Hemangiol propranolol hydrochloride 3.75mg/mL oral solution
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
propranolol hydrochloride
Available from:
Pierre Fabre Australia Pty Ltd
INN (International Name):
Propranolol hydrochloride
Authorization status:
Registered
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
Version: A03-090818
1
Supercedes: A02-1216
HEMANGIOL
® 3.75 MG/ML ORAL SOLUTION
_Propranolol _
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hemangiol
®
.
It does not contain all the
information that is known
about Hemangiol
®
.
It does not take the place
of talking to your doctor or
pharmacist.
All medicines have
benefits and risks. Your
doctor has weighed the
risks of giving your child
Hemangiol
®
against the
benefits this medicine is
expected to have.
If you have any concerns
about this medicine, ask
your doctor or pharmacist.
Keep this leaflet with the
medicine. You may need
to read it again.
WHAT HEMANGIOL
®
IS
USED FOR
Hemangiol
®
is used to
treat a condition in infants
called hemangioma.
A hemangioma is a
collection of extra blood
vessels that have formed
a lump in or under the
skin. A 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
®
contains the
medicine, propranolol
which belongs to a group
of medicines known as
beta-blockers. Beta-
blockers are used to treat
a variety of heart and
blood vessel conditions.
Your doctor may have
prescribed Hemangiol
®
for
another reason.
Ask your doctor if you
have any questions about
why Hemangiol
®
has been
prescribed for your child.
This medicine is only
available with a doctor’s
prescription.
BEFORE HEMANGIOL
®
IS GIVEN TO YOUR
CHILD
_WHEN IT MUST NOT BE _
_GIVEN TO YOUR CHILD _
DO NOT GIVE HEMANGIOL
®
if your child:
•
is born prematurely and
has not reached the
corrected age of 5
weeks. (The corrected
age is worked out by
subtracting the number of
weeks your child was
premature from your
child’s actual age, i.e. the
age of your child minus
the number of weeks
premature);
•
has an allergy to
propranolol
or any of
the ingredients listed at
the end of this leaflet.
An allergic reaction can
include a rash, itching,
hives, shortness of
breath, wheezing, or
difficulty breathing
Read the complete document
Summary of Product characteristics
Version: A02-090818
Page 1 of 21
Supercedes: A01-0615
PRODUCT INFORMATION
HEMANGIOL
®
3.75 MG/ML ORAL SOLUTION
NAME OF THE MEDICINE
propranolol hydrochloride
CAS Registry Number: 318-98-9
DESCRIPTION
Propranolol hydrochloride is a white to off-white powder with the
molecular formula
C
16
H
21
NO
2
.
HCI and a molecular weight of 295.8. It is soluble in water and
ethanol,
slightly soluble in chloroform and practically insoluble in ether. It
is non-hygroscopic
with a pKa of 9.5. Propranolol hydrochloride has a chiral centre; its
synthesis
produces a racemic mixture.
Hemangiol
®
drug product is presented as a colourless to slightly yellow, clear,
oral
solution with a fruity odour. One mL of Hemangiol
®
oral solution contains 3.75 mg of
propranolol base (as propranolol hydrochloride 4.28 mg). Hemangiol
®
also contains
the excipients: hydroxyethylcellulose, saccharin sodium, citric acid
monohydrate,
purified water and strawberry (proprietary ingredient number: 109091)
and vanilla
(proprietary ingredient number: 109044) flavours.
Attention is drawn to the difference in the labelling of the content
of propranolol in
Hemangiol
®
compared to other propranolol dosage forms: Hemangiol
®
solution is
labelled in terms of the amount of _propranolol base_ per mL whereas
propranolol
tablets are labelled in terms of the amount of _propranolol
hydrochloride_ per tablet.
Propylene glycol is the major component of the strawberry and vanilla
flavours.
Propylene glycol exposure is up to 2.08 mg/kg/day which does not
present a
significant safety concern for the pediatric patient population, no
risk for health of
treated children is expected_._
Version: A02-090818
Page 2 of 21
Supercedes: A01-0615
_ _
PHARMACOLOGY
PHARMACODYNAMICS
Propranolol is a non-selective beta-blocker that is characterised by
three
pharmacological properties:
•
The absence of cardioselective beta-1 beta-blocking activity;
•
An antiarrhythmic effect;
•
Lack of partial agonist activity (or intrinsic sympathomimetic
activity).
The pathogenesis of infantil
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