


Ask a doctor about a prescription for FORTASEC PLUS 2 mg / 125 mg TABLETS
Fortasec Plus 2 mg/ 125 mg tablets
Loperamide hydrochloride / Simethicone
Read the entire leaflet carefully before starting to use this medication because it contains important information for you
Follow the administration instructions of the medication contained in this leaflet or as indicated by your pharmacist.
Contents of the leaflet:
Package contents and additional information
The tablets contain two active ingredients:
Fortasec Plus is used in adults and adolescents from 12 years old for the treatment of diarrhea when associated with stomach cramps, bloating, and gas.
Do not take Fortasec plus:
Warnings and precautions:
Consult your doctor or pharmacist before starting to take Fortasec plus
Some of the adverse reactions may be more bothersome.
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). Serious heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide, one of the active ingredients of Fortasec plus.
In acute diarrhea, the symptoms usually disappear within two days. If the symptoms persist after 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 any liver or kidney disease, or if you are pregnant or breastfeeding. Large amounts of benzyl alcohol can accumulate in your body and cause side effects (called "metabolic acidosis").
This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".
This medication contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of alcohol in this medication will not have any noticeable effect.
This medication contains maltodextrin, which contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Children
Children under 12 years old should not take Fortasec plus.
Use of Fortasec plus with other medications
Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including:
Tell your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription, because 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 medication.
Breastfeeding: Fortasec plus is not recommended if you are breastfeeding. Small amounts of the medication may pass into breast milk.
Driving and using machines:
This medication may make you feel tired, dizzy, or drowsy. If you are affected, do not drive or use machinery.
Follow the administration instructions of the medication contained in this leaflet or as indicated by your pharmacist. In case of doubt, consult your pharmacist.
Use in adults over 18 years
Start 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
Start 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
Do not give the tablets to children under 12 years old.
If you take more Fortasec plus than you should
If you have taken too much Fortasec plus, contact a doctor or hospital immediately for help. The symptoms may include: increased heart rate, irregular heartbeats, cardiac arrhythmias (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Children react more severely to high amounts 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 to a medical center or call the Toxicology Information Service, Phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Fortasec plus
Take one tablet after the next diarrheal stool (bowel movement). Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
Like all medications, this medication can have side effects, although not everyone will experience them.
If you experience any of these effects, stop taking the medication and consult your doctor immediately.
Allergic reactions include swelling of the face, tongue, and throat, difficulty swallowing, unexplained wheezing, shortness of breath, which is usually accompanied by a skin rash or hives.
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 acute pancreatitis. If you experience any of these effects, stop taking the medication and talk to your doctor
Other effects that may occur include:
Common side effects (less than 1 in 10 but more than 1 in 100 people experience them)
Uncommon side effects (less than 1 in 100 but more than 1 in 1000 people experience them):
Rare side effects (less than 1 in 1000 but more than 1 in 10,000 people experience them):
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
Composition of Fortasec plus:
Appearance of the product and package contents:
The tablets are white, capsule-shaped, and engraved with "IMO" on one side, and the other side is engraved with a line between "2" and "125".
Each package contains 6, 8, 10, 12, 15, 16, 18, or 20 tablets in blister packs.
Only some package sizes may be marketed.
Marketing authorization 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 ITALIA
or Johnson & Johnson Consumer, Michel De Braeystraat 52, Antwerpen, 2000, Belgium or Johnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany
This medication is authorized in the following EU countries under the following names:
Belgium:Imodium Duo 2mg/125mg Tablets
Bulgaria: Imodium Plus 2 mg/125 mg Caplets
Cyprus: Imodium Plus
Czech Republic: Imodium Plus
Denmark:Imodium Plus
Finland:Imodium Plus Tablets
France:Imodium Duo Tablets
Germany:Imodium Akut Duo
Greece:Imodium Plus
Hungary:Imodium Plus 2 mg/125 mg tablets
Ireland:Imodium Plus 2 mg/125 mg tablets
Luxembourg:Imodium Duo 2 mg/125 mg Tablets
Netherlands:Imodium Duo 2 mg/125 mg tablets
Norway:Imodium Comp
Portugal:Imodium Plus 2 mg/125 mg Tablets
Romania: Imodium Plus 2 mg/125 mg tablets
Slovakia: Imodium Plus
Spain:Fortasec plus 2 mg/125 mg tablets
Sweden:Imodium Plus 2 mg/125 mg tablets
United Kingdom (Northern Ireland) :Imodium Dual Action Relief Tablets
This leaflet was revised in April 2023
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FORTASEC PLUS 2 mg / 125 mg TABLETS – subject to medical assessment and local rules.