Details for: TOLAK
Company: HILL DERMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02485346 | TOLAK | FLUOROURACIL (FLUOROURACIL SODIUM) | 4 % / W/W | CREAM | TOPICAL |
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
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.
What it does
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.
When it should not be used
Do not use Tolak® if:
- You are pregnant or may become pregnant. Females who are pregnant or plan to get pregnant:
- Tolak® may harm your unborn child or may make you lose the pregnancy.
- Before you start using Tolak®, a pregnancy test should be performed on all women who can get pregnant.
- You should use effective methods of birth control while taking Tolak®. Keep using birth control for 1 month after the last time you use Tolak®.
- Talk to your healthcare professional about methods of birth control that may be right for you during your treatment with Tolak®.
- If you do become pregnant while taking Tolak®, stop using it and tell your healthcare professional right away.
- Your body does not make enough of (you are deficient in) the enzyme called dihydropyrimidine dehydrogenase (DPD). If you do not have enough of this enzyme, you may get serious side effects if you use Tolak®. If you have stomach-area abdominal pain, bloody diarrhea, vomiting, fever, and chills, contact your healthcare professional right away. These may be signs that you are experiencing serious side effect of Tolak® use called systemic toxicity.
- You are allergic to fluorouracil or any of other ingredients in this medicine.Tolak® contains peanut oil.
What the medicinal ingredient is
fluorouracil (as fluorouracil sodium)
What the non-medicinal ingredients are
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.
What dosage form it comes in
Cream, 4% (w/w)
Warnings and precautions
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:
- Are breastfeeding or plan to breastfeed. It is not known if Tolak® passes into breast milk. You and your healthcare professional should decide if you will use Tolak® or breastfeed.
- Are going to be exposed to sunlight, sun lamps, and tanning beds. Exposure to ultraviolet light immediately following application of Tolak® may cause severe sunburn.
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.
Interactions with this medication
The following may interact with Tolak®:
- Medicines that affect how well the enzyme DPD works, like capecitabine, brivudine, sorivudine and interferon-a
- A medicines called warfarin, which is used to prevent blood clots. You may experience bleeding complications if Tolak® is used with warfarin.
- A medicine called phenytoin, which is used to treat seizures.
- A medicine called leucovorin, which may be used in the treatment of some cancers. Leucovorin can increase the action and the side effects of Tolak®.
Proper use of this medication
How to use Tolak®:
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.
- Before applying Tolak®, gently wash, rinse and pat dry the skin areas to be treated.
- Apply a thin layer of Tolak® to affected areas.
- Gently massage evenly into your skin.
- Use only on affected areas and not on skin that does not have actinic keratosis. Avoid transfer of Tolak® from your body to other people.
- After applying Tolak®, wash your hands well.
- Tolak® is for topical use only. Avoid use in your eyes, mouth, lips, nostrils or vagina.
- Do not cover the treated areas with an airtight dressing after applying Tolak®.
- Avoid sunlight. Tolak® can make your skin sensitive to the sun. You could get severe sunburn. Limit your time in the sun during treatment with Tolak®.
Usual Dose
Apply Tolak® to affected areas of skin once a day for 4 weeks.
Overdose
Missed Dose
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.
Side effects and what to do about them
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.
- Reactions at the application site (redness, scaling/dryness, swelling, crusting, breakdown of skin, stinging/burning, and itching).
- Allergic contact dermatitis (severe itching or red rash at treated areas or other areas away from the treatment site).
- Eye irritation
- Eye swelling
- Trouble sleeping
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Systemic toxicity (symptoms reported with the topical use of fluorouracil in a patient with DPD deficiency): Fever, chills, vomiting, bloody diarrhea, severe abdominal pain. | ✔ | ✔ | |
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 Tolak® at 20°C to 25°C.
- Do not freeze Tolak®.
- Do not use Tolak® after the expiration date printed on the tube
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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Tolak®:
- 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 (http://www.canada.ca/en/health-canada.html); the manufacturer’s website www.hillderm.com, or by calling 1-800-344-5707.
Date of Revision: January 31, 2019