Tolak

Tolak (for the skin) is used to treat scaly skin growths (actinic or solar keratosis).

Tolak is also used to treat superficial basal cell carcinoma.

Tolak may also be used for reasons not mentioned in this medication guide.

Do not use if you are pregnant.

• Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use Tolak if you are allergic to fluorouracil, or if you have:

• a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.

Do not use Tolak if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

You should not breastfeed while using Tolak.

Tolak is not approved for use by anyone younger than 18 years old.

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

Tolak may cause serious side effects. Stop using Tolak and call your doctor right away if you have:

• severe pain or swelling of treated skin;
• severe itching, burning, or irritation;
• new or worsening skin sores;
• fever, chills; or
• severe stomach pain, bloody diarrhea, vomiting.

Before your skin starts to heal, it will become red, dry, tender, and crusty. This is a normal skin reaction, even if these symptoms worsen for a short time. Gradually, the dead skin will start to shed, and you'll see raw skin appear. Ask your doctor when to stop using the medicine after you notice signs of healing.

Common side effects of Tolak may include:

• skin pain, itching, burning, or irritation;
• skin darkening or scarring;
• skin redness and swelling; or
• small blood vessels under the skin.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and immediately after applying this medicine, unless it is being used to treat a hand condition. Caregivers who apply this medicine should wear rubber gloves.

Apply only enough medicine to cover the affected skin with a thin film. Do not cover the treated skin area with bandaging or plastic unless your doctor tells you to.

Do not apply Tolak to skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using this medicine.

You may need to use Tolak for up to 6 weeks. Treated skin may have an undesirable appearance as it heals, which may take several weeks.

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

Do not use Tolak to treat a skin condition that has not been checked by your doctor.

Apply the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not apply two doses at the same time.

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

Do not use Tolak on your eyelids or in your eyes, nose, or mouth. Rinse with water or saline if this medicine gets in your eyes.

Do not let Tolak build up in the skin folds around your mouth, nose, or eyes. Use caution when applying the medicine around these areas.

Avoid using other medications on the areas you treat with fluorouracil unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Tolak can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.