Over-the-counter medication

IMODIUM LiquiCaps BOX 12

Name: Imodium liquicaps 12 capsules
Brand: Johnson & Johnson
SKU: 3119
Price: 6.66 EUR
Availability: InStock

Brand : Johnson & Johnson

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Reference : 3400921801019

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Imodium liquicaps capsule is a drug indicated for the short-term treatment of acute passing diarrhea in adults and children over 15 years of age.

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IMODIUM LIQUICAPS BOX 12

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description

Imodium liquicaps capsule is a medication indicated for the short-term treatment of transient acute diarrhea in adults and children over 15 years of age. This treatment is a complement to dietary measures.

Acute transient diarrhea
It manifests as a sudden change in the frequency and consistency of stool.
In practice, we talk about diarrhea when there are more than 3 loose or liquid stools per day.
Other signs may be associated: nausea and / or vomiting, abdominal pain (cramps), even fever.
Be careful because acute transient diarrhea, especially if it is accompanied by vomiting, can lead to complications such as dehydration, especially in the elderly.

Composition

Loperamide hydrochloride: 2 mg for a soft capsule
Excipients:

Capsule: Propylene glycol monocaprylate, propylene glycol, purified water.
Capsule shell: Gelatin, 99% glycerol, propylene glycol, bright blue FCF (E133), soy lecithin, medium chain triglycerides.

User advice

Route of administration: Oral route

Reserved for adults and children over 15 years old.
Do not start 2 capsules in a single dose, i.e. 4 mg of loperamide.
If the diarrhea continues: after each unmolded bowel movement, take 1 additional capsule.
In all cases, never exceed 6 capsules per day, and never exceed 2 days of treatment.
Swallow the capsules with a glass of water.

Precautions for use

Contraindications :

If you suffer from a chronic disease of the intestine and the colon, in particular during the acute attacks of ulcerative colitis (inflammatory disease of the rectum and sometimes of the large intestine manifested by diarrhea with mucus and blood).
In case of allergy to one of the constituents of the capsule.
If you have a high fever (above 38 ° C) or if there is blood in the stool or vomiting.
If your diarrhea occurs after taking antibiotics.
If you are constipated or have abdominal swelling.
In children under 15 years of age.

Caution :

You must stop this treatment and consult your doctor quickly in the following cases: in case of fever, vomiting, in the presence of blood or mucus in the stool, in the absence of improvement after 2 days of treatment , in case of constipation or abdominal distension, but also in case of intense thirst, sensation of dry tongue. These last two symptoms show the onset of dehydration, i.e. significant loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration which can be done orally or intravenously.
Use this medicine only with caution: take the advice of your doctor in case of liver disease because medical monitoring during treatment is necessary.
Diarrhea causes loss of fluids and mineral salts. It is therefore necessary to rehydrate with abundant drinks, salty or sweet, in order to compensate for the loss of liquids due to diarrhea (drink at least 2 liters). It is also advisable to eat the time of diarrhea by removing raw vegetables, fruits, green vegetables, spicy dishes, dairy products as well as frozen foods or drinks and by favoring grilled meats, white rice.
If you are pregnant or breastfeeding, do not take this medicine without asking your doctor or pharmacist for advice. This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue this treatment. Breastfeeding is still possible with brief treatment with this drug.
Please note that this medicine sometimes causes discreet and transient drowsiness or dizziness which can be dangerous when driving vehicles and using certain machines.
Keep out of the reach and sight of children.
Do not use after the expiration date.
Do not store above 30 ° C.

Conditioning

Box of 12 soft capsules.

Summary of product characteristics (ANSM)

Warnings on drugs that treat digestive issues

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 31/05/2017

Name of the medicinal product

IMODIUMLIQUICAPS 2 mg soft capsule

Loperamide Hydrochloride

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after 2 days.

What is in this leaflet?

1. What is IMODIUMLIQUICAPS 2 mg, soft capsule and in which cases is it used?

2. What should I know before taking IMODIUMLIQUICAPS 2 mg, soft capsule?

3. How to take IMODIUMLIQUICAPS 2 mg, soft capsule?

4. What are the possible side effects?

5. How to store IMODIUMLIQUICAPS 2 mg, soft capsule?

6. Package contents and other information.

1. WHAT IS IMODIUMLIQUICAPS 2 mg, soft capsule AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: Anti-diarrheal , ATC code: A07DA03 (A: digestive system and metabolism).

Short-term treatment of acute transient diarrhea in adults and children from 15 years.

This treatment is a complement to the dietary measures: read carefully the chapter "Warnings and Precautions".

You should contact your doctor if you experience no improvement or feel less well after 2 days.

