Fortasec Flas 2 mg oral lyophilisate
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Fortasec Flas 2 mg lyophilisate for oral use is and what it is used for
- 2. What you need to know before taking Fortasec Flas 2 mg oral lyophilisate
- 3. How to take Fortasec Flas 2 mg oral lyophilisate
- 4. Possible adverse effects
- 5. Storage of Fortasec Flas 2 mg oral lyophilisate
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Fortasec Flas 2 mg oral lyophilisate
Loperamide hydrochloride
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use of this medicine as described 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.
- You should consult a doctor if you worsen or do not improve within 2 days.
Contents of the leaflet:
- What Fortasec Flas 2 mg oral lyophilisate is and what it is used for.
- What you need to know before taking Fortasec Flas 2 mg oral lyophilisate.
- How to take Fortasec Flas 2 mg oral lyophilisate.
- Possible side effects.
- How to store Fortasec Flas 2 mg oral lyophilisate.
- Contents of the pack and other information.
1. What Fortasec Flas 2 mg lyophilisate for oral use 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) diarrhea in adults and children over 12 years of age.
You should consult a doctor if symptoms worsen or do not improve after 2 days.
2. What you need to know before taking Fortasec Flas 2 mg oral lyophilisate
Do not take Fortasec Flas 2 mg oral lyophilisate
- Children under 12 years of age
- If you are allergic (hypersensitive) to loperamide hydrochloride or to any of the other components of this medicine (listed in section 6)
- If you have high fever (above 38°C) or blood in stools
- If you suffer from ulcerative colitis (inflammation of the intestine)
- If you have severe diarrhoea after taking antibiotics
- If you have diarrhoea 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 (absence of intestinal movements) occur.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Fortasec Flas 2 mg.
If you have severe diarrhoea, your body loses more fluids, sugars, and salts than normal, and you will need to replenish fluids by drinking more than usual. Ask your pharmacist about rehydration preparations to replace sugars and salts.
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Treatment with this medicine is only symptomatic, so diarrhoea should be treated based on its underlying cause.
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If you have AIDS and your stomach swells, stop taking this medicine immediately and consult your doctor.
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If you have any liver disease, consult your doctor before taking this medicine, as it could lead to toxicity in the central nervous system.
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If you are taking narcotic-type painkillers, consult your doctor or pharmacist before taking this medicine, as it may interact with them.
If there is no improvement within 48 hours, or if fever, constipation, or other symptoms appear, stop treatment and consult your doctor.
Patients with diarrhoea should drink plenty of fluids to avoid dehydration, which is characterized by dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in children and the elderly.
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 (with symptoms including rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide, the active ingredient in Fortasec Flas.
Children and adolescents
Do not use in children or adolescents under 12 years of age.
Taking Fortasec Flas with other medicines
Tell 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:
- Ritonavir, saquinavir (used to treat HIV).
- Quinidine (used to treat abnormal heart rhythms).
- Oral desmopressin (used to treat central diabetes insipidus and nocturnal urinary incontinence in children).
- Itraconazole or ketoconazole (used to treat fungal infections).
- Gemfibrozil (used to lower cholesterol).
- St. John's wort (used to improve mood).
- Valerian (used to treat mild anxiety).
- Opioid analgesics (used to treat severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or reduced consciousness).
- Broad-spectrum antibiotics, as Fortasec may worsen or prolong antibiotic-induced 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 Fortasec Flas unless prescribed by a doctor, as there is no experience with its use in pregnant women.
Do not take Fortasec Flas if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
You may drive and operate machinery unless you experience fatigue, dizziness, or drowsiness. Do not drive in such cases.
Warnings about excipients
Fortasec Flas contains aspartame (E-951)
This medicine contains 0.750 mg of aspartame per oral lyophilisate.
Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Fortasec Flas contains sodium:
This medicine contains less than 23 mg of sodium (1 mmol) per oral lyophilisate; therefore, it is essentially “sodium-free”.
Fortasec Flas contains propylene glycol (E-1520)
This medicine contains 0.00003 mg of propylene glycol (E-1520) in each oral lyophilisate.
Fortasec Flas contains benzyl alcohol
This medicine contains 0.00066 mg of benzyl alcohol in each oral lyophilisate. 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 medicine contains corn maltodextrin, which contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Fortasec Flas contains traces of sulphites
This medicine may cause severe allergic reactions and bronchospasm because the mint flavour contains traces of sulphites.
3. How to take Fortasec Flas 2 mg oral lyophilisate
Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage:
Adults
2 oral lyophilisates (4 mg) as an initial dose, followed by 1 lyophilisate (2 mg) after each diarrheal bowel movement.
The maximum daily dosage for adults is 8 lyophilisates (16 mg).
Children over 12 years
1 oral lyophilisate (2 mg) as an initial dose, followed by 1 oral lyophilisate (2 mg) after each diarrheal bowel movement.
In children, the maximum daily dosage should be related to body weight:
Child's weight | Maximum number of lyophilisates per day |
From 27 kg | Maximum 4 lyophilisates |
From 34 kg | Maximum 5 lyophilisates |
From 40 kg | Maximum 6 lyophilisates |
From 47 kg | Maximum 7 lyophilisates |
Patients with liver disease: Should consult their doctor.
Advanced age and patients with kidney disease
Follow the same indications described 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 Flas 2 mg oral lyophilisate than you should
Taking too many oral lyophilisates 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 medication and 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, FortasecFlas may cause adverse effects, although not everyone experiences them.
Frequency not known (cannot be estimated from the 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 using the medicine and seek immediate medical help.
Very rare adverse reactions (may affect up to 1 in 10,000 patients):
- swelling of the face, lips, tongue or throat which may cause difficulty swallowing or breathing (angioedema)
- allergic reactions (including anaphylactic shock)
- Glosodimia
- fatigue
- decreased amount of urine
- loss or reduction of consciousness
- abnormal coordination
- increased muscle tension (hypertonia)
- stupor
- pupil contraction (miosis)
- loss of intestinal mobility (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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fortasec Flas 2 mg oral lyophilisate
This medicine does not require any special storage temperature. Keep it in the original packaging to protect it from moisture.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point located at the pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fortasec Flas 2 mg oral lyophilisate
The active substance 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 flavour (containing corn maltodextrin (containing glucose), propylene glycol (E-1520), benzyl alcohol and traces of sulphites), and sodium hydrogen carbonate.
Appearance of the product and contents of the pack
Fortasec Flas are oral lyophilisates.
It is available in packs containing 6 and 12 oral lyophilisates.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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)
or
JNTL Consumer Health (France) S.A.S.
Domaine de Maigremont
Val de Reuil
- France
Date of the most recent review of this leaflet: March 2022
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