Pierre Fabre Pharmaceuticals, Inc. 8 Campus Drive Parsippany, NJ 07054
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
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Important Safety Information for HEMANGEOL
HEMANGEOL can cause serious side effects, including low blood sugar (hypoglycemia), for your child. Please read the important safety information for HEMANGEOL and speak with your doctor before taking HEMANGEOL.
Do not give HEMANGEOL to your child if your child:
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.
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.
Call your doctor or go to the nearest hospital emergency room if your child has:
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.
