Tolak

Topical Administration

Apply q12hr with nonmetallic applicator, gloved hands or fingertips

If fingertips used, wash hands immediately afterwards

Solution considered more effective than cream for equivalent strength

Complete healing of lesions typically not evident for 1-2 months

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical (for the skin) is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes not listed in this medication guide.

This medication can harm an unborn baby or cause birth defects. Do not use fluorouracil topical if you are pregnant.

You should not use fluorouracil topical if you are allergic to it.

To make sure fluorouracil topical is safe for you, tell your doctor if you have:

• dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

This medication can harm an unborn baby or cause birth defects. Do not use fluorouracil topical if you are pregnant. Use effective birth control to avoid pregnancy during your treatment with fluorouracil topical. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether fluorouracil topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical (for the skin) is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes not listed in this medication guide.

This medication can harm an unborn baby or cause birth defects. Do not use fluorouracil topical if you are pregnant.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medicine, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Caregivers who apply this medicine should wear rubber gloves.

Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

Do not cover the treated skin area unless your doctor tells you to.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine container tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fluorouracil topical and call your doctor at once if you have:

• severe pain or swelling of treated skin;

• severe itching, burning, or irritation;

• open skin sores; or

• shedding of dead skin.

Common side effects may include:

• skin redness, followed by dryness, tenderness, and crusting;

• skin peeling or flaking;

• skin darkening or scarring;

• small blood vessels under the skin;

• mild rash; or

• mild irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Tolak by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Wait 10 minutes after washing affected part before putting drug on skin.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Do not put on healthy skin.
• Do not let the skin where this medicine was used touch anyone else's skin after you have used Tolak (fluorouracil (topical)).
• If you get this medicine in the eyes, flush right away with cool water and get medical help.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tolak, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tolak. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tolak.

Review Date: October 4, 2017