Prospecto: information for the user

HEMANGIOL 3.75 mg/ml, oral solution

propranolol

Read this prospect carefully before your child starts taking this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

•This medicine has been prescribed only for your child, and should not be given to other people, 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 they are not listed in this prospect. See section 4.

1. What is HEMANGIOL and for what it is used

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

3. How to give HEMANGIOL to your childa your child

4. Possible adverse effects

5. Storage of HEMANGIOL

6. Contents of the container and additional information

What is HEMANGIOL

The name of your medicine is HEMANGIOL. The active ingredient is propranolol.

Propranolol belongs to a group of medicines known as beta-blockers.

What is it used for

This medicine is used to treat a disease called hemangioma. A hemangioma is an excess of blood vessels that have formed a lump in the skin or beneath it. The 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 is initiated in children who are between 5 weeks and 5 months old, when:

• the location and/or extent of the lesions pose a risk to life or organ function (they could affect 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.

No use HEMANGIOL

If your child:

• has been born prematurely and has not reached the corrected age of 5 weeks (corrected age is the age the premature infant would have if it had been born on the expected date);
• is allergic to propranolol or any of the other components of this medication (listed in section 6). An allergic reaction may include a skin rash, itching, or difficulty breathing;
• has asthma or a history of respiratory difficulties;
• has a slow heart rate for their age. Consult your doctor if you are unsure;
• has a heart problem (such as arrhythmias and heart failure);
• has very low blood pressure;
• has circulatory problems that cause numbness and paleness in the fingers and toes;
• has a propensity for 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 medications that should not be used with HEMANGIOL (see “If you are breastfeeding your child” and “Use of HEMANGIOL with other medications”),do not administerthis medication to your child.

Warnings and precautions

Before your child starts taking HEMANGIOL, inform your doctor:

• if your child has liver or kidney problems. This medication is not recommended in cases of liver or renal insufficiency;
• if your child has ever had an allergic reaction, regardless of its origin (for example, medications or food substances, etc.). An allergic reaction may include a skin rash, itching, or difficulty breathing;
• if your child has psoriasis (a skin disease that produces red, dry, and hardened skin plaques), because this medication may worsen the symptoms of this disease;
• if your child has diabetes: in this case, the frequency of monitoring your child's blood glucose levels should be increased;
• if your child has PHACE syndrome (a disorder that combines hemangioma and vascular malformations that can affect cerebral blood vessels), because this medication may increase the risk of cerebral stroke.

Important signs to look for after administering HEMANGIOL

Hypoglycemia risks

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

• Mild: pallor, fatigue, sweating, tremors, palpitations, anxiety, hunger, difficulty getting up;
• Severe: excessive somnolence, difficulty responding, feeding problems, decreased body temperature, convulsions (seizures), brief pauses in breathing, loss of consciousness.

The risk of developing hypoglycemia remains elevated throughout the treatment period.

Risks of bronchoconstriction

Interrupt treatment and contact a doctor immediately if, after administering HEMANGIOL to your child, you observe the following symptoms indicative of bronchoconstriction (transient restriction of bronchial passages that causes respiratory difficulty): cough, rapid or difficult breathing, or wheezing, associated or not with blue skin discoloration.

Risk of hypotension and bradycardia (slow heart rate)

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

Risk of hyperkalemia

HEMANGIOL may increase blood potassium levels (hyperkalemia). In cases of large ulcerated hemangioma, your child's blood potassium levels should be measured.

If your child is to be administered general anesthesia

Inform your doctor that your child is taking HEMANGIOL. This is because your child may have low blood pressure if certain anesthetics are administered while taking this medication (see “Use of HEMANGIOL with other medications”). It may be necessary to interrupt HEMANGIOL at least 48 hours before anesthesia.

If you are breastfeeding your child

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

Use of HEMANGIOL with other medications

• Inform your doctor, pharmacist, or nurse if you are administering, have administered recently, or may need to administer any other medication to your child. This is because HEMANGIOL may modify the way other medications work, and some medications may affect the way HEMANGIOL works.
• Additionally, if you are breastfeeding your child, it is essential to inform your doctor, pharmacist, or nurse of the medications you are taking, as they may pass into breast milk and interfere with your child's treatment. Your doctor will advise you if it is necessary to interrupt breastfeeding or not.

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

• diabetes medications;
• medications for heart and blood vessel problems, such as irregular heartbeats, chest pain, or high blood pressure, or heart failure;
• medications for anxiety and depression, as well as more severe mental health problems, and epilepsy;
• medications for tuberculosis;
• medications for pain and inflammation;
• medications used to reduce blood fats;
• medications used for anesthesia.

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

HEMANGIOL contains sodium and propylene glycol

This medication contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

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

The treatment of your child has been initiated by a doctor with experience in the diagnosis, treatment, and management of infantile hemangioma.

Follow exactly the administration instructions for this medication given to your child by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Never modify the dose you are administering to your child yourself. All dose increases and all weight adjustments for your child must be made by your doctor..

Dose

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

.

•When necessary, you can dilute the medication in a small amount of infant formula or apple and/or orange juice adapted to the child's age, and administer it to your child in a bottle. Do not mix the medication directly with a full bottle of milk or juice.

