NOTICE
ANSM - Updated on : 13/04/2023
Product name
LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet
Loperamide hydrochloride
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 2 days.
What does this leaflet contain?
1. What is LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet and what is it used for?
2. What do I need to know before taking LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
3. How do I take LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
4. What are the possible side effects?
5. How do I keep LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
6. Package contents and other information.
1. WHAT IS LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTI-DIARRHEALS - ATC code: A07DA03 (A: digestive system and metabolism).
Short-term treatment of transient acute diarrhea in adults and children aged 15 and over.
This treatment is a complement to dietary measures: please read the "Warnings and Precautions" section carefully.
You should contact your doctor if you do not feel any improvement or if you feel worse after 2 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
Never take LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet:
- if you are allergic to loperamide hydrochloride or to any of the other components of this medicine mentioned in section 6,
- if you have blood in your stools and/or a high fever,
- if you suffer from chronic bowel and colon disease, particularly during acute flare-ups 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 invasive bacteria (bacterial enterocolitis),
- in children under 15 years of age,
- in cases of phenylketonuria (hereditary disease detected at birth), due to the presence of daspartam.
This drug should not be used when a stoppage or reduction in intestinal transit must be avoided.
Treatment should be discontinued in the event of constipation, abdominal distension or intestinal obstruction.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet.
You must stop treatment and consult your doctor immediately in the following cases:
- if there is no improvement after 2 days of treatment,
- if you develop fever or vomiting during treatment,
- if you notice blood or mucus in your stools,
- in the event of intense thirst or dry tongue. These signs indicate the onset of dehydration, i.e. significant fluid loss due to diarrhea. Your doctor will then decide whether you need oral or intravenous rehydration,
- If you are infected with the Human Immunodeficiency Virus (HIV), discontinue treatment immediately at the first signs of abdominal distension (swelling of the abdomen).
If you suffer from hepatic insufficiency (poor liver function), tell your doctor; close medical supervision may be necessary during treatment with this medicine.
The following dietary recommendations should be followed during treatment:
- rehydrate with plenty of salty or sweet drinks, to compensate for fluid losses due to diarrhea (the average daily water intake for adults is 2 liters),
- eat sufficiently during diarrhea,
o by avoiding certain foods, particularly milk, raw vegetables, fruit, green vegetables, spicy dishes and iced foods and drinks.
o with a preference for grilled meats and rice.
Only take this product for its intended use (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (symptoms may include rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in LOPERAMIDE BGR CONSEIL.
Children and adolescents
Not applicable.
Other medicines and LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including :
- litraconazole or ketoconazole (used to treat fungal infections),
- gemfibrozil (used to treat high blood fat levels),
- oral desmopressin (used in particular to limit thirst and durin production in patients suffering from diabetes insipidus).
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This medicine contains LOPERAMIDE. Other drugs contain LOPERAMIDE. Do not combine them, so as not to exceed the maximum recommended doses (see section 3).
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LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
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Do not take this medicine without consulting your doctor or pharmacist.
This medicine should only be used during pregnancy on the advice of your doctor.
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If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue treatment.
Breast-feeding is not recommended when taking this medicine.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and using machines
Use caution when driving. Do not drive without reading the instructions.
This medicine may cause drowsiness, dizziness or fatigue. Because of these risks, caution is advised when driving or operating machinery.
LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet contains sodium, laspartam and sucrose.
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, i.e. it is essentially "sodium-free".
It contains 5 mg daspartam per orodispersible tablet. Laspartam contains a source of phenylalanine. It may be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by an accumulation of phenylalanine that cannot be eliminated properly.
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
3. HOW DO I TAKE LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
FOR ADULTS AND CHILDREN aged 15 and over.
Start with 2 orodispersible tablets in a single dose (4 mg loperamide hydrochloride).
If diarrhoea continues: after each loose stool, take 1 additional orodispersible tablet, but :
- never exceed 6 orodispersible tablets a day,
- never exceed 2 days' treatment.
Method of administration
Oral administration.
The orodispersible tablet should be placed on the tongue. The tablet disintegrates immediately on the tongue and is swallowed with saliva. The tablet can also be dissolved in a glass of water.
Duration of treatment
The duration of use is limited to 2 days.
If you have taken more LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet than you should have
If you have taken too much LOPERAMIDE BGR CONSEIL, seek medical advice immediately. Symptoms may include: increased heart rate, irregular heartbeat, changes in your heart rhythm (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or respiratory distress, or decreased alertness, pupil constriction, bloating or constipation.
In such cases, you need to go to hospital, where an antidote (naloxone) can be administered. Hospital monitoring should be maintained for at least 48 hours. Children react more strongly than adults to high doses of LOPERAMIDE BGR CONSEIL. If a child takes too much or shows any of the above symptoms, contact a doctor immediately.
If you forget to take LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The most frequent side effects (more than 1 in 100 patients) are constipation, flatulence, headache and nausea.
The following adverse reactions have also been reported with loperamide:
- allergic reactions which may include breathing or swallowing difficulties, facial swelling or skin reactions (rash, urticaria, itching);
- vomiting, difficulty digesting, dry mouth, severe constipation, abdominal pain or swelling, abdominal discomfort, intestinal obstruction, tongue pain;
- skin rashes, sometimes severe;
- fatigue;
- difficulty in urinating;
- dizziness, drowsiness, loss or reduction of consciousness, stupor, increased muscle tone, difficulty coordinating movements;
- pupil constriction (miosis);
- pain in the upper abdomen, abdominal pain radiating to the back, tenderness of the abdomen to touch, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis) (frequency undetermined (cannot be estimated on the basis of available data)).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet contains
- The active substance is :
Loperamide hydrochloride...................................................................................................... 2 mg
per orodispersible tablet.
Other ingredients are: croscarmellose sodium, aspartam (E951), fruit flavoring (containing: gum arabic [E414], sugar [sucrose], maltodextrin [potato], triacetin, propylene glycol), banana flavoring (containing corn maltodextrin), magnesium stearate, mannitol.
What is LOPERAMIDE BGR CONSEIL 2 mg, orodispersible tablet and what does it contain?
This medicine comes in the form of round, white to off-white orodispersible tablets, approximately 7 mm in diameter.
Boxes of 5, 6, 10 or 12 orodispersible tablets.
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
Tiofarma B.V.
Hermanus Boerhaavestraat 1
3261 ME Oud-Beijerland
NETHERLANDS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice
Diarrhea causes a loss of fluids and mineral salts.
This medicine treats the symptoms of acute diarrhoea in adults and children over 15, but does not dispense with rehydration, accompanied by dietary hygiene.
Drink plenty of sweetened beverages (fruit juices) and salty broths to compensate for these losses. Avoid milk, green vegetables, raw vegetables, fruit and spices until the diarrhoea disappears.