HIDRASEC INFANTS 10 MG GRANULES FOR ORAL SUSPENSION

Package leaflet: Information for the user

HIDRASEC INFANTS 10mg
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 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
c o m p l e m e n t a r y t re a t m e n t w h e n c a u s a l
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 1 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 infants with diabetes, if the doctor has
prescribed to your child more than 5 sachets of
Hidrasec per day (which corresponds to more
than 5 g of sucrose), this 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 infants weighing up to 9 kg: one sachet per
dose.
In infants weighing from 9 to 13 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.
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.
This medicinal product does not require any
special storage conditions.

Each sachet contains 10 mg of racecadotril.
The other ingredients are:
Sucrose,
Colloidal anhydrous silica,
polyacrylate dispersion 30 per cent,
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 100
sachets (100 sachets for hospital use).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder (s)
Bioprojet Europe Ltd.
101 Furry Park road
Killester
EI-DUBLIN 5
Manufacturer (s)
SOPHARTEX
21 rue du 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-Tiorfan (100mg)
PORTUGAL:
Tiorfan
SLOVAK REPUBLIC: Hidrasec
SLOVENIA:
Hidrasec
SWEDEN:
Hidrasec
UNITED KINGDOM: Hidrasec
This leaflet was last revised in
February 2017
Hidrasec is marketed in the UK by Lincoln
Medical Ltd.,
Unit 8 Wilton Business Centre, Wilton,
Salisbury, SP2 0AH, UK
Medical information contact:
+44 (0) 1748 827277

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