Uses of Dolutegravir 10 mg:

• It is used to treat HIV infection.

What do I need to tell my doctor BEFORE I take Dolutegravir 10 mg?

• If you are allergic to dolutegravir 10 mg; any part of dolutegravir 10 mg; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you are taking any of these drugs: Dofetilide, etravirine, nevirapine, oxcarbazepine, phenobarbital, phenytoin, or St. John's wort.
• If you are trying to get pregnant.
• If you are pregnant or may be pregnant. Do not take dolutegravir 10 mg if you are in the first trimester of pregnancy.
• If you are breast-feeding. Do not breast-feed while you take dolutegravir 10 mg.

This is not a list of all drugs or health problems that interact with dolutegravir 10 mg.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dolutegravir 10 mg with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dolutegravir 10 mg?

• Tell all of your health care providers that you take dolutegravir 10 mg. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine interacts with many other drugs. The chance of side effects may be raised or how well dolutegravir 10 mg works may be lowered. Check with your doctor and pharmacist to make sure that it is safe for you to take dolutegravir 10 mg with all of your other drugs (prescription or OTC, natural products, vitamins).
• If you have had hepatitis B or C, talk with your doctor.
• Some other drugs may need to be taken at some other time than dolutegravir 10 mg. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than dolutegravir 10 mg.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting dolutegravir 10 mg. Talk with your doctor.
• This medicine may cause harm to an unborn baby. Women must use birth control while taking dolutegravir 10 mg. If you get pregnant, call your doctor right away.

How is this medicine (Dolutegravir 10 mg) best taken?

Use dolutegravir 10 mg as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking dolutegravir 10 mg as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of dolutegravir 10 mg during treatment.
• If you take products that have iron, aluminum, calcium, or magnesium in them (like some antacids or vitamins), you may need to take them at some other time than dolutegravir 10 mg. Talk with your doctor or pharmacist.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Fever.
• Muscle or joint pain.
• Mouth sores.
• Eye irritation.
• Shortness of breath.
• Feeling very tired or weak.
• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take dolutegravir 10 mg. Tell your doctor right away if you have any new signs after you start dolutegravir 10 mg, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

What are some other side effects of Dolutegravir 10 mg?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Dolutegravir 10 mg?

• Store in the original container. Do not take out the antimoisture cube or packet.
• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about dolutegravir 10 mg, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?