Hydrasec 100 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
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.
Follow exactly the instructions for administration of this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse.
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Keep this leaflet as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
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You should consult a doctor if you get worse or do not improve after 2 days.
Contents of the leaflet:
- What Hidrasec is and what it is used for
- What you need to know before taking Hidrasec
- How to take Hidrasec
- Possible side effects
- How to store Hidrasec
- Contents of the pack and other information
1. What Hidrasec is and what it is used for
Hidrasec is a medicine containing racecadotril as the active substance.
It is indicated for the treatment of symptoms of acute nonspecific diarrhoea in adults.
You should consult a doctor if you worsen or do not improve after 2 days.
2. What you need to know before taking Hidrasec
Do not take Hidrasec
If you are allergic to racecadotril or to any of the other ingredients of this medicine (listed in section 6).
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking racecadotril.
Warnings and precautions
Consult your doctor or pharmacist before taking 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 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 uncontrollable vomiting.
Racecadotril, the active substance in Hidrasec, may cause an allergic reaction called angioedema, which can result in swelling of the face, lips, throat, or tongue. If you experience these adverse effects, stop treatment immediately and contact your doctor. Swelling may occur at any time during treatment with this product.
Concomitant use of this product and other medicines may increase the risk of angioedema (see "Other medicines 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 such cases, treatment with Hidrasec must be stopped immediately and the patient should not take it again.
If no improvement is seen within 48 hours, stop treatment and consult your doctor.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril treatment. Discontinue the use of racecadotril and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Patients with diarrhea should drink plenty of fluids to prevent dehydration, which manifests as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in elderly individuals.
Children and adolescents
Hidrasec must not be used in children and adolescents.
Taking Hidrasec with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Especially inform your doctor if you are taking any of the following medicines, which may increase the risk of adverse effects (see Warnings and Precautions):
- ACE inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, or ramipril) used to lower blood pressure or to treat heart failure.
- Angiotensin II antagonists (e.g., candesartan or irbesartan) used to treat high blood pressure and heart failure.
- Sacubitril, used for the treatment of heart failure.
- Some immunosuppressants (e.g., sirolimus or everolimus).
- Some antidiabetic agents (e.g., sitagliptin or vildagliptin).
- Estramustine, used for cancer treatment.
- Alteplase, used for the treatment of blood clots.
Pregnancy and breastfeeding
Hidrasec is not recommended if you are pregnant, think you may be pregnant, or 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Hidrasec
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is one capsule (100 mg) taken three times a day, swallowed with a glass of water.
Hidrasec should preferably be taken before main meals; however, when starting treatment, you may take one Hidrasec capsule at any time of the day.
Treatment should be continued until two normal bowel movements occur. The maximum duration of treatment is 2 days.
To compensate for fluid loss due to diarrhea, this medicine should be used together with adequate fluid and salt (electrolyte) replacement. The best way to replace fluids and salts is with an oral rehydration solution (please ask your doctor or pharmacist if you are unsure).
Dose adjustment is not required in elderly patients.
Use in children and adolescents
Children and adolescents must not take this medicine.
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 at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Hidrasec
Do not take a double dose to make up for a missed dose. Simply continue with your treatment as usual.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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:
- Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
- Breathing difficulty, swelling, dizziness, tachycardia, sweating, and feeling faint—symptoms of a severe and sudden allergic reaction.
The following adverse effects have been reported:
Common (may affect up to 1 in 10 people): headache
Uncommon (may affect up to 1 in 100 people): rash and erythema (redness of the skin)
Frequency not known (frequency cannot be estimated from the available data): erythema multiforme (reddish lesions on limbs and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (inflammation appearing as lumps under the skin), papular rash (skin rash with small, firm, raised lesions), prurigo (itchy skin lesions), pruritus (generalized itching), and toxic skin eruption.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Hidrasec
Keep this medicine out of sight and reach of children.
Do not use Hidrasec after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.
No special storage conditions are required.
6. Contents of the pack and other information
Composition of Hidrasec
The active substance is racecadotril. Each capsule contains 100 mg of racecadotril.
The other components are lactose, pregelatinized corn starch, magnesium stearate and anhydrous colloidal silica. The capsule shell contains gelatin, yellow iron oxide (E 172) and titanium dioxide (E171).
Appearance of Hidrasec and contents of the pack
Hidrasec is presented as hard capsules of ivory color.
Each pack 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 Vallès, Barcelona (Spain)
or
SOPHARTEX,
21 rue de Pressoir,
28500 Vernouillet (France)
Date of the most recent revision of this leaflet: June 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es.