HIDRASEC 100 MG HARD CAPSULES

Package leaflet: Information for the user

HIDRASEC 100 mg hard capsules
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 you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
– If you 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
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 indicated for the treatment of
symptoms of acute diarrhoea in adults, when
diarrhoea 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 you are allergic to racecadotril or any of the
other ingredients of Hidrasec (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Hidrasec if:
– There is blood or pus in your stools and if you
have fever. The cause of the diarrhoea may be
a bacterial infection that should be treated by
your doctor,
– You are suffering from chronic diarrhoea or
diarrhoea caused by antibiotics,
– You are suffering from kidney disease or
impaired liver function,
– Yo u a re s u ff e r i n g f ro m p ro l o n g e d o r
uncontrolled vomiting,
– You have intolerance to lactose (see “Important
information about some of the ingredients of
Hidrasec”).
Occurrence of skin reactions has been reported
with the use of the 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 you are using, have
recently used or might use any other medicines.
Especially tell your doctor if you 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 if you are
pregnant, you think you might be or if you are
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 or use machinery.
Important information about some of the
ingredients of Hidrasec
Hidrasec contains lactose (a type of sugar). If
you have been told by your doctor that you have
intolerance to some sugars, ask your doctor
before taking Hidrasec.
This medicine does not contain gluten.
3. How to take Hidrasec
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Hidrasec is presented in the form of capsules.
The usual dose is one capsule three times daily
to be swallowed with a glass of water.
Hidrasec should be taken preferably before the
main meals, but to begin with your treatment,
you may take one capsule of Hidrasec at any
time during the day.
Your doctor will tell you how long your treatment
with Hidrasec will last. It should be continued
until two normal stools are produced, not
exceeding 7 days.
To compensate for the loss of liquid due to your
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).
No dosage adjustment is required in the elderly.
Children
Other forms of Hidrasec are available for use in
children and infants.
If you take more Hidrasec than you should,
please contact your doctor or pharmacist
immediately.
If you forget to take Hidrasec
Do not take a double dose to make up for a
forgotten dose. Simply continue with the treatment.

4. Possible side effects
Like all medicines, Hidrasec can cause side
effects, although not everybody gets them.
You should stop taking Hidrasec and see your
doctor immediately if you experience symptoms
of angioedema, such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breath
The most common side effects are headache
(affects 1 to 10 users in 100).
The following side effects have been reported:
Uncommon (may affect up 1 in 100 people):
rash and erythema (skin redness).
Not known (frequency cannot be estimated
from the available data):
erythema multiforme (pinklesions 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), toxic
skin eruption.
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 Hidrasec after the expiry date which
is stated on the outer packaging after EXP.
The expiry date refers to the last day of the
month.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicine via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Bioprojet Europe Ltd.
101 Furry Park road
Killester
EI-DUBLIN 5
IRELAND
Manufacturer
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:
Tiorfan
PORTUGAL:
Tiorfan
SLOVAK REPUBLIC: Hidrasec
SLOVENIA:
Hidrasec
SWEDEN:
Hidrasec
UNITED KINGDOM:
Hidrasec
This leaflet was last revised in
April 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.
Each capsule contains 100 mg of racecadotril.
The other ingredients are lactose monohydrate,
pregelatinised maize starch, magnesium stearate
and colloidal anhydrous silica. The capsule
contains gelatin, yellow iron oxide (E172) and
titanium dioxide (E171).
What Hidrasec looks like and contents of
the pack
Hidrasec is in the form of ivory-coloured hard
capsules.
Each pack contains 6, 10, 20, 100 or 500 hard
capsules. 100 or 500 pack sizes are for hospital
use only.
17108_UK_TA_N