Hemangiol

Package leaflet: Information for the user

HEMANGIOL 3.75 mg/mL oral solution

propranolol
Please read this leaflet carefully before giving this medicine to your child
because it contains important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same as your child’s, because it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What HEMANGIOL is and what it is used for
2. What you need to know before giving HEMANGIOL to your child
3. How to give HEMANGIOL to your child
4. Possible side effects
5. How to store HEMANGIOL
6. Contents of the pack and other information

1 What HEMANGIOL is and what it is used for
What HEMANGIOL is
The name of the medicine is HEMANGIOL. The active substance is propranolol.
Propranolol belongs to a group of medicines known as beta-blockers.
What it is used for
This medicine is used to treat a condition called haemangioma. A haemangioma consists of a tangle of blood vessels forming a small mass on or under the skin.
The haemangioma may be superficial or deep. It is sometimes called a "strawberry mark" because its surface resembles a strawberry.
Hemangiol is given to children aged between 5 weeks and 5 months when:

• the location and/or extent of the lesions pose a threat to life or function (it may damage vital organs or senses such as vision or hearing);
• the haemangioma is ulcerated (e.g., with a skin sore that does not heal) and associated with pain, and/or does not respond to standard wound care;
• there is a risk of permanent scarring or deformity.

2 What you need to know before giving HEMANGIOL to your child
Do not give HEMANGIOL
If your child:

• was born prematurely and has not reached a corrected age of 5 weeks (corrected age is the age a premature infant would be if born on the due date).
• is allergic to propranolol or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, or shortness of breath.
• has asthma or a history of breathing difficulties.
• has a slow heart rate for their age. If in doubt, consult your doctor.
• has a heart condition (e.g., heart rhythm disorders or heart failure).
• has very low blood pressure.
• has circulation problems causing cold and pale fingers and toes.
• is prone to low blood sugar levels.
• has high blood pressure caused by a tumour of the adrenal gland called "phaeochromocytoma".

If you are breastfeeding your child and are taking medicines that should not be used in combination with HEMANGIOL (see “If you are breastfeeding your child” and “Other medicines and HEMANGIOL”), do not give this medicine to your child.
Warnings and precautions
Tell your doctor before giving HEMANGIOL to your child:

• If your child has liver or kidney problems. This medicine is not recommended in case of liver or kidney failure.
• If your child has had allergic reactions of any kind (e.g., to medicines or foods). An allergic reaction may include rash, itching, or shortness of breath.
• If your child has psoriasis (a skin condition presenting with red, dry, thickened skin patches), as this medicine may worsen symptoms of this condition.
• If your child has diabetes: in this case, your child’s blood glucose levels should be monitored more frequently.
• If your child has PHACE syndrome (a condition associating haemangiomas and cardiovascular abnormalities, including in cerebral blood vessels), as this medicine may increase the risk of stroke.

Important signs to watch for after giving HEMANGIOL
Risk of hypoglycaemia
This medicine may mask the warning signs of hypoglycaemia (also known as low blood sugar). It may also worsen hypoglycaemia in children, particularly during periods of fasting (e.g., poor oral intake, concurrent infection, vomiting) or when glucose demands increase (e.g., cold, stress, infections), or in case of overdose.
These symptoms may include:

• Mild symptoms: paleness, tiredness, sweating, trembling, palpitations, anxiety, hunger, difficulty waking up.
• Severe symptoms: excessive sleepiness, difficulty responding, poor feeding, drop in body temperature, seizures (fits), brief pauses in breathing, loss of consciousness.

The risk of hypoglycaemia remains significant throughout the duration of treatment.
To avoid the risk of hypoglycaemia, you must give HEMANGIOL during or immediately after a
meal/feeding and avoid giving the last dose just before bedtime
(see section 3). Your child must be fed sufficiently and regularly during treatment.
If your child is not eating enough, has another illness, or is vomiting, it is recommended to skip the dose. DO NOT GIVE HEMANGIOL TO YOUR CHILD UNTIL THEY ARE FEEDING PROPERLY AGAIN.
If your child shows symptoms of hypoglycaemia while taking HEMANGIOL, stop the treatment and consult a doctor immediately or go directly to hospital. If your child is conscious, give them a sugary drink.
Risk of bronchospasm
Stop treatment and contact a doctor immediately if, after giving HEMANGIOL, your child develops symptoms indicating bronchospasm (temporary narrowing of the airways causing breathing difficulties): cough, rapid or laboured breathing, or wheezing, with or without bluish skin colour.
Stop treatment and contact a doctor immediately if your child develops cold-like symptoms associated with breathing difficulties and/or wheezing while taking HEMANGIOL.
Risk of hypotension and bradycardia (slow heart rate)
HEMANGIOL may lower blood pressure (hypotension) and heart rate (bradycardia). For this reason, your child will be closely monitored clinically and their heart rate carefully observed for 2 hours after the first dose or after any dose increase. Thereafter, your child will remain under regular medical supervision during treatment.
Stop treatment and contact a doctor immediately if your child shows signs of fatigue, coldness, paleness, bluish skin, or fainting during treatment with HEMANGIOL.
Risk of hyperkalaemia
HEMANGIOL may increase potassium levels in the blood (hyperkalaemia) in the presence of large ulcerated haemangiomas. It is necessary to measure potassium levels in your child’s blood.
If your child needs general anaesthesia
Inform the doctor if your child is taking HEMANGIOL, as blood pressure drops may occur when certain anaesthetics are administered together with this medicine (see “Other medicines and HEMANGIOL”). It may be necessary to stop HEMANGIOL at least 48 hours before anaesthesia.
If you are breastfeeding your child

