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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 Tolak (fluorouracil topical), it's important to be aware of potential interactions with other substances:

• Photosensitizing Agents: Combining Tolak with medications that increase skin sensitivity to light, such as aminolevulinic acid, methoxsalen, methyl aminolevulinate, porfimer, and verteporfin, can heighten the risk of severe skin reactions. It's advisable to avoid using these agents together with Tolak.

• Cannabis Products: Using cannabis while on Tolak may alter the effects of cannabinoids like THC and CBD, potentially leading to adverse reactions. It's recommended to discuss cannabis use with your healthcare provider during Tolak treatment.

• Medications Affecting Blood Clotting: Tolak may reduce platelet counts, increasing bleeding risk. When combined with anticoagulants, NSAIDs, or other drugs that affect clotting, this risk may be amplified. Caution is advised when using these medications concurrently.

• Enzyme Deficiency Considerations: Individuals with a deficiency in the enzyme dihydropyrimidine dehydrogenase (DPD) may experience severe side effects from Tolak. Symptoms like abdominal pain, bloody diarrhea, vomiting, fever, or chills should prompt immediate medical attention.

• Peanut Allergy Alert: Tolak contains Peanut Oil. Those with peanut allergies should avoid using this medication to prevent allergic reactions.

Always inform your healthcare provider about all medications, supplements, and herbal products you are using to ensure safe and effective use of Tolak.