Lamivudine (HBV), Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat chronic hepatitis B virus infection
• You need to have lab tests regularly while you are taking this medicine and for several months after you stop taking it. Keep all appointments for these tests.
• Lactic acidosis is a rare but serious problem that can happen with use of this medicine. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antiviral

Generic and brand names: lamivudine (HBV), oral; Epivir-HBV

What is this medicine used for?

This medicine is taken by mouth to treat chronic hepatitis B virus (HBV) infection. This medicine will not cure chronic hepatitis B virus infection.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Kidney disease
• HIV infection (You may become resistant to another type of this medicine used to treat HIV if you take this medicine)
• Other liver problems besides hepatitis B
• Problems with the pancreas

This medicine should NOT be taken with other medicines that contain lamivudine or emtricitabine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Changing your dosage on your own can make liver disease worse.

Check with your healthcare provider before using this medicine in children under age 2 years.

Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping this medicine may cause severe liver problems.

This medicine comes in tablet or liquid forms. If you cannot swallow the tablets, tell your healthcare provider. If you have the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

You may take this medicine with or without food.

Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You should be tested for HIV infection before taking this medicine and while taking this medicine. Epivir-HBV, used to treat hepatitis B, is a lower dose than Epivir, which is used to treat HIV. If you have an HIV infection and take Epivir-HBV, the HIV virus can become resistant to the drug, so that the Epivir is no longer effective.

You need to have lab tests regularly while you are taking this medicine and for several months after you stop taking it. Keep all appointments for these tests.

Lactic acidosis is a rare but serious problem that can happen with use of this medicine. Stop taking this medicine and contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling weak or tired
• Unusual muscle pain
• Having trouble breathing
• Stomach pain with nausea and vomiting
• Feeling cold
• Feeling dizzy or lightheaded
• Suddenly developing a fast or irregular heartbeat

Tell the healthcare provider who prescribed this medicine if you develop any new symptoms or if you start taking any new medicine.

Alcohol may increase damage to the liver. Do not drink alcohol while taking this medicine. Ask your healthcare provider about this.

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine does not cure hepatitis B or keep you from spreading it to other people. Practice safe sex and do not share needles, toothbrushes, or razor blades with others.

Adults over the age of 65 and young children may be at greater risk of side effects and may need lower dosages. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: The liquid medicine contains sugar (sucrose). It may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe tiredness or weakness, nausea, vomiting, fever, dark urine, muscle or joint pain, light-colored bowel movements, fast or irregular heartbeat, trouble breathing, severe dizziness, feeling cold, yellowing of your eyes or skin, unexplained loss of appetite, sudden and severe stomach pain, numbness or pain in arms or legs.

Other: Headache; tiredness; trouble sleeping; dizziness; ear, nose, and throat infections; diarrhea; rash.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiarrhythmic medicines (to treat irregular heartbeat) such as digoxin (Lanoxin), dofetilide (Tikosyn), procainamide, and quinidine
• Antiviral medicines such as acyclovir (Zovirax), ganciclovir (Cytovene), ribavirin (Copegus, Rebetol, Ribasphere, Virazole), valacyclovir (Valtrex), and valganciclovir (Valcyte)
• HIV medicines such as efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), and zalcitabine (Hivid)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Memantine (Namenda)
• Metformin (Fortamet, Glucophage, Riomet)
• Midodrine
• Morphine (Kadian, MS Contin)
• Other medicines that contain lamivudine such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Epivir), or lamivudine/zidovudine (Combivir)
• Quinine
• Sulfamethoxazole/trimethoprim (Bactrim, Septra) or trimethoprim (Primsol)
• Triamterene/hydrochlorothiazide (Dyazide, Maxzide) and triamterene (Dyrenium)

Do not drink alcohol while you are taking this medicine. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.