When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to propranolol, or if you have asthma or certain heart problems. Hemangeol™ should not be given to children weighing less than 2 kilograms or to premature babies younger than 5 weeks of age. It should not be given to children who are vomiting or not eating, have pheochromocytoma, or have a history of asthma or a breathing problem.

How to Use This Medicine:
Long Acting Capsule, Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• Extended-release capsule: Take at bedtime. This medicine may be taken with or without food, but always take it the same way each time.
• Oral liquid: Measure your dose with the dropper that comes with the package. You may mix the liquid with water or juice to make it easier to swallow.
• Hemangeol™ oral liquid: Measure the dose with the dosing syringe that comes with the package. The medicine should be given directly into the child's mouth 2 times a day (at least 9 hours apart). It is given during or right after eating or breastfeeding. Do not administer the dose if the child is not eating or vomiting. It may also be mixed with milk or fruit juice and given in a baby's bottle. Do not shake before use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away any unused Hemangeol™ after 2 months.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how propranolol works. Tell your doctor if you are using any of the following medicines:
  
  • Bupropion, chlorpromazine, cimetidine, ciprofloxacin, digoxin, dobutamine, epinephrine, fluconazole, fluoxetine, montelukast, phenobarbital, phenytoin, rifampin, theophylline, thioridazine, or ticlopidine
  • Other blood pressure medicine (clonidine, diltiazem, nicardipine, nifedipine, nisoldipine, prazosin, verapamil), medicine for heart rhythm problems (propafenone, quinidine), medicine to lower cholesterol (cholestyramine, colestipol, lovastatin, pravastatin), medicine to treat migraine headaches (rizatriptan, zolmitriptan), a steroid medicine, an MAO inhibitor, medicine to treat depression, NSAID pain or arthritis medicine (aspirin, diclofenac, ibuprofen, naproxen, celecoxib), or warfarin

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, angina (chest pain), heart failure, breathing problems, diabetes, glaucoma, or an overactive thyroid. Tell your doctor if you have Wolff-Parkinson-White syndrome or a history of severe allergic reactions.
• This medicine may cause the following problems:
  
  • Worsening of chest pain, heart attack (if treatment is stopped suddenly)
  • Heart failure
  • Low blood sugar levels
  • An increased risk of stroke in children with PHACE syndrome (severe blood vessel problems in the brain)
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Chest pain
• Lightheadedness, dizziness, or fainting
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Slow, fast, or uneven heartbeat
• Trouble breathing or wheezing

If you notice these less serious side effects, talk with your doctor:

• Change in sleeping patterns (in children)
• Diarrhea (in children)
• Feeling agitated or irritable, unusual dreams (in children)
• Feeling sleepy or drowsy (in children)

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088