3.75 mg / ml oral solution
propranolol
1. What HEMANGIOL is and what it is used for
What HEMANGIOL is
The name of the drug is HEMANGIOL. The active substance is propranolol.
Propranolol belongs to a group of medicines called beta-blockers.
What it is used for
This medicine is used to treat a condition called a hemangioma. A hemangioma is a collection of extra blood vessels that have formed a lump in or under the skin. Hemangiomas can be superficial or deep. They are sometimes called “strawberry marks” because the surface of a hemangioma resembles a strawberry.
Hemangiol treatment should be started in infants aged 5 weeks to 5 months when:
- the location and / or extent of the damage is life-threatening or functional (may damage vital organs or senses such as sight or hearing);
- the hemangioma is sore (ie wounds on the skin that do not heal) and painful, and / or does not get better with regular wound care;
- there is a risk of permanent scarring or disfigurement.
2. What you need to know before your child gets HEMANGIOL
Do not give HEMANGIOL
About your child:
- has been born prematurely and has not reached 5 weeks of corrected age (the corrected age is the age a premature baby would have had if he / she had been born at the estimated time).
- is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching or shortness of breath.
- have asthma or have previously had difficulty breathing.
- has a slow heart rate for its age. Consult a doctor if you are unsure.
- have heart problems (such as arrhythmias and heart failure ).
- have very low blood pressure .
- have circulatory problems that cause toes and fingers to become numb and turn white.
- have easy to get low blood sugar.
- have high blood pressure caused by a tumor on the adrenal gland. This is called a “pheochromocytoma”.
If you are breast-feeding your baby, and if you are taking medicines that must not be used with HEMANGIOL, (see “If you are breast-feeding your baby” and “Other medicines and HEMANGIOL”), do not give this medicine to your child.
Warnings and cautions
Before your child receives HEMANGIOL, tell your doctor:
- If your child has problems with their liver or kidneys. This medicine is not recommended in case of renal or hepatic impairment.
- If your child has had an allergic reaction before, for whatever reason (eg medicines or nutritional products, etc.). An allergic reaction can manifest itself as a rash, itching or shortness of breath.
- If your child has psoriasis (a skin condition that causes red, dry scales of thickened skin), this medicine may worsen the symptoms of this condition.
- If your child has diabetes . In diabetes , your child’s blood sugar level should be checked more often.
- If your child has PHACE syndrome (a combination of hemangiomas and vascular malformations such as blood vessels in the brain), this medicine may increase the risk of stroke .
Important signs to pay attention to after administering HEMANGIOL
Risk of low blood pressure and slow heart rate
HEMANGIOL can lower blood pressure ( hypotension ) and heart rate ( bradycardia ). This is why your child will be closely monitored clinically and the heart rate will be monitored for 2 hours after taking the first dose one or after an increase in dose one. Thereafter, the doctor will periodically examine the child during treatment.
| Contact your doctor immediately if your child has symptoms such as fatigue, chills, paleness, bluish skin, or fainting when he/she gets HEMANGIOL. |
Risk of low blood sugar
This medicine may obscure warning signs of low blood sugar (hypoglycemia), especially if the child does not eat if he vomits, or in case of overdose. These characters can be:
- Mild: pallor, fatigue, sweating, tremors, palpitations, anxiety, hunger, difficulty waking up.
- Severe: abnormal amount of sleep, less contact, poor appetite, lowering of body temperature, seizures, shortness of breath, unconsciousness.
| Feed your child regularly during treatment to avoid low blood sugar. If your child does not eat, develops another disease, or vomits, the dose should be skipped. DO NOT GIVE HEMANGIOL TO YOUR CHILD UNTIL IT EATS PROPERLY AGAIN. If your child shows signs of low blood sugar while receiving HEMANGIOL, try to get your child to drink a fluid that contains sugar and, if symptoms persist, contact a doctor immediately or go directly to the hospital. |
Risks of bronchospasm (difficulty breathing)
Discontinue treatment and contact your doctor immediately if, after giving HEMANGIOL to your child, you notice the following symptoms that indicate bronchospasm (temporary contraction of the trachea leading to difficulty breathing): cough, rapid breathing, or difficulty breathing or wheezing, possibly in combination with bluish skin.
Risk of hyperkalemia
HEMANGIOL may increase the level of potassium in the blood (hyperkalemia). If the hemangioma is large and sore, your baby’s potassium levels in the blood should be measured.
If your child is to be anesthetized (get anesthesia)
Tell your doctor that your child is getting HEMANGIOL. Your child may have low blood pressure if he/she is given certain anesthetics at the same time as treatment with this medicine (see “Other medicines and HEMANGIOL”). HEMANGIOL treatment may need to be stopped at least 48 hours before anesthesia.
