IMODIUMLINGUAL 2MG LYOC 12

IMODIUMLINGUAL 2MG LYOC 12 View larger

3400936666795

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For warnings, the precautions and cons-indications, please see the instructions.

Description

The lingual Imodium (freeze-dried) is an anti-diarrheal medication, it is a short-term treatment of acute transient diarrhea. This treatment is a supplement to dietary measures.

For adults and children over 15 years

Composition:

  • Loperamide hydrochloride 2 mg
  • Excipients (lingual form): gelatin, aspartame (E 951), sodium bicarbonate, mannitol, mint flavor.

Dosage:

  • 2 capsules in a single dose, the first dose (4 mg loperamide). If diarrhea continues: after each unformed stool, take 1 additional capsule, but never exceed 6 capsules per day and 2 days of treatment.
At the onset of constipation, administration of this drug should be stopped quickly.

 

Cons-indications:

  • Acute exacerbations of ulcerative colitis
  • Hypersensitivity to the constituents

Oral

Read carefully the instructions

Packaging: box of 12 lyophylisats.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

IMODIUMLINGUAL

antidiarrheal

loperamide

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

PRESENTATIONS (summary)

IMODIUMLINGUAL: oral lyophilisate (mint flavoring); box of 12.
-

Laboratory

COMPOSITION (summary)
p lyoph
Loperamide hydrochloride 2 mg
aspartame +

INDICATIONS (summary)
It is an antidiarrheal which acts by slowing the intestinal transit and reducing the intestinal secretions.
It is used in the symptomatic treatment of acute diarrhea in adults, in addition to dietary measures.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medication can be obtained without a prescription. However, it should not be used in children under 15 years of age or in patients with hepatic impairment without medical advice.
This antidiarrhoeal is not suitable for the treatment of diarrhea due to certain antibiotics .
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)
The lyophilisate can be dissolved in a glass of water or placed directly on the tongue for a quick effect.

Usual dosage:

  • Adult: start with 2 lyophilisates, then 1 additional lyophilisate after each liquid saddle, without exceeding 6 lyophilisates per day and 2 days of treatment; If the symptoms persist, consult a doctor.
    Follow your pharmacist's recommended dosage carefully.
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 .


phenylketonuria
Gradual opacification of the lens. It may be due to aging, a disease or prolonged use of certain medications such as corticosteroids.


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 may occur when liquid stool emissions are repeated throughout 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.).


lyophilisate
Powder resulting from rapid drying (at low temperature and under vacuum) of a substance dissolved in water (eg soluble coffee). As medicaments, lyophilisates may be dissolved in a solvent for the preparation of an injectable, atrial, nasal, etc. solution. or be presented as a tablet to be dissolved in a glass of water, sucked or allowed to melt under the tongue.


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.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.


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).

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 31/05/2017

Name of the medicinal product

IMODIUMLINGUAL 2 mg oral lyophilisate

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 medication exactly as prescribed 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 IMODIUMLINGUAL 2 mg oral lyophilisate and in which cases it is used?

2. What should be known before taking IMODIUMLINGUAL 2 mg oral lyophilisate?

3. How to take IMODIUMLINGUAL 2 mg oral lyophilisate?

4. What are the possible side effects?

5. How to store IMODIUMLINGUAL 2 mg oral lyophilisate?

6. Package contents and other information.

1. WHAT IS IMODIUMLINGUAL 2 mg, oral lyophilisate AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: Anti-diarrheal , ATC code: A07DA03 (A: digestive system and metabolism) .A 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 IMODIUMLINGUAL 2 mg oral lyophilisate?

Do not take IMODIUMLINGUAL 2 mg oral lyophilisate:

· 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.

· in the case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.

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 IMODIUMLINGUAL 2 mg oral lyophilisate.

You should stop treatment and consult your doctor promptly if:

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

· in the event of fever or 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.

This medicine contains "sulfite" and can cause severe allergic reactions and respiratory discomfort.

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 IMODIUMLINGUAL.

Other medicines and IMODIUMLINGUAL 2 mg oral lyophilisate

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 IMODIUMLINGUAL 2 mg, oral lyophilisate?).

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).

IMODIUMLINGUAL 2 mg, oral lyophilisate 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.

IMODIUMLINGUAL 2 mg, oral lyophilisate contains aspartam (E951): source of phenylalanine and traces of sulfites .

3. HOW TO TAKE IMODIUMLINGUAL 2 mg oral lyophilisate?

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 lyophilisates in a single dose (4 mg of loperamide hydrochloride).

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

· never exceed 6 lyophilisates per day,

· never exceed 2 days of treatment.

Administration mode

Oral use.

The lyophilisates are brittle and should not be pushed through the aluminum film.

Proceed as follows to remove the lyophilisates from the wafer.

Let the oral lyophilisate melt on the tongue to obtain a quick effect (do not chew) or drink immediately after dissolution in a small amount of water.

Duration of the treatment

The duration of use is limited to 2 days.

If you take more IMODIUMLINGUAL 2 mg oral lyophilisate than you should:

If you have taken too much IMODIUMLINGUAL, immediately seek 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 IMODIUMLINGUAL than adults. If a child takes too much or has any of the above symptoms, contact a doctor immediately.

If you forget to take IMODIUMLINGUAL 2 mg oral lyophilisate:

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

If you stop taking IMODIUMLINGUAL 2 mg, oral lyophilisate:

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 obstruction, 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 shrinkage (Miosis).

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 IMODIUMLINGUAL 2 mg oral lyophilisate?

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 in the original package in order to protect from moisture.

Do not throw any medicines into drains or sewers. 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 IMODIUMLINGUAL 2 mg contains, oral lyophilisate

· The active substance is:

Loperamide Hydrochloride ............................................... ................................................ 2,000 mg

Amount corresponding to loperamide base 1, 858 mgfor an oral lyophilisate.

· The other components are:

Gelatin, aspartame (E951), mint flavor, sodium bicarbonate, mannitol.

What is IMODIUMLINGUAL 2 mg, oral lyophilisate and contents of the pack

This medication is in the form of oral lyophilisates. Box of 5, 6, 10 or 12.

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

JANSSEN PHARMACEUTICA NV

TURNHOUTSEWEG 30

2340 BEERSE

BELGIUM

Or

JANSSEN CILAG SPA

VIA C. JANSSEN

BORGO SAN MICHELE

04010 LATINA (LT)

ITALY

Or

JANSSEN CILAG

DOMAIN OF MAIGREMONT

27100 VAL-DE-REUIL

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.

Cheap Imodium in your medicine approved Ars  

Imodium is a drug indicated for the treatment of acute transient acute diarrhea

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