Skip to Content

HIDRASEC CHILDREN 30MG GRANULES FOR ORAL SUSPENSION

Active substance(s): RACECADOTRIL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Hidrasec® Children 30 mg,
Granules for oral suspension
(racecadotril)
This product is available using the above name but
will be referred to as Hidrasec throughout the
following leaflet.
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for your child.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as your child’s.
− If your child get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Hidrasec is and what it is used for
2. What you need to know before you take Hidrasec
3. How to take Hidrasec
4. Possible side effects
5. How to store Hidrasec
6. Contents of the pack and other information
1. What Hidrasec is and what it is used for
Hidrasec is a medicine for the treatment of diarrhoea.
Hidrasec is used for the treatment of symptoms of
acute diarrhoea in children over three months of age.
It should be used together with an abundant liquid
intake and the usual dietary measures, when these
measures are not sufficiently effective on their own to
control the diarrhoea, and when diarrhoea cannot be
treated causally.
Racecadotril
can
be
administered
as
a
complementary treatment when causal treatment is
possible.
2. What you need to know before you take
Hidrasec
Do not use Hidrasec
− If your child is allergic to racecadotril or any of the
other ingredients of Hidrasec (listed in section 6).
− If you have been told by your doctor that your child
has intolerance to some sugars, ask your doctor
before you give Hidrasec to your child.
Warnings and precautions
Talk to your doctor or pharmacist before giving
Hidrasec to your child if:
− Your child is under three months of age,
− There is blood or pus in your child stools and if
he/she has fever. The cause of the diarrhoea may
be a bacterial infection that should be treated by
your doctor,

− Your child is suffering from chronic diarrhoea or
diarrhoea caused by antibiotics,
− Your child is suffering from kidney disease or
impaired liver function,
− Your child is suffering from prolonged or
uncontrolled vomiting,
− Your child is suffering from diabetes (see
“Important information about some of the
ingredients of Hidrasec”).
Occurrence of skin reactions has been reported with
the use of this product. These are in most cases mild
and moderate. When experiencing severe skin
reactions, the treatment has to be stopped
immediately.
Other medicines and Hidrasec
Please tell your doctor if your child is using, has
recently used or might use any other medicines.
Especially tell your doctor if your child use any of the
following medicines:
− ACE inhibitor (e.g. captopril, enalapril, lisinopril,
perindopril, ramipril) used to lower the blood
pressure or facilitate heart labour.
Pregnancy and breast-feeding
Use of Hidrasec is not recommended in case of
pregnancy and breast feeding.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Hidrasec has little or no effect on the ability to drive
and use machinery.
Hidrasec contains sucrose
Hidrasec contains about 3 g of sucrose per sachet. If
you have been told by your doctor that your child has
intolerance to some sugars, ask your doctor before
you give Hidrasec to your child. In children with
diabetes, the quantity of sucrose ingested with
Hidrasec should be taken into account in the child’s
total daily intake of sugar.
3. How to take Hidrasec
Always give Hidrasec to your child exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Hidrasec is supplied in the form of granules.
The granules should be added to food or mixed with
water in a glass or baby bottle. Mix well and give
immediately to your child.

The recommended daily dose depends on your
child’s weight: 1.5 mg/kg per dose (corresponding to
1 to 2 sachets), three times daily at regular intervals.
In children weighing from 13 to 27 kg: one sachet per
dose.
In children of approximate weight more than 27 kg:
two sachets per dose.
Your doctor will tell you how long the treatment with
Hidrasec will last. It should be continued until your
child has two normal stools, not exceeding 7 days.
To compensate for the loss of liquid due to your
child’s diarrhoea, this medicinal product should be
used together with an adequate replacement of fluid
and salts (electrolytes). The best replacement of fluid
and salts is achieved with a so-called oral
rehydration solution (please ask your doctor or
pharmacist if you are not sure).
If you give more Hidrasec than you should
If your child has taken more Hidrasec than he/she
should have contact your doctor or pharmacist
immediately.
If you forget to give Hidrasec
Do not give a double dose to your child to make up
for a forgotten dose. Simply continue with the
treatment.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You should stop giving Hidrasec to your child and
see your doctor immediately if your child experiences
symptoms of angioedema, such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breath
The following side effects have also been reported
Uncommon (may affect up to 1 in 100 people):
tonsillitis (inflammation of the amygdales), rash and
erythema (skin redness).
Not known (frequency cannot be estimated from the
available data):
erythema multiforme (pink lesions in the extremities
and inside the mouth), inflammation of the tongue,
inflammation of the face, inflammation of the lip,
inflammation of the eyelid, urticaria, erythema
nodosum (inflammation in the form of a nodule under
the skin), rash papular (eruption in the skin with small
lesions, hard and nodulated), prurigo (itching skin
lesions), pruritus (generalised itching).

