PATIENT INFORMATION LEAFLET

Hidrasec 100 mg Hard Capsules

Racecadotrilo

Read this leaflet carefully before you start to take this medicinebecause it contains important information for you

Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor or pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor or pharmacist or nurse,even if they do not appear in this leaflet. See section 4.

• You must see a doctor if you get worse or do not improveafter 2 days.

1. What Hidrasec is and what it is used for

2. What you need to know before you start taking Hidrasec

3. How to take Hidrasec

4. Possible side effects

5. Storage of Hidrasec

6. Contents of the pack and additional information

Hidrasecis a medication that contains racecadotrilo as the active ingredient.

It is indicated for the treatment of symptoms of acute nonspecific diarrhea in adults.

Consult a doctor if symptoms worsen or do not improve after 2 days.

Do not take Hidrasec

If you are allergic to racecadotrilo or any of the other components of this medication (listed in section 6).

If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking racecadotrilo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidrasec if:

-there is blood or pus in your stools or if you have a fever. The cause of diarrhea may be a bacterial infection that must be treated by your doctor,

-you have chronic diarrhea or diarrhea caused by antibiotics,

-you have kidney or liver disease,

-you have prolonged or uncontrolled vomiting,

Skin reactions have been reported with the use of this product. In most cases, these have been mild or moderate. In case of experiencing severe skin reactions, treatment must be interrupted immediately.

If no improvement is observed in 48 hours, discontinue treatment and consult your doctor.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), associated with racecadotrilo treatment have been reported. Discontinue use of racecadotrilo and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4

Patients with diarrhea should drink plenty of liquids to avoid dehydration, which manifests as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and confusion. This is especially important in elderly individuals.

Children and adolescents

Hidrasec should not be used in children and adolescents.

Use of Hidrasec with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially inform your doctor if you are taking any of the following medications:

- ACE inhibitor (e.g., captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or facilitate heart work.

Pregnancy, breastfeeding, and fertility

Hidrasec is not recommended if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and operating machinery

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

Hidrasec contains lactose

Hidrasec contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended doseis one capsule (100 mg) taken three times a day, which should be swallowed with a glass of water.

Hidrasecshould be taken preferably before the main meals, but to start your treatment, you can take a Hidraseccapsule at any time of the day.

Treatment should be continued until two normal bowel movements occur.The maximum duration of treatment will be 2 days.

To compensate for the loss of fluid due to your diarrhea, this medication should be used along with an adequate fluid and electrolyte replacement (rehydration oral solution). Please ask your doctor or pharmacist if you are unsure.

No dose adjustment is required in elderly patients.

Use in children and adolescents

Children and adolescents cannot take this medication.

If you take more Hidrasec than you should

If you take more Hidrasecthan you should, please contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, Teléfono91 562 04 20(indicating the medication and the amount ingested).

If you forgot to take Hidrasec

Do not take a double dose to compensate for a missed dose.Simply continue with the treatment.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop taking Hidrasec and contact a doctor immediately if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or pharynx
• Difficulty swallowing
• Rashes and difficulty breathing

Suspend the use of racecadotrilo and seek medical attention immediately if you notice any of the following symptoms:

• Generalized skin eruption, elevated body temperature, and lymph node enlargement (DRESS syndrome).
• Respiratory difficulty, swelling, dizziness, tachycardia, sweating, and sensation of loss of consciousness, symptoms of a severe and sudden allergic reaction.

The following adverse effects have been described:

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

Infrequent (may affect up to 1 in 100 people): rash and erythema (skin redness).

Unknown frequency (frequency cannot be estimated from available data): erythema multiforme (red lesions on extremities and interior of the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (inflammation in the form of lumps under the skin), papular eruption (skin eruption with small, hard, and swollen lesions), prurigo (skin lesions with itching), pruritus (generalized itching), and toxic skin eruption.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Hidrasec after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

No special storage conditions are required.

Composition of Hidrasec

The active substance is racecadotrilo.Each capsule contains 100 mg of racecadotrilo.

The other components are lactose, pregelatinized cornstarch,magnesium stearate, and anhydrous colloidal silica.The capsule contains gelatin,yellow iron oxide(E 172)and titanium dioxide(E171).

Appearance of Hidrasec and content of the packaging

Hidrasecis presented in the form of hard, off-white capsules.

Each package contains 6 or 10 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BIOPROJET-FERRER, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

FERRER INTERNACIONAL, S.A.

Joan Buscalla 1-9

08173 Sant Cugat del Valles, Barcelona (Spain)

or

SOPHARTEX,

21 rue de Pressoir,

28500 Vernouillet (France)

Last revision date of this leaflet: February 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es.