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This document outlines crucial safety information concerning the use of Tolak (fluorouracil) 4% cream. It is important to thoroughly review these warnings and discuss any questions or concerns with your healthcare provider.

• Skin Reaction: Nearly all users of Tolak (fluorouracil) 4% cream experience skin reactions at the application sites, such as dryness, redness, and pain. These symptoms typically resolve within a month after discontinuation of the treatment.

• Sensitive Areas: Do not apply Tolak (fluorouracil) 4% cream to sensitive skin or near mucous membranes, including the eyes, mouth, or nose, to prevent skin damage. Wash your hands thoroughly after application to avoid unintentional contact with sensitive areas.

• Allergic Reactions: Although rare, some individuals may experience an allergic reaction to topical fluorouracil, characterized by severe itching or rash, which may occur away from the application site. Individuals with a peanut allergy may be at increased risk.

• Sun Sensitivity: Use of Tolak (fluorouracil) 4% cream can heighten skin sensitivity to ultraviolet (UV) light, potentially leading to severe sunburn. It is advised to limit sun exposure and avoid sun lamps and tanning beds while using the cream and shortly thereafter. Consult your dermatologist about appropriate sunscreen use and protective clothing, such as hats and long sleeves.

• Pregnancy Warning: Tolak (fluorouracil) 4% cream can harm an unborn baby, potentially causing birth defects or miscarriage. It is crucial to inform your dermatologist if you are pregnant or planning to become pregnant during treatment.

• Enzyme Deficiency Caution: There have been reports of serious side effects, including stomach pain, bloody diarrhea, vomiting, and fever, in individuals with a dihydropyrimidine dehydrogenase (DPD) deficiency using fluorouracil. This condition may lead to inflammation and sores in the mouth, stomach, and intestines.

Contraindications:

• Use of Tolak (fluorouracil) 4% cream is not recommended for individuals who are currently pregnant or those with a known dihydropyrimidine dehydrogenase (DPD) deficiency due to potential serious health risks. If these conditions apply to you, it is imperative to consult with your healthcare provider before using this medication.

When using this medication, some individuals may experience mild side effects. These can include skin irritation such as redness, dryness, crusting, itching, and a stinging or burning sensation at the application site. Swelling in the treated area is also common. Generally, these effects are mild and temporary. However, if they persist or worsen, it is advisable to consult with a healthcare provider to address your concerns.

Other side effects that may occur include eye irritation, trouble sleeping, and feelings of irritability. While these effects are usually not severe, monitoring them and discussing any changes with a healthcare professional can be beneficial for your peace of mind.

It is important to be aware of more serious side effects, though they are rare. These can manifest as severe allergic reactions, which may include symptoms like a skin rash, hives, or swelling of the face, lips, tongue, or throat. Additionally, if you experience painful swelling, warmth, or redness of the skin, blisters, or sores, seek immediate medical attention. While these serious effects are uncommon, they require prompt care to ensure your safety.