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HEMANGEOL (propranolol hydrochloride) oral solution 4.28 mg/mL
Important Safety Information

Important Safety Information for HEMANGEOL

HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body.

Who should NOT take HEMANGEOL?

Do not give HEMANGEOL to your child if they:

  • Were born early and are less than 5 weeks corrected age
  • Weigh less than 4.5 lbs
  • Have asthma or a history of breathing problems (bronchospasm)
  • Have certain heart conditions (such as slow heart rate, heart block, or heart failure)
  • Have very low blood pressure
  • Have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”
  • Are allergic to propranolol or any of the ingredients in HEMANGEOL

IMPORTANT SAFETY INFORMATION

HEMANGEOL may cause serious side effects, including:

Low blood sugar (hypoglycemia), which can be serious and may lead to seizures, loss of consciousness, or even death. This is more likely if your child is not eating well, is vomiting, or is sick. Always give HEMANGEOL during or right after feeding. Do not give a dose if your child is not eating or is vomiting. Signs of low blood sugar may include pale skin, sweating, irritability, unusual sleepiness, or seizures.

Bradycardia and hypotension. HEMANGEOL may slow your child's heart rate or lower their blood pressure. Call your healthcare provider if your child seems unusually tired, dizzy, faints, or has pale or cold skin.

Bronchospasm. HEMANGEOL can cause breathing problems or make them worse. Get medical help right away if your child has wheezing or trouble breathing.

Cardiac failure. In certain patients with preexisting heart conditions, HEMANGEOL can worsen the heart's ability to pump blood.

Increased risk of stroke. HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome). Your healthcare provider may check for these conditions, especially in infants with large facial hemangiomas, before starting treatment.

Hypersensitivity. HEMANGEOL may make severe allergic reactions worse and may make it harder to treat these reactions with epinephrine (a medicine used in emergencies).

What are the most common side effects of HEMANGEOL?

The most common side effects include trouble sleeping, respiratory infections (such as colds or bronchitis), diarrhea, and vomiting.

Drug interactions

Tell your healthcare provider about all medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect how HEMANGEOL works or increase the risk of side effects, including medicines that affect how the body processes propranolol or increase the risk of low blood sugar (such as corticosteroids).

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for more information.

What is HEMANGEOL?

(propranolol hydrochloride oral solution)

HEMANGEOL is a prescription medicine used to treat proliferating infantile hemangioma that requires treatment with a medicine that spreads throughout the body.

Important Safety Information

USE: HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body.

WHO SHOULD NOT TAKE HEMANGEOL?: Do not give HEMANGEOL to your child if they were born early and are less than 5 weeks corrected age; weigh less than 4.5 lbs; have asthma or a history of breathing problems (bronchospasm); have certain heart conditions (such as slow heart rate, heart block, or heart failure); have very low blood pressure; have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”; or are allergic to propranolol or any of the ingredients in HEMANGEOL.