Hemangiol 3.75 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HEMANGIOL 3.75 mg/ml, oral solution

propranolol

Read all of this leaflet carefully before your child starts taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only; do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What HEMANGIOL is and what it is used for
2. What you need to know before your child takes HEMANGIOL
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 your 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 hemangioma. A hemangioma is an abnormal accumulation of blood vessels that have formed a lump in the skin or beneath it. The hemangioma may be superficial or deep. Sometimes it is called a "strawberry mark" because the surface of a hemangioma resembles a strawberry.

Hemangiol is initiated in children aged from 5 weeks up to 5 months when:

• the location and/or extent of the lesions endanger life or organ function (could impair vital organs or senses such as vision or hearing);
• the hemangioma is ulcerated (i.e., a skin wound that does not heal) and is painful, and/or does not respond to basic wound care measures;
• there is a risk of permanent scarring or disfigurement.

2. What you need to know before your child starts taking HEMANGIOL

Do not use 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 any of the other components of this medicine (listed in section 6). An allergic reaction may include rash, itching, or difficulty breathing;
• has asthma or a history of breathing difficulties;
• has a slow heart rate for their age. You should consult your doctor if you are unsure;
• has a heart problem (such as heart rhythm disorders or heart failure);
• has very low blood pressure;
• has circulation problems causing pale and numb fingers and toes;
• is prone to low blood sugar levels;
• has high blood pressure due to a tumor of the adrenal gland. This is called "pheochromocytoma".

If you are breastfeeding your child and you are taking medicines that should not be used with HEMANGIOL (see "If you are breastfeeding your child" and "Use of HEMANGIOL with other medicines"), do not administer this medicine to your child.

Warnings and precautions

Before your child starts taking HEMANGIOL, inform your doctor:

• if your child has liver or kidney problems. This medicine is not recommended in cases of hepatic or renal insufficiency;
• if your child has ever had an allergic reaction, regardless of cause (e.g., medications, food substances, etc.). An allergic reaction may include rash, itching, or difficulty breathing;
• if your child has psoriasis (a skin disease causing red, dry, thickened skin patches), as this medicine may worsen symptoms of this condition;
• if your child has diabetes: in this case, the frequency of blood glucose monitoring should be increased;
• if your child has PHACE syndrome (a disorder combining hemangioma and vascular malformations that may affect cerebral blood vessels), as this medicine may increase the risk of stroke.

Important signs to watch for after administration of HEMANGIOL

Risk of hypoglycemia

This medicine may mask the warning signs of hypoglycemia (also known as low blood sugar). It may also worsen hypoglycemia in children, especially during periods of fasting (e.g., poor oral food intake, infection, vomiting), when glucose demands increase (cold, stress, infections), or in case of overdose. These signs may be:

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

The risk of developing hypoglycemia remains high throughout the entire treatment period.

To avoid the risk of hypoglycemia, HEMANGIOL must be administered during or immediately after a meal, and the last dose should not be given close to bedtime (see section 3). You must feed your child adequately and frequently during treatment. If your child does not eat enough, develops another illness, or vomits, it is recommended to skip the dose. DO NOT ADMINISTER HEMANGIOL TO YOUR CHILD UNTIL THEY HAVE BEEN PROPERLY FED. If your child shows any signs of hypoglycemia while taking HEMANGIOL, stop treatment immediately and contact your doctor promptly or go directly to the hospital. If the child is conscious, give an oral liquid containing sugar.

Risk of bronchospasm

Discontinue treatment and contact a doctor immediately if, after administering HEMANGIOL to your child, you observe the following symptoms indicative of bronchospasm (transient narrowing of the bronchial tubes causing breathing difficulty): coughing, rapid or difficult breathing, or wheezing, with or without bluish skin color.

Stop treatment and contact a doctor immediately if your child has cold-like symptoms associated with difficulty breathing and/or wheezing while taking HEMANGIOL.

Risk of hypotension and bradycardia (slow heart rate)

HEMANGIOL may reduce blood pressure (hypotension) and heart rate (bradycardia). For this reason, your child must be under close clinical and heart rate monitoring for 2 hours after the first dose and after any dose increase. Afterwards, during treatment, your doctor will perform periodic clinical examinations for your child.

Stop treatment and contact a doctor immediately if your child shows any signs such as fatigue, feeling cold, paleness, bluish discoloration of the skin, or fainting while taking HEMANGIOL.

