Gepotidacin Tablets

What is this medication?

GEPOTIDACIN (JEP oh ti DAY sin) treats urinary tract infections caused by bacteria. It belongs to a group of medications called antibiotics. It will not treat colds, the flu, or infections caused by viruses.

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

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

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

• Having surgery
• Heart disease
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low levels of potassium in your blood
• Recent heart attack
• Slow heartbeat
• Stomach or intestine problems, such as colitis
• An unusual or allergic reaction to gepotidacin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it right after you eat a meal. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years 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?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Lopinavir
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Benztropine
• Cyclosporine
• Digoxin
• Donepezil
• Some medications for fungal infections, such as itraconazole or ketoconazole
• Some medications that relax muscles for surgery, such as succinylcholine
• Other medications that cause heart rhythm changes, such as quinidine
• Oxybutynin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your care team if you have diarrhea that lasts more than 2 days or if it is severe and watery.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increased saliva or tears, increased sweating, stomach cramping, diarrhea, small pupils, unusual weakness or fatigue, slow heartbeat
• Seizures
• Severe diarrhea, fever
• Unusual vaginal discharge, itching, or odor

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

• Diarrhea
• Dizziness
• Headache
• Nausea
• Stomach pain

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.