Gepotidacin

WHY is this medicine prescribed?

Gepotidacin is used to treat urinary tract infections (UTIs). Gepotidacin is in a class of medications called antibiotics. It works by killing bacteria.

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?

Gepotidacin comes as a tablet to take by mouth. Take twice a day after a meal (about 12 hours apart) for 5 days. Take gepotidacin at around the same times every day.

Take gepotidacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take gepotidacin until you finish the prescription, even if you feel better. If you stop taking gepotidacin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

You will be given the Medication Guide when you begin treatment with gepotidacin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking gepotidacin,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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 gepotidacin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with gepotidacin: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking gepotidacin. Do not start any of this medication while taking gepotidacin without discussing with your healthcare provider.

• tell your doctor if you or anyone in your family has or has ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or a slow or irregular heartbeat. Also tell your doctor if you have or have ever had a heart attack, a low level of potassium in your blood, liver problems, kidney problems, kidney failure, or if you are on dialysis.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking gepotidacin, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking gepotidacin.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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?

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

• nausea
• vomiting
• diarrhea
• gas
• stomach pain
• headache
• dizziness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash hives; itching; difficulty breathing or swallowing; dizziness; or swelling of the face, throat, tongue, lips, and eyes
• watery or bloody stools, stomach cramps, or fever during treatment or for up to two or more months after stopping treatment
• fast, pounding, slow, or uneven heartbeat; chest pain or tightness; feeling lightheaded or dizzy; or feeling faint or fainting
• muscle spasms, trouble speaking clearly, unusual sweating, increased saliva, diarrhea, nausea, vomiting, stomach pain, shortness of breath, difficulty breathing, or fainting
• seizures

Gepotidacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 (https://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 it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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:

• fast, pounding, or uneven heartbeat; feeling lightheaded or dizzy; or feeling faint or fainting

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to gepotidacin.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking gepotidacin.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.