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Please read the following important safety and warning information carefully:

• If you have both hepatitis B and HIV, discontinuing this medication may lead to a worsening or serious escalation of hepatitis symptoms. Consult with your healthcare provider before stopping the medication. Your doctor will monitor your liver function for several months after cessation.

• For individuals using this medication to prevent HIV infection, it is crucial to confirm your HIV-negative status prior to starting the treatment. Your doctor will conduct laboratory tests before beginning the medication and will continue to monitor every three months during treatment to ensure you remain HIV-negative.

• This medication does not guarantee prevention of HIV infection. To maximize its effectiveness, take it exactly as prescribed and adhere to all recommended preventative measures.

• Notify your doctor immediately if you experience any symptoms suggestive of an HIV infection, such as a persistent sore throat, fatigue, fever, night sweats, diarrhea, joint or muscle pain, or swollen lymph nodes.

Adhering to these guidelines is essential for your health and safety.

Experiencing diarrhea, headaches, difficulty sleeping, back pain, or changes in skin color on your palms or soles can be common when taking this medication. These side effects are generally mild, but if they persist or worsen, contact your healthcare provider for advice. As your treatment for HIV strengthens your immune system, you might notice the return of symptoms from previous infections or new symptoms if your immune system becomes overactive. This could occur shortly after beginning treatment or even months later. Seek immediate medical attention if you experience serious symptoms such as unexplained weight loss, persistent fatigue, ongoing muscle aches or weakness, severe headaches, joint pain, numbness or tingling in extremities, vision changes, fever, chills, swollen lymph nodes, breathing difficulties, persistent cough, or non-healing sores. Symptoms of an overactive thyroid or Guillain-Barre syndrome, such as irritability, rapid heartbeat, or loss of coordination, also require urgent medical care.

Be attentive to serious side effects like mood changes, depression, anxiety, or signs of kidney issues, such as changes in urine output or blood in urine, and report them to your healthcare provider promptly. Rarely, this medication may lead to severe liver issues or lactic acidosis, which can be life-threatening. Watch for symptoms like persistent nausea or vomiting, loss of appetite, abdominal pain, yellowing skin or eyes, and dark urine, and seek immediate medical attention. Though very rare, a severe allergic reaction is possible, characterized by rash, swelling (particularly of the face, tongue, or throat), severe dizziness, or difficulty breathing. This list is not exhaustive, so if you notice any other unusual effects, reach out to your healthcare provider for guidance.