HIDRASEC CHILDREN 30 MG GRANULES FOR ORAL SUSPENSION

Active substance: RACECADOTRIL

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Package leaflet: Information for the user

HIDRASEC® CHILDREN 30 mg
Granules for oral suspension
Racecadotril
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 symptoms are the
same as your child’s.
– If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
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
diarroea can not 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 (hypersensitive) to
racecadotril or any of the other ingredients
of Hidrasec.
– 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
You should tell your doctor 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,

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– 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).
Other medicines and Hidrasec
Please tell your doctor if you are using or
have recently used any other medicines,
including medicines obtained without a
prescription.
Pregnancy, breast-feeding and fertility
Use of Hidrasec is not recommended in case
of pregnancy and breast feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Hidrasec has little or no effect on the ability to
drive or use machinery.
Important information about some of the
ingredients of Hidrasec
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
Dosage and instructions for use
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.
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.
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.

FRONT

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.
The following uncommon side effects have
been reported (affects 1 to 10 users in 1,000):
tonsillitis (inflammation of the amygdales),
rash and erythema (skin redness).
Other side effects (frequency cannot be
estimated from the available data) are:
erythema multiforma (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, angioedema (inflammation below the
skin in different parts of the body), 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).
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
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist
5. How to store Hidrasec
Keep this medicine out of the sight and reach
of children.
Do not use Hidrasec after the expiry date which
is stated on the outer packaging after EXP
The expiry date refers to the last day of that
month.
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
This medicinal product does not require any
special storage conditions.
Read the package leaflet before use.

The other ingredients are sucrose, colloidal
anhydrous silica, polyacrylate dispersion
30 per cent, and apricot flavour.
What Hidrasec looks like and contents of
the pack
Hidrasec is supplied in the form of granules
for oral suspension contained in sachets.
Each pack contains 10, 16, 20, 30, 50 or
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Bioprojet Europe Ltd.
29 Earlsfort Terrace
Dublin 2
IRELAND
Manufacturer
SOPHARTEX,
21 rue de Pressoir,
28500 Vernouillet (France)
This medicinal product is authorised in the
Member States of the EEA under the
following names:
SPAIN:
Tiorfan
AUSTRIA:
Hidrasec
BELGIUM:
Tiorfix
CZECH REPUBLIC:
Hidrasec
DENMARK:
Hidrasec
ESTONIA
Hidrasec
FINLAND:
Hidrasec
GERMANY:
Tiorfan
GREECE:
Hidrasec
HUNGARY:
Hidrasec
IRELAND:
Hidrasec
ITALY:
Tiorfix
LATVIA:
Hidrasec
LITHUANIA:
Hidrasec
LUXEMBURG:
Tiorfix
THE NETHERLANDS:
Hidrasec
NORWAY:
Hidrasec
POLAND:
Hidrasec
PORTUGAL:
Tiorfan
SLOVAK REPUBLIC:
Hidrasec
SLOVENIA:
Hidrasec
SWEDEN:
Hidrasec
UNITED KINGDOM:
Hidrasec
This leaflet was last revised in
August 2012.
Under licence from Bioprojet
Hidrasec is supplied in the UK by Abbott
Laboratories Ltd, Vanwall Business Park,
Vanwall Road, Maidenhead, Berkshire

6. Contents of the pack and other
information
What Hidrasec contains
The active substance is racecadotril. Each
sachet contains 30 mg of racecadotril.

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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.

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