Reporting of side effects
If you get 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 Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Hidrasec
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the outer packaging after EXP. The
expiry date refers to the last day of that month.
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.
If your medicine become discoloured or show any
signs of deterioration, you should seek the advice of
your pharmacist.
6. Contents of the pack and other information
What Hidrasec contains
The active substance is racecadotril. Each sachet
contains 30 mg of racecadotril.
The other ingredients are sucrose, colloidal
anhydrous silica, polyacrylate dispersion 30% and
apricot aroma.
What Hidrasec looks like and contents of the
pack
Hidrasec is supplied in the form of white granules
with a characteristic apricot aroma.
Each pack contains 30 sachets.
PL: 27777/0027

POM

Manufactured by SOPHARTEX, 21 Rue du Pressoir,
28500 Vernouillet, France.
Procured from within the EU by the Product Licence
holder: Vital Supplies (UK) Ltd., Unit 9, Enterprise
Court, Eastways Industrial Estate, Witham CM8 2TJ.
Repackaged by O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet issue and revision (Ref.) 15.08.2017.
Hidrasec is a registered trademark of Bioprojet
Pharma S.A.R.L.

To request a copy of this leaflet in
Braille, large print or audio please
call 01923 332 796.

Package leaflet: Information for the user

Racecadotril Children 30 mg,
Granules for oral suspension
This product is available using the above name but
will be referred to as Racecadotril Children
throughout the following leaflet.
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for your child.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as your child’s.
− If your child get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Racecadotril Children is and what it is used
for
2. What you need to know before you take
Racecadotril Children
3. How to take Racecadotril Children
4. Possible side effects
5. How to store Racecadotril Children
6. Contents of the pack and other information
1. What Racecadotril Children is and what it is
used for
Racecadotril Children is a medicine for the treatment
of diarrhoea.
Racecadotril Children is used for the treatment of
symptoms of acute diarrhoea in children over three
months of age. It should be used together with an
abundant liquid intake and the usual dietary
measures, when these measures are not sufficiently
effective on their own to control the diarrhoea, and
when diarrhoea cannot be treated causally.
Racecadotril can be administered as a complementary
treatment when causal treatment is possible.
2. What you need to know before you take
Racecadotril Children
Do not use Racecadotril Children
− If your child is allergic to racecadotril or any of the
other ingredients of Racecadotril Children (listed in
section 6).
− If you have been told by your doctor that your child
has intolerance to some sugars, ask your doctor
before you give Racecadotril Children to your
child.