• Inform your doctor before giving the medicine.
• Do not give this medicine to your child if you are taking medicines that should not be combined with HEMANGIOL (see “Other medicines and HEMANGIOL”).

Other medicines and HEMANGIOL

• Inform your doctor, pharmacist, or nurse if your child is taking, has recently taken, or might take any other medicines, because HEMANGIOL may alter the effect of other medicines and some medicines may affect how HEMANGIOL works.
• Also, if you are breastfeeding, it is important to inform your doctor, pharmacist, or nurse about any medicines you are taking, as they may pass into breast milk and interfere with your child’s treatment. Your doctor will advise whether you should stop breastfeeding.

In particular, if you are breastfeeding, inform your doctor or pharmacist if you are taking or if your child is taking:

• Medicines for diabetes,
• Medicines for heart or vascular problems such as irregular heartbeat, chest pain or angina, high blood pressure, heart failure,
• Medicines for anxiety and depression and for more serious mental conditions, and epilepsy,
• Medicines for the treatment of tuberculosis,
• Painkillers and anti-inflammatory medicines,
• Medicines to lower blood lipids,
• Anaesthetic medicines.

For further questions, consult your doctor or pharmacist.
HEMANGIOL contains sodium and propylene glycol
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
This medicine contains 2.08 mg of propylene glycol/kg/day. If your child is less than 4 weeks old, speak to your doctor or pharmacist before giving this medicine, especially if your child is taking other medicines containing propylene glycol or alcohol.
3 How to give HEMANGIOL to your child
Your child’s treatment has been initiated by a doctor experienced in the diagnosis, treatment, and management of infantile haemangiomas.
Give this medicine to your child exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Never change the dose given to your child on your own initiative. Any dose increase or adjustment based on your child’s weight must be prescribed by the doctor.
Dosage

• The dosage is based on your child’s body weight according to the following schedule:

• If necessary, mix the medicine with a small amount of infant milk or fruit juice suitable for children of that age (e.g., apple and/or orange juice) and administer it to the child using a feeding bottle. Do not put the medicine into a full bottle of milk or juice. For children up to 5 kg body weight, the dose may be mixed with a teaspoon of milk (approximately 5 ml). For children weighing more than 5 kg, the dose may be mixed with a tablespoon of milk or fruit juice (approximately 15 ml). Use the mixture within 2 hours after preparation.

How to administer HEMANGIOL to the child

• Hemangiol is for oral use.
• The medicine should be administered during or immediately after a meal.
• The dose must always be measured using the oral syringe provided with the bottle.
• Administer HEMANGIOL directly into the child’s mouth using the oral syringe supplied with the bottle.
• Feed the child regularly to avoid prolonged fasting.
• If the child does not eat or vomits, it is recommended to skip the dose.
• If the child vomits after administration or if you are unsure whether the full dose was taken, do not administer another dose; wait until the next scheduled dose.
• HEMANGIOL and meals should be administered by the same person to avoid the risk of hypoglycemia. If different people are caring for the child, communication is essential to ensure the child’s safety.

Instructions for use:

• Step 1. Remove items from the packaging The packaging contains the following items needed to administer the medicine:
  • The glass bottle containing 120 mL of propranolol oral solution
  • The oral syringe graduated in mg provided with the medicine
    Remove the bottle and the oral syringe from the packaging and remove the syringe from the plastic pouch.

• Step 2. Check the dose Check the dose of HEMANGIOL in milligrams (mg) as prescribed by the doctor. Locate the corresponding number on the oral syringe.

• Step 3. Open the bottle The bottle is equipped with a child-resistant cap. To open, follow these instructions: press the cap downwards and simultaneously turn it counterclockwise (to the left). Do not shake the bottle before use.

