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INDICATION AND IMPORTANT SAFETY INFORMATION

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What is Metopirone®?

METOPIRONE is used, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adults and pediatric patients.

Important Safety Information you should know about METOPIRONE®

What is the most important information I should know about METOPIRONE®?

METOPIRONE may cause adrenal insufficiency.

Do not use METOPIRONE if you have adrenal cortical insufficiency or are allergic to METOPIRONE or to any of its ingredients.

Adrenal insufficiency is when the adrenal glands do not produce enough hormones. Contact your doctor if you have any of the following symptoms: anxiety, stomach pain, nausea, vomiting, diarrhea and confusion.

METOPIRONE may cause some patients to become dizzy, drowsy, or less alert then normal. Do not drive or do anything dangerous if you are dizzy or not alert while taking this medication.

What should I tell my doctor before taking METOPIRONE®?

You are taking the following medications:
Anticonvulsants (such as phenytoin)
Psychotropic drugs (drugs that effect your mind, emotions, or behavior)
Hormone preparations (such as estrogen)
Steroids (hydrocortisone)
Antithyroid agents (such as Tapazole)
Cyproheptadine
Acetaminophen (Tylenol)
Estrogen
Phenytoin

Are pregnant or plan to become pregnant. METOPIRONE should be given to a pregnant woman only if clearly needed.

Are breastfeeding or plan to breastfeed.

What are the most common side effects of METOPIRONE®?

The most common side effects of METOPIRONE include:
Nausea (upset stomach) and vomiting
Sedation
Stomach discomfort or pain
Hypotension (low blood pressure)
Leukopenia, anemia, thrombocytopenia (decrease in the amount of red blood cells, white blood cells or platelets in the blood)
Diarrhea
Dizziness
Rash
Headache

These are not all of the possible side effects of METOPIRONE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-597-6373 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, for METOPIRONE® (metyrapone), capsules.

HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, Chatillon, FRANCE
Tel: +33 (0) 1 40 33 93 14 / Fax: +33 (0) 1 40 33 30 87
© 2020 HRA Pharma Rare Diseases | Metopirone is a registered trademark of HRA Pharma Rare Diseases
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Last updated: June 2023; MTP – US – 0028

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