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The following safety information and warnings are crucial for anyone considering or currently using the medication Symfi. It is essential to understand the potential risks and necessary precautions, and to consult with a healthcare provider if you have any questions or concerns.

• Hepatitis B Exacerbation: If you have both HIV and hepatitis B (HBV), stopping Symfi may worsen your HBV. It is important to get tested for HBV before starting Symfi. Do not discontinue the medication without consulting your doctor. Your liver function will need to be monitored for a few months after stopping. Contact your healthcare provider immediately if you experience symptoms such as fever, fatigue, nausea, vomiting, dark urine, clay-colored stool, or yellowing of the skin or eyes.

• Lactic Acidosis and Liver Damage: Symfi contains lamivudine, which is associated with rare but potentially life-threatening conditions such as high blood acid levels and liver damage. Symptoms can include loss of appetite, stomach pain, muscle pain, rapid breathing, severe fatigue, and sudden weakness. Cease taking Symfi and seek emergency medical care if these occur. Risk factors include being female or having obesity.

• Kidney Issues: Tenofovir in Symfi can lead to new or worsening kidney problems. Avoid using other kidney-harming drugs like high doses of NSAIDs (e.g., ibuprofen or naproxen). Regular monitoring of kidney function may be required. Report symptoms of kidney damage such as bone pain, leg and foot pain, easy fractures, and muscle pain or weakness to your provider promptly.

• Mental Health Effects: Efavirenz in Symfi can lead to mood changes, depression, suicidal thoughts, intense anger, or hallucinations. Inform your healthcare provider of any mood changes. Seek immediate medical attention if you have thoughts of self-harm or harming others. Risk increases with a history of mental health issues or substance abuse.

• Central Nervous System Side Effects: Efavirenz may cause dizziness, sleep disturbances, concentration difficulties, drowsiness, and vivid dreams, particularly in the first month of treatment. If these persist or interfere with daily medication adherence, consult your provider. The risk is heightened by alcohol or other CNS-affecting drugs.

• Rash: Efavirenz can induce a rash, typically mild and self-resolving within a month. However, if you experience severe skin reactions such as fever or blistering, discontinue Symfi and seek immediate medical care.

• Liver Toxicity: Efavirenz can cause severe liver damage, especially in individuals with pre-existing liver issues or infections like hepatitis B or C. Regular liver function tests may be necessary. Report symptoms such as fatigue, nausea, vomiting, dark urine, clay-colored stool, abdominal pain, or jaundice to your healthcare provider immediately.

• Pancreatitis: Symfi may cause pancreatitis, particularly in children with a history of pancreatitis or prior NRTI use. Seek urgent medical attention if you or your child experience severe abdominal pain spreading to the back, nausea, vomiting, rapid heartbeat, or fever.

• Immune Reconstitution Syndrome: As Symfi strengthens your immune system, it may lead to inflammation due to the body fighting infections more robustly. Your provider may conduct tests for infections before starting treatment. Report any fever, breathing difficulties, or sudden health changes after beginning Symfi.

• Contraindications: Do not use Symfi in conjunction with elbasvir/grazoprevir (Zepatier), as this combination poses significant health risks. Always discuss potential contraindications with your healthcare provider.

When taking this medication, you might experience common side effects like dizziness, difficulty sleeping, drowsiness, unusual dreams, and trouble concentrating. These symptoms usually start within a day or two of beginning the treatment and tend to improve over the next few weeks. Taking the medication at bedtime may help alleviate these effects. Other common side effects include tiredness, headaches, and diarrhea. Though generally mild, if these persist or worsen, it's important to consult your healthcare provider.

In rare cases, more serious side effects can occur. As the immune system strengthens, you may experience symptoms of infections you had before or new symptoms if the immune system becomes overactive. Seek medical attention if you notice unexplained weight loss, severe fatigue, persistent muscle aches, intense headaches, joint pain, numbness, vision changes, or signs of infection such as fever and swollen lymph nodes. Additionally, symptoms like irritability, rapid heartbeat, and bulging eyes could indicate thyroid problems.

Other serious side effects to watch for include mood changes like depression or anxiety, hallucinations, confusion, or signs of kidney issues, such as changes in urination. Symptoms indicating a buildup of lactic acid in the blood, liver problems, or pancreatitis are also serious and require immediate medical attention. These symptoms include severe tiredness, dizziness, yellowing of the skin or eyes, and abdominal pain.

Changes in body fat distribution can occur, though the long-term effects are unknown. Discuss with your doctor the possibility of using exercise to manage this. Tenofovir may increase the risk of bone loss, so speak with your healthcare provider about calcium and vitamin D supplements. Be alert for symptoms like bone pain or easily fractured bones.

Rashes are a common side effect but can sometimes signal a severe reaction. Report any rash to your doctor immediately. Although a severe allergic reaction is rare, seek emergency help if you experience symptoms such as a rash with blisters, peeling skin, severe dizziness, or difficulty breathing. Always communicate any unusual side effects to your healthcare provider for guidance.

Some drugs may interact with this medication, including Orlistat, Sorbitol, and certain kidney-affecting drugs like Adefovir, Cidofovir, and aminoglycosides such as Amikacin or gentamicin. Avoid using this medication alongside other HIV treatments or products containing Efavirenz, Lamivudine, or tenofovir. Certain medications, including St. John's wort and some seizure medications like Carbamazepine, may alter how efavirenz/lamivudine/tenofovir is processed in your body, potentially impacting its effectiveness.

Additionally, efavirenz/lamivudine/tenofovir can hasten the elimination of other drugs from your system, which might reduce their effectiveness. This includes medications such as Atazanavir, atovaquone/proguanil, azole antifungals (e.g., Voriconazole), bedaquiline, cabotegravir, cobicistat, elbasvir/grazoprevir, elvitegravir, macrolide antibiotics (e.g., Clarithromycin), rilpivirine, and sofosbuvir/velpatasvir, among others.

This medication may also reduce the efficacy of hormonal birth control methods like pills, patches, or rings, increasing the risk of pregnancy. Consult with your healthcare provider about using additional reliable birth control methods while taking this medication, and report any new spotting or breakthrough bleeding.

Inform your doctor or pharmacist if you are using other products that can cause drowsiness, including alcohol, marijuana, certain antihistamines (like Cetirizine and diphenhydramine), sleep or anxiety medications (such as Diazepam and Zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check labels on all medications for ingredients that may cause drowsiness, and consult your pharmacist for safe usage.

Note that this medication can interfere with certain laboratory tests, such as urine cannabinoid tests, potentially leading to false results. Ensure all laboratory personnel and your healthcare providers are aware of your medication use.