Hemangeol

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow or uneven heartbeats;
• a light-headed feeling, like you might pass out;
• wheezing or trouble breathing;
• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head);
• cold feeling in your hands and feet;
• depression, confusion, hallucinations;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• low blood sugar in a baby--pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation, stomach cramps;
• decreased sex drive, impotence, or difficulty having an orgasm;
• sleep problems (insomnia); or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with propranolol, especially:

• a blood thinner--warfarin, Coumadin, Jantoven;

• an antidepressant--amitriptyline, clomipramine, desipramine, imipramine, and others;

• drugs to treat high blood pressure or a prostate disorder--doxazosin, prazosin, terazosin;

• heart or blood pressure medicine--amiodarone, diltiazem, propafenone, quinidine, verapamil, and others;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine--prednisone and others.

This list is not complete. Other drugs may interact with propranolol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. .

Propranolol may cause heart failure in some patients. Check with your doctor right away if you or your child are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, weight gain, or wheezing.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you or your child have these problems or if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. Do not stop taking this medicine before surgery without your doctor's approval.

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking propranolol.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Propranolol will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may increase risk of stroke in PHACE syndrome patients with severe blood vessel problems in the brain. Talk to your child's doctor about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• It is used to treat proliferating infantile hemangioma.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Loose stools (diarrhea).
• Not able to sleep.
• Throwing up.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hemangeol is contraindicated in the following conditions:

• Premature infants with corrected age < 5 weeks
• Infants weighing less than 2 kg
• Known hypersensitivity to propranolol or any of the excipients [see Description (11)]
• Asthma or history of bronchospasm
• Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure
• Blood pressure <50/30 mmHg
• Pheochromocytoma

Hypoglycemia

Hemangeol prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. Hemangeol can cause hypoglycemia in children, especially when they are not feeding regularly or are vomiting; withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. If a child has clinical signs of hypoglycemia, discontinue Hemangeol and call their health care provider immediately or take the child to the emergency room.

Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [see Drug Interactions (7)].

Bradycardia and Hypotension

Hemangeol may cause or worsen bradycardia or hypotension. In the studies of Hemangeol for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.

Bronchospasm

Hemangeol can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.

Cardiac Failure

Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure.

Increased Risk of Stroke in PHACE Syndrome

By dropping blood pressure, Hemangeol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies.

Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to Hemangeol therapy. 

Hypersensitivity

Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis.

Pregnancy

Hemangeol is not intended to be prescribed to pregnant women [see Indications and Usage (1)].

Pregnancy Category C.

In a series of reproductive and developmental toxicology studies, propranolol hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation. At a dose of 150 mg/kg/day [which is about 2 times the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride in adults on a body surface area basis], treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered in the feed to rabbits throughout pregnancy and lactation at doses up to 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose in adults). No evidence of embryo or neonatal toxicity was noted.

There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy. Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia, and respiratory depression. Adequate facilities for monitoring such infants at birth should be available.

Nursing Mothers

Hemangeol is not intended to be prescribed to breastfeeding women [see Indications and Usage (1)].

Propranolol is excreted in human milk.

Pediatric Use

Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with Hemangeol starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24 [see Clinical Studies (14)].

Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.

Hepatic Impairment

There is no experience in infants with hepatic impairment.

Renal Impairment

There is no experience in infants with renal impairment.

See FDA-approved patient labeling (Medication Guide and Instructions for Use).

Patient advice

Advise parents or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Instructions for using oral dosing syringe

Instruct parents or caregivers on use of the oral dosing syringe.

Risk of hypoglycemia

Inform parents or caregivers that there is a risk of hypoglycemia when Hemangeol is given to infants who are not feeding regularly or who are vomiting. Instruct them to skip dosing under such conditions.

Instruct parents or caregivers how to recognize the signs of hypoglycemia. Tell them to discontinue Hemangeol and call their health care provider immediately or take the child to the emergency room in case of suspected hypoglycemia.

Cardiovascular risks

Advise parents or caregivers that there is a potential risk for bradycardia, aggravation of pre-existing conduction disorders, and hypotension associated with the use of Hemangeol. Instruct them to contact their healthcare provider in case of fatigue, pallor, slow or uneven heart beats, peripheral coldness or fainting.

Respiratory risks

Inform parents or caregivers that Hemangeol carries risk of bronchospasm or exacerbation of lower respiratory tract infections. Instruct them to contact their healthcare provider or go to the nearest hospital emergency room if their child has breathing problems or wheezing during treatment with Hemangeol.

Other risks

Inform parents or caregivers that changes in sleep patterns may occur during Hemangeol therapy.

Ask parents or caregivers to tell you all the medications they are administering to their child including prescription and over the counter medicines, vitamins, and herbal supplements. Ask breastfeeding mothers to tell you all the medications they are currently taking, as these may pass into the milk.