For children weighing up to 5 kg, you can mix the dose with a teaspoon of infant formula (approximately 5 ml). For children weighing more than 5 kg, you can mix the dose with a tablespoon of infant formula 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 medication must be administered during the child's feeding or immediately after it.
• The dose must always be measured with the oral syringe provided with the bottle.
• Administer HEMANGIOL directly into your child's mouth using the oral syringe provided with the bottle.
• Feed your child frequently to avoid prolonged fasting.
• If your child does not eat, or if they vomit, it is recommended to omit the dose.
• If your child vomits a dose, or if you are unsure if they received the entire medication, do not administer another dose, simply wait until the next scheduled dose.
• One person should administer HEMANGIOL and the child's feeding to avoid the risk of hypoglycemia. If different people are involved, it is essential to have good communication to ensure the child's safety.

Usage instructions:

• Step 1. Remove the different elements from the case

The case contains the followingelementsthat you will need to administer the medication:

- The glass bottle containing 120 ml of oral solution of propranolol.

- The oral syringe dosifier in mg that comes with this medication.

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

• Step 2. Check the dose

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

Locate this number on the oral syringe.

• Step 3. Open the bottle

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

Do not shake the bottle before use.

• Step 4. Insert the syringe

Insert the tip of the oral syringe into the bottle in a vertical position, and push the plunger all the way.

Do not remove the adapter from the syringe's mouth.

Use only the oral syringe provided with the medication to measure and administer the dose. Do not use a spoon or any other dispenser.

• Step 5: Extract the dose

With the oral syringe in place, turn the bottle upside down. Pull the plunger of the syringe until the number of mg needed is reached.

•Step 6: Check for air bubbles

If you see air bubbles in the syringe, hold the syringe vertically, push the plunger up enough to expel all large air bubbles, and adjust it to the prescribed dose by the doctor.

• Step 7. Extract the syringe

Turn the bottle to a vertical position, and separate the syringe from the bottle. Be careful not to push the plunger during this step.

• Step 8. Close the bottle

Put the plastic cap back 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 in the inner cheek.

Now you can slowly expel HEMANGIOL from the syringe directly into your child's mouth.

Do not put the child to bed immediately after administering the medication.

• Step 10: Clean the syringe.

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

1- Take a clean glass of water

2- Pull the plunger to the end

3- Pour the water down the sink

4-Repeat this cleaning process 3 times.

Do not use any soap or alcohol-based product to clean it. Dry the exterior with a cloth. Do not insert the syringe into a sterilizer or dishwasher.

Store the bottle and syringe together in the case until the next use, in a safe place where the child cannot see or reach it. Dispose of the syringe when the bottle is finished.

If you administer more HEMANGIOL to your child than you should

If you have administered more HEMANGIOL to your child than you should, consult your doctor immediately.

If you forget to administer HEMANGIOL to your child

Omit the missed dose, and do not administer a double dose to compensate for the missed doses. Continue treatment at the usual frequency. One dose in the morning and one in the afternoon.

If you interrupt your child's treatment with HEMANGIOL

HEMANGIOL may be discontinued suddenly at the end of treatment, as decided by the doctor.

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

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

Additionally, after administration of HEMANGIOL, important warning signs of possible side effects such as low blood pressure, low heart rate, low blood sugar concentration, or bronchospasm (difficulty breathing) should be sought. See section 2 of this prospectus.

Side effectsvery frequent (can affect more than 1 in 10 people):

• bronchitis (inflammation of the bronchi),

• sleep disorders (insomnia, poor quality sleep, and difficulty waking up),

• diarrhea and vomiting.

Side effectscommon (can affect up to 1 in 10 people):

• bronchospasm (respiratory difficulty),

•bronchiolitis (inflammation of small bronchi with respiratory difficulty and wheezing in the chest, associated with cough and fever),

• decreased blood pressure,

• decreased appetite,

• agitation, nightmares, irritability,

• drowsiness,

• cold extremities,

• constipation, abdominal pain,

• erythema (cutaneous erythema).

• Diaper dermatitis.

Side effectsinfrequent (can affect up to 1 in 100 people):

• conduction or cardiac rhythm disorders (slow or irregular heartbeats),

• urticaria (skin allergic reaction), alopecia (hair loss),

• decreased blood sugar concentration,

• reduction in the number of leukocytes (white blood cells in the blood).

The frequency of the following side effects isunknown (cannot be estimated from available data)

Communication of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. Mediante thecommunication of side effects you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the label of the bottle. The expiration date is the last day of the month indicated.

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

After the first opening of the bottle, the medication must be used within a maximum period of 2 months.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of HEMANGIOL

Appearance of HEMANGIOL and contents of the container

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

Les Cauquillous

81500 Lavaur

FRANCE

Responsible for manufacturing

FARMEA

10 rue Bouché Thomas

ZAC Sud d’Orgemont

49000 ANGERS

FRANCE

O

PIERRE FABRE MEDICAMENT PRODUCTION

Site PROGIPHARM, Rue du Lycée

45500 GIEN

FRANCE

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu .