Fortasec 2 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

FORTASEC 2 mg Hard capsules

Loperamide hydrochloride

Read the entire 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 as directed by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You must consult a doctor if your condition worsens or if you do not improve after 2 days.

Leaflet contents:

1. What FORTASEC 2 mg Hard capsules is and what it is 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 adverse effects.

5. How to store FORTASEC 2 mg Hard capsules.

6. Contents of the pack and other information.

1. What FORTASEC 2 mg Hard Capsules is and what it is used for

It is an antidiarrheal medicine that reduces intestinal movements and secretions, thereby decreasing the frequency of liquid stools.

It is indicated for the symptomatic treatment of acute nonspecific (occasional) diarrhoea in adults and children aged 12 years and older.

You should consult a doctor if symptoms worsen or do 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 to any of the other ingredients of this medicine (listed in section 6)
• If you have high fever (above 38°C) or blood in your stools
• If you have ulcerative colitis (inflammation of the intestine)
• If you have severe diarrhoea following antibiotic treatment
• If your diarrhoea is due to an infection caused by organisms such as Salmonella, Shigella, and Campylobacter
• Treatment must be stopped immediately and you should consult your doctor if constipation, abdominal distension (bloating), or ileus (lack of intestinal movement) occurs.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take FORTASEC 2 mg Hard Capsules
• If you have severe diarrhoea, your body loses more fluids, sugars, and salts than normal. You will need to replace fluids by drinking more than usual. Ask your pharmacist about rehydration preparations to replace sugars and salts.
• Treatment with this medicine is only symptomatic, so the underlying cause of the diarrhoea should also be treated.
• If you have AIDS and your stomach becomes swollen, stop taking this medicine immediately and consult your doctor.
• If you have liver disease, consult your doctor before taking this medicine, as central nervous system toxicity may occur.
• If you are taking narcotic-type painkillers, consult your doctor or pharmacist before taking this medicine, as it may interact with them.

Do not take this medicine for any use other than that indicated (see section 1), and never take more than the recommended dose (see section 3). Serious heart problems (including symptoms such as rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide.

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

Patients with diarrhoea should drink plenty of fluids to prevent dehydration, which may manifest as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. 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

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

It is considered especially important if you are taking medicines containing:

1. Ritonavir, saquinavir (used to treat HIV)
2. Quinidine (used to treat abnormal heart rhythms)
3. Oral desmopressin (used to treat central diabetes insipidus and nocturnal urinary incontinence in children)
4. Itraconazole or ketoconazole (used to treat fungal infections)
5. Gemfibrozil (used to lower cholesterol)
6. St. John’s wort (used to improve mood)
7. Valerian (used to treat mild anxiety)
8. Opioid analgesics (used to treat severe pain), as this may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or reduced consciousness)
9. Broad-spectrum antibiotics, as FORTASEC may worsen or prolong antibiotic-associated diarrhoea and increase blood levels of loperamide.

Pregnancy and breastfeeding

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

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

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

Driving and using machines

You may drive and operate tools or machinery unless you experience fatigue, dizziness, or drowsiness. Do not drive or use machines if these symptoms occur.

FORTASEC 2 mg Hard Capsules contains lactose

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

3. How to take FORTASEC 2 mg Hard Capsules

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults

2 capsules (4 mg) as the initial dose, followed by 1 capsule (2 mg) after each diarrheal bowel movement.

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

Children over 12 years

1 capsule (2 mg) as the initial dose, followed by 1 capsule (2 mg) after each diarrheal bowel movement.

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

Take the capsules with a full glass of water.

Patients with hepatic disease: Should consult their doctor.

Elderly patients and patients with renal disease

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

Use in children and adolescents

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

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

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

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 FORTASEC

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

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

4. Possible adverse effects

Like all medicines, FORTASEC may cause adverse effects, although not everyone experiences them.

Frequency not known (cannot be estimated from available data)

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

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

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

• Swelling of the face, lips, tongue or throat which may cause difficulty swallowing or breathing (angioedema)
• allergic reactions (including anaphylactic shock)
• fatigue
• decreased amount of urine
• loss or reduction of consciousness
• abnormal coordination
• increased muscle tension (hypertonia)
• stupor
• constriction of the pupil (miosis)
• loss of intestinal motility (ileus including paralytic ileus)
• pruritus or urticaria
• Somnolence
• abnormal dilation of the colon (megacolon)
• Bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the carton after “Expiry”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of FORTASEC 2 mg Hard Capsules

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

The other components (excipients) are: Lactose, talc, magnesium stearate and maize starch. Gelatin, yellow iron oxide (E172), titanium dioxide (E171), indigotine (E132), erythrosine (E127) and black iron oxide (E172).

Appearance of the product and contents of the container

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

Available in packs 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.

Vía 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 most recent review of this leaflet: November 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es