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FORTASEC 2 mg HARD CAPSULES

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About the medicine

How to use FORTASEC 2 mg HARD CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Leaflet: Information for the Patient

FORTASEC 2 mg Hard Capsules

Loperamide Hydrochloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

  • Keep this leaflet as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.
  • You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Leaflet:

  1. What FORTASEC 2 mg Hard Capsulesare and what they are used for.
  2. What you need to know before taking FORTASEC 2 mg Hard Capsules.
  3. How to take FORTASEC 2 mg Hard Capsules.
  4. Possible side effects.
  5. Storage of FORTASEC 2 mg Hard Capsules.
  1. Package contents and additional information.

1. What FORTASEC 2 mg Hard Capsules are and what they are used for

It is an antidiarrheal medicine that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

It is indicated for the symptomatic treatment of acute nonspecific diarrhea (occasional) in adults and children from 12 years of age.

You should consult a doctor if it worsens or does not improve after 2 days.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking FORTASEC 2 mg Hard Capsules

Do not take FORTASEC 2 mg Hard Capsules

  • Children under 12 years of age
  • If you are allergic (hypersensitive) to loperamide hydrochloride or any of the other components of this medicine (listed in section 6)
  • If you have a high fever (above 38°C) or blood in your stool.
  • If you suffer from ulcerative colitis (inflammation of the intestine)
  • If you suffer from severe diarrhea after taking antibiotics.
  • If you suffer from diarrhea due to an infection caused by organisms such as Salmonella, Shigellaand Campylobacter
  • Treatment should be stopped quickly and a doctor consulted if constipation, abdominal distension (swelling) or ileus (absence of intestinal movements) occurs.

Warnings and precautions

  • Consult your doctor or pharmacist before starting to take FORTASEC 2 mg Hard Capsules
  • If you have severe diarrhea, your body loses more fluids, sugars, and salts than usual, you will need to replenish fluids by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts
  • Treatment with this medicine is only symptomatic, so the diarrhea should be treated from its cause.
  • If you have AIDS and your stomach swells, stop taking this medicine immediately and consult your doctor
  • If you have liver disease, consult your doctor before taking this medicine, as it could produce toxicity in the central nervous system.
  • If you are taking any narcotic analgesic, consult your doctor or pharmacist before taking this medicine, as it may interact with them.

Do not take this medicine for a use other than indicated (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide.

If there is no improvement within 48 hours or if fever, constipation, or other symptoms appear, stop treatment and consult your doctor.

Patients 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 drowsiness. This is especially important in children and the elderly.

Children and adolescents

Do not use in children and adolescents under 12 years of age.

Taking FORTASEC 2 mg Hard Capsules with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use another medicine.

  1. It is considered especially important if you are taking medicines that contain
  2. Ritonavir, saquinavir (used to treat HIV).
  3. Quinidine (used to treat abnormal heart rhythms).
  4. Desmopressin oral (used to treat central diabetes insipidus and nocturnal urinary incontinence in children).
  5. Itraconazole or ketoconazole (used to treat fungal infections).
  6. Gemfibrozil (used to lower cholesterol).
  7. St. John's Wort (used to improve mood).
  8. Valerian (used to treat mild anxiety).
  9. Opioid analgesics (used to treat intense pain) as it may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or decreased consciousness).
  10. Broad-spectrum antibiotics, as FORTASEC may worsen or prolong antibiotic-induced diarrhea and increase loperamide blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnant women should not take this medicine unless prescribed by a doctor, as there is no experience with its use in pregnant women.

Do not take FORTASEC 2 mg Hard Capsulesif you are breastfeeding. Small amounts of the medicine may pass into breast milk.

Driving and using machines

You can drive and use tools and machines unless you feel tired, dizzy, or drowsy. Do not drive or use machines in those cases.

FORTASEC 2 mg Hard Capsules contain lactose

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

3. How to take FORTASEC 2 mg Hard Capsules

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

The recommended dose is:

Adults

2 capsules (4 mg) as an initial dose followed by 1 capsule (2 mg) after each diarrheal stool.

The maximum dose for adults is 8 capsules (16 mg) per day.

Children over 12 years of age

1 capsule (2 mg) as an initial dose followed by 1 capsule (2 mg) after each diarrheal stool.

In children, the maximum daily dose should be related to body weight:

Child's weight

Maximum number of capsules per day

From 27 kg

Maximum 4 capsules

From 34 kg

Maximum 5 capsules

From 40 kg

Maximum 6 capsules

From 47 kg

Maximum 7 capsules

Take the capsules with a full glass of water.

Patient with liver disease:Should consult a doctor.

Advanced age and patients with kidney disease

Follow the same instructions described for adults and children over 12 years of age

Use in children and adolescents

Children under 12 years of age should not take this medicine. It is contraindicated.

If you take more FORTASEC 2 mg Hard Capsules than you should

Taking too many capsules can cause abnormal coordination, stupor, pupil constriction, increased muscle tension, difficulty breathing (children are more sensitive to these effects than adults), and decreased urine output.

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 medicine and the amount ingested).

If you forget to take FORTASEC

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, FORTASECcan cause side effects, although not everyone gets them.

Frequency not known (cannot be estimated from available data)

Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).

If you experience any of these symptoms, stop using the medicine and seek medical help immediately.

Very rare adverse reactions(may affect up to 1 in 10,000 people):

  • Swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing (angioedema)
  • Allergic reactions (including anaphylactic shock)
  • Fatigue
  • Decreased urine output
  • Loss or decreased consciousness
  • Abnormal coordination
  • Increased muscle tension (hypertonia)
  • Stupor
  • Pupil constriction (miosis)
  • Loss of intestinal mobility (ileus, including paralytic ileus)
  • Itching or hives
  • Drowsiness
  • Abnormal dilation of the colon (megacolon)
  • Bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of FORTASEC 2 mg Hard Capsules

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the carton after "Expiration Date". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of FORTASEC 2 mg Hard Capsules

The active ingredient is: loperamide hydrochloride (2 mg per capsule)

The other ingredients (excipients) are: lactose, talc, magnesium stearate, and cornstarch. Gelatin, yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), and black iron oxide (E172).

Appearance of the product and package contents

They are hard gelatin capsules of dark gray and green color.

They are presented in packages of 12 and 20 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer

JANSSEN-CILAG S.P.A.

Via C. Janssen

04010 Borgo S.Michele

Latina (Italy)

JNTL Consumer Health (France) S.A.S.

Domaine de Maigremont

27100 Val de Reuil

France

Date of the last revision of this leaflet: November 2023

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

Online doctors for FORTASEC 2 mg HARD CAPSULES

Discuss questions about FORTASEC 2 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (5)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
0.0 (0)
Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (1061)
Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80
5.0 (184)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50
0.0 (0)
Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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€55
0.0 (0)
Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

Camera Book a video appointment
€60

Frequently Asked Questions

Is a prescription required for FORTASEC 2 mg HARD CAPSULES?
FORTASEC 2 mg HARD CAPSULES does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FORTASEC 2 mg HARD CAPSULES?
The active ingredient in FORTASEC 2 mg HARD CAPSULES is loperamide. This information helps identify medicines with the same composition but different brand names.
Who manufactures FORTASEC 2 mg HARD CAPSULES?
FORTASEC 2 mg HARD CAPSULES is manufactured by Jntl Consumer Health (Spain) S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FORTASEC 2 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FORTASEC 2 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FORTASEC 2 mg HARD CAPSULES?
Other medicines with the same active substance (loperamide) include ABECLIN 2 mg TABLETS, DIARFIN 2 mg HARD CAPSULES, DIARFIN FLAS 2 mg ORAL LYOPHILIZED. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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