Lamivudine; Tenofovir Disoproxil Fumarate Tablets

What is this medication?

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (la MI vyoo deen; te NOE fo veer) is 2 antiretroviral medicines in 1 tablet. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CIMDUO, TEMIXYS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bone problems
• kidney disease
• liver disease
• pancreatitis
• an unusual or allergic reaction to lamivudine, tenofovir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your treatment to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• atazanavir
• certain antibiotics like gentamicin, tobramycin
• darunavir
• emtricitabine
• interferon
• ledipasvir; sofosbuvir
• lopinavir; ritonavir
• medicines for viral infection like acyclovir, adefovir, cidofovir, ganciclovir, valacyclovir, valganciclovir
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• ribavirin
• saquinavir
• sofosbuvir; velpatasvir
• sorbitol-containing medicines
• trimethoprim

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

If you have hepatitis B and HIV, talk to your doctor if you plan to stop this medicine. The symptoms of hepatitis B may get worse if you stop this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bone pain
• breathing problems
• fast, irregular heartbeat
• muscle pain or weakness
• severe stomach pain with or without nausea or vomiting
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs of infection like fever or chills; cough; sore throat

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• depressed mood
• diarrhea
• headache
• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.