Hemangiol - patient leaflet, side effects, dosage

Patient leaflet - Hemangiol

If your child get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What HEMANGIOL is and what it is used for
2. What you need to know before your child receives 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 ingredient 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 disease called haemangioma. A haemangioma is a collection of extra blood vessels that have formed a lump in or under the skin. Haemangioma can be superficial or deep. It is sometimes called ‘strawberry mark’ because the surface of a haemangioma looks a bit like a strawberry.

Hemangiol is started in infants aged 5 weeks to 5 months, when:

– the localisation and/or extend of the lesions are life- or function threatening (might impair vital organs or senses such as vision or hearing);
– the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful, and/or does not respond to simple wound care measures;
– there is a risk of permanent scars or disfigurement.

2 What you need to know before your child receives HEMANGIOL

Do not give HEMANGIOL

If your child:

is born prematurely and he/she has not reached the corrected age of 5 weeks (the corrected age being the age a premature baby would be if he/she had been born on their due date).
is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath.
has asthma or history of breathing difficulties.
has a slow heart rate for his/her age. Please 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 level.
has a high blood pressure caused by a tumour on the adrenal gland. This is called ‚phaeochromocytoma‘.

If you are breastfeeding your child, and if you are taking medicines that must not be used 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

Before your child receives HEMANGIOL, tell your doctor:

If your child has problems with his/her liver or kidneys. This medicine will not be recommended in case of liver or kidneys impairment.
If your child has ever had an allergic reaction whatever its origin (e.g. medicine or alimentary substance etc.). An allergic reaction can include a rash, itching or shortness of breath.
If your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin), as this medicine may worsen the symptoms of this condition.
If your child has diabetes: in this case, your child’s blood sugar level should be measured more frequently.
If your child has a PHACE syndrome (a condition combining haemangioma and vascular abnormalities including cerebral blood vessels), as this medicine may increase the risk of cerebral stroke.

Important signs to look after administration of HEMANGIOL

Risks of hypoglycaemia

This medicine can mask the warning signs of hypoglycaemia (also known as low blood sugar level). It can also aggravate hypoglycaemia in children, especially during fasting period (e.g. poor oral food intake, concomitant infection, vomiting) or when glucose demands are increased (cold, stress, infections). or in case of overdose. These signs may be:

Minor: pallor, tiredness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up.
Major: excessive sleeping, difficulty responding, poor feeding, decrease in body temperature, convulsions (fits), brief pauses in breathing, loss of consciousness.

The risk of developing hypoglycaemia remains prominent throughout the whole treatment period.

To avoid risks of hypoglycaemia, you should give HEMANGIOL during or straight after a feed and avoid giving last dose close to night bedtime (see section 3) . Your child must be fed sufficiently and regularly during treatment. If your child is not eating enough, develops another illness or is vomiting, it is recommended to skip the dose. DO NOT GIVE HEMANGIOL TO YOUR CHILD UNTIL HE IS BEING CORRECTLY FED AGAIN.

If your child has any signs of hypoglycaemia while taking HEMANGIOL, stop treatment and call a doctor straight away or go directly to hospital. If the child is conscious, give him/her a drink of liquid containing sugar.

Risks of bronchospasm

Stop treatment and contact a doctor immediately if after giving HEMANGIOL to your child you observe the following symptoms suggestive of a bronchospasm (temporary restriction of the bronchial tubes that leads to difficulty breathing): cough, quick or difficult breathing or wheezing, associated or not with a bluish- coloured skin.

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

Risk of hypotension and bradycardia (low heart rate)

HEMANGIOL can decrease blood pressure (hypotension) and heart rate (bradycardia). This is why your child will be kept under close clinical and heart rate monitoring for 2 hours after the first dose or after a dose increase. Then, your doctor will regularly examine your child during treatment.

Stop treatment and contact a doctor immediately if your child has any signs such as tiredness, coldness, pallor, bluish-coloured skin, or fainting while taking HEMANGIOL.

Risk of hyperkaliemia

HEMANGIOL may increase potassium blood level (hyperkaliemia). In case of large ulcerated haemangioma,, your child’s blood potassium level should be measured.

If your child should undergo a general anaesthesia

Tell the your doctor that he/she is taking HEMANGIOL. This is because your child can get low blood pressure if given certain anaesthetics while taking this medicine (see “Other medicines and HEMANGIOL”). HEMANGIOL might need to be discontinued at least 48h before the anaesthesia.

If you are breastfeeding your child

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 any other medicines to your child. This is because HEMANGIOL can change the way other medicines work, and some medicines can have an effect on the way HEMANGIOL works.
Moreover, if you are breastfeeding your child, it is important to tell your doctor, pharmacist or nurse which medicines you are yourself taking, as they may pass into your breast-milk and interfere with the treatment of your child. Your doctor will advise you on whether you need to stop breastfeeding or not.

In particular, in case you are breastfeeding, tell your doctor or pharmacist if you are or if your child is taking:

Medicines for diabetes,
Medicines for heart and blood vessels problems such as uneven heart beats, chest pain or angina, high blood pressure, heart failure,
Medicines to treat anxiety and depression as well as more serious mental health problems, and epilepsy,
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 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, i.e. essentially ‘sodium- free’.

