Consumer medicine information

Hemangiol Oral Solution



Brand name

Hemangiol Oral Solution

Active ingredient





Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hemangiol Oral Solution.

What is in this leaflet

This leaflet answers some common questions about Hemangiol®.

It does not contain all the information that is known about Hemangiol®.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of giving your child Hemangiol® against the benefits this medicine is expected to have.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Hemangiol® is used for

Hemangiol® is used to treat a condition in infants called hemangioma.

A hemangioma is a collection of extra blood vessels that have formed a lump in or under the skin. A hemangioma can be superficial or deep.

It is sometimes called a ‘strawberry mark’ because the surface of a hemangioma looks a bit like a strawberry.

Hemangiol® contains the medicine, propranolol which belongs to a group of medicines known as beta-blockers. Beta-blockers are used to treat a variety of heart and blood vessel conditions.

Your doctor may have prescribed Hemangiol® for another reason.

Ask your doctor if you have any questions about why Hemangiol® has been prescribed for your child.

This medicine is only available with a doctor’s prescription.

Before Hemangiol® is given to your child

When it must not be given to your child

Do not give Hemangiol® if your child:

  • is born prematurely and has not reached the corrected age of 5 weeks. (The corrected age is worked out by subtracting the number of weeks your child was premature from your child’s actual age, i.e. the age of your child minus the number of weeks premature);
  • has an allergy to propranolol or any of the ingredients listed at the end of this leaflet. An allergic reaction can include a rash, itching, hives, shortness of breath, wheezing, or difficulty breathing;
  • asthma or a history of breathing difficulties;
  • has a slow heart beat for their age. Check with your doctor if you are not sure;
  • has a heart problem (such as disorders of the heart rhythm and heart failure);
  • has very low blood pressure.
  • has circulation problems which make the toes and fingers numb and pale;
  • is prone to low blood sugar levels;
  • has high blood pressure caused by a tumour on the adrenal gland. This is called, ‘phaeochromocytoma’.

If you are breastfeeding your child and you are taking medicines that must not be used with Hemangiol® (see “Taking other medicines”), do not give Hemangiol® to your child.

Hemangiol® must not be used after the expiry date printed on the pack. The expiry date refers to the last day of that month.

If this medicine is taken after the expiry date has passed, it may not work as well.

Do not use Hemangiol® if the packaging is torn or shows signs of tampering.

If your medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether Hemangiol® should be given to your child, talk to your doctor.

Before Hemangiol® is given to your child

Tell your doctor if your child has any medical conditions or a family history of any medical conditions, especially the following:

  • if your child has liver or kidney problems. Hemangiol® is not recommended in children with liver or kidney impairment.
  • if your child has allergies to any other medicines, foods, preservatives or dyes;
  • if your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin). Hemangiol® may make the psoriasis worse.
  • If your child has diabetes or low blood sugar; in which case, your child’s blood sugar level should be measured more frequently;
  • if your child has PHACE syndrome (a condition involving haemangioma and blood vessel abnormalities including blood vessels of the brain), as Hemangiol® may increase the risk of stroke;
  • if your child has asthma or serious breathing problems;
  • heart problems or heart defects;
  • low blood pressure;
  • circulation problems.

It may not be safe for your child to have Hemangiol® if they have any of these conditions.

Tell your doctor if your child has not been feeding well or has been vomiting.

Taking other medicines

Tell your doctor or pharmacist about any other medicines that your child is being given, has recently been given or might be given, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Hemangiol® may interfere with each other. They may affect how well Hemangiol® works or Hemangiol® may affect how well they work.

Your child may need to take different amounts of other medicines, or may need to take different medicines. Your doctor or pharmacist will advise you.

Know the medicines that your child takes. Keep a list of these medicines with you to show the doctor and pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or to avoid giving your child while your child is taking Hemangiol®.

Do not give your child any new medicine while your child is taking Hemangiol®. Talk to your doctor first.

If you are breastfeeding your child, it is important to tell your doctor, pharmacist or nurse which medicines you yourself are taking.

These medicines can pass into your breast milk and interfere with the treatment of your child.

In particular, tell your doctor or pharmacist if you (if you are breastfeeding) or your child are taking:

  • medicines for diabetes;
  • medicines for heart problems such as an irregular heart beat, chest pain, high blood pressure or heart failure;
  • medicines used to treat anxiety and depression as well as more serious health problems, and epilepsy;
  • medicines used to treat pain and inflammation;
  • medicines to treat tuberculosis;
  • medicines to treat pain and inflammation;
  • medicines used to lower lipids in the blood;
  • medicines used for anaesthesia.

If you have not told your doctor or pharmacist about any of the above, tell them before you start giving your child Hemangiol®.

How to give Hemangiol®

Give Hemangiol® to your child exactly as your doctor has prescribed.

How much to give

Your doctor will decide what dose to give, how often and when to give Hemangiol® to your child.

The recommended dose of Hemangiol® will be reached gradually with weekly increases under medical supervision. Dosing is based on your baby’s weight. Your doctor will readjust the dose as your child’s weight changes.

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box or bottle, ask your doctor or pharmacist for help.

How to give it

Give Hemangiol® twice a day, one dose in the morning and one late afternoon with at least 9 hours between each dose, during or immediately after feeding your child.

Give Hemangiol® directly into your child’s mouth using the oral syringe supplied with the bottle.

If necessary, you may mix the dose of Hemangiol® with a small amount of your child’s milk or apple or orange juice suitable for your child’s age and give it to your child in a baby’s bottle. Do not mix the dose of Hemangiol® with a full bottle of milk or juice.

For children weighing up to 5 kg you may mix the Hemangiol® dose with one teaspoonful of milk (approximately 5 mL).

For children weighing more than 5 kg, the dose may be mixed with a tablespoonful of milk or juice (approximately 15 mL).

Use the mixture within 2 hours of preparation.

Feed your child regularly while your child is taking Hemangiol®.

If your child is not feeding or is vomiting, then do not give Hemangiol® to your child until their feeding is back to normal and tell your doctor.

If your child spits up a dose or if you are uncertain whether he/she got all of the medicine, do not give another dose. Just wait until the next scheduled dose.

The dose of Hemangiol® and the child’s food must be given by the same person to avoid the risk of hypoglycaemia (low sugar levels in the blood). If different people are involved, good communication is essential in order to ensure the safety of your child.

How long to give it

Continue giving Hemangiol® to your child for as long as your doctor tells you. Treatment will usually last for a six month period.

If you forget to give it

Do not give a double dose to make up for the dose you missed. Give the next dose of Hemangiol® when you are meant to then continue giving it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have given too much (overdose)

Contact your doctor immediately or the Poisons Information Centre (in Australia telephone 131 126; in New Zealand telephone 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital immediately, if you think that too much Hemangiol® has been given to your child.

Your child may need urgent medical attention.

While your child is taking Hemangiol®

Things you must do

Call your doctor immediately or seek emergency medical assistance if your child shows any signs such as fatigue, coldness, pallor, bluish-coloured skin or fainting while taking Hemangiol®.

Hemangiol® can lower blood pressure (hypotension) and slow heart rate (bradycardia). That is why your child will be kept under close medical supervision with clinical and heart monitoring for 2 hours after the first dose or after a dose increase. Then, your doctor will regularly examine your child during treatment.

To avoid the risk of hypoglycaemia, your child must be fed regularly during treatment. If your child is not feeding or is vomiting, treatment with Hemangiol® should be stopped temporarily. DO NOT RESUME TREATMENT WITH HEMANGIOL® UNTIL YOUR CHILD HAS STOPPED VOMITING AND IS FEEDING NORMALLY AGAIN.

Hemangiol® may cause low blood sugar (hypoglycaemia) or mask the warning signs of low blood sugar, especially if the baby is not feeding, vomiting or in the case of overdose. These signs may be minor: pallor, drowsiness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up; or major: excessive sleeping, difficulty getting a response, poor feeding, drop in body temperature, convulsions (fits), brief pauses in breathing, loss of consciousness.

If your child shows any signs of hypoglycaemia while taking Hemangiol®, make your child drink a liquid containing sugar and stop the treatment with Hemangiol® until you have informed your doctor. If symptoms persist, call your doctor immediately or seek emergency medical assistance.
If your child is coughing, breathing quickly or having difficulty breathing, wheezing or has bluish-coloured skin, stop treatment and contact your doctor immediately or seek emergency medical assistance.

These are symptoms of bronchospasm (narrowing of the airways).

If your child is going to have surgery, tell the surgeon or anaesthetist that your child is taking Hemangiol®. Hemangiol® may need to be discontinued at least 48 hours before the anaesthesia.

If your child is about to be started on any new medicine, remind your doctor and pharmacist that your child is taking Hemangiol®.

Tell any other doctors, dentists and pharmacists who are treating your child that your child is taking Hemangiol®.

Things you must not do

Do not give Hemangiol® to any other child, even if they seem to have the same condition.

Do not give Hemangiol® to treat any other complaints unless your doctor tells you to.

Side effects

Tell your doctor as soon as possible if your child becomes unwell while taking Hemangiol®.

Like other medicines, Hemangiol® can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Do not be alarmed by the following list of possible side effects. Your child may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Very common side effects (may affect more than 1 in 10 people):

  • bronchitis (inflammation of the bronchial tubes)
  • sleep disorders (insomnia, poor quality of sleep, difficulties waking up)
  • vomiting
  • diarrhoea

Common side effects (may affect up to 1 in 10 people):

  • bronchospasm (difficulty breathing)
  • bronchiolitis (inflammation of the small bronchi with breathing difficulties and wheeze in the chest)
  • decreased blood pressure
  • reduced appetite
  • agitation, nightmares, irritability
  • somnolence (drowsiness)
  • cold extremities (hands and/or feet)
  • constipation
  • stomach pain
  • erythema (skin redness or flushing)

Uncommon side effects (may affect up to 1 in 100 people):

  • heart conduction or rhythm disorders (slow or uneven heart beats)
  • urticaria (rash, itching or hives on the skin)
  • alopecia (hair loss)
  • decreased blood sugar levels
  • reduction of the number of white blood cells

The frequency of the following side effects is not known:

  • convulsions (fits) linked to abnormally low blood sugar levels (hypoglycaemia),
  • abnormally slow heart rate (bradycardia)
  • low blood pressure
  • very low levels of white blood cells that fight infection
  • circulation problems which make the toes and fingers numb and pale
  • Elevated levels of potassium in the blood

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else which may be causing your child to be unwell.

After using Hemangiol®


The bottle of Hemangiol® solution should be stored in a dry place where the temperature stays below 30°C. Do not freeze it.

Use within 2 months of opening.

Always keep the bottle of Hemangiol® solution in its outer carton to protect it from light.

Store the oral syringe with the bottle in the outer carton between each use.

Do not store Hemangiol® or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car on hot days.

Heat and dampness can destroy some medicines.

Keep this medicine where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.


If your doctor tells you to stop the treatment with Hemangiol®, or it has passed its expiry date, ask your pharmacist what to do with any of the medicine left over. Do not dispose of this medicine via wastewater or household waste. This will help to protect the environment.

Product description

What it looks like

Hemangiol® is a clear, colourless to pale yellow solution with a fruity odour. It comes in an amber glass bottle with a child-resistant screw cap and is supplied with a 5 mL dispensing oral syringe.


Active ingredient:

  • propranolol hydrochloride

Other ingredients:

  • hydroxyethylcellulose
  • saccharin sodium
  • citric acid monohydrate
  • purified water
  • strawberry (proprietary ingredient number: 109091) and vanilla (proprietary ingredient number: 109044) flavours


Hemangiol® is supplied in Australia by:

Pierre Fabre Australia Pty Limited
Suite 601, 504 Pacific Highway, St Leonards,
NSW 2065

Australian Registration Number:

This leaflet was prepared in June 2015.


Brand name

Hemangiol Oral Solution

Active ingredient





Name of the medicine

Propranolol hydrochloride.


Hemangiol also contains the excipients: hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, purified water and strawberry proprietary ingredient number: 109091) and vanilla (proprietary ingredient number: 109044) flavours.


Molecular formula: C16H21NO2.HCl. MW: 295.8. CAS: 318-98-9. Propranolol hydrochloride is a white to off-white powder. It is soluble in water and ethanol, slightly soluble in chloroform and practically insoluble in ether. It is non hygroscopic with a pKa of 9.5. Propranolol hydrochloride has a chiral centre; its synthesis produces a racemic mixture.
Hemangiol drug product is presented as a colourless to slightly yellow, clear, oral solution with a fruity odour. One mL of Hemangiol oral solution contains 3.75 mg of propranolol base (as propranolol hydrochloride 4.28 mg). Hemangiol also contains the excipients: hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, purified water and strawberry (proprietary ingredient number: 109091) and vanilla (proprietary ingredient number: 109044) flavours.
Attention is drawn to the difference in the labelling of the content of propranolol in Hemangiol compared to other propranolol dosage forms: Hemangiol solution is labelled in terms of the amount of propranolol base per mL whereas propranolol tablets are labelled in terms of the amount of propranolol hydrochloride per tablet.
Propylene glycol is the major component of the strawberry and vanilla flavours. Propylene glycol exposure is up to 2.08 mg/kg/day which does not present a significant safety concern for the pediatric patient population, no risk for health of treated children is expected.



Propranolol is a non-selective beta-blocker that is characterised by three pharmacological properties:
The absence of cardioselective beta-1 beta-blocking activity;
An antiarrhythmic effect;
Lack of partial agonist activity (or intrinsic sympathomimetic activity).
The pathogenesis of infantile haemagioma remains poorly understood, however, neovascularisation and angiogenesis mechanisms are probably involved.
The effect of propranolol in proliferating infantile haemangioma could be attributed to the following proposed mechanisms described in the literature:


Propranolol inhibits vasodilation via beta-receptors leading to vasoconstriction, thus inducing a reduction of blood flow within the haemangioma.

Inhibition of angiogenesis.

Characterised by a decrease in the proliferation of vascular endothelial cells, a reduction of the neovascularisation and formation of vascular tubules, a reduction in the secretion of matrix metalloproteinase 9 (MMP-9) which is crucial for endothelial cell migration.

Induction of apoptosis in capillary endothelial cells of haemangioma.

Beta-2 adrenoreceptors are expressed on the capillary endothelial cells. Their activation promotes the vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) signalling pathways and the resulting proangiogenesis/proliferation; their blockade by propranolol can inhibit capillary endothelial cell proliferation.




