4%(w/w) fluorouracil (as fluorouracil sodium)
Tolak® is used in adults to treat actinic keratosis (AK) on the face, ears, or scalp. AK is a rough, crusty or scaly patch on the top layer of skin that is made up of fast growing precancerous cells.
It is not known if Tolak® is safe and effective in children.
Tolak® works by destroying the AK cells. The active ingredient in Tolak®, fluorouracil, enters the AK cells. This interrupts the function of the cell causing it to die.
As Tolak® destroys abnormal AK cells, the skin becomes irritated. The skin will return to normal within 4 weeks after stopping treatment.
Medicinal ingredients: fluorouracil (as fluorouracil sodium)
Non-medicinal ingredients: arlacel-165, butylated hydroxytoluene, cetyl alcohol, anhydrous citric acid, glycerin, isopropyl myristate, methyl gluceth-10, methylparaben, peanut oil, propylparaben, purified water, sodium hydroxide, stearic acid, and stearyl alcohol.
Cream, 4% (w/w)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use Tolak®. Talk about any health conditions or problems you may have, including if you:
Avoid applying Tolak® in your eyes, mouth, lips, nostrils or other mucous membranes like the vagina. Irritation, inflammation and ulcers can occur in these areas after applying Tolak®.
Severe skin reactions may occur when using Tolak®. If you experience severe itching or eczema at the spot where you have applied Tolak® or somewhere else on your body, stop using Tolak®. Contact your healthcare professional right away.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Always use Tolak® exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure.
Apply Tolak® to affected areas of skin once a day for 4 weeks.
In case of accidental ingestion, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If an application (dose) of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose.
These are not all the possible side effects you may feel when using Tolak®. If you experience any side effects not listed here, contact your healthcare professional.
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.
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.
Store Tolak® at 20°C to 25°C.
Keep out of reach and sight of children.
Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Derma-Smoothe/FS® Body Oil (Canada)
Derma-Smoothe/FS® Scalp Oil (Canada)
DermOtic® Oil Ear Drops (Canada)
Pr Tolak® (fluorouracil) Cream 4% (Canada)