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Imodium Duo 2/125 Mg 12 Tablets

The tablets contain two active substances:

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

Fortasec Plus is used in adults and adolescents 12 years and older for the treatment of diarrhea when associated with stomach cramps, swelling and gas.

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€10.04 (tax incl.) €11.15
Reference:
659414
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Description

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

 

The tablets contain two active ingredients:

 

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

 

Fortasec Plus is used in adults and adolescents from 12 years of age to treat diarrhea when it is associated with stomach cramps, bloating and gas.

2. What you need to know before you take 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 a high fever (above 38ºC) or blood in your stools.
  • If you suffer from inflammation of the intestine such as ulcerative colitis.
  • If you have severe diarrhea after taking antibiotics.
  • If you are constipated or if you have a bloated stomach.

 

Warnings and precautions:

Check with your doctor or pharmacist before taking 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 usual you will need to replace fluids by drinking more than usual. Ask your pharmacist about preparations to replace sugars and salts
  • If you have AIDS and your stomach swells, stop taking the tablets immediately and consult your doctor.
  • If you have liver disease, check with your doctor before taking the tablets.

 

Some of the adverse reactions can be more bothersome.

Do not take this medicine for a use other than that indicated (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (the symptoms of which include fast or irregular heartbeats) have been reported in patients who have taken too much loperamide, the active substance in Fortasec plus.

 

In acute diarrhea, symptoms usually disappear within two days. If symptoms persist after this period, stop treatment and consult your doctor.

 

Children

Children under 12 years of age should not take Fortasec plus.

Using Fortasec plus with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might 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 infection and AIDS)

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

 

Tell your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription because Fortasec plus tablets may interact with them.

 

Pregnancy and breastfeeding

Pregnancy: If you are pregnant, think you might be or are planning to become pregnant, consult your doctor before taking this medicine.

Lactation: Fortasec plus is not recommended if you are breastfeeding. Small amounts of the medicine may pass into breast milk.

 

Driving and using machines:

This medicine may make you feel tired, dizzy, or sleepy. If you are affected, do not drive or use machinery.

 

3. How to take Fortasec Plus

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your pharmacist. If in doubt, ask your pharmacist.

  • Swallow the correct number of tablets whole 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 a 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 a day. If your symptoms persist after 2 days, stop treatment and consult your doctor.

 

Use in children under 12 years

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 help. Symptoms may include: increased heart rate, irregular heartbeat, abnormal heartbeat (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 exhibits 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 Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine 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 a forgotten dose.

 

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

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone gets them.

 

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

Allergic reactions include swelling of the face, tongue and throat, difficulty swallowing, unexplained wheezing, shortness of breath which is often accompanied by a skin rash or hives.

 

If you experience any of the effects, stop taking the medicine and talk to your doctor.

  • Difficulty swallowing water
  • Severe abdominal pain, abdominal lump or swelling, or fever that may be due to blockage or distention of the intestine
  • Severe constipation

 

Other effects that can occur include:

Common side effects (less than 1 in 10 but more than 1 in 100 people get 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
  • Eruption

 

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

  • Loss or decrease of consciousness
  • Excessive constriction of the pupil of the eye
  • Skin rash, which can lead to severe blistering or peeling
  • Urticaria
  • Itching
  • Fatigue

 

 

 

Communication of adverse effects

 

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

of side effects not listed in this leaflet. You can also report them directly to

through the Spanish Pharmacovigilance System for Medicines for Human Use:

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

provide more information on the safety of this medicine.

5. How to store FORTASEC PLUS

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

 

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration 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. Deposit the containers and medicines you do not need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine and containers. This way you will help to protect the environment.

 

6. Package contents and additional information

 

Composition of Fortasec plus:

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

 

  • The other ingredients are: hydrogenated calcium phosphate, microcrystalline cellulose, acesulfame potassium, artificial vanilla flavor (includes propylene glycol, maltodextrin and benzyl alcohol), sodium carboxymethyl starch (type A) and stearic acid.

 

Appearance of the product and contents of the container:

The tablets are white capsule-shaped, engraved with " IMO " on one side, the other side is engraved with a line between "2" and "125".

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

Only some pack sizes may be marketed.

 

Marketing authorization holder:

Johnson & Johnson SA

Walk of the Twelve Stars 5-7

28042 Madrid

Spain

 

Responsible for manufacturing:

Janssen-Cilag - Val de Reuil, Domaine de Maigremont, Val de Reuil, 27100, France

or


Janssen-Cilag SPA, Via C. Janssen. Borgo San Michele, Latina. 04100 ITALY

or

Johnson & Johnson Consumer NV / SA, Antwerpseweg 15-17, B- 2340 Beerse

or

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

This medicine is authorized 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 compressed

Germany: Imodium Akut N 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 Tabletten

Netherlands: Imodium Duo 2 mg / 125, tabletten

Norway: Imodium Comp

Portugal: Imodium Plus 2 mg / 125 mg Tablets

Romania : Imodium Plus 2   mg / 125   mg compress

Slovakia : Imodium Plus

Spain: Fortasec plus 2 mg / 125 mg Tablets

Sweden: Imodium Plus 2 mg / 125 mg tablett

UK: Imodium Plus 2mg / 125mg caplets

 

This leaflet was revised in November 2018.

 

Detailed and updated information on this drug is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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Product Details
659414
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