If you are breast-feeding your baby
- Tell your doctor before giving this medicine.
- Do not give this medicine to your child if you are taking medicines that must not be used with HEMANGIOL (see “Other medicines and HEMANGIOL”).
Other medicines and HEMANGIOL
- Tell your doctor, pharmacist or nurse if you are giving, have recently given or might give other medicines to your child. HEMANGIOL may alter the effect of other medicines, and some medicines may affect the effect of HEMANGIOL.
- If you are breast-feeding your baby, it is also important to tell your doctor, pharmacist or nurse which medicines you are taking, as these may pass into breast milk and affect the treatment of your baby. Your doctor will decide if you need to stop breast-feeding or not.
You must tell your doctor or pharmacist if you (if you are breast-feeding) or your baby is taking:
- Drugs for diabetes .
- Medicines for cardiovascular problems such as irregular heartbeat, chest pain or angina, high blood pressure , heart failure .
- Drugs for the treatment of anxiety and depression as well as more serious mental health problems, and epilepsy .
- Drugs for the treatment of tuberculosis .
- Medicines for the treatment of pain and inflammation .
- Drugs used to lower blood fats.
- Drugs used in anesthesia and anesthesia.
If you have any further questions, ask your doctor or pharmacist.
HEMANGIOL contains sodium and propylene glycol
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
This medicine contains 2.08 mg propylene glycol / kg / day. If your child is younger than 4 weeks, talk to a doctor or pharmacist before giving this child this medicine, especially if your child is taking other medicines that contain propylene glycol or alcohol.
How to give HEMANGIOL to your child
The treatment of your child should be started by a doctor who has the competence to diagnose, treat and treat hemangiomas in infants (infantile hemangiomas).
Always give this medicine to your child according to the doctor’s or pharmacist’s instructions. Ask your doctor or pharmacist if you are unsure.
Never change the dose yourself that you give to your child. Each dose increase and each dose adjustment adjusted to your child’s weight must be made by your doctor.
Dose
- Dosage one is based on the child’s weight, see the table below.
| Week(daily dose ) | Dos per intag | Time of ingestion |
| The first week(1 mg / kg / day) | 0.5 mg / kg | once in the morning once in the late afternoon at least 9 hours between each intake |
| Second week(2 mg / kg / day) | 1 mg / kg | |
| From the third week (3 mg/kg/day) | 1.5 mg / kg |
- If necessary, you can mix the medicine with a little infant formula or age-appropriate apple juice and / or orange juice, and give it to your baby in a baby bottle. Do not mix the medicine with a full bottle of milk or juice.For children weighing up to 5 kg, you can mix dose one with a teaspoon of milk (about 5 ml). For children weighing more than 5 kg, a dose can be mixed with a tablespoon of milk or fruit juice (about 15 ml).Use mixture one within 2 hours after preparation.
How to give HEMANGIOL to your child
- HEMANGIOL should be taken by mouth (orally).
- The medicine should be given during or immediately after breast-feeding / feeding.
- Dose one should always be measured using the dosing syringe that comes with the bottle.
- Give HEMANGIOL directly into your baby’s mouth using the dosing syringe provided with the bottle.
- Feed your baby regularly to avoid prolonged fasting.
- If your child does not eat or vomits, the dose should be skipped.
- If your child spits out a dose or you are unsure if the child has ingested all the medicine, do not give another dose but wait until it is time for the next dose .
- HEMANGIOL and food must be given by the same person to reduce the risk of low blood sugar. If different people are involved, good communication is very important to ensure your child’s safety.
Instructions for use:
Step 1. Remove the items from the box
The carton contains the following items that you need to give the medicine:
– The glass bottle contains 120 ml propranolol oral solution
– A dosing syringe graduated in mg is included with this medicine
Take the bottle and dosing syringe out of the carton and take the dosing syringe out of the plastic bag.
Step 2. Check dose one
Check HEMANGIOL- dose one in milligrams (mg), which is prescribed by the doctor. Find the number of mg on the dosing syringe.
Step 3. Open the bottle
The bottle has been fitted with a child-resistant cork. To open the bottle: Press down on the plastic cap and at the same time turn the cap counterclockwise (to the left).
Do not shake the bottle before use.
Step 4. Insert the syringe.
Insert the tip of the dosing syringe into the bottle while holding the bottle upright and push the plunger down.
Do not remove the syringe adapter from the neck of the bottle.
Use only the dosing syringe provided with the medicine to measure and dose one.
Do not use a spoon or other dosage measure.
Step 5: Pull up dose one
With the dosing syringe in place, turn the bottle upside down.
