Naldemedine Tablets

What is this medication?

NALDEMEDINE (nal DEM e deen) treats constipation caused by opioids. It works by blocking the effect of opioids in your intestine, which helps the muscles in your intestine move stool. This helps produce a bowel movement. It belongs to a group of medications called opioid blockers.

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

COMMON BRAND NAME(S): SYMPROIC

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

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

• Cancer or tumor in abdomen, intestine, or stomach
• Diverticulitis
• History of bowel blockage
• History of stomach ulcer
• Inflammatory bowel disease
• Kidney disease
• Liver disease
• Ogilvie's syndrome
• Stomach or intestine problems
• An unusual or allergic reaction to naldemedine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Tell your care team if you stop taking your pain medication. If you stop taking your pain medication, you should also stop taking this medication. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

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 almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Amiodarone
• Aprepitant
• Atazanavir
• Captopril
• Carbamazepine
• Certain medications for fungal infections, such as ketoconazole and itraconazole
• Clarithromycin
• Cyclosporine
• Diltiazem
• Erythromycin
• Methylnaltrexone
• Naloxone
• Naltrexone
• Phenytoin
• Quercetin
• Quinidine
• Rifampin
• Ritonavir
• Saquinavir
• St. John's Wort
• Verapamil

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 check-ups. Tell your care team if your symptoms do not get better or if they get worse.

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
• Stomach pain that is severe, does not go away, or gets worse

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

• Diarrhea
• 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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

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.