This medicine contains 2.08 mg of propylene glycol/kg/day. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

3 How to give HEMANGIOL to your child

The treatment of your child has been initiated by a physician who has expertise in the diagnosis, treatment and management of infantile haemangioma.

Always give this medicine to your child exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Never change the dose you are giving to your child yourself. Every increase in dose or any dose adjustment to your baby’s weight must be done by your doctor.

Dose

Dosing is based on your baby’s weight following the scheme below:
one in the morning
one in late afternoon
at least 9 hours interval between two intakes

Second week (2 mg/kg/day)

1mg/kg

Third and following weeks (3 mg/kg/day)

1.5 mg/kg

If necessary, you may mix the medicine with a small quantity of baby-milk or age-adapted apple and/or orange fruit juice and give it to your child 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 may mix the 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 fruit juice (approximately 15 mL).

Use the mixture within 2 hours of preparation.

How to give HEMANGIOL to your child

Hemangiol is for oral use.
The medicine is to be given during or straight after a feed.
The dose should always be measured using the oral syringe supplied with the bottle.
Give HEMANGIOL directly into your child's mouth using the oral syringe supplied with the bottle.
Feed your child regularly to avoid prolonged fast.
If your child is not eating or is vomiting it is recommended to skip the dose.
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.
HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia. If different people are involved, good communication is essential in order to ensure the safety of your child.

Instructions for use:

Step 1. Remove the items from the box

The carton contains the following items that you will need to administer the medicine:

– The glass bottle containing 120 mL propranolol oral solution
– The oral syringe graduated in mg provided with this medicine

Remove the bottle and oral syringe from the box and remove the syringe from the plastic bag.

Step 2. Check the dose

Check the HEMANGIOL dose in milligrams (mg) as prescribed by your doctor. Locate this number on the oral syringe.

Step 3. Open the bottle

The bottle comes with a child-proof cap. Here is how to open it: push down the plastic cap while turning the cap counter-clockwise (to the left).

Do not shake the bottle before use.

Step 4. Insert the syringe

Insert tip of the oral syringe into the upright bottle and push the plunger all the way down.

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

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

Step 5: Remove the dose

With the oral syringe in place, turn the bottle upside down.

Pull the plunger 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 upright, push the plunger upwards just far enough to completely push out any large air bubbles and then readjust to the dose prescribed by your doctor.

Step 7. Remove the syringe

Turn bottle upright and remove the entire syringe from the bottle. Be careful, do not push the plunger in during this step.

Step 8. Close the bottle.

Replace the plastic cap on the bottle by turning it clock-wise (to the right).

Step 9. Give HEMANGIOL to your child

Insert the syringe into your baby’s mouth and place it against the inside of the cheek.

Now you can slowly squirt HEMANGIOL from the syringe directly into your baby’s mouth.

Do not lie the child down immediately after the administration.

Step 10: Clean the syringe.

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

1– Take a glass of clean water
2– Pull the plunger in
3– Discard the water into your sink
4- Repeat this cleaning process 3 times.

Do not use any soap or alcohol based product to clean. Wipe the outside dry.

Do not put the syringe through a sterilizer or dishwasher.

Store the bottle and the syringe together in the carton until next use in a safe place where your child can’t see or reach it. Discard the syringe once the bottle is finished.

If you give to your child more HEMANGIOL than you should

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

If you forget to give HEMANGIOL to your child

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

If you stop giving HEMANGIOL to your child

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

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important warning signs of potential side effects such as low blood pressure, low heart rate, low blood sugar level, and bronchospasm (breathing difficulties) should be looked after following administration of HEMANGIOL. Please 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 quality of sleep and difficulties to wake-up),
Diarrhoea and vomiting.

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

Bronchospasm (breathing difficulties),
Bronchiolitis (inflammation of small bronchi with breathing difficulties and wheeze 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),
Nappy rash.

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

Heart conduction or rhythm disorders (slow or uneven heart beats),
Urticaria (allergic reaction of the skin), alopecia (loss of hair),
Decreased blood sugar levels,
Reduction of the number of white blood cells.

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

Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),
Bradycardia (abnormally low heart rate),
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 level of potassium in the blood

Reporting of side effects

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you 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 which is stated on the outer carton and bottle label. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light. Store the bottle and the oral syringe in the outer carton between each use. Do not freeze.

After first opening, the medicine should be used within 2 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water. See section 2 under ‘HEMANGIOL contains sodium and propylene glycol’ for further information.

What HEMANGIOL looks like and contents of the pack

HEMANGIOL is a clear, colourless to slightly yellow oral solution, with a fruity odour.
It is supplied in a 120-mL amber glass bottle, with a child resistant screw-cap. Box of 1 bottle.
An oral polypropylene syringe graduated in mg of propranolol, is provided with each bottle.

Marketing Authorisation Holder

PIERRE FABRE DERMATOLOGIE

45 Place Abel Gance