Warnings and precautions
Talk to your doctor or pharmacist before giving
Racecadotril Children to your child if:
− Your child is under three months of age,
− There is blood or pus in your child stools and if
he/she has fever. The cause of the diarrhoea may
be a bacterial infection that should be treated by
your doctor,
− Your child is suffering from chronic diarrhoea or
diarrhoea caused by antibiotics,
− Your child is suffering from kidney disease or
impaired liver function,
− Your child is suffering from prolonged or
uncontrolled vomiting,
− Your child is suffering from diabetes (see
“Important information about some of the
ingredients of Racecadotril Children”).
Occurrence of skin reactions has been reported with
the use of this product. These are in most cases mild
and moderate. When experiencing severe skin
reactions, the treatment has to be stopped
immediately.
Other medicines and Racecadotril Children
Please tell your doctor if your child is using, has
recently used or might use any other medicines.
Especially tell your doctor if your child use any of the
following medicines:
− ACE inhibitor (e.g. captopril, enalapril, lisinopril,
perindopril, ramipril) used to lower the blood
pressure or facilitate heart labour.
Pregnancy and breast-feeding
Use of Racecadotril Children is not recommended in
case of pregnancy and breast feeding.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Racecadotril Children has little or no effect on the
ability to drive and use machinery.
Racecadotril Children contains sucrose
Racecadotril Children contains about 3 g of sucrose
per sachet. If you have been told by your doctor that
your child has intolerance to some sugars, ask your
doctor before you give Racecadotril Children to your
child. In children with diabetes, the quantity of
sucrose ingested with Racecadotril Children should
be taken into account in the child’s total daily intake
of sugar.

3. How to take Racecadotril Children
Always give Racecadotril Children to your child
exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Racecadotril Children is supplied in the form of
granules.
The granules should be added to food or mixed with
water in a glass or baby bottle. Mix well and give
immediately to your child.
The recommended daily dose depends on your
child’s weight: 1.5 mg/kg per dose (corresponding to
1 to 2 sachets), three times daily at regular intervals.
In children weighing from 13 to 27 kg: one sachet per
dose.
In children of approximate weight more than 27 kg:
two sachets per dose.
Your doctor will tell you how long the treatment with
Racecadotril Children will last. It should be continued
until your child has two normal stools, not exceeding
7 days.
To compensate for the loss of liquid due to your
child’s diarrhoea, this medicinal product should be
used together with an adequate replacement of fluid
and salts (electrolytes). The best replacement of fluid
and salts is achieved with a so-called oral
rehydration solution (please ask your doctor or
pharmacist if you are not sure).
If you give more Racecadotril Children than you
should
If your child has taken more Racecadotril Children
than he/she should have contact your doctor or
pharmacist immediately.
If you forget to give Racecadotril Children
Do not give a double dose to your child to make up
for a forgotten dose. Simply continue with the
treatment.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You should stop giving Racecadotril Children to your
child and see your doctor immediately if your child
experiences symptoms of angioedema, such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breath
The following side effects have also been reported
Uncommon (may affect up to 1 in 100 people):
tonsillitis (inflammation of the amygdales), rash and
erythema (skin redness).
Not known (frequency cannot be estimated from the
available data):
erythema multiforme (pink lesions in the extremities
and inside the mouth), inflammation of the tongue,

inflammation of the face, inflammation of the lip,
inflammation of the eyelid, urticaria, erythema
nodosum (inflammation in the form of a nodule under
the skin), rash papular (eruption in the skin with small
lesions, hard and nodulated), prurigo (itching skin
lesions), pruritus (generalised itching).
Reporting of side effects
If you get 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 Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Racecadotril Children
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the outer packaging after EXP. The
expiry date refers to the last day of that month.
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.
If your medicine become discoloured or show any
signs of deterioration, you should seek the advice of
your pharmacist.
6. Contents of the pack and other information
What Racecadotril Children contains
The active substance is racecadotril. Each sachet
contains 30 mg of racecadotril.
The other ingredients are sucrose, colloidal
anhydrous silica, polyacrylate dispersion 30% and
apricot aroma.
What Racecadotril Children looks like and
contents of the pack
Racecadotril Children is supplied in the form of white
granules with a characteristic apricot aroma.
Each pack contains 30 sachets.
PL: 27777/0027

POM

Manufactured by SOPHARTEX, 21 Rue du Pressoir,
28500 Vernouillet, France.
Procured from within the EU by the Product Licence
holder: Vital Supplies (UK) Ltd., Unit 9, Enterprise
Court, Eastways Industrial Estate, Witham CM8 2TJ.
Repackaged by O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet issue and revision (Ref.) 15.08.2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01923 332 796.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide