FORTASEC PLUS 2 mg / 125 mg TABLETS

Introduction

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.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the leaflet:

1. What is Fortasec plus and what is it used for
2. What you need to know before taking Fortasec plus
3. How to take Fortasec plus
4. Possible side effects
5. Storage of Fortasec plus

Package contents and additional information

1. What is Fortasec Plus and what is it used for

The tablets contain two active ingredients:

• Loperamide hydrochloride, helps reduce diarrhea by decreasing intestinal activity. It also helps absorb more water and salts from the intestine.
• Simethicone, breaks down trapped air in the intestine, which causes cramps and bloating.

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.

2. What you need to know before starting to take Fortasec Plus

Do not take Fortasec plus:

• In children under 12 years old
• If you are allergic to loperamide hydrochloride, simethicone, or any of the other components of this medication included in section 6.
• If you have a high fever (above 38°C) or blood in your stool.
• If you suffer from intestinal inflammation such as ulcerative colitis.
• If you have severe diarrhea after taking antibiotics.
• If you are constipated or if you experience stomach bloating.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Fortasec plus

• Fortasec plus only treats the symptoms of diarrhea. In some cases, the cause of the diarrhea may require treatment. If the symptoms persist or worsen, consult your doctor. If you have severe diarrhea, your body loses more fluids, sugars, and salts than normal, and you will need to replenish them by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts.
• If you have AIDS and your stomach becomes bloated, stop taking the tablets immediately and consult your doctor.
• If you have liver disease, consult your doctor before taking the tablets.

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:

• 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)
• Desmopressin (used to control thirst and urine production in patients with diabetes insipidus)

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.

3. How to take Fortasec Plus

Follow the administration instructions of the medication contained in this leaflet or as indicated by your pharmacist. In case of doubt, consult your pharmacist.

• Swallow the correct number of whole tablets with a glass of water
• Use only orally
• Do not take more than the established dose

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.

4. Possible side effects

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

• Difficulty swallowing water

• Severe abdominal pain, abdominal distension or bloating, or fever that may be due to intestinal blockage or obstruction
• Severe constipation

Other effects that may occur include:

Common side effects (less than 1 in 10 but more than 1 in 100 people experience them)

• Headache
• Feeling sick
• Change in the taste of some things

Uncommon side effects (less than 1 in 100 but more than 1 in 1000 people experience them):

• Drowsiness
• Dizziness
• Weakness
• Constipation
• Vomiting
• Indigestion
• Flatulence
• Dry mouth
• Rash

Rare side effects (less than 1 in 1000 but more than 1 in 10,000 people experience them):

• Loss or decreased consciousness
• Excessive contraction of the pupil
• Skin rash, which can lead to severe blisters or peeling
• Hives
• Itching
• Fatigue
• Muscle tension
• Uncoordinated movements

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

5. Storage of FORTASEC PLUS

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.

6. Package contents and additional information

Composition of Fortasec plus:

• The active ingredients are: loperamide hydrochloride (2 mg per tablet) and simethicone (measured as 125 mg of dimethicone per tablet).

• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, potassium acesulfame, artificial vanilla flavor (including propylene glycol, maltodextrin, ethanol, and benzyl alcohol), sodium carboxymethylcellulose (type A), and stearic acid.

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