MEDICATION GUIDE

Hemangeol® (he-man je-ohl)

(propranolol hydrochloride oral solution)

What is the most important information I should know about Hemangeol?

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, for example, 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.

What is Hemangeol?

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

Who should not take 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. See the end of this Medication Guide for a list of 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”

What should I tell my doctor before giving my child Hemangeol?

Before you start giving Hemangeol to your child,tell your doctor about all of your child’s medical conditions.

Tell your doctor about all of the medicines that your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Hemangeol and some medicines may interact with each other and cause serious side effects. Especially tell your doctor if your child takes a steroid medicine. Taking a steroid medicine during treatment with Hemangeol may increase your child’s risk of low blood sugar.

If you are breastfeeding your child, it is important to tell your doctor about all the medicines you take.  Certain medicines may pass to your child through your breast-milk and interact with Hemangeol. Your doctor should tell you if you should stop breastfeeding.

How should I give Hemangeol to my child?

Follow the detailed Instructions for Use that come with Hemangeol for information about the correct way to prepare and give a dose of Hemangeol.

• Give Hemangeol to your child exactly as your doctor tells you.
• Your doctor may change the dose until it is right for your child, and as your child’s weight changes.
• Always give Hemangeol with a feeding or right away after a feeding.
• Hemangeol is given 2 times each day, at least 9 hours apart.
• If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.

What are the possible side effects of Hemangeol?

See “What is the most important information I should know about Hemangeol?”

Hemangeol can cause serious side effects, including:

• New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension). Call your doctor if your child has any of these symptoms: pale skin color, slow or uneven heartbeats, arms or legs feel cold, blue or purple skin color, or fainting.
• Breathing problems or wheezing.  Hemangeol can cause spasms of your child’s airway. Call your doctor or go to the nearest hospital emergency room if your child has breathing problems or wheezing during treatment with Hemangeol.
• 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.

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 may report side effects to FDA at 1-800-FDA-1088.

How should I store Hemangeol?

• Store Hemangeol at room temperature between 68o F to 77o F (20o C to 25o C). Do not freeze.  Do not shake before use.
• Safely throw away any opened bottle of Hemangeol after 2 months, even if there is medicine left in the bottle.

Keep Hemangeol and all medicines out of the reach of children.

General information about the safe and effective use of Hemangeol.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about Hemangeol that is written for health professionals. Do not use Hemangeol for a condition for which it was not prescribed. Do not give Hemangeol to other people, even if they have the same symptoms your child has. It may harm them.

What are the ingredients in Hemangeol?

Active ingredient: propranolol hydrochloride

Inactive ingredients: strawberry flavor, vanilla flavor, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.

Manufactured for: Pierre Fabre Pharmaceuticals, Inc., Parsippany, NJ 07054

For more information, call 1-855-PFPHARM (737-4276)

This Medication Guide has been approved by the U.S. Food and Drug Administration                                 Issued: Jan 2015

Instructions for Use

Hemangeol® (he-man je-ohl)

(propranolol hydrochloride oral solution)

Read these Instructions for Use before giving a dose of Hemangeol to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of Hemangeol to your child before you give it for the first time.

Important: Read the Medication Guide that comes with Hemangeol.

• To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give Hemangeol either during a feeding or right away after a feeding.
• Do not give a dose of Hemangeol if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar. 

When you get Hemangeol from your doctor or pharmacist, you will receive a box that contains the supplies needed to give Hemangeol to your child, including:

• One glass bottle of Hemangeol
• One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of Hemangeol (See Figure A).  If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure Hemangeol.

Figure A

Preparing to give your child a dose of Hemangeol:

Step 1. Place your box of supplies on a clean flat work surface, such as a table.

Step 2. Remove the Hemangeol bottle and oral dosing syringe from the box (See Figure A above). Do not shake the bottle before use. Keep the box for storage.

Step 3. Remove the oral dosing syringe from the plastic bag. Safely throw the plastic bag away. The barrel of the syringe has markings in milliliters (mL). Look at the markings on the barrel of the oral dosing syringe and find the mL marking that matches the Hemangeol dose in mL prescribed by your doctor (See Figure B).

Figure B

Step 4. Open the bottle of Hemangeol by pushing down on the plastic cap while turning the cap to the left (See Figure C).

• Write down on the box the date when you first open the bottle.

Figure C

Step 5. Place the bottle on your work surface. Use one hand to hold the bottle upright.Use your other hand to insert the tip of the oral dosing syringe into the syringe adapter at the top of the bottle. Push the plunger all the way down (See Figure D).

• Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.

Figure D

Step 6: Use one hand to hold the oral dosing syringe in place. With your other hand, turn the bottle upside down. Pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the syringe that matches the dose of Hemangeol prescribed by your doctor (See Figure E). Your child’s dose may be different than the dose shown in Figure E.