• Step 4. Insert the syringe Keeping the bottle in an upright position, insert the tip of the oral syringe into the bottle and push the plunger fully down. Do not remove the syringe adapter from the neck of the bottle. Use only the oral syringe provided with the medicine to measure and administer the dose. Do not use spoons or other administration devices.

• Step 5: Withdraw the dose With the oral syringe inserted, turn the bottle upside down. Pull the syringe plunger up to the required number of mg.

• Step 6: Check for absence of air bubbles If the syringe contains air bubbles, hold the syringe vertically and push the plunger upwards just enough to completely eliminate the air bubbles, then pull it back to the prescribed dose.

• Step 7. Remove the syringe Turn the bottle upright and completely remove the syringe from the bottle. Be careful not to push the plunger during this step.

• Step 8. Close the bottle Replace the plastic cap on the bottle by turning it clockwise (to the right).

• Step 9. Administer HEMANGIOL to the child Insert the syringe into the child’s mouth and place it against the inside wall of the cheek. Slowly inject HEMANGIOL from the syringe directly into the child’s mouth. Do not lay the child down immediately after administering the medicine.

• Step 10: Clean the syringe Do not disassemble the syringe. After each use, rinse the empty syringe by washing it in a glass of water:
  1- Fill a glass with clean water
  2- Pull the plunger
  3- Empty the water into the sink
  4- Repeat this cleaning procedure 3 times.

Do not use cleaning or alcohol-based products to clean the syringe. Dry the outside part.
Do not place the syringe in a sterilizer or dishwasher.
Store the bottle and syringe together in the cardboard box until the next use, keeping them in a safe place out of sight and reach of children.
Dispose of the syringe once the contents of the bottle have been used up.

If the child takes more HEMANGIOL than required
If you have administered more HEMANGIOL than prescribed, contact the doctor immediately.

If you forget to administer HEMANGIOL to the child
Skip the missed dose and do not administer a double dose to make up for the forgotten dose. Continue treatment as usual: one dose in the morning and one dose in the late afternoon.

If you stop administering HEMANGIOL to the child
Administration of HEMANGIOL may be stopped immediately at the end of treatment, as decided by the doctor.

For further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Important warning signs of potential side effects such as low blood pressure, slow heart rate, low blood sugar levels, and bronchospasm should be monitored after administration of HEMANGIOL.
Refer to section 2 of this leaflet.

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

• Bronchitis (inflammation of the bronchi),
• Sleep disorders (insomnia, poor sleep quality, difficulty waking up),
• Diarrhoea and vomiting.

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

• Bronchospasm (breathing difficulties),
• Bronchiolitis (inflammation of the bronchioles accompanied by breathing difficulties and wheezing, associated with cough and fever),
• Low blood pressure,
• Loss of appetite,
• Restlessness, nightmares, irritability,
• Drowsiness,
• Cold extremities,
• Constipation, abdominal pain,
• Erythema (skin redness),
• Diaper rash.

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

• Heart conduction or rhythm disorders (slow or irregular beats),
• Urticaria (allergic skin reaction), alopecia (hair loss),
• Low blood sugar levels,
• Reduction in the number of white blood cells.

Frequency of the following side effects is not known (frequency cannot be estimated from the available data)

• Seizures (fits) related to hypoglycaemia (excessively low blood sugar level),
• Bradycardia (excessively low heart rate),
• Low blood pressure,
• Very low levels of white blood cells that fight infections,
• Circulatory problems causing cold and pale fingers and toes,
• High potassium levels in the blood.

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult a doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5 How to store HEMANGIOL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle. The expiry date refers to the last day of that month.
Keep the bottle in the outer packaging to protect the medicine from light. Store the bottle and the oral syringe together in the outer packaging after each use. Do not freeze.
After first opening, the medicine must be used within 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6 Contents of the pack and other information

What HEMANGIOL contains

• The active substance is propranolol. Each mL contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol.
• The other components are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water. See section 2 “HEMANGIOL contains sodium and propylene glycol” for further information.

Description of the appearance of HEMANGIOL and contents of the pack

• HEMANGIOL is a clear, colourless to pale yellow oral solution with a fruity odour.
• It is contained in a 120 mL amber glass bottle with a child-resistant screw cap. The pack contains 1 bottle.
• One polypropylene oral syringe graduated in mg of propranolol is supplied with the bottle.

Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
FRANCE

Manufacturer
FARMEA
10 rue Bouché Thomas
ZAC Sud d’Orgemont
49000 ANGERS
FRANCE
OR
PIERRE FABRE MEDICAMENT PRODUCTION
Site PROGIPHARM, Rue du Lycée
45500 GIEN
FRANCE

For further information on this medicine, contact the Marketing Authorisation Holder.

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.