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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, 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

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.

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.

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:

AUSTRIA:

BELGIUM:

CZECH REPUBLIC: DENMARK:

ESTONIA:

FINLAND:

GERMANY:

GREECE:

HUNGARY:

IRELAND:

ITALY:

LATVIA:

LITHUANIA:

LUXEMBURG:

THE NETHERLANDS: NORWAY:

POLAND:

PORTUGAL:

SLOVAK REPUBLIC: SLOVENIA:

SWEDEN:

UNITED KINGDOM:

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.

Abbott

MKP-01838-2012

MKP-01838-2012_d1