Figure E

Step 7:  Check for air bubbles in the oral dosing syringe. If you see air bubbles, push up on the plunger towards the bottle just enough to remove any large air bubbles and then pull back to the measured dose (See Figure F).

Figure F

Step 8. Turn bottle upright again and place it in on your work surface. Remove the oral dosing syringe from the bottle (See Figure G). Do not push the plunger in during this step. The syringe adapter should stay attached to the bottle.

Figure G

Giving your child a dose of Hemangeol:

Step 9. Slowly squirt Hemangeol into your child’s mouth after placing the oral dosing syringe against the inside of the cheek (See Figure H).

• Keep your child in an upright position for a few minutes right after giving a dose of Hemangeol.

Figure H

• If needed, you can dilute the dose of Hemangeol in a small amount of milk or fruit juice and give it to your child in a baby’s bottle. If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.

Step 10. Replace the plastic cap on the bottle. Close the bottle by turning the plastic cap to the right (See Figure I).

Figure I

Cleaning the oral dosing syringe:

Step 11: Clean the oral dosing syringe after each use by rinsing with clean tap water (See Figure J).

• Do not take apart the oral dosing syringe.
• Do not use any soap or alcohol based product to clean. Wipe the outside dry.
• Do not put the oral dosing syringe through a sterilizer or dishwasher.

Figure J

Step 12: Place the bottle and the oral dosing syringe in the box.

How should I store Hemangeol?

• When not in use, keep the bottle of Hemangeol and the oral dosing syringe in the box it comes in.
• Store Hemangeol at room temperature, between 68o F to 77o F (20o C to 25o C). Do not freeze.
• Safely throw away any opened bottle of Hemangeol after 2 months, even if there is medicine left in the bottle.

Keep Hemangeol and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Pierre Fabre Pharmaceuticals, Inc.

Parsippany, NJ 07054

Made in France

Issued: May 2015

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label 

NDC 64370-375-01

Hemangeol®

(propranolol hydrochloride)

4.28 mg/mL

Dispense with enclosed Medication Guide

Rx only

120 mL

PRINCIPAL DISPLAY PANEL - 120 mL Carton Label

NDC 64370-375-01

Hemangeol®

(propranolol hydrochloride)

4.28 mg/mL

Dispense with enclosed Medication Guide

Rx only

120 mL

Applies to propranolol: oral capsule extended release, oral solution, oral tablet

Other dosage forms:

• intravenous solution

Along with its needed effects, propranolol (the active ingredient contained in Hemangeol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking propranolol:

• Cough producing mucus
• difficulty with breathing
• tightness in the chest

• Abdominal or stomach pain and tenderness
• black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine
• bloody nose
• bloody stools
• blurred or loss of vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• confusion about identity, place, and time
• congestion
• constipation
• cough
• cracks in the skin
• crying
• decreased awareness or responsiveness
• decreased urine output
• depersonalization
• diarrhea
• difficulty with swallowing
• dilated neck veins
• disturbed color perception
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dryness or soreness of the throat
• dysphoria
• euphoria
• extreme fatigue
• fast, pounding, slow, or irregular heartbeat
• fever and chills
• general feeling of discomfort, illness, or weakness
• hair loss
• halos around lights
• headaches
• heavier menstrual periods
• hoarseness
• irregular breathing
• lightheadedness, dizziness, or fainting
• loss of heat from the body
• mental depression
• mimicry of speech or movements
• muscle or joint pain
• mutism
• nausea
• negativism
• night blindness
• noisy breathing
• overbright appearance of lights
• paleness or cold feeling in the fingertips and toes
• paranoia
• peculiar postures or movements, mannerisms, or grimacing
• pinpoint red or purple spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• quick to react or overreact emotionally
• rapidly changing moods
• rectal bleeding
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• reddening of the skin, especially around the ears
• runny nose
• scaly skin
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• short-term memory loss
• shortness of breath
• skin irritation or rash, including rash that looks like psoriasis
• skin rash, hives, or itching
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the eyes, face, fingers, feet, or lower legs
• swollen glands
• tender, swollen glands in the neck
• tightness in the chest
• tingling or pain in fingers or toes when exposed to cold
• tunnel vision
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting
• weight gain

Some side effects of propranolol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• dry mouth
• hyperventilation
• irritability
• restlessness
• shaking
• sleepiness or unusual drowsiness
• trouble sleeping
• unusual dreams

• Decreased appetite

• Dry eyes
• heartburn
• loss of strength or energy
• muscle weakness
• pain or discomfort in the chest, upper stomach, or throat
• stomach cramps
• unusual drowsiness, dullness, or feeling of sluggishness
• vivid dreams