Lamivudine and Zidovudine

IMPORTANT WARNING:

Lamivudine and zidovudine may decrease the number of certain cells in your blood, including red and white blood cells. Tell your doctor if you have or have ever had a low number of any type of blood cells or any blood disorders such as anemia (a lower than normal number of red blood cells) or bone marrow problems. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; shortness of breath; pale skin; fever, sore throat, chills, and other signs of infection; or unusual tiredness or weakness.

Lamivudine and zidovudine may cause muscle disorders, especially when used for a long period of time. Tell your doctor if you have or have ever had any disease of the muscles or muscle weakness. If you experience muscle pain or muscle weakness, call your doctor immediately.

Lamivudine and zidovudine may cause life-threatening damage to the liver and a potentially life-threatening condition called lactic acidosis (buildup of lactic acid in the blood). Tell your doctor if you have or have ever had liver disease. If you have liver disease your doctor will probably tell you not to take lamivudine and zidovudine. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: nausea, vomiting, pain in the upper right part of your stomach, loss of appetite, extreme tiredness, unusual bleeding or bruising, weakness, dizziness, lightheadedness, fast or irregular heartbeat, trouble breathing, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes, feeling cold, especially in the arms or legs, or muscle pain that is different than any muscle pain you usually experience.

Tell your doctor if you have or think you may have hepatitis B virus infection (HBV; an ongoing liver infection). Your doctor may test you to see if you have HBV before you begin your treatment with lamivudine and zidovudine. If you have HBV and you take lamivudine and zidovudine, your condition may suddenly worsen when you stop taking lamivudine and zidovudine. Your doctor will examine you and order lab tests regularly for several months after you stop taking lamivudine to see if your HBV has worsened.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests during and after your treatment to check your body's response to lamivudine and zidovudine.

WHY is this medicine prescribed?

The combination of lamivudine and zidovudine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Lamivudine and zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the blood. Although the combination of lamivudine and zidovudine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of lamivudine and zidovudine comes as a tablet to take by mouth. It is usually taken twice a day with or without food. Take lamivudine and zidovudine at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take this medication exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lamivudine and zidovudine controls HIV infection but does not cure it. Continue to take lamivudine and zidovudine even if you feel well. Do not stop taking lamivudine and zidovudine without talking to your doctor. When your supply of lamivudine and zidovudine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking lamivudine and zidovudine, your condition may become more difficult to treat.

What SPECIAL PRECAUTIONS should I follow?

Before taking lamivudine and zidovudine,

• tell your doctor or pharmacist if you are allergic to lamivudine (Epivir, Epivir HBV, others); zidovudine (Retrovir); any other medications; or any of the ingredients in lamivudine and zidovudine tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking lamivudine and zidovudine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..

• in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had pancreatitis (swelling of the pancreas that does not go away) or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lamivudine and zidovudine, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking lamivudine and zidovudine.

• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at any time during your treatment with lamivudine and zidovudine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lamivudine and zidovudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• heartburn
• difficulty falling asleep or staying asleep
• depression
• stuffy nose
• cough
• joint pain

Some side effects can be serious. The following side effects are uncommon, but if you experience any of them, or any of those listed in the IMPORTANT WARNING section, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• numbness, tingling, or burning in your fingers or toes
• fever
• wheezing

Lamivudine and zidovudine may cause other side effects. Call your doctor if you have any unusual problems while taking lamivudine and zidovudine.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets in the refrigerator or at room temperature but away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• headache
• vomiting
• extreme tiredness

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of lamivudine and zidovudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.