Risk of hyperkalaemia

HEMANGIOL may increase blood potassium levels (hyperkalaemia). In the case of a large ulcerated haemangioma, your child's blood potassium concentration should be measured.

If your child is to receive general anaesthesia

Inform your doctor that your child is taking HEMANGIOL. This is because your child may have low blood pressure if certain anaesthetics are administered while taking this medicine (see "Use of HEMANGIOL with other medicines"). It may be necessary to discontinue HEMANGIOL at least 48 hours before anaesthesia.

If you are breastfeeding your child

• Inform your doctor before administering this medicine.
• Do not administer this medicine to your child if you are taking medicines that should not be used with HEMANGIOL (see "Use of HEMANGIOL with other medicines").

Use of HEMANGIOL with other medicines

• Inform your doctor, pharmacist, or nurse if you are giving, have recently given, or may need to give any other medicines to your child. This is because HEMANGIOL may alter the way other medicines work, and some medicines may affect how HEMANGIOL works.
• Additionally, 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 breastfeeding should be interrupted or not.

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

• medicines for diabetes;
• medicines for heart or blood vessel problems, such as irregular heartbeat, chest pain or angina, high blood pressure, or heart failure;
• medicines for anxiety and depression, as well as more serious mental health conditions, and epilepsy;
• medicines for treating tuberculosis;
• medicines for treating pain and inflammation;
• medicines used to lower blood fats;
• medicines used for anaesthesia.

If you have any further questions, consult your doctor or pharmacist.

HEMANGIOL contains sodium and propylene glycol

This medicine contains less than 23 mg of sodium (1 mmol) per dose, which is essentially "sodium-free".

This medicine contains 2.08 mg of propylene glycol/kg/day. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to administer HEMANGIOL to your child

Your child's treatment has been initiated by a doctor experienced in the diagnosis, treatment, and management of infantile hemangioma.

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine to your child. If you have any doubts, consult your doctor or pharmacist again.

Never adjust the dose you are giving to your child on your own. All dose increases and all adjustments based on your child's weight must be made by your doctor.

Dosage

• The dose is based on your child's weight, according to the following scheme:

Weeks (daily dose)	Dose per administration	Times of administration
First week (1 mg/kg/day)	0.5 mg/kg	one in the morning one in the late afternoon • minimum interval of 9 hours between doses
Second week (2 mg/kg/day)	1 mg/kg
Third week and onwards (3 mg/kg/day)	1.5 mg/kg

.

• If necessary, you may dilute the medicine in a small amount of infant milk or age-appropriate apple and/or orange juice, and administer it to your child using a feeding bottle. Do not mix the medicine directly with a full bottle of milk or juice.

For children weighing up to 5 kg, you may mix the dose with one teaspoon of infant milk (approximately 5 ml). For children weighing more than 5 kg, you may mix the dose with one tablespoon of infant milk or fruit juice (approximately 15 ml).

Use the mixture within 2 hours of preparation.

How to administer HEMANGIOL to your child

• HEMANGIOL is for oral use.
• The medicine should be administered during your child's feeding or immediately after.
• The dose must always be measured using the oral syringe provided with the bottle.
• Administer HEMANGIOL directly into your child's mouth using the oral syringe supplied with the bottle.
• Feed your child frequently to avoid prolonged fasting.
• If your child does not eat or vomits, it is recommended to skip the dose.
• If your child vomits after receiving a dose, or if you are unsure whether they received the full dose, do not administer another dose; simply wait until the next scheduled dose.
• The same person should administer both HEMANGIOL and your child's feeding to avoid the risk of hypoglycemia. If different people are involved, good communication is essential to ensure your child's safety.

Instructions for use:

• Step 1. Remove the components from the box

The box contains the following components you will need to administer the medicine:

• The glass bottle containing 120 ml of propranolol oral solution.
• The oral dosing syringe in mg supplied with this medicine.

Remove the bottle and the oral syringe from the box, and take the syringe out of the plastic bag.

• Step 2. Check the dose

Check the prescribed dose of HEMANGIOL in milligrams (mg) as indicated by your doctor.

Locate this number on the oral syringe.

• Step 3. Open the bottle

The bottle has a child-resistant cap. To open it: press down on the plastic cap while turning it counterclockwise (to the left).

Do not shake the bottle before use.

• Step 4. Insert the syringe

Insert the tip of the oral syringe vertically into the bottle, and push the plunger fully in.

Do not remove the syringe adapter from the mouth of the bottle.

Use only the oral syringe supplied with the medicine to measure and administer the dose. Do not use a spoon or any other dispensing device.

• Step 5: Draw up the dose

With the oral syringe in place, turn the bottle upside down. Pull the syringe plunger to the prescribed mg mark.

• Step 6: Check for air bubbles

If you see air bubbles in the syringe, hold the syringe vertically and push the plunger upward enough to completely expel all large air bubbles, then readjust to the dose prescribed by the doctor.

• Step 7. Remove the syringe

Turn the bottle back to an upright position and remove the entire syringe. 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 your child

Insert the syringe into your child's mouth and place it against the inside of the cheek.

Now slowly dispense HEMANGIOL from the syringe directly into your child's mouth.

Do not lay the child down immediately after administering the medicine.

• Step 10: Clean the syringe

Do not disassemble the syringe. Rinse the empty syringe in a glass of clean water after each use:

1- Take a glass of clean water

2- Pull the plunger to the end

3- Pour the water into the sink

4- Repeat this cleaning process 3 times.

Do not use any soap or alcohol-based products to clean it. Dry the outside with a cloth. Do not place the syringe in a sterilizer or dishwasher.

Store the bottle and syringe together in the box until the next use, in a safe place out of your child's sight and reach. Dispose of the syringe when the bottle is empty.

If you have administered more HEMANGIOL to your child than you should

If you have given your child more HEMANGIOL than prescribed, contact your doctor immediately.

If you forgot to administer HEMANGIOL to your child

Skip the missed dose, and do not administer a double dose to make up for missed doses. Continue treatment at the usual frequency: one dose in the morning and another in the late afternoon.

If you stop your child's treatment with HEMANGIOL

HEMANGIOL may be stopped abruptly at the end of treatment, as decided by the doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In addition, after administration of HEMANGIOL, important warning signs of possible adverse effects such as low blood pressure, low heart rate, low blood sugar concentration, or bronchospasm (difficulty breathing) should be monitored. See section 2 of this leaflet.

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

• bronchitis (inflammation of the bronchi),
• sleep disorders (insomnia, poor quality sleep, and difficulty waking up),
• diarrhoea and vomiting.

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

• bronchospasm (difficulty breathing),
• bronchiolitis (inflammation of small bronchi with breathing difficulty and wheezing in the chest, associated with cough and fever),
• decreased blood pressure,
• decreased appetite,
• agitation, nightmares, irritability,
• somnolence,
• cold extremities,
• constipation, abdominal pain,
• erythema (skin redness),
• diaper dermatitis.

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

• conduction or heart rhythm disorders (slow or irregular heartbeats),
• urticaria (allergic skin reaction), alopecia (hair loss),
• decreased blood sugar concentration,
• reduction in the number of leukocytes (white blood cells in the blood).

Frequency of the following adverse effects is unknown (cannot be estimated from available data):

• seizures (fits) related to hypoglycaemia (abnormally low blood glucose concentration),
• bradycardia (abnormally low heart rate),
• low blood pressure,
• very low white blood cell counts (white blood cells that fight infections),
• circulatory problems causing numbness and pallor in fingers of hands and feet,
• increased blood potassium concentration.

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of HEMANGIOL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle. The expiry date refers to the last day of the month indicated.

Store the bottle in the outer packaging to protect it from light. Keep the bottle and the oral syringe in the case between uses. Do not freeze.

After first opening the bottle, the medicine should be used within a maximum of 2 months.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of HEMANGIOL

• The active substance is propranolol. Each ml contains 4.28 mg of propranolol hydrochloride, equivalent to 3.75 mg/ml of propranolol.
• The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate and purified water. For more information, see section 2, "HEMANGIOL contains sodium and propylene glycol".

Appearance of HEMANGIOL and contents of the pack

• HEMANGIOL is a transparent, colourless or slightly yellow oral solution with a fruity odour.
• It is supplied in a 120 ml amber glass bottle with a child-resistant screw cap. Pack size: 1 bottle.
• A polypropylene oral dosing syringe graduated in mg of propranolol is supplied with each bottle.

Marketing Authorisation Holder

PIERRE FABRE MEDICAMENT

Les Cauquillous

81500 Lavaur

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 more information about this medicine, contact the local representative of the Marketing Authorisation Holder.

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.