NOTICE
ANSM - Updated on : 09/12/2024
Product name
LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate
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 VIATRIS CONSEIL 2 mg, oral lyophilisate and what is it used for?
2. What do I need to know before taking LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate?
3. How should LOPERAMIDE VIATRIS CONSEIL 2 mg, lyophilisat oral be taken?
4. What are the possible side effects?
5. How do I keep LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate?
6. Package contents and other information.
1. WHAT IS LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Anti-diarrheals, intestinal anti-inflammatories and anti-infectives, intestinal motor retardants - ATC code: A07DA03.
This medicine contains loperamide hydrochloride, which helps to stop diarrhoea by making stools more solid and less frequent. It is used in the symptomatic treatment of acute diarrhoea in adults and adolescents aged 12 and over.
This medicine should not be used for more than 2 days without medical advice and supervision.
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 VIATRIS CONSEIL 2 mg, oral lyophilisate?
Never take LOPERAMIDE VIATRIS CONSEIL 2 mg, lyophilisat oral:
- if you have a known hypersensitivity to loperamide hydrochloride or to any of the excipients listed in section 6,
- if your child is less than 2 years old,
- if you suffer from acute dysentery characterized by blood in the stools and high body fever,
- if you suffer from acute ulcerative colitis,
- if you suffer from bacterial denterocolitis caused by invasive bacteria such as Salmonella, Shigella or Campylobacter,
- if you suffer from pseudomembranous colitis associated with the use of broad-spectrum antibiotics,
- in all situations where cessation of intestinal transit must be avoided. Treatment should be discontinued immediately if constipation or abdominal distension occurs.
If any of these situations apply to you, talk to your doctor or pharmacist before taking loperamide hydrochloride.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking this medicine:
- if you have AIDS and your stomach becomes swollen, stop taking oral lyophilisates immediately and consult your doctor immediately,
- if you suffer from liver disease,
- if you have been suffering from diarrhea for more than 48 hours, stop taking the drug immediately and consult your doctor.
- if you suffer from severe diarrhoea, you will lose a lot of fluid (dehydration). With this fluid, other important substances are also lost. Symptoms of dehydration may include dry mouth and/or dizziness. Vomiting can lead to dehydration. The risk of dehydration is greatest in young children and the elderly. They should therefore be the first measure against diarrhea: supplement and maintain fluid in the body. This means drinking plenty of fluids and supplementing sugar and salt. You can buy a special salt-sugar mixture (ORS) at the chemist's, to be dissolved in water. Ask your doctor or pharmacist for advice.
Children and teenagers
Not applicable.
Other medicines and LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including
- ritonavir (used in the treatment of HIV)
- quinidine (used to treat heart rhythm abnormalities or malaria)
- oral desmopressin (used in particular to limit durin production)
- litraconazole or ketoconazole (used to treat fungal infections),
- gemfibrozil (used to treat high cholesterol).
If you are unsure about any of the medicines you are taking, show the bottle or package to your pharmacist. If any of these apply to you (or have previously applied to you), contact a doctor or pharmacist.
LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
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.
Pregnancy
The use of LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate should be avoided during pregnancy, particularly during the first trimester.
Lactation
Small quantities of the active substance may pass into breast milk. Consult your doctor for appropriate treatment.
Driving vehicles and operating machinery
During episodes of diarrhea, you may feel dizzy, drowsy or tired. If you experience any of these effects, you should not drive, operate machinery or take part in activities that could endanger yourself or others.
LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate contains laspartame and sodium.
This medicine contains less than 1 mmol (23 mg) sodium per oral lyophilisate, i.e. it is essentially "sodium-free".
It contains 1.0 mg daspartam per oral lyophilisate. 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.
3. HOW DO I TAKE LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Check the table below to find out how much medicine to take.
- Peel off the capsule and remove the tablet. Do not push tablets through the capsule.
- Place the correct number of oral lyophilisates on the tongue. Oral lyophilisates dissolve quickly in your mouth, so you don't need water to swallow them. Do not chew. For oral use only.
- Do not use more than the dose indicated in the tables.
