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. 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 https://www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for more information.
Important Safety Information for HEMANGEOL
Do not give HEMANGEOL to your child if your child:
- was born prematurely and has not reached the corrected age of 5 weeks
- weighs less than 4 ½ pounds
- is allergic to propranolol or any of the other ingredients in HEMANGEOL
- has asthma or a history of breathing problems
- has a heart problem, slow heart rate (less than 80 heart beats per minute), very low blood pressure
- is at risk for low blood sugar, for example is vomiting or unable to take feedings
- has high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”
Tell your doctor about all of your child’s medical conditions, all of the medicines your child takes, and all of the medicines that you take if you are breastfeeding your child.
HEMANGEOL can cause serious side effects, including:
Low blood sugar (hypoglycemia), especially if your child is not taking feedings, or is vomiting. HEMANGEOL may make it more difficult to recognize the signs and symptoms of low blood sugar in your child. To help reduce the risk of low blood sugar with HEMANGEOL, give HEMANGEOL during or shortly after feeding your child. Feed your child regularly during treatment. Tell your doctor if your child has a poor appetite. If your child is not taking feedings, due to an illness or vomiting, do not give HEMANGEOL until your child is taking feedings normally again.
If your child has any of the signs or symptoms of low blood sugar listed below during treatment with HEMANGEOL, stop giving your child HEMANGEOL and call your doctor or go to the nearest emergency room right away.
Signs or symptoms of low blood sugar include: pale, blue or purple skin color, sweating, irritability, crying for no apparent reason, irregular or fast heartbeat, poor feeding, low body temperature, unusual sleepiness, seizures, breathing stops for short periods of time, and loss of consciousness
If your child is conscious, give him/her a drink of a liquid containing sugar.
Other serious side effects can include:
- New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension).
- Breathing problems or wheezing.
- Stroke. HEMANGEOL may increase the risk of stroke in certain children who have severe problems with the blood vessels in their brain, particularly if your child has a large hemangioma that affects the face or head.
Call your doctor or go to the nearest hospital emergency room if your child has:
- pale skin color, slow or uneven heartbeats, arms or legs feel cold, blue or purple skin color, or fainting.
- breathing problems or wheezing during treatment with HEMANGEOL.
The most common side effects include: sleep problems, worsening respiratory tract infections, diarrhea, and vomiting.
These are not all the possible side effects of HEMANGEOL. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information and Medication Guide.