TALICIA is a formulation comprised of omeprazole magnesium, amoxicillin, and rifabutin in delayed-release capsules for oral administration. The capsule contains omeprazole magnesium in its delayed-release form and the other two components in an immediate-release form. Omeprazole magnesium acts as a proton pump inhibitor, while amoxicillin is a semi-synthetic antibacterial drug, and rifabutin is an antibacterial agent. The formulation is intended to be taken orally.

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. Take it with food. 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. Special care may be needed.

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 4 hours or less before your next scheduled dose, take the missed dose and delay your next dose to ensure there are at least 4 hours in between each dose. Do not take double or extra doses.

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 medication 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, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other 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.

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
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe diarrhea, fever
• Severe or prolonged vomiting or diarrhea
• 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
• Headache
• Nausea
• Stomach pain
• Vomiting

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.

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

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

• Kidney disease
• Liver disease
• Lupus
• Tuberculosis (TB) infection
• Wear contact lenses
• An unusual or allergic reaction to omeprazole, amoxicillin, rifabutin, other antibiotics, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Atazanavir
• Cabotegravir
• Dasabuvir; ombitasvir; paritaprevir; ritonavir
• Delavirdine
• Idelalisib
• Lonafarnib
• Ombitasvir; paritaprevir; ritonavir
• Ranolazine
• Rilpivirine
• Voriconazole

This medication may also interact with the following:

• Allopurinol
• Birth control pills
• Certain antivirals for HIV
• Certain medications for fungal infections, such as fluconazole, ketoconazole, itraconazole, or posaconazole
• Certain medications that treat or prevent blood clots, such as warfarin
• Clopidogrel
• Cyclosporine
• Dasatinib
• Digoxin
• Disulfiram
• Erlotinib
• Iron
• Methotrexate
• Mycophenolate mofetil
• Nilotinib
• Phenytoin
• Probenecid
• Rifampin
• St. John's Wort
• Tacrolimus

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?

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.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Contraception may not work properly while you are taking this medication. Talk to your care team about using an extra method of contraception.

This medication can color your teeth, urine, sweat, tears, and mucous. The color may stain your teeth for good. The color in tears may also stain soft contact lenses for good. If you wear contact lenses, ask your care team when you can use your lenses again.

If you have diabetes, you may get a false-positive result for sugar in your urine. Check with your care team.