- Oral lyophilisates are not intended for long-term treatment.
Short-term diarrhea
|
Age
|
Initial dose
|
Additional dose
|
Maximum daily dose
|
|
Adolescents aged 12 and over
|
1 oral lyophilisate
|
1 oral lyophilisate after each unmolded bowel movement
|
4 oral lyophilisates
|
|
Adults
|
2 oral lyophilisates
|
1 oral lyophilisate after each unmolded bowel movement
|
6 oral lyophilisates
|
Do not exceed the maximum daily dose.
The duration of treatment is limited to 2 days.
Replace lost fluids by drinking more fluids than usual.
Elderly subjects
No dosage adjustment necessary.
Renal insufficiency
No dosage adjustment necessary.
Hepatic insufficiency
If you suffer from hepatic insufficiency, consult your doctor or pharmacist before taking this medicine.
How long to take LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate for acute diarrhoea
You can take this medicine for up to 48 hours.
If the diarrhea attack lasts longer than 48 hours, or if you suffer from repeated diarrhea attacks or if your symptoms change, stop taking loperamide hydrochloride and consult your doctor.
If you have taken more LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate than you should have
If you have taken too much loperamide hydrochloride, 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.
Children react more strongly to high doses of loperamide hydrochloride than adults. If a child takes too much or shows any of the above symptoms, contact a doctor immediately.
If you forget to take LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate
Take this medicine only when you need it, carefully following the dosage instructions above.
If you miss a dose, take a dose after the next loose stool. Do not take a double dose to make up for the one you missed.
If you stop taking LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause undesirable effects, but they do not always occur in everyone.
Seek medical advice immediately.
Common (may affect up to 1 in 10 people)
- nausea, constipation, flatulence;
- headaches.
Uncommon (may affect up to 1 in 100 people)
- itching or hives;
- abdominal pain or swelling;
- dizziness or drowsiness;
- vomiting, indigestion;
- dry mouth.
Rare (may affect up to 1 in 1,000 people)
- hypersensitivity reactions including unexplained wheezing, shortness of breath, loss of consciousness or swelling of the face or throat;
- skin rashes which may be severe and accompanied by blistering and peeling;
- loss of consciousness, decreased level of consciousness (fainting or reduced alertness), uncoordinated movements;
- difficulty in urinating (urinary retention);
- severe constipation;
- burning of the tongue or a tingling sensation on the tongue;
- miosis (narrowing of the pupils);
- fatigue.
Undetermined frequency (cannot be estimated on the basis of available data)
- 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).
If you experience any of the following side effects, discontinue use and seek medical advice immediately. Consult a doctor as soon as possible.
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 are helping to provide more information on drug safety.
5. HOW TO CONSERVE LOPERAMIDE VIATRIS CONSEIL 2 mg, lyophilisat oral?
Keep out of sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiration date indicated on the box and blister after EXP. The expiration date refers to the last day of that month.
Do not dispose of any medicine with your household waste. Ask your pharmacist to delimit any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate contains
- The active substance is loperamide hydrochloride.
Each oral lyophilisate contains 2 mg loperamide hydrochloride.
- The other components are :
Pullulane (E1204), mannitol (E421), sodium bicarbonate (E500), aspartam (E951), polysorbate 80 (E433), mint flavouring (corn maltodextrin, flavouring ingredients and modified waxy corn starch, 1450).
What is LOPERAMIDE VIATRIS CONSEIL 2 mg, oral lyophilisate and what does it contain?
Oral lyophilisate.
6, 10 or 12 oral lyophilisates in blister packs.
Blisters (PVC/polyamide/Aluminium/PVC) with detachable cover (Paper/PET/Aluminium).
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
SANTA SA
STR. PANSELELOR NR. 25, NR. 27, SI NR.29
BRASOV, JUD. BRASOV - 500419
ROMANIA
OR
FAIRMED HEALTHCARE GmbH
MARIA-GOEPPERT-STRASSE 3
23562 LÜBECK
GERMANY
Drug names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
Not applicable.
Other
Detailed information on this drug is available on the ANSM (France) website.