • Store the medicine upright, at room temperature, away from heat and direct light. Do not refrigerate.
• Cream
  • Attach the applicator to the tube of medicine. Squeeze the tube to fill it with the cream.
  • After you fill the applicator, gently insert it into the anus. Push the plunger to release the medicine.
  • If you have a reusable applicator, wash it with warm, soapy water after use. If you have a disposable applicator, throw it away after use.
• Do not cover the treated skin with tight-fitting diapers or plastic pants if you are using this medicine on a child's diaper area.
• Missed dose:Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Hydrocortisone Acetate (hye-droe-KOR-ti-sone AS-e-tate), Pramoxine Hydrochloride (pram-OX-een hye-droe-KLOR-ide)

Treats inflammation of the rectum and anus. This medicine contains a corticosteroid.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Weight gain around your neck, upper back, face, or waist

If you notice these less serious side effects, talk with your doctor:

• Rectal irritation, burning, or itching

• Tell your doctor if you are pregnant or breastfeeding.
• This medicine may cause adrenal gland problems. It may also cause you to get infections more easily, so tell your doctor if you have any type of infection.
• This medicine may delay growth in children. If you think your child is not growing properly while using this medicine, talk with your doctor.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Call your doctor if your symptoms do not improve or if they get worse.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.