Studies with propranolol hydrochloride in humans indicate that it is almost completely absorbed from the intestine. A large part of the absorbed drug is lost to the systemic circulation due to the first pass metabolism in the liver. After repeated administration, the first pass removal process becomes saturated and, at steady state, the plasma concentration is proportional to the dose, although there is some variation between patients as to the blood levels achieved at a given dose. In addition, correlation of plasma level to therapeutic effect varies considerably with propranolol as with some other β-blockers. Blood level measurements show that after intravenous administration, the concentration in the circulation decreases rapidly due mainly to uptake by tissues generally.


In general, the peak blood level occurs between 1 and 3 hours after oral administration, and will have an average value of 0.1 microgram/mL per 80 mg single dose. The peak blood level is proportional to the dose. With chronic administration the mean plasma half-life is from 3 to 6 hours, determined by clearance and plasma binding.
Following intravenous administration the plasma half-life of propranolol is about 2 hours and the ratio of metabolites to parent drug in the blood is lower than after oral administration. In particular 4-hydroxypropranolol is not present after intravenous administration.


Propranolol is absorbed from the circulation and is widely distributed throughout the body tissues.

Protein binding.

Approximately 93% is plasma bound in humans.


Propranolol is metabolised, primarily by the liver. Hydroxylation of the aromatic nucleus occurs with degradation of the isoprenaline side chain. Over 20 metabolites have been identified. One of these, the 4-hydroxy metabolite, found only after oral administration has β-adrenergic blocking properties.


Some 95 to 100% of a dose of propranolol hydrochloride is excreted as metabolites and their conjugates in the urine.


The plasma half-life of oral propranolol is of the order of 3 to 6 hours. The pharmacological effect lasts much longer.

Paediatric population.

The pharmacokinetics of propranolol and 4-OH-propranolol were evaluated in a multiple dose 12 week study conducted in 23 male and female infants 35 to 150 days of age with haemangioma. The infants were stratified by age (35 to 90 days and 91 to 150 days). The starting dose was 1.2 mg/kg/day which was titrated to the target dose of 3.4 mg/kg/day in 1.1 mg/kg/day increments at weekly intervals. At steady state, following administration of 3.4 mg/kg/day twice daily, peak plasma propranolol concentrations were observed within 2 hours of oral administration. Clearance of propranolol in infants was similar across the age range studied (2.7 (SD=0.03) L/h/kg in infants <90 days of age and 3.3 (SD=0.35) L/h/kg in infants >90 days of age) and to that in adults when adjusted by body weight. The median elimination half-life of propranolol was about 3.5 hours. Plasma propranolol concentrations approximate a dose proportional increase in the dose range of 1.2 mg/kg/day to 3.4 mg/kg/day.
Plasma concentration of 4-OH-propranolol, the main metabolite, was about 5% of total plasma exposure of propranolol.

Clinical Trials

For ethical reasons relating to the use of placebo, the demonstration of efficacy was not established in patients with high-risk infantile haemangioma (IH). Infants with life-threatening IH, function-threatening IH (e.g. those causing impairment of vision, or respiratory compromise caused by airway lesions), and/or complicated ulcerated IH were excluded from the clinical development program. Evidence of the efficacy of propranolol in patients with high-risk IH is based on studies reported in the literature and from a specific compassionate use program performed with propranolol.
The efficacy of propranolol for the treatment of proliferating infantile haemangioma requiring systemic therapy was established in a randomised, multidose, placebo-controlled, double-blind, multicentre, 2-stage adaptive phase II/III study in infants aged 5 weeks to 5 months at treatment initiation (Study 201).
At Stage 1, a total of 460 patients were randomised to 5 treatment arms (4 regimens of propranolol and placebo): 99 and 101 patients on propranolol 1 mg/kg/day and 3 mg/kg/day respectively for 3 months then placebo for 3 months; 103 and 102 patients on propranolol 1 mg/kg/day and 3 mg/kg/day respectively for 6 months; and 55 patients on placebo for 6 months. Propranolol dosing included a 3 week titration phase. Overall, 70% of patients had haemangiomas on the head and face and a majority of the haemangiomas were localised (89%).
At the end of Stage 1, an interim analysis for regimen selection was performed by an independent statistician on the first 190 randomised patients from all five regimens who had completed Week 24 (or prematurely withdrawn from treatment). The ‘best’ regimen (defined as the most efficacious regimen with a good safety profile) selected for the primary efficacy analysis was propranolol 3 mg/kg/day for 6 months. Stage 2 comprised two treatment arms: placebo and the selected active regimen.
The primary efficacy analysis ITT data set comprised 55 patients in the placebo 6 months regimen and 101 patients in the 3 mg/kg/day 6 months regimen (Table 1). Treatment success was defined as a complete or nearly complete resolution of the target haemangioma at week 24 compared to baseline. Efficacy was assessed by evaluation of digital photographs by two blinded, independent, trained and validated readers.
Two patients (3.6%) in the placebo 6 month regimen and 61 patients (60.4%) in the 3 mg/kg/day 6 month regimen presented complete or nearly complete resolution of their haemangioma between baseline and Week 24 (p < 0.0001). 11.4% of patients needed to be re-treated after treatment discontinuation.


