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Details for: TEVA-PROCTOSONE

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02226383TEVA-PROCTOSONEHYDROCORTISONE (HYDROCORTISONE ACETATE); DIBUCAINE HYDROCHLORIDE; FRAMYCETIN SULFATE; ESCULIN0.5 %; 0.5 %; 1 %; 1 %OINTMENTRECTAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • To reduce the swelling and pain of hemorrhoids.
  • To reduce the swelling and pain of sores on your rectum or anus.
  • To treat swelling, irritation, itching and cracking of the rectum and anus.
  • TEVA-PROCTOSONE contains an antibacterial ingredient called framycetin sulfate, and it should be used exactly as directed by your healthcare professional.
What it does

TEVA-PROCTOSONE contains the following medicinal ingredients: hydrocortisone acetate, framycetin sulfate, cinchocaine hydrochloride and esculin. Hydrocortisone is a steroid medicine. Framycetin sulfate is an antibiotic. Cinchocaine hydrochloride is a pain medicine. Esculin protects the blood vessels. These work together to reduce swelling and pain and to relieve itching.

When it should not be used

Do not use TEVA-PROCTOSONE if you:

  • Have tuberculosis
  • Have a fungal infection
  • Have a viral infection
  • Are sensitive to any of the ingredients in TEVA-PROCTOSONE
What the medicinal ingredient is

hydrocortisone acetate, framycetin sulfate, cinchocaine hydrochloride, esculin

What the non-medicinal ingredients are

Non-medicinal ingredients (suppositories): semisynthetic glycerides
Non-medicinal ingredients (ointment): lanolin, light mineral oil and petrolatum

What dosage form it comes in

5 mg hydrocortisone (as acetate), 10 mg framycetin sulfate, 5 mg cinchocaine HCl, 10 mg esculin per gram of ointment or per suppository.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-PROCTOSONE. Talk about any health conditions or problems you may have, including if you:

  • Have been using another product that contains hydrocortisone
  • Are pregnant

Other warnings you should know about:
Tell your healthcare professional if you get any sensitivity while using TEVAPROCTOSONE.

Interactions with this medication

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Proper use of this medication

How to take TEVA-PROCTOSONE:

Ointment:

  • External treatment:
  • Apply a small quantity to the affected area in the morning and in the evening and after every bowel movement.
  • Internal treatment:
  • Attach the rectal cannula to the tube,
  • insert cannula into rectum to full extent,
  • squeeze the tube gently from the lower end while removing it from your rectum.
  • Apply in the morning and evening and after every bowel movement.

Suppositories:

  • Insert one suppository into your rectum in the morning and in the evening and after every bowel movement.
  • Misuse or overuse of TEVA-PROCTOSONE could lead to the growth of bacteria that will not be killed by framycetin sulfate. This means that TEVA-PROCTOSONE or other medicines containing framycetin sulfate may not work for you in the future.
  • Do not share your medicine.

Usual Dose

A small quantity of ointment or one suppository in the morning and evening and after each bowel movement.

Overdose

If you think you have taken too much TEVA-PROCTOSONE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

  • If you forget to apply TEVA-PROCTOSONE, apply it when you remember.
  • Then, continue to apply in the morning and evening and after every bowel movement.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking TEVAPROCTOSONE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Discomfort, irritation or pain of the anus
  • Discomfort or pain of the rectum
  • Burning, irritation or pain at the application site
  • Itching
  • Rash

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store between 15° and 30°C.
Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting www.healthcanada.gc.ca/medeffect for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about TEVA-PROCTOSONE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp);

This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9

Last Revised: June 7, 2019

Date modified: