Consumer Information for: ROFACT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for
  • ROFACT is used to treat tuberculosis of the lungs.
  • It is taken along with other medicines used to treat tuberculosis.
  • Antibacterial drugs like ROFACT treat only bacterial infections. They do not treat viral infections.
What it does
  • ROFACT kills bacteria and stop its reproduction.
  • ROFACT works best when bacteria are reproducing.
  • ROFACT takes a few weeks to be effective.
When it should not be used
  • You are allergic to any of the ingredients in ROFACT.
  • You have liver problems.
  • You are breastfeeding.

ROFACT should not be given to premature or newborn infants.

What the medicinal ingredient is

Rifampicin

What the non-medicinal ingredients are

Croscarmellose Sodium, Magnesium Stearate, Sodium Lauryl Sulfate, Talc

What dosage form it comes in

150 mg and 300 mg capsules.

Warnings and precautions

Serious Warnings and Precautions

Do not take ROFACT if you are taking saquinavir/ritonavir at the same time for treatment of HIV.

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

  • Are pregnant or are looking to become pregnant;
  • Drink alcohol.
  • Are taking an oral birth control medicine.

Other warnings you should know about:

  • If you take blood thinner medicines, the dose of your blood thinners may need to be adjusted.
  • Children younger than 13 years of age should not take ROFACT along with ethambutol. Your urine, feces, saliva, mucus, sweat, and tears may turn red or orange while you are taking ROFACT.
  • ROFACT can permanently stain soft contact lenses red or orange.
  • ROFACT can make birth control drugs that contain estrogen less effective. If your birth control method contains estrogen, you should use an additional birth control method that does not contain estrogen. For example, you could use your usual birth control method and a condom.

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

Interactions with this medication
  • PAS (4-Aminosalicylic acid or para-aminosalicylic acid)
  • Blood thinner medicines like warfarin, rivaroxaban and apixaban.
  • Hypoglycemic agents which are medicines used to treat diabetes
  • Dapsone which is an antibiotic medicine
  • Digitalis compounds like dioxin which are medicines used to treat heart problems.
  • Corticosteroids medicines like prednisone and prednisolone
  • Birth control drugs that contain estrogen. If you are not sure if your medicine contains estrogen, talk to you doctor.
  • Ethambutol, another medicine used to treat tuberculosis.
Proper use of this medication
  • Take ROFACT exactly as it has been prescribed to you by your doctor.
  • Although you may feel better early in treatment, ROFACT should be used exactly as directed.
  • Misuse or overuse of ROFACT could lead to the growth of bacteria that will not be killed by ROFACT (resistance). This means that ROFACT may not work for you in the future.
  • Do not share your medicine.

Usual dose

  • The usual dose of ROFACT is 600 mg taken once a day.
  • Take ROFACT capsules on an empty stomach, 1 hour before a meal.

Overdose

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

Missed Dose

  • If you forget a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and take the next one.
  • Do not take double dose to make up for a missed dose.
Side effects and what to do about them

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

Side effects may include:

  • confusion
  • change in vision
  • dizziness
  • drowsiness
  • headache
  • upset stomach
  • indigestion
  • menstruation changes (spotting, absence of periods, longer time between periods or longer periods)
  • muscle weakness
  • nausea
  • sore mouth or tongue
  • tiredness
  • trouble concentrating
  • vomiting
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Anaphylactic reactions (allergic reactions): difficulty breathing, fever, hives, itchy skin, rash, swelling of your tongue or throat     ✔
Ataxia (lack of voluntary coordination of muscle movements): poor coordination, slurred speech, trouble eating and swallowing, difficulty walking, eye movement abnormalities, etc.     ✔
Clostridium-difficile colitis (bowel inflammation caused by an infection): abdominal pain, tenderness or cramps, bloody diarrhea, diarrhea (loose or watery stool) fever     ✔
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (severe reaction to a medicine that involves the skin and other organs): fever, flu-like feeling, severe rash, swollen lymph glands     ✔
Hemolytic anemia (decrease in red blood cells): fatigue, loss of energy, weakness, shortness of breath     ✔
Leukopenia (decrease in white blood cells): general discomfort, fatigue, weakness, dizziness, loss of appetite, irritability and fever     ✔
Jaundice with evidence of hepatocellular damage (liver damage): yellowing of the skin or eyes, dark colored urine, abdominal pain, loss of appetite     ✔
Pain in Extremities and Generalized Numbness     ✔
Thrombocytopenia (decrease in platelets): bruising, bleeding, fatigue and weakness.     ✔

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

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:

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
  • 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); by contacting the sponsor: Valeant Canada LP, 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1-800-361-4261.

This leaflet was prepared by Valeant Canada LP

Last Revised: June 28, 2019

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