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Generic Name: naldemedine
Dosage Form: Tablets
Date of Approval: March 23, 2017
Company: Shionogi Inc.

Treatment for: Opioid-Induced Constipation

FDA Approves Symproic

The U.S. Food and Drug Administration (FDA) has approved Symproic (naldemedine) 0.2 mg tablets C-II, a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Symproic is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Never give it to anyone else, because it may cause death or harm them. Selling or giving away Symproic may harm others and is against the law.

Tell your doctor if you (or a family member) has ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Symproic may cause serious side effects, including:

  • Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that does not go away, stop treatment and get emergency medical help right away.
  • Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment, including sweating, chills, tearing, warm or hot feeling to your face (flush), sneezing, fever, feeling cold, abdominal pain, diarrhea, nausea, and vomiting. Tell your healthcare provider if you have any of these symptoms.

What is Symproic?

Symproic is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by cancer.

It is not known if Symproic is safe and effective in children.

Do not take Symproic if you:

  • have a bowel blockage (intestinal obstruction) or have a history of bowel blockage.
  • are allergic to Symproic or any of the ingredients listed at the end of this page. Tell your healthcare provider or pharmacist before you start or stop any medicines during your treatment.

Before starting Symproic

Before you start taking Symproic, tell your healthcare provider about all of your medical conditions, including if you:

  • have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
  • have liver problems.
  • are pregnant or plan to become pregnant. Taking Symproic during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Symproic passes into your breast milk. You should not breastfeed during treatment, and for 3 days after your last dose. Taking Symproic while you are breastfeeding may cause opioid withdrawal symptoms in your baby. You and your healthcare provider should decide if you will take Symproic or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way Symproic works.

How should I take Symproic?

  • Take this medicine exactly as your healthcare provider tells you to take it.
  • Take your prescribed dose one time each day.
  • The tablets can be taken with or without food.
  • Symproic has been shown to be effective in people who have taken opioid pain medicines for at least four weeks.
  • Tell your healthcare provider if you stop taking your opioid pain medicine. If you stop taking your opioid pain medicine, you should also stop taking Symproic.

Symproic side effects

See Important information.

The most common side effects include stomach (abdomen) pain, diarrhea, and nausea.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Symproic?

  • Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets in the original bottle.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Symproic.

Medicines are sometimes prescribed for purposes other than those in a Medication Guide. Do not take this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.

What are the ingredients in Symproic?

Active Ingredient: naldemedine tosylate

Inactive ingredients: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow ferric oxide.