Fortasec Flas 2 mg lyophilized oral

Loperamide hydrochloride

Read this leaflet carefully before you start to take this medicine, because it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if it worsens or does not improve after 2 days.

It is an anti-diarrheal medication that reduces intestinal movementsand secretions, resulting in a decrease in liquid stools..

It is indicated for the symptomatic treatment of acute non-specific diarrhea (occasional) in adults and children over 12 years old.

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

Do not take Fortasec Flas 2 mg lyophilized oral

- Children under 12 years old

• If you are allergic (hypersensitivity) to loperamide hydrochloride or to any of the other components of this medication (including in section 6)
• If you have high fever (above 38°C) or blood in 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, Shigella, and Campylobacter
• Stop treatment immediately and consult your doctor if you experience constipation, abdominal distension (swelling) or ileus (absence of intestinal movements).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fortasec Flas 2 mg.

If you have severe diarrhea, your body loses more fluids, sugars, and salts than normal, you will need to replenish the fluids by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts.

• The treatment with this medication is only symptomatic, so diarrhea should be treated from its cause.
• If you have AIDS and your stomach swells, stop taking this medication immediately and consult your doctor

• If you have any liver disease, consult your doctor before taking this medication, as it may cause central nervous system toxicity.
• If you are taking any narcotic analgesic, consult your doctor or pharmacist before taking this medication, as it may interact with them.

If you do not observe improvement in 48 hours or appear fever, constipation, or other symptoms, interrupt treatment and consult your doctor.

Patients with diarrhea should drink plenty of fluids to avoid dehydration, which manifests as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in children and the elderly.

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

Children and adolescents

Do not use in children or adolescents under 12 years old.

Use of Fortasec Flas with other medications

Inform your doctor or pharmacist that you are using or have used recently or may have to use any other medication.

1. It is especially important if you are taking medications 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 states).
8. Valerian (used to treat mild anxiety).
9. Opioid analgesics (used to treat very 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 diarrhea caused by antibiotics and increase loperamide levels in the blood.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

Pregnant women should not take Fortasec Flas unless prescribed by a doctor, as there is no experience of its use in pregnant women.

Do not take Fortasec Flas if you are breastfeeding. Small amounts of the medication may pass into breast milk.

Driving and operating machinery

You can drive and operate machinery unless you feel drowsiness, dizziness, or somnolence. Do not drive in those cases.

Warnings about excipients

Fortasec Flas contains aspartame (E-951)

This medication contains 0.750mg of aspartame in each lyophilized.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Fortasec Flas contains sodium:

This medication contains less than 23 mg of sodium (1mmol) per oral lyophilized; it is essentially "sodium-free".

Fortasec Flas contains propylene glycol (E-1520)

This medication contains 0.00003 mg of propylene glycol (E-1520) in each oral lyophilized.

Fortasec Flas contains benzyl alcohol

This medication contains 0.00066 mg of benzyl alcohol in each oral lyophilized. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Fortasec Flas contains corn maltodextrin

This medication contains corn maltodextrin that contains glucose.If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Fortasec Flas contains traces of sulfites

This medication may cause severe allergic reactions and bronchospasm because the menthol aroma contains traces of sulfites.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults

2 oral lyophilizates (4 mg) as the initial dose followed by 1 lyophilizate (2 mg) after each diarrheal stool.

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

Children over 12 years old

1 oral lyophilizate (2 mg) as the initial dose followed by 1 oral lyophilizate (2 mg) after each diarrheal stool.

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

Patients with liver disease: Should consult their doctor.

Advanced age and patients with renal disease

Follow the same indications described for adults and children over 12 years old.

Use in children and adolescents

Children under 12 years old cannot take this medication. It is contraindicated.

If you take more Fortasec Flas 2 mg lyophilized oral than you should

Too many oral lyophilizates can cause abnormal coordination, stupor, pupil constriction, muscle tension increase, breathing difficulty (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 Toxicological Information Service, Telephone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Fortasec

Do not take a double dose to compensate for the missed doses.

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

Like all medications,FortasecFlasmay cause adverse effects, although not everyone will experience them.

Unknown frequency (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 acute pancreatitis.

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

Very Rare Adverse Reactions(may affect up to 1 in 10,000 patients):

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require any special temperature for conservation. Keep in the original packaging to protect it from humidity.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “Expiration Date”. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fortasec Flas 2 mg lyophilized oral

The active ingredient is loperamide 1.86 mg provided by 2 mg of loperamide hydrochloride.

The other components (excipients) are: gelatin, mannitol (E-421), aspartame (E-951), peppermint aroma(contains corn maltodextrin (contains glucose), propylene glycol (E-1520), benzyl alcohol, and traces of sulfites)and sodium hydrogen carbonate.

Appearance of the product and content of the packaging

Fortasec Flas are oral lyophilizates.

They are presented in packaging of 6 and 12 oral lyophilizates.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing

JANSSEN-CILAG S.P.A.

Vía C. Janssen

04010 Borgo S.Michele

Latina (Italy)

or

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

Domaine de Maigremont

Val de Reuil

27100. France

Last review date of this leaflet: March 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es