Fortasec Plus 2 mg/ 125 mg Tablets

Loperamide Hydrochloride/ Simethicone

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any 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 you worsen or do not improve after 2 days.

Contents of the package and additional information

The tablets contain two active ingredients:

• Loperamide hydrochloride, helps to reduce diarrhea by decreasing intestinal activity. It also helps to 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 aged 12 years and above for the treatment of diarrhea associated with stomach cramps, bloating, and gas.

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 high fever (above 38°C) or blood in 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 diarrhea may require 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 the fluids by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts.
• If you have AIDS and your stomach swells, stop taking the tablets immediately and consult your doctor
• If you have any 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). Severe 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 principles of Fortasec plus.

In acute diarrhea, symptoms usually disappear in two days. If symptoms persist after this period, discontinue 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 may accumulate in your body and cause secondary 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 contained in this medication will not have any perceptible effect.

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

Children

Children under 12 years old should not take Fortasec plus.

Use of Fortasec plus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including:

• Quinidine (used for the treatment of abnormal heart rhythm or malaria)

• Itraconazole or ketoconazole (antifungals)

• Gemfibrozil (used for the treatment of high cholesterol)

• Ritonavir (used for the treatment of HIV and AIDS infection)

• Desmopressin (used for the control of thirst and urine production in patients with diabetes insipidus)

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired 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 operating machinery:

This medication may make you feel drowsy, dizzy, or tired. If you are affected, do not drive or operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those 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 by oral route
• 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 (intestinal movement). Do not take more than 4 tablets per day. If your symptoms persist after 2 days, discontinue 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 (intestinal movement). Do not take more than 4 tablets per day. If your symptoms persist after 2 days, discontinue treatment and consult your doctor.

Use in children under 12 years

Do not administer tablets to children under 12 years.

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 to seek help. Symptoms may include: increased heart rate, irregular heartbeats, heart rhythm disturbances (these symptoms may 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 presents 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 center or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Fortasec plus

Take a tablet after the next diarrheal stool (intestinal movement). Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of these side effects, stop taking the medicine and consult your doctor immediately.

Allergic reactions include swelling of the face, tongue, and throat, difficulty swallowing, unexplained shortness of breath, shortness of breath often accompanied by skin rash or urticaria.

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 (pancreatitis).Ifyou experience any of these side effects, stop taking the medicine and speak with your doctor

• Difficulty swallowing water

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

Other side effects that may occur include:

Frequent 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.

Rare 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 decrease of consciousness
• Excessive contraction of the pupil of the eye
• Rash on the skin, which may lead to the appearance of severe blisters or peeling
• Urticaria
• Itching
• Fatigue
• Muscle tension
• Uncoordinated movements

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it is

side effects that do not appear in this prospectus. You can also report them directly to

through the Spanish System for the Pharmacovigilance of Medicines for Human Use:

www.notificaRAM.es. By reporting side effects, you can contribute to

providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drain or in the trash.Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy.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 plus:

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

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

Appearance of the productand contents of the packaging:

The tablets are white in capsule shape, engraved with “IMO” on one of their faces, the other face is engraved with a line between “2” and “125”.

Each package contains 6, 8, 10, 12, 15, 16, 18 or 20 tablets in blister strips.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

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

28033-MADRID

Responsible for manufacturing:

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, Belgica.
or

Johnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany

This medicine is authorized in the following EU countries under the following denominations:

Belgium:Imodium Duo 2mg/125mg Tablets

Bulgaria:Imodium Plus 2mg/125mg Caplets

Cyprus:Imodium Plus

Czech Republic:Imodium Plus

Denmark:Imodium Plus

Finland:Imodium Plus Tablets

France:Imodiumduo Tablet

Germany:Imodium Akut Duo

Greece:Imodium Plus

Hungary:Imodium Plus 2 mg/125 mg tablet

Ireland:Imodium Plus 2 mg/125 mg tablet

Luxembourg:Imodium Duo 2 mg/125 mg Tablets

Netherlands:Imodium Duo 2 mg/125, tablets

Norway:Imodium Comp

Portugal:Imodium Plus 2 mg/125 mg Tablets

Romania:Imodium Plus 2mg/125mg tablets

Slovakia:Imodium Plus

Spain:Fortasec plus 2 mg/125 mg Tablets

Sweden:Imodium Plus 2 mg/125 mg tablet

United Kingdom (Northern Ireland) :ImodiumDual Action Relief Tablets

This leaflet has been reviewed in April 2023

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