2. BEFORE YOU TAKE IMODIUMLIQUICAPS 2 mg, soft capsule?

Do not take IMODIUMLIQUICAPS 2 mg, soft capsule:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· if blood is present in your stool and / or in case of high fever.

· if you are suffering from chronic bowel and colon disease, especially during acute outbreaks of ulcerative colitis (inflammatory bowel disease with bleeding).

· if you suffer from inflammation of the intestine with diarrhea and pain following the use of antibiotics (pseudomembranous colitis).

· if you suffer from inflammation of the intestine due to an invasive bacteria (bacterial enterocolitis).

· in children under 15 years of age.

This medication should not be used when stopping or decreasing intestinal transit should be avoided.

Treatment should be discontinued in the event of constipation, abdominal distention or intestinal occlusion.

IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking IMODIUMLIQUICAPS 2 mg soft capsule.

You should stop treatment and consult your doctor promptly if:

· if you do not notice improvement after 2 days of treatment,

· in case of fever, vomiting during treatment,

· in the presence of blood or mucus in the stools,

· in case of intense thirst, sensation of dry tongue. Indeed, these signs show an onset of dehydration, that is to say a significant loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.

· if you are infected with the Human Immunodeficiency Virus (HIV), immediately stop treatment at the 1 ^st abdominal distension signs (resulting in swelling of the abdomen).

In case of liver failure (liver malfunction), tell your doctor; a close medical supervision may be necessary if this medication is used.

You should follow the following dietary rules during treatment:

· rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (the adult's average daily water intake is 2 liters),

· you feed enough time of diarrhea,

o avoiding certain intakes and especially milk, raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.

o favoring grilled meats, rice.

Take this product only for the intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (symptoms may include a rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient of IMODIUMLIQUICAPS.

Other medicines and IMODIUMLIQUICAPS 2 mg, soft capsule

This medicine contains loperamide . Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses (see How to take IMODIUMLIQUICAPS 2 mg, soft capsule?).

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines, including:

- itraconazole or ketoconazole (used to treat infections caused by fungi),

- gemfibrozil (used to treat high levels of fat in the blood),

- of desmopressin by the oral route (used in particular to limit thirst and urine production in patients suffering from diabetes insipidus).

IMODIUMLIQUICAPS 2 mg, soft capsule with food and beverages

Not applicable.

Pregnancy and breast feeding

Do not take this medicine without consulting your doctor or pharmacist.

This medication will only be used during pregnancy on the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

Breast-feeding is not recommended when taking this medication.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Be careful. Do not drive without reading the instructions.

This medication may cause drowsiness, dizziness, or fatigue. Due to these risks, caution is advised when driving vehicles or using machines.

3. HOW TO TAKE IMODIUMLIQUICAPS 2 Mg, Soft Capsule?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

Reserved for adults and children from 15 years.

Start with 2 capsules in one dose (4 mg of loperamide hydrochloride).

If diarrhea continues: after each unmolded saddle, take 1 extra capsule, but:

· never exceed 6 capsules per day,

· never exceed 2 days of treatment.

Administration mode

Oral use.

Swallow the capsules with a glass of water.

Duration of the treatment

The duration of use is limited to 2 days.

If you take more IMODIUMLIQUICAPS 2 mg, soft capsule than you should:

If you have taken too many IMODIUMLIQUICAPS, seek immediate advice from a doctor or a hospital. Symptoms may include: increased heart rate, irregular heartbeat, changes in your heart rate (these symptoms may have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movement, drowsiness, difficulty passing urine or respiratory distress, decreased vigilance, shrinking of the pupil, bloating or constipation.

In this case, you should go to the hospital where an antidote (naloxone) can be given to you. Hospital supervision should be maintained for at least 48 hours.

Children respond more strongly to high doses of IMODIUMLIQUICAPS than adults. If a child takes too much or has any of the above symptoms, contact a doctor immediately.

If you forget to take IMODIUMLIQUICAPS 2 mg, soft capsule:

Do not take a double dose to make up for the missed dose.

If you stop taking IMODIUMLIQUICAPS 2 mg, soft capsule:

Not applicable.

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

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The most common side effects (more than 1 in 100 patients) are constipation, flatulence, headache and nausea.

The following side effects have also been reported with loperamide:

· Allergic reactions that may include breathing difficulties or swallowing, swelling of the face or skin reactions (rash, hives, itching).

· Vomiting, difficulty digesting, dry mouth, severe constipation, stomach pain or swelling, abdominal discomfort, intestinal occlusion, tongue pain.

· Sometimes severe cutaneous eruptions.

· Tired.

· Difficulty in urinating.

· Dizziness, somnolence, loss or diminution of consciousness, stupor, increase in muscle tone, difficulty in coordinating its movements.

