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This document outlines important safety warnings and precautions for using Pylera. Please read carefully and consult your healthcare provider with any questions or concerns.

• Cancer Risk: There is uncertainty about whether Pylera increases cancer risk in humans. However, studies in rats have shown that lifetime exposure to metronidazole, a component of Pylera, is linked to tumor development in organs such as the liver and lungs. Adhere strictly to your prescriber’s dosage instructions.

• Pregnancy Risks: The antibiotic tetracycline in Pylera can harm unborn babies, potentially leading to permanent tooth discoloration and affecting bone development. If you are pregnant or planning to become pregnant, discuss alternative treatments with your healthcare provider.

• Tooth Discoloration: Tetracycline may cause permanent yellow, gray, or brown tooth discoloration. This risk is heightened for pregnant individuals, children under 8 years of age, and long-term users. Consult your prescriber if concerned.

• Severe Skin Reactions: Pylera can cause serious and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and toxic epidermal necrolysis (TEN). Seek medical attention immediately if you experience symptoms like fever, burning eyes, skin pain, or blistering skin rash.

• Neurological Issues: Rarely, Pylera may cause seizures, brain swelling, nerve pain, or meningitis, leading to symptoms such as difficulty walking, dizziness, blurry vision, numbness, speech difficulties, or uncontrolled body movements. Contact your prescriber or seek emergency medical help if these occur.

• Black Tongue and Stool: Bismuth subcitrate in Pylera may cause a harmless darkening of the tongue and stool. However, if you notice black, tarry stools or blood in your stool, contact your prescriber immediately.

• Sun Sensitivity: Pylera can increase sensitivity to sunlight, raising sunburn risk. Use sunblock, wear protective clothing, and avoid tanning salons. If you develop skin redness or a rash, stop taking the medication and inform your prescriber.

Contraindications: Do not use Pylera if you have any of the following conditions or are in the following situations, as serious health risks may occur:

• Concurrent use with methoxyflurane
• Use within two weeks of taking disulfiram
• Consumption of alcohol during and for three days after treatment
• Cockayne syndrome
• Serious kidney problems
• Current pregnancy

Consult your healthcare provider if any of these apply to you before starting Pylera.

When taking this medication, some common side effects may occur, such as nausea, diarrhea, upset stomach, abdominal pain, headache, dizziness, and changes in taste. It's important to know that while these effects are usually mild and temporary, you should contact a healthcare provider if they persist or worsen. Additionally, you might notice a harmless darkening of the tongue or stools, but inform your doctor if you suspect blood in the stool.

There are also other potential side effects to be aware of, including constipation, dry mouth, changes in urine, itchy skin, anxiety, higher appetite, weight gain, and elevated liver enzymes. Although these are less common, they should not be ignored, especially if they become troubling.

Serious side effects are rare but require immediate medical attention. These include severe allergic reactions characterized by fever, rash, swelling, or trouble breathing. Brain-related issues such as seizures, severe headaches, vision changes, and numbness or tingling in the limbs are also critical warning signs. In some cases, the medication can cause an increase in brain pressure, leading to vision problems or other neurological symptoms.

Another serious condition to watch for is a severe intestinal issue caused by C. difficile, which might present as persistent diarrhea, severe abdominal pain, or blood in the stool. If such symptoms arise, avoid using anti-diarrhea medications and seek medical help immediately. Lastly, this medication can occasionally lead to oral thrush or yeast infections, noticeable by white patches in the mouth or changes in vaginal discharge. Always be vigilant and consult your healthcare provider with any concerning symptoms.