Patient leaflet - Hidrasec 175 mg film-coated tablets

1. What Hidrasec 175 mg, film-coated tablet is and what it is used for

Hidrasec 175 mg, film-coated tablet, is a medicine for the treatment of diarrhoea.

This medicine 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 175 mg, film-coated tablet

If you have been told by your doctor that you have intolerance to some sugars, ask your doctor before taking Hidrasec 175 mg, film-coated tablet.

Do not take Hidrasec 175 mg, film-coated tablet

if you are allergic to racecadotril (active substance) or any of the other ingredients of this medicine (listed in section 6).
If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking racecadotril.

Warnings and precautions

Diarrhoea leads to a loss of liquids and electrolytes 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)

Talk to your doctor or pharmacist before taking Hidrasec 175 mg, film-coated tablet if:

There is blood or pus in your stools and if you have fever. The cause of the diarrhea 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.

Hidrasec 175 mg, film-coated tablet contains 139.6 mg (0.4mmol) of lactose anhydrous.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Hypersensitivity/Angioneurotic Oedema (swellings) have been reported in patients with racecadotril (the active substance of this product). Angioedema of the face, extremities, lips, mucous membranes, etc., or swelling of the upper airways, e.g. tongue, glottis and/or larynx (throat) may occur. These may appear at any time during therapy. If you experience such adverse events, please stop the treatment immediately and contact your doctor.

Patients with a history of angioedema (swelling) unrelated to racecadotril therapy may be at increased risk of angioedema.

Concomitant use of this medicinal product and ACE inhibitors (e.g. perindopril and ramipril) may increase the risk of angioedema (see “Other medicines and Hidrasec 175 mg, film-coated tablet”).

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. Racecadotril should not not reintroduced.

Take special care with racecadotril:

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with racecadotril treatment. Stop using racecadotril and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents

Hidrasec 175 mg film-coated tablets cannot be used in children and adolescents More appropriate formulations of racecadotril indicated in this population, such as granules in sachet, should be used.

Other medicines and Hidrasec 175 mg, film-coated tablet

Tell your doctor if you are using, have recently used or might use any other medicines, specially the following medicines:

ACE inhibitor (e.g. perindopril and ramipril) used to lower the blood pressure or facilitate heart labor.

Hidrasec 175 mg, film-coated tablet with food, drink and alcohol

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Given the available data, this medicine is not recommended if you are pregnant or if you are breast- feeding.

Driving and using machines

Hidrasec has little or no effect on the ability to drive or use machinery.

Hidrasec 175 mg, film-coated tablet contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking racecadotril.

This medicine does not contain gluten.

3. How to take Hidrasec 175 mg, film-coated tablet

It is presented as film-coated tablet.

For adult only Posology

“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 first day: one tablet straightaway regardless of the time of day, then, depending on the time of the first intake, up to a maximum of 2 tablets spread over the day, counting in these 2 tablets the first tablet taken straightaway. Taken should preferably be done before meals. The following days: one tablet in the morning and one tablet in the evening, i.e. 2 tablets per day, preferably before meals.

Your doctor will tell you how long your treatment will last.

Your treatment 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).”

Dosage adjustment is not necessary in the elderly person.

Mode of Administration:

Oral route. Swallow with a glass of water.

If you take more Hidrasec 175 mg, film-coated tablet than you should

Contact you doctor or your pharmacist immediately.

If you forget to take Hidrasec 175 mg, film-coated tablet

Do not take a double dose to make up for a forgotten tablet. Continue with the next one.

If you stop taking Hidrasec 175 mg, film-coated tablet

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Hidrasec 175 mg film-coated tablet and see your doctor immediately if you feel symptoms of angioedema, such as:

Swollen face, tongue or pharynx
Difficulty to swallow
Hives and difficulties to breath

Stop using racecadotril and seek medical attention immediately if you notice any of the following symptoms:

Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
Breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and a feeling of loss of consciousness which are symptoms of a sudden, severe allergic reaction.

The following side effects have been reported:

Common (may affect up to 1 in 10 people): headache

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 (pink lesions in the extremities and inside the mouth), inflammation of the tongue, inflammation of the lip, inflammation of the eyelid, inflammation of the face, angioedema (subcutaneous inflammation about 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.

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 viathe Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hidrasec 175 mg, film-coated tablet

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 label after EXP. The expiry date refers to the last day of that month.

This medical product does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Hidrasec 175 mg, film-coated tablet contains

The active substance is racecadotril. Each tablet contains 175 mg of racecadotril.
The other ingredients are lactose monohydrate, calcium carmellose, hydroxypropylcellulose, cellulose microcrystalline, pregelatinised starch (maize), magnesium stearate
Coating : OPADRY white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc)

What Hidrasec 175 mg, film-coated tablet looks like and contents of the pack

Hidrasec 175 mg is a film-coated tablet.

Packs of 3, 6 and 12 tablets.

Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing autorisation holder

BIOPROJET PHARMA

9 RUE RAMEAU

75002 PARIS

FRANCE

Manufacturers

BENTA LYON

29, avenue Charles de Gaulle

69230 Saint Genis Laval