Treatment of proliferating IH requiring systemic therapy:
Life- or function-threatening haemangioma.
Ulcerated haemangioma with pain and/or lack of response to simple wound care measures.
Haemangiomas with a risk of permanent scars or disfigurement.


The use in infants less than 5 weeks of age is contraindicated.
The use in infants less than 2.5kg is contraindicated.
Hemangiol is contraindicated in premature infants for whom the corrected age of 5 weeks post-term has not been reached. The corrected age is calculated by subtracting the number of weeks of prematurity from the actual age (in weeks).
Breastfed infants if the mother is treated with medicines contraindicated with propranolol.
Hypersensitivity to propranolol or to any of the excipients.
Asthma or a history of bronchospasm.
Second- or third-degree atrioventricular blocks.
Disease of the sinus node (including sinoatrial block).
Bradycardia below the following limits. See Table 2.
Low blood pressure below the following limits. See Table 3.
Cardiogenic shock.
Heart failure not controlled by medication.
Prinzmetal’s angina.
Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon).
Subjects prone to hypoglycaemia.


Initiation of treatment.

Treatment with Hemangiol should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling adverse events, including those requiring urgent measures, are available.
Prior to initiating propranolol therapy, screening for risks associated with propranolol use must be performed. An analysis of the medical history and a full clinical examination must be performed including heart rate, cardiac and pulmonary auscultation.
During the titration phase, each dose increase must be managed and monitored by a physician in the same conditions as the administration of the initial dose. After the titration phase, the dose will be readjusted by the physician according to the changes in the child’s weight.
Clinical monitoring of the child’s condition and dose readjustment need to be performed at least monthly.
In infants with a suspected cardiac abnormality, specialist advice must be sought before Hemangiol initiation to determine any subjacent contra-indication.
In infants with an acute broncho-pulmonary abnormality, the initiation of Hemangiol treatment should be postponed.
Parents or guardians should be advised to read the ‘Consumer Medicine Information’ and ‘Handling Instructions’ before use and instructed on the use of the oral dosing syringe. Parents or guardians should also be informed of the risk of hypoglycaemia, cardiovascular, respiratory and other risks associated with the use of Hemangiol (see Hypoglycaemia, Bradycardia and hypotension, Respiratory disorders).


Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia. It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger. It can aggravate hypoglycaemia in children, especially in the case of fasting, vomiting or overdose. These hypoglycaemic episodes associated with taking propranolol may present exceptionally in the form of seizures and/or coma.
If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment. Appropriate monitoring of the child is required until symptoms disappear. In children with diabetes, blood glucose monitoring should be increased.
Parents or guardians should be informed that there is a risk of hypoglycaemia when Hemangiol is given to infants who are not feeding regularly or who are vomiting. They should be instructed on how to recognise the signs of hypoglycaemia. Tell them to discontinue Hemangiol and call their doctor immediately or take the child to the nearest hospital Accident and Emergency Department in case of suspected hypoglycaemia.

Bradycardia and hypotension.

Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities. Bradycardia should be diagnosed if the heart rate declines by more than 30 bpm from baseline. Bradycardia is defined as a heart rate less than 80 bpm.
After the first intake and each dose increase, clinical monitoring, including blood pressure and heart rate must be performed at least hourly for at least 2 hours. In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought.
In case of severe and/or symptomatic bradycardia or hypotension occurring at any time during treatment, treatment must be discontinued and specialist advice should be sought.
Parents or guardians should be advised that there is a potential risk of bradycardia and hypotension associated with the use of Hemangiol. They should be instructed to contact their doctor in case of fatigue, pallor, slow or uneven heart beats, peripheral coldness or fainting.

Respiratory disorders.

Propranolol can cause bronchospasm. In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment with Hemangiol should be temporarily discontinued. The administration of beta-2 agonists and inhaled corticosteroids might be required. The re-administration of Hemangiol may be considered when the child has fully recovered. In infants with reoccurrence of respiratory symptoms, treatment with Hemangiol should be permanently discontinued. In infants with isolated bronchospasm following Hemangiol exposure, Hemangiol must be permanently discontinued.
Parents of guardians should be informed that Hemangiol carries the risk of bronchospasm or exacerbation of lower respiratory tract infections. They should be instructed to contact their doctor or take their child to the nearest hospital Accident and Emergency Department if their child has breathing problems or wheezing during treatment with Hemangiol.

Cardiac failure.

Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure. Its inhibition by beta blockade may precipitate more severe failure.

PHACE syndrome.

Very limited safety data of propranolol in PHACE syndrome patients are available. Propranolol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies by dropping blood pressure and attenuating flow through occluded, narrow or stenotic vessels.
Infants with large facial infantile haemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Specialist advice should be sought.

Paediatric use.

