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MEDICATION GUIDE
BLUJEPA (blu – JEP – ah)
(gepotidacin)
tablets, for oral use
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What is the most important information I should know about BLUJEPA?
BLUJEPA, an antibiotic, can cause serious side effects, including:
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QTc prolongation. BLUJEPA can cause QTc prolongation (also called prolonged QTc interval) that can lead to serious heart rhythm problems, including Torsade de Pointes. There may be changes in your heartbeat (a fast or irregular heartbeat).
Before starting BLUJEPA, tell your healthcare provider if you:
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- ○ or anyone in your family has ever had a heart rhythm problem (problem with heart rate or heartbeat) or QTc prolongation.
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- ○ are taking any medicines to treat heart rhythm problems. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider.
Tell your healthcare provider right away if you have any of the following symptoms:
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- ○ fast, pounding, or uneven heartbeat
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- ○ feeling dizzy
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- ○ you lose consciousness (pass out)
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- ○ feeling lightheaded
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- ○ feeling faint
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cholinergic effects. BLUJEPA can cause an increase of a certain chemical in your nervous system, called acetylcholine. When acetylcholine is increased in your nervous system it may cause symptoms (cholinergic effects).
The following symptoms may be caused by an increase in acetylcholine:
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- ○ diarrhea
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- ○ vomiting
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- ○ feeling faint
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- ○ trouble saying words clearly
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- ○ muscle spasms
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- ○ nausea
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- ○ more saliva in the mouth
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- ○ more sweating
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- ○ stomach pain
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Call your healthcare provider right away if you have trouble saying words clearly, have shortness of breath, or if you faint. These symptoms may be cholinergic effects of BLUJEPA.
Increased acetylcholine can also be connected to other symptoms. Call your healthcare provider right away if you have any of these additional symptoms.
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- ○ irregular heartbeat (heart block)
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- ○ slow heartbeat (bradycardia)
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- ○ seizures
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- ○ fainting
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- ○ chest tightness causing difficulty breathing
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allergic reactions. Allergic reactions can happen in people who take BLUJEPA including a severe allergic reaction called anaphylaxis. Stop taking BLUJEPA and get medical help right away if you have any symptoms of a severe allergic reaction, including:
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- ○ hives
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- ○ feeling faint or dizzy
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- ○ rash
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- ○ swelling of your lips, tongue, or throat
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diarrhea. Diarrhea is a common side effect caused by antibiotics including BLUJEPA. The diarrhea usually stops after the antibiotic is stopped. In some cases, diarrhea may be caused by Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can happen up to 2 months after finishing treatment with antibiotic medicines, including BLUJEPA. CDI can be life-threatening and can lead to death. Do not take medicines to treat diarrhea without checking first with your healthcare provider. Call your healthcare provider right away if you have the following symptoms:
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- ○ stomach cramps
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- ○ fever
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- ○ watery diarrhea
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- ○ diarrhea that does not go away
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- ○ bloody stools
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What is BLUJEPA?
BLUJEPA is an antibiotic used to treat women and girls 12 years of age and older weighing at least 88 pounds who have an infection of the bladder (known as an uncomplicated urinary tract infection [uUTI]) caused by certain types of bacteria.
It is not known if BLUJEPA is safe and effective in children under 12 years of age or weighing less than 88 pounds.
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Do not take BLUJEPA if:
you have had a severe allergic reaction to BLUJEPA. See the end of this Medication Guide for a complete list of ingredients in BLUJEPA.
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Before taking BLUJEPA, tell your healthcare provider about all of your medical conditions, including if you:
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- have heart rhythm problems. See “What is the most important information I should know about BLUJEPA?”
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- have a slow heartbeat (bradycardia).
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- have recently had a heart attack.
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- have low potassium in your blood (hypokalemia).
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- are planning to have a medical or surgical procedure that puts you to sleep (general anesthesia) that will use a type of medicine given through your veins (I.V.) that relaxes your muscles.
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- have liver problems.
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- have kidney problems, kidney failure, or are on dialysis.
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- are pregnant or plan to become pregnant. It is not known if BLUJEPA will harm your unborn baby.
Tell your healthcare provider if you become pregnant or think you are pregnant during your treatment with BLUJEPA.
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Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who are exposed to BLUJEPA during pregnancy. The purpose of this registry is to check the health of you and your baby. If you are pregnant or become pregnant during your treatment with BLUJEPA, talk to your healthcare provider about registering with GlaxoSmithKline. You can register by calling GlaxoSmithKline at 1‑888‑825‑5249.
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- are breastfeeding or plan to breastfeed. It is not known if BLUJEPA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with BLUJEPA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BLUJEPA and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take medicines to treat heart rhythm problems.
Ask your healthcare provider or pharmacist, if you are not sure if you are taking any of these medicines. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
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How should I take BLUJEPA?
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- Take BLUJEPA exactly as your healthcare provider tells you to take it. Check with your healthcare provider if you are not sure.
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- Take two tablets of BLUJEPA by mouth, 2 times each day (about 12 hours apart), for 5 days.
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- Take BLUJEPA after a meal to decrease the chance of stomach upset.
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- If you miss a dose, take it as soon as possible, then continue your treatment as before. Do not take 2 doses to make up for a missed dose.
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- If you take too much BLUJEPA, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
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- Take the full course of treatment with BLUJEPA. Do not stop taking BLUJEPA during your treatment unless your healthcare provider tells you to, even if you are feeling better. If you do not complete your full course of treatment, the infection may come back.
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What are the possible side effects of BLUJEPA?
BLUJEPA can cause serious side effects including:
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See the “What is the most important information I should know about BLUJEPA?”
The most common side effects of BLUJEPA include:
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- ○ diarrhea
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- ○ nausea
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- ○ stomach pain
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- ○ gas
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- ○ headache
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- ○ soft stools
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- ○ dizziness
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- ○ vomiting
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- ○ yeast infections
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These are not all the possible side effects of BLUJEPA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store BLUJEPA?
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- Store BLUJEPA tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep BLUJEPA and all medicines out of the reach of children.
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General information about the safe and effective use of BLUJEPA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BLUJEPA for a condition for which it was not prescribed. Do not give BLUJEPA to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about BLUJEPA that is written for health professionals.
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What are the ingredients in BLUJEPA?
Active ingredient: gepotidacin mesylate
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.
Manufactured for:
GlaxoSmithKline, Durham, NC 27701
©2025 GSK group of companies or its licensor.
BLJ:1MG
For more information, call 1-888-825-5249 or go to www.gsk.com.
Trademarks are owned by or licensed to the GSK group of companies.
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