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HIDRASEC 100 MG HARD CAPSULES

Active substance: RACECADOTRIL

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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.
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
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 you are allergic (hypersensitive) 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.
You should tell your doctor 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,
- You are suffering from prolonged or
uncontrolled vomiting,
- You have intolerance to lactose (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,

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including medicines obtained without a
prescription.
Pregnancy, breast-feeding and fertility
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
Hidrasec is presented in the form of capsules.
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
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

FRONT

effects, although not everybody gets them.
The most common side effects are headache
(affects 1 to 10 users in 100).
The following uncommon side effects have
been reported (affects 1 to 10 users in 1,000):
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), toxic
skin eruption.
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
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 the
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.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holders
Bioprojet Europe Ltd.
29 Earlsfort Terrace
EI-Dublin 2
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
August 2012.
Under licence from Bioprojet.
Hidrasec is supplied in the UK by Abbott
Laboratories Ltd., Vanwall Business Park,
Vanwall Road, Maidenhead, Berkshire
SL6 4XE.

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 (E 172) 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
Not all pack sizes may be marketed.

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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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