Use in children aged less than 5 weeks post-term is contraindicated. Safety and effectiveness of Hemangiol have not been established in this age group.
There are no clinical efficacy and safety data in the clinical studies carried out with Hemangiol to recommend its initiation in children aged more than 5 months.

Use in lactation.

Propranolol passes through breast milk. Mothers being treated with propranolol who breastfeed their infant should inform their infant’s treating physician before treatment is initiated in their child.

Liver or kidney impairment.

Hemangiol is metabolised in the liver and excreted by the kidneys. In the absence of data in children, Hemangiol is not recommended in infants with renal or hepatic impairment.


In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to a worsening of the reaction and resistance to its treatment with adrenaline at normal doses.

General anaesthesia.

Beta-blockers will result in attenuation of reflex tachycardia and an increased risk of hypotension during surgery. In addition, beta-blockers can exacerbate bradycardias that can occur during general anaesthesia. When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure.


Hyperkalaemia has been reported in patients with large ulcerated haemangioma. These patients should have their electrolytes monitored regularly.


A worsening of the disease has been reported with beta-blockers in patients suffering from psoriasis. Therefore, the need for treatment should be carefully weighed against this risk.

Effects on fertility.

Although some reversible effects on male and female fertilities were reported in adult rats receiving high doses of propranolol in the literature, the study performed in juvenile animals did not show any effect on fertility.


Based on in vivo and in vitro data, propranolol is unlikely to pose a genotoxic risk to patients.


Long-term carcinogenicity studies conducted via dietary administration in mice and rats showed no evidence of tumourigenicity.


In the absence of specific studies in children, potential drug interactions with Hemangiol documented in this section are those which are known from studies in adults.
Interactions with Hemangiol may occur:
when the infant is being treated with any other medicines, notably those mentioned below and/or;
when the infant is being breast fed by a mother taking any other medicines which may interact with Hemangiol. In this case, the need to discontinue breast feeding should be discussed. Whenever stopping breastfeeding is considered, the benefits of breastfeeding should be weighed against the risks posed by the presence of the specific conditions listed.
Close clinical surveillance of any impaired tolerance of Hemangiol is recommended.

Concomitant use not recommended.

Bradycardia-inducing calcium-channel blockers (diltiazem, verapamil).

Co-administration with propranolol can cause altered automaticity (excessive bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disorders, and increased risk of ventricular arrhythmias (torsades de pointes) along with heart failure.
This combination must only be administered under close clinical and ECG monitoring, particularly at the start of the treatment.

Interactions requiring caution.

Cardiovascular drugs.


Propranolol exposure is increased by co-administration of propafenone. Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol despite a reassuring study in healthy volunteers.
The metabolism of propranolol is reduced by co-administration of quinidine, leading to a two-three fold increased blood concentration and consequent increased beta-blockade that may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers such as propranolol. Automatism and conduction disorders are expected because of the suppression of sympathetic compensative mechanisms.
The metabolism of intravenous lidocaine is inhibited by co-administration of propranolol, resulting in a 25% increase in lidocaine concentrations. Lidocaine toxicity (neurological and cardiac adverse events) has been reported following co-administration with propranolol.
Caution should be exercised when administering propranolol with drugs that slow atrio-ventricular nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers because of the risk of significant bradycardias.

Digitalis glycosides.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.


Caution should be exercised when patients receiving a beta blocker are administered a dihydropyridine. Both agents may induce hypotension, heart failure in patients whose cardiac function is partially controlled because of additive inotropic effects. Reduction of reflex sympathetic response involved when excessive distal vasodilatation.

Calcium channel blockers.

Caution should be exercised when patients receiving a beta blocker are administered a calcium channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction. The mean Cmax and AUC of propranolol are increased respectively by 50% and 30% by co-administration of nisoldipine and by 80% and 47% by co-administration of nicardipine. The mean Cmax and AUC of nifedipine are increased by 64% and 79% respectively by co-administration of propranolol.
There have been reports of significant bradycardia, heart failure and cardiovascular collapse with concurrent use of verapamil and beta-blockers. Propranolol does not affect the pharmacokinetics of verapamil and norverapamil and conversely, verapamil does not affect the pharmacokinetics of propranolol. Co-administration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high-degree heart block and heart failure.

Antihypertensives (ACE Inhibitors, angiotensin II-receptor antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc).

When combined with beta-blockers, drugs that decrease arterial pressure can cause or increase hypotension, notably orthostatic. With centrally-acting antihypertensives, beta-blockers may exacerbate the rebound hypertension after clonidine abrupt withdrawal, and propranolol should be stopped several days before discontinuing clonidine.

ACE inhibitors.

When combined with beta-blockers, ACE inhibitors can cause hypotension.


Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. Propranolol should be withdrawn several days before discontinuing clonidine (even in the case of clonidine treatment discontinuation for the breastfeeding mother).

Alpha blockers.

Prazosin has been associated with hypotension in the presence of beta-blockers.


Patients receiving catecholamine-depleting drugs such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity which my result in hypotension, marked bradycardia, vertigo, syncopal attacks or orthostatic hypotension.

Inotropic agents.

Patients on long-term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore relatively contraindicated in the treatment of propranolol overdose.

Isoproterenol and dobutamine.

Propranolol is a competitive inhibitor of beta-receptor agonists. Its effects can be reversed by administration of such agents, e.g. dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing investigation for myocardial ischemia.

Sympathomimetic agents and epinephrine.

Concomitant use of sympathomimetic agents e.g. epinephrine, may counteract the effect of beta-blocker drugs. Caution should be taken in the parenteral administration of preparations containing epinephrine in people taking beta-blockers as vasoconstriction, hypertension and reflex bradycardia may result.

Non-cardiovascular drugs.


Patients with infantile haemangioma may be at increased risk if they have received or are concomitantly receiving treatment with corticosteroids because adrenal suppression may result in loss of the counter-regulatory cortisol response and increase the risk of hypoglycaemia. This also applies when children are breastfed by mothers treated with corticosteroids in case of high dosage or prolonged treatment.

Nonsteroidal anti-inflammatory drugs.

Nonsteroidal anti-inflammatory drugs (NSAIDS) have been reported to blunt the antihypertensive effect of beta-blockers.
Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.

Drugs inducing orthostatic hypotension (nitrate derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen).

Therapeutic classes which induce orthostatic hypotension may add their effects to that of beta-blockers. Administration of zolmitriptan or rizatriptan with propranolol resulted in increased blood concentrations of zolmitriptan (AUC and Cmax increased by 56% and 37% respectively) and rizatriptan (AUC and Cmax increased by 67% and 75% respectively).

Enzyme inducers.

Blood levels of propranolol may be decreased by co-administration of enzyme inducers like rifampicin or phenobarbital.


Caution should be exercised if ergotamine, dihydroergotamine or related compounds are given in combination with propranolol as arterial spasm with ischaemia of the extremities have been reported in a few patients. Clinical monitoring should be intensified, particularly during the first few weeks of co-administration.


Co-administration of theophylline with propranolol decreases oral theophylline clearance by 30% to 52%.


The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers.


Propranolol can inhibit the metabolism of diazepam resulting in increased concentrations of diazepam and its metabolites. Diazepam does not alter the pharmacokinetics of propranolol. The pharmacokinetics of oxazepam, triazolam, lorazepam and alprazolam are not affected by co-administration of propranolol.

Neuroleptic drugs.

Hypotension and cardiac arrest have been reported with the concomitant use of propranolol and haloperidol. Co-administration of long-acting propranolol at doses greater than or equal to 160 mg/day resulted in increased thioridazine plasma concentrations ranging from 55% to 369% and increased thioridazine metabolite (mesoridazine) concentrations ranging from 33% to 209%. Co-administration of chlorpromazine with propranolol resulted in a 70% increase in propranolol plasma level.


Co-administration of baclofen with propranolol may increase the risk of hypotension, particularly postural hypotension. Blood pressure should be monitored and the antihypertensive dose adjusted, if necessary.

Anti-ulcer drugs.

Co-administration of propranolol with cimetidine, a non-specific CYP450 inhibitor, increased propranolol AUC and Cmax by 46% and 35%, respectively. Co-administration with aluminium hydroxide gel (1200 mg) may result in a decrease in propranolol concentrations. Co-administration of metoclopramide with long-acting propranolol did not have a significant effect on propranolol’s pharmacokinetics.

Hypoglycaemic agents.

Hemangiol can mask certain symptoms and signs of hypoglycaemia such as palpitations and tachycardia. Use of Hemangiol in patients with diabetes mellitus should be used with caution as it may exacerbate the response to insulin, resulting in hypoglycaemia. The parents/guardians of an infant with diabetes mellitus should be informed of the risks of Hemangiol treatment. The frequency of blood glucose monitoring should be increased, particularly at the start of treatment when the dose is being up-titrated.

Lipid lowering drugs.

Co-administration of cholestyramine or colestipol with propranolol resulted in up to 50% decrease in propranolol concentrations. Co-administration of propranolol with lovastatin or pravastatin decreased the AUC of lovastatin and pravastatin by 18-23% but did not alter their pharmacodynamics. Propranolol did not have an effect on the pharmacokinetics of fluvastatin.

Halogenated anaesthetic agents.

Methoxyflurane and trichloroethylene may significantly depress myocardial contractility when administered with propranolol. Beta stimulating agents may be used to counteract the beta-blockade.


Concomitant administration of propranolol and warfarin has been shown to increase warfarin bioavailability and resultant prothrombin time.


Concomitant use of alcohol may increase plasma levels of propranolol.

Adverse Effects

In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse drug reactions in infants treated with Hemangiol were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea and vomiting.
The most severe risks reported in the compassionate use program and in the literature concerned hypoglycaemia (and related events such as hypoglycaemic seizure) and aggravated respiratory tract infections with respiratory distress.
Adverse drug reactions observed in two clinical trials comprising 424 patients treated with Hemangiol 1 mg/kg/day or 3 mg/kg/day for a maximum treatment duration of 6 months are presented in Table 4.
Frequency of adverse reactions is defined as: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1000 and < 1/100); and not known (cannot be estimated from available data). Due to the clinical trial data base size, rare (≥ 1/10,000 and < 1/1000) and very rare (< 1/10,000) categories are not represented. Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
With lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with Hemangiol due to the bronchoconstrictive effect of propranolol. These effects rarely resulted in definitive treatment discontinuation (see Precautions).
Sleep disorders were in the form of insomnia, poor quality of sleep and hypersomnia. Other CNS disorders were principally observed during the early periods of treatment.
Diarrhoea was frequently reported and was not always associated with an infectious gastrointestinal disease. The occurrence of diarrhoea seems to be dose-dependent between 1 and 3 mg/kg/day. None of the cases was severe nor led to treatment discontinuation.
Cardiovascular events reported during clinical studies were asymptomatic. During the 4 hours cardiovascular monitoring on the titration days, a decrease in heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) was observed following drug administration. One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation. Isolated cases of symptomatic bradycardia and hypotension have been reported in the literature.
Decreases in blood sugar observed during clinical studies were usually asymptomatic. However, several reports of hypoglycaemia with related seizure were reported during the compassionate use program, especially in cases of altered glucose intake during intercurrent illness (see Precautions).
Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycaemia (see Interactions with Other Medicines).
Hyperkalemia has been reported in the literature in a few patients with large ulcerated haemangioma.

Dosage and Administration


Hemangiol should be initiated in infants aged 5 weeks post-term to 5 months.
The dosage is expressed in propranolol base.
The recommended starting dose of Hemangiol is 0.15 mL/kg (0.5 mg/kg) (see Table 5) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.0 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.5 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases.


To reduce the risk of hypoglycaemia, administer Hemangiol orally during or immediately after a feeding. Skip the dose if the child is not eating or is vomiting (see Precautions, Hypoglycaemia).
Monitor heart rate and blood pressure for 2 hours after Hemangiol inititiation or dose increases (see Precautions, Bradycardia and hypotension).
The dose should be delivered directly into the child’s mouth using the graduated oral syringe, calibrated in mL of propranolol base, which is supplied with the product. The bottle should not be shaken before use.
If necessary, Hemangiol oral solution may be diluted in a small quantity of breast milk or age-adapted apple or orange juice and delivered to your child in a baby’s bottle. Hemangiol should not be mixed with a full bottle of milk or juice. For children weighing up to 5 kg, the Hemangiol dose may be mixed with one teaspoonful of milk (approximately 5 mL). For children weighing more than 5 kg, the dose may be mixed with a tablespoonful of milk or fruit juice (approximately 15 mL).
Use the mixture within 2 hours of preparation.
Ideally, Hemangiol should be given to the child by the same person in order to avoid the risk of accidental overdose and hypoglycaemia. If different carers are involved, good communication is essential in order to ensure the safety of the child.
If the child is not eating or is vomiting, it is recommended that the child miss the next dose. In case the child regurgitates the dose or does not take all of the medicine, no other dose should be given before the next scheduled dose.
Clinical monitoring of the child’s condition and dose readjustment should be performed at least monthly.

Duration of treatment.

Hemangiol should be administered for a 6-month period. Discontinuation of treatment does not require tapering of the dose.
If haemangiomas recur, treatment may be re-initiated. Based on data from the literature, 10 to 25% of patients showed a relapse of haemangioma signs and symptoms after treatment discontinuation. When treatment was re-initiated, a satisfactory response was observed in a majority of patients.


The toxicity of beta-blockers is an extension of their therapeutic effect. Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. Atrioventricular blocks, intraventricular conduction delays and congestive heart failure can occur with more severe poisoning. Bronchospasm may develop particularly in patients with asthma. Hypoglycaemia may develop and manifestations of hypoglycaemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity.
Propranolol is highly lipid-soluble and may cross the blood brain barrier and cause seizures.

Support and treatment.

In the event of overdose, monitor the patient’s airway, breathing and circulation; cardiac monitoring should be performed; assess vital signs, mental status and blood glucose. Give intravenous fluids for hypotension and atropine for bradycardia. Glucagon then catecholamines should be considered if the patient does not respond appropriately to intravenous fluid. Isoproterenol and aminophylline may be used to treat bronchospasm.


Hemangiol is available as a 3.75 mg/mL oral solution in a 120 mL amber-glass type III bottle fitted with a low density polyethylene insert and closed with a child-resistant, tamper-evident polypropylene screw cap. It is supplied with a 5 mL polypropylene oral syringe. The syringe is graduated in mL of propranolol base.


Store below 30°C. Do not freeze.
Use within 2 months of opening.
Protect from light.

Poison Schedule