Pull the plunger out of the syringe up to the number of mg you need.
Step 6: Check for air bubbles
If you see air bubbles in the syringe, hold the syringe straight up. Push the plunger back just enough to expel large air bubbles. Then the dose in the syringe is adjusted to the one prescribed by the doctor.
Step 7. Remove the syringe
Turn the vial correctly again and remove the entire dosing syringe from the vial. Be careful not to push the plunger when removing the syringe.
Step 8. Close the bottle
Screw the plastic cap onto the bottle by turning it clockwise (to the right).
Step 9. Give HEMANGIOL to your child
Put the dosing syringe in your child’s mouth and place it on the inside of the cheek.
You can now slowly inject HEMANGIOL from the dosing syringe directly into the baby’s mouth.
Do not lay the child down immediately after receiving the medicine.
Step 10: Clean the syringe.
Do not disassemble the dosing syringe. Rinse the empty dosing syringe after use in a glass of clean water:
- Bring out a glass of clean water
- Pull out the plunger
- Spray the water in your sink
- Repeat this cleaning process three times.
Do not use soap or alcohol-based products for cleaning. Wipe the outside dry.
Do not clean the dosing syringe in a sterilizer or dishwasher.
Keep the bottle and dosing syringe together in the carton in a safe place where your child can not see or reach it, until the next time it is to be used. Discard the dosing syringe when the bottle is empty.
If you give too much HEMANGIOL to your child
If you have given your child too much HEMANGIOL, contact a doctor immediately.
If you forget to give HEMANGIOL to your child
Skip the missed dose one and do not give a double dose to compensate for a missed dose. Continue treatment at the usual frequency: one dose in the morning and one in the afternoon.
If you stop giving HEMANGIOL to your child
You can stop giving HEMANGIOL immediately when your doctor decides to stop treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be aware of important warning signs of possible side effects after administration of HEMANGIOL, such as low blood pressure, low heart rate, low blood sugar, and bronchospasm (difficulty breathing) after administration of HEMANGIOL;
See section 2 of this leaflet.
Very common side effects (may affect more than 1 in 10 people):
- Bronchitis ( inflammation of the trachea).
- Sleep disorders (insomnia, poor sleep quality and difficulty waking up).
- Diarrhea and vomiting.
Common side effects (may affect up to 1 in 10 people)
- Bronchospasm (difficulty breathing).
- Bronchiolitis ( inflammation of small airways with difficulty breathing and wheezing in the chest) associated with cough and fever).
- Lowered blood pressure .
- Decreased appetite.
- Anxiety, nightmares, irritability.
- Somnolence.
- Cold arms and legs.
- Constipation, abdominal pain.
- Erythema (reddening of the skin).
- Diaper rash.
Uncommon side effects (may affect up to 1 in 100 people )
- Disorders of the heart’s conduction system or heart rhythm disorders (slow or irregular heartbeat).
- Hives ( allergic reaction in the skin), alopecia (hair loss).
- Lowered blood sugar levels.
- Decreased white blood cell count .
The frequency of the following side effects is unknown (frequency cannot be calculated from the available data)
- Seizures due to low blood sugar ( hypoglycaemia ).
- Bradycardia (abnormally slow heartbeat).
- Low blood pressure .
- Very low levels of white blood cells , which fight infection you.
- Circulatory problems that cause toes and fingers to become numb and turn white.
- Elevated potassium levels in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 which is stated on the carton and bottle label. The expiration date is the last day of the specified month.
Store the bottle in the outer carton. Sensitive to light. Keep the bottle and the oral dosing syringe in the outer carton between each use. Do not freeze.
After the first opening, the medicine should be used within 2 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is propranolol. Each ml contains 4.28 mg of propranolol hydrochloride corresponding to 3.75 mg of propranolol.
- The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavor (contains propylene glycol), vanilla flavor (contains propylene glycol), citric acid monohydrate and purified water. For more information, see section 2 under “HEMAGIOL contains sodium and propylene glycol”.
What the medicine looks like and contents of the pack
- HEMANGIOL is a clear, colorless to pale yellow oral solution, with a fruity scent.
- It comes in a 120-ml amber glass bottle, with child-resistant screw cap. Carton with 1 bottle.
- A polypropylene dosing syringe, graded in mg propranolol, is included with each bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
PIERRE FABRE DERMATOLOGY
45 Place Abel Gance
92100 BOULOGNE
FRANCE
Manufacturer
FARMEA
10 rue Bouché Thomas
ZAC Sud d’Orgemont
49000 ANGERS
FRANCE
Or
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM site, Rue du Lycée
45500 GIEN
FRANCE
Contact the marketing authorization holder to find out more about this medicine.