FORTASEC 2 mg HARD CAPSULES

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.

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:

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

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