Fortasec Plus 2 mg/125 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Fortasec Plus 2 mg/125 mg tablets
Loperamide hydrochloride / Simethicone
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You must consult a doctor if your condition worsens or if you do not improve within 2 days.
Leaflet contents:
- What Fortasec Plus is and what it is used for
- What you need to know before taking Fortasec Plus
- How to take Fortasec Plus
- Possible adverse effects
- How to store Fortasec Plus
Pack contents and other information
1. What Fortasec Plus is and what it is used for
The tablets contain two active substances:
- Loperamide hydrochloride, which helps reduce diarrhoea by decreasing intestinal activity. It also helps increase the absorption of water and salts from the intestine.
- Simeticone, which breaks up trapped air in the intestine, relieving cramps, bloating and gas.
Fortasec Plus is used in adults and adolescents aged 12 years and older for the treatment of diarrhoea when associated with abdominal cramps, bloating and gas.
2. What you need to know before taking Fortasec Plus
Do not take Fortasec Plus:
- In children under 12 years of age
- If you are allergic to loperamide hydrochloride, simethicone, or 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 suffer from intestinal inflammation such as ulcerative colitis.
- If you have severe diarrhea following antibiotic treatment.
- If you are constipated or experience abdominal bloating.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Fortasec Plus.
- Fortasec Plus only treats the symptoms of diarrhea. In some cases, the underlying cause of diarrhea may require specific treatment. If symptoms persist or worsen, consult your doctor. If you have severe diarrhea, your body loses more fluids, sugars, and salts than normal. You will need to replenish fluids by drinking more than usual. Ask your pharmacist about rehydration solutions to restore sugars and salts.
- If you have AIDS and experience abdominal swelling, stop taking the tablets immediately and consult your doctor.
- If you have liver disease, consult your doctor before taking the tablets.
Some adverse reactions may be more troublesome.
Do not use this medicine for any purpose other than that specified (see section 1), and never exceed the recommended dose (see section 3). Serious heart problems (symptoms include rapid or irregular heartbeat) have been reported in patients who took excessive amounts of loperamide, one of the active substances in Fortasec Plus.
In acute diarrhea, symptoms usually resolve within two days. If symptoms persist beyond this period, stop treatment and consult your doctor.
Important information about some ingredients of Fortasec Plus:
Each Fortasec Plus tablet contains less than 0.026 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease, or if you are pregnant or breastfeeding. Large amounts of benzyl alcohol may accumulate in your body and cause side effects (called "metabolic acidosis").
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".
This medicine contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of alcohol in this medicine will not produce any noticeable effect.
This medicine contains maltodextrin, which includes glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Children
Children under 12 years of age must not take Fortasec Plus.
Taking Fortasec Plus with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including:
- Quinidine (used to treat abnormal heart rhythm or malaria)
- Itraconazole or ketoconazole (antifungals)
- Gemfibrozil (used to treat high cholesterol)
- Ritonavir (used to treat HIV and AIDS infection)
- Desmopressin (used to control thirst and urine production in patients with diabetes insipidus)
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription, as Fortasec Plus tablets may interact with them.
Pregnancy and breastfeeding
Pregnancy: If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Breastfeeding: Fortasec Plus is not recommended during breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines:
This medicine may cause fatigue, dizziness, or drowsiness. If affected, do not drive or operate machinery.
3. How to take Fortasec Plus
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your pharmacist. If in doubt, consult your pharmacist.
- Swallow the correct number of whole tablets with a glass of water
- Use only by oral route
- Do not take more than the prescribed dose
Use in adults over 18 years of age
Begin treatment by taking 2 tablets, followed by 1 tablet after each diarrheal stool (bowel movement). Do not take more than 4 tablets per day. If your symptoms persist after 2 days, stop treatment and consult your doctor.
Use in children and adolescents between 12 and 18 years of age
Begin treatment by taking 1 tablet, followed by 1 tablet after each diarrheal stool (bowel movement). Do not take more than 4 tablets per day. If your symptoms persist after 2 days, stop treatment and consult your doctor.
Use in children under 12 years of age
Do not administer the tablets to children under 12 years of age.
