HIDRASEC 100 mg HARD CAPSULES

2. What you need to know before taking Hidrasec

Do not take Hidrasec

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

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

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 the diarrhea may be a bacterial infection that needs to 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,

Racecadotril, the active ingredient of Hidrasec, may cause an allergic reaction called angioedema, which can cause swelling of the face, lips, throat, or tongue. If you experience these side effects, stop treatment immediately and contact your doctor. The swelling can occur at any time during treatment with this product.

The concomitant use of this product and other medications may increase the risk of angioedema (see "Other medications and Hidrasec").

Skin reactions have been reported with the use of this product. In most cases, they are mild and do not require treatment. In some cases, severe skin reactions may occur. In these cases, treatment with Hidrasec should be stopped immediately and the patient should not take it again.

If there is no improvement within 48 hours, stop treatment and consult your doctor.

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

Patient with diarrhea should drink plenty of fluids to avoid dehydration, which is manifested by dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and fainting. This is especially important in elderly people.

Children and adolescents

Hidrasec should not be used in children and adolescents.

Use of Hidrasec with other medications

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

Especially inform your doctor if you are taking any of the following medications that may increase the risk of side effects (see Warnings and Precautions):

• ACE inhibitor (e.g., captopril, enalapril, lisinopril, perindopril, or ramipril) used to lower blood pressure or treat heart failure.
• Angiotensin II antagonists (e.g., candesartan or irbesartan) used to treat high blood pressure and heart failure.
• Sacubitril, used to treat heart failure.
• Some immunosuppressants (e.g., sirolimus or everolimus)
• Some antidiabetics (e.g., sitagliptin or vildagliptin)
• Estramustine, used to treat cancer.
• Alteplase, used to treat blood clots.

Pregnancy and breastfeeding

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

Driving and using machines

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

Hidrasec contains lactose

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

3. How to take Hidrasec

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

Hidrasec should be taken preferably before main meals, but to start treatment, you can take a capsule of Hidrasec at any time of the day.

Treatment should be continued until two normal stools are produced. The maximum duration of treatment will be 2 days.

To compensate for fluid loss due to diarrhea, this medication should be used in conjunction with adequate fluid and electrolyte replacement. The best replacement of fluids and salts is achieved with an oral rehydration solution (please ask your doctor or pharmacist if you are not sure).

No dose adjustment is required in elderly people.

Use in children and adolescents

Children and adolescents cannot take this medication.

If you take more Hidrasec than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, Phone 91 562 04 20 (indicating the medication and the amount ingested).

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 medications, this medication can cause side 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
• hives and difficulty breathing

Discontinue the use of racecadotril and seek immediate medical attention if you notice any of the following symptoms:

• Widespread skin rash, elevated body temperature, and increased lymph nodes (DRESS syndrome).
• Difficulty breathing, swelling, dizziness, tachycardia, sweating, and feeling of loss of consciousness, symptoms of a severe and sudden allergic reaction.

The following side effects have been reported:

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

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

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

Reporting side effects

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

5. Storage of Hidrasec

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

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

No special storage conditions are required.

6. Package contents and additional information

Hidrasec composition

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

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 (E 171).

Appearance of Hidrasec and package contents

Hidrasec is presented in the form of hard ivory-colored capsules.

Each package contains 6 or 10 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

BIOPROJET-FERRER, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscalla 1-9

08173 Sant Cugat del Valles, Barcelona (Spain)

or

SOPHARTEX,

21 rue de Pressoir,

28500 Vernouillet (France)

Date of the last revision of this prospectus: June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.