NOTICE
ANSM - Last updated: 10/04/2014
Name of the medicinal product
LOPERAMIDE BIOGARAN TIP 2 mg capsule
Loperamide Hydrochloride
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist after 2 days of treatment, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT IS LOPERAMIDE BIOGARAN TIP 2 mg, hard capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
3. HOW TO TAKE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS LOPERAMIDE BIOGARAN TIP 2 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTI-DIARRHEA
Therapeutic indications
Short-term treatment of acute transient diarrhea in adults and adolescents over 15 years of age.
This treatment is a complement to the dietary measures: read carefully the Precautions d'emploi .
2. BEFORE YOU TAKE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take LOPERAMIDE BIOGARAN CONSEIL 2 mg, capsule:
· If you are allergic (hypersensitive) to the active substance (loperamide) or to any of the other ingredients of this medication. You will find the list of components in section 6.
· If you suffer from a long-term bowel disease and the large intestine (colon), especially when you have bloody diarrhea (acute outbreaks of hemorrhagic recto-colitis).
· In children under 15 years of age.
Precautions for use; special warnings
Take special care with LOPERAMIDE BIOGARAN TIP 2 mg, capsule:
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
CAUTION: Do not take this medication:
· in case of fever, vomiting,
· in the presence of blood or mucus in the stools,
· if your diarrhea occurs during an antibiotic treatment (risk of severe bowel disease).
Similarly you should stop this treatment and consult your doctor promptly in the following cases:
· in case of fever, vomiting,
· in the presence of blood or mucus in the stools,
· in the absence of improvement after 2 days of treatment,
· in the case of constipation or abdominal distension,
· in case of intense thirst, sensation of dry tongue. Indeed, these signs show a beginning of dehydration, that is to say a large loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.
This medicine contains a sugar (lactose). Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Precautions for use
Use this medicine only with caution
TAKE ADVICE OF YOUR DOCTOR in case of liver disease because medical supervision during treatment is necessary
Diarrhea causes loss of liquids and mineral salts.
It is necessary that:
· rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (drinking at least 2 liters)
· feeding the time of diarrhea,
o remove raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
o favor grilled meats, rice.
Interaction with other medicines
Taking or using other medicines
This medicine contains loperamide. Other medicines contain it. Do not combine them in order not to exceed the maximum recommended doses (the recommended doses are detailed in section 3).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Food and drinks
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
If you are pregnant or breastfeeding,
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 this treatment.
Breast-feeding is still possible if this medication is used for short periods.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Take this medicine by mouth with a glass of water. Do not take your medicine more often than directed. This medication may cause drowsiness, dizziness or drowsiness when driving and using certain machines.
List of excipients with known effect
Lactose.
3. HOW TO TAKE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Do not use this medication in adolescents under 15 years of age
Dosage
Reserved for adults and adolescents over 15 years of age
· Start with 2 capsules in a single dose (4 mg loperamide).
· 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 treatment
The duration of treatment is limited to 2 days.
Symptoms and Instructions for Overdose
If you take more LOPERAMIDE BIOGARAN TIP 2 mg, capsule you should:
In case of accidental overdose, STOP TREATMENT AND SEEK YOUR DOCTOR QUICKLY .
Instructions for omission of one or more doses
If you forget to take LOPERAMIDE BIOGARAN TIP 2 mg capsule
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, LOPERAMIDE BIOGARAN CONSEIL 2 mg, capsule is likely to have side effects, although not everyone is subject to it.
· Constipation and / or stomach distension,
· Stomach pain, bloating, nausea, vomiting, dry mouth,
· Allergic reactions (rash, urticaria and exceptionally severe allergic shock),
· Fatigue, drowsiness, dizziness.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE LOPERAMIDE BIOGARAN TIP 2 mg, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use LOPERAMIDE BIOGARAN TIP 2 mg capsule after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does LOPERAMIDE BIOGARAN CONSEIL contain 2 mg, capsule?