If you take more Fortasec Plus than you should
If you have taken too much Fortasec Plus, contact a doctor or hospital as soon as possible for assistance. Symptoms may include: increased heart rate, irregular heartbeat, disturbances in cardiac rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Children react more severely to high doses of Fortasec Plus than adults. If a child takes an excessive amount or shows any of the above symptoms, call a doctor immediately.
If you have taken too many tablets, consult your doctor or go immediately to a medical facility or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.
If you forget to take Fortasec Plus
Take 1 tablet after the next diarrheal stool (bowel movement). Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
If you experience any of these effects, stop taking the medicine and consult your doctor immediately.
Allergic reactions include swelling of the face, tongue and throat, difficulty swallowing, unexplained wheezing, breathing difficulty, usually accompanied by a skin rash or urticaria.
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 effects, stop taking the medicine and speak to your doctor.
- Difficulty swallowing water
- Severe abdominal pain, abdominal bulging or swelling, or fever that may be due to intestinal blockage or distension
- Severe constipation
Other possible adverse effects include:
Frequent adverse effects (affects less than 1 in 10 but more than 1 in 100 people):
- Headache
- Feeling sick
- Change in the taste of certain things
Uncommon adverse effects (affects less than 1 in 100 but more than 1 in 1,000 people):
- Drowsiness
- Dizziness
- Weakness
- Constipation
- Vomiting
- Indigestion
- Flatulence
- Dry mouth
- Rash
Rare adverse effects (affects less than 1 in 1,000 but more than 1 in 10,000 people):
- Loss or reduction of consciousness
- Excessive constriction of the pupil of the eye
- Skin rash, which may lead to the development of severe blisters or skin peeling
- Urticaria
- Itching
- Fatigue
- Muscle tension
- Incoordinated movements
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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of FORTASEC PLUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fortasec plus:
-
The active substances are: loperamide hydrochloride (2 mg per tablet) and simethicone (expressed as 125 mg of dimethicone per tablet).
-
The other components are: calcium hydrogen phosphate, microcrystalline cellulose, potassium acesulfame, artificial vanilla flavour (containing propylene glycol, maltodextrin, ethanol and benzyl alcohol), sodium carboxymethylstarch (type A) and stearic acid.
Appearance of the product and contents of the pack:
The tablets are white, capsule-shaped, engraved with "IMO" on one side and a line between "2" and "125" on the other side.
Each pack contains 6, 8, 10, 12, 15, 16, 18 or 20 tablets in blister strips.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder:
JNTL Consumer Health (Spain), S.L.
C/ Vía de los Poblados 1, Edificio E, planta 3
28033-MADRID
Manufacturer:
JNTL Consumer Health (France) SAS Domaine de Maigremont
27100 Val de Reuil France
or
Janssen-Cilag S.P.A, Via C. Janssen. Borgo San Michele, Latina. 04100 ITALY
or Kenvue Belgium NV, Michel De Braeystraat 52, Antwerpen, 2000, Belgium.
or Johnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany
This medicinal product is authorised in the following EU countries under the following names:
Belgium: Imodium Duo 2mg/125mg Tabletten
Bulgaria: Imodium Plus 2 mg/125 mg Caplets
Cyprus: Imodium Plus
Czech Republic: Imodium Plus
Denmark: Imodium Plus
Finland: Imodium Plus Tabletit
France: Imodiumduo comprimé
Germany: Imodium Akut Duo
Greece: Imodium Plus
Hungary: Imodium Plus 2 mg/125 mg tabletta
Ireland: Imodium Plus 2 mg/125 mg tablet
Luxembourg: Imodium Duo 2 mg/125 mg Comprimés
Netherlands: Imodium Duo 2 mg/125 mg tabletten
Norway: Imodium Comp
Portugal: Imodium Plus 2 mg/125 mg Comprimidos
Romania: Imodium Plus 2 mg/125 mg comprimate
Slovakia: Imodium Plus
Spain: Fortasec plus 2 mg/125 mg Comprimidos
Sweden: Imodium Plus 2 mg/125 mg tablett
United Kingdom (Northern Ireland): Imodium Dual Action Relief Tablets
This patient information leaflet was last reviewed in April 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es