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This document outlines critical safety warnings and precautions associated with the use of Talicia. It is vital to review these warnings carefully and discuss any concerns with your healthcare provider.

• Severe Allergic Reactions: Talicia may trigger severe allergic reactions, including life-threatening conditions like anaphylaxis. This risk increases if you have previously reacted to Talicia's components or have a history of allergies to penicillin or cephalosporin antibiotics. Symptoms such as difficulty breathing, facial or tongue swelling, severe rash, or chest pain require immediate medical attention. Individuals with known allergies to omeprazole, amoxicillin, or rifabutin should exercise caution.

• Severe Skin Rash: Talicia has been linked to severe skin conditions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Indications include fever, body aches, cough, peeling skin, and painful blisters, particularly around sensitive areas. Discontinue use and seek medical help immediately if these symptoms occur.

• Severe Gut-related Reaction: Amoxicillin in Talicia can cause drug-induced enterocolitis syndrome (DIES), mainly in children, characterized by forceful vomiting, paleness, fatigue, low blood pressure, and diarrhea within a day of ingestion. Immediate medical intervention is necessary if these symptoms appear.

• Infectious Diarrhea: Talicia usage can lead to C. difficile-associated diarrhea (CDAD), which is a serious condition caused by bacterial overgrowth in the gut. Recent antibiotic or PPI use increases this risk. Consult with your healthcare provider if you experience severe diarrhea.

• Kidney Damage: Talicia can cause acute tubulointerstitial nephritis, a kidney condition often linked to allergies to PPIs or penicillin antibiotics. Symptoms include blood in urine, changes in urination, nausea, fever, or confusion. Cease use and contact your healthcare provider if these occur.

• Drug Interactions: Talicia can interact with various medications. For instance, fluconazole and itraconazole can increase Talicia levels, raising side effect risks, while St. John's Wort can decrease its effectiveness. Inform your healthcare provider of all medications and supplements you are taking.

• Lupus: PPIs like omeprazole can trigger or exacerbate lupus symptoms. If you develop a butterfly rash, fatigue, joint pain, or skin lesions, stop taking Talicia and consult your healthcare provider.

• Eye Swelling: Rarely, rifabutin in Talicia may cause eye swelling (uveitis), especially with macrolide antibiotics or fluconazole. Report any vision changes to your healthcare provider immediately, as an eye exam may be necessary.

Contraindications: Talicia should not be used if you have:

• An allergy to amoxicillin, omeprazole, rifabutin, or related medications.
• Currently taking rilpivirine (Edurant), delavirdine (Rescriptor), or voriconazole (Vfend).

Consult your healthcare provider before starting Talicia to ensure it is safe for your use.

When taking this medication, you may experience some common side effects such as headache, diarrhea, and a harmless discoloration of urine, which may turn brown-orange. These effects are usually mild, but if they persist or worsen, it is important to consult your healthcare provider. Other side effects include nausea, stomach pain, heartburn, vomiting, throat pain, and vaginal yeast infections. Some users may also notice a rash, which is generally not serious, but any rash should be evaluated by a healthcare professional to rule out a severe allergic reaction.

There are also rare but serious side effects that require immediate medical attention. These include signs of a serious allergic reaction such as trouble breathing, swelling of the face or tongue, severe rash, or chest pain. Additionally, severe skin reactions like blistering or peeling, and any severe gut-related symptoms like persistent vomiting, diarrhea, or stomach pain, should prompt urgent care. A rare condition, C. difficile-related diarrhea, could present with severe stomach pain, fever, and watery stools.

Other serious side effects involve signs of liver disease such as persistent nausea, yellowing of the eyes or skin, and dark urine, as well as sudden kidney problems indicated by changes in urination, blood in the urine, and fever. If you experience muscle weakness, easy bruising, or signs of lupus or infections, contact your healthcare provider promptly. Always remain vigilant for any unusual symptoms and seek medical advice as necessary.

Certain drugs can interact with this medication, impacting their effectiveness. Azole antifungals like itraconazole, ketoconazole, posaconazole, and voriconazole may interact with it, along with medications such as clopidogrel and methotrexate, particularly at high doses. Rifabutin can accelerate the elimination of various drugs from your system, potentially reducing their effectiveness. This includes medications like artemether/lumefantrine, lurasidone, mavacamten, phenytoin, ranolazine, suvorexant, and calcium channel blockers such as diltiazem, nifedipine, and verapamil.

Additionally, certain substances can influence how omeprazole is removed from your body, altering its effectiveness. Examples include rifampin and St. John's wort. Omeprazole lowers stomach acid, which can affect the absorption of certain drugs that require acid for proper absorption, such as atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, and sparsentan.

This medication might also reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, increasing the risk of pregnancy. It's important to discuss with your healthcare provider whether you should use additional birth control methods. Notify your doctor if you experience any unusual spotting or breakthrough bleeding, as these could indicate that your birth control is not working effectively.

Avoid using medications containing esomeprazole while taking omeprazole, as they are very similar. Furthermore, this medication may interfere with certain laboratory tests, such as urine glucose tests, potentially leading to incorrect results. Ensure that all healthcare providers and laboratory personnel are aware that you are using this medication.