· Pupil narrowing (myosis).

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE IMODIUMLIQUICAPS 2 mg, soft capsule?

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

Do not use this medicine after the expiry date which is stated on the carton or label. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 30 ° C.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What IMODIUMLIQUICAPS 2 mg contains, soft capsule

· The active substance is:

Loperamide Hydrochloride ............................................... .................................................. ... 2.0 mg

Amount corresponding to loperamide base ............................................. ............................... 1.86 mg

For a soft capsule.

· The other components are:

Capsule : Propylene glycol monocaprylate, propylene glycol, purified water.

Capsule envelope : Gelatin, glycerol 99%, propylene glycol, brilliant blue FCF (E133), soy lecithin, medium chain triglycerides.

What is IMODIUMLIQUICAPS 2 mg, soft capsule and contents of the pack

This medication is in the form of a soft capsule. Box of 6, 10 or 12.

The capsules are oval, light blue.

Not all pack sizes may be marketed.

Marketing Authorization Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Marketing Authorization Operator

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Maker

CATALENT FRANCE BEINHEIM SA

74 PRINCIPAL STREET

67930 BEINHEIM

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Health Education Council:

Diarrhea causes loss of liquids and mineral salts.

This medicine treats the symptoms of acute diarrhea in adults, but does not provide rehydration, accompanied by dietary hygiene.

It is therefore necessary to drink plenty of sugary drinks (fruit juices) and salted broths to compensate for these losses. Avoid milk, green vegetables, raw vegetables, fruits, spices until diarrhea disappears.

Vidal file

VIDAL OF THE FAMILY

IMODIUMLIQUICAPS

antidiarrheal

loperamide

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

IMODIUMLIQUICAPS: soft capsule (light blue); box of 12.
-

Laboratory

COMPOSITION ^(summary)

	p caps
Loperamide hydrochloride	2 mg

INDICATIONS ^(summary)

This medication is an antidiarrheal agent that works by slowing down intestinal transit and reducing intestinal secretions.
It is used in the short-term treatment of acute diarrhea, in addition to dietary measures.

CONTRAINDICATIONS ^(summary)

This medication should not be used in the following cases:

presence of blood in feces or high fever,
acute crisis of ulcerative colitis ,
diarrhea due to certain antibiotics ,
child under 15 years of age.

WARNING ^(Contents)

This medication can be obtained without a prescription. Nevertheless, it should not be used in children under 15 years of age or in case of liver failure without the advice of your doctor.
Diarrhea accompanied by numbness, thirst, fever, or blood in the stool requires prompt medical attention.
Treatment should be discontinued as soon as stools begin to form again. The prolonged use of the drug exposes the patient to a significant risk of constipation.
If you must drive or use a hazardous machine, make sure that this medication does not alter your vigilance.

PREGNANCY AND BREAST-FEEDING ^(summary)

Pregnancy :
Studies currently available have not revealed any particular problem in the occasional use of this drug in pregnant women. However, it is not recommended during pregnancy without medical advice.

Breastfeeding:
This drug passes weakly into breast milk; it can be used during breastfeeding.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

Capsules should be swallowed with a glass of water.

Usual dosage:

Adult and child over 15 years: start with 2 capsules, then 1 extra capsule after each liquid stool, without exceeding 6 capsules per day and 2 days of treatment; If the symptoms persist, consult a doctor.

TIPS ^(summary)

This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Diarrhea can cause dehydration, especially in the elderly. This loss of water by the body must be compensated by rehydration solutions or abundant drinks (salted broth, sugary drinks) because it can cause fatigue, discomfort or confusion of ideas.
Diarrhea diet is based on a light diet, based on:

banana, potato, soup or mashed potatoes;
pasta, rice or tapioca, cooked water, rice;
apple or quince sauce, quince or blueberry jelly;
biscuits or sweet.

Should be avoided: raw fruit juices and fruit, vegetables rich in fiber, meats, eggs, dairy products and iced drinks.

POSSIBLE ADVERSE EFFECTS ^(summary)

Constipation, bloating, abdominal pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness , allergic reaction .
Exceptionally: severe constipation, especially in case of excessive dosage .

GLOSSARY ^(summary)

antibiotics
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .

diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally, stools are pasty, but the emission of liquid or barely formed stools, without pain or particular associated disorder, is not pathological. Diarrhea can occur when liquid stool emissions are repeated during the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.

Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).

dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.

allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.

ulcerative colitis
Inflammatory disease of the rectum and colon, which evolves by flare-ups. Each flare is accompanied by fever, bloody stools.

intestinal transit
Feeding from the stomach to elimination in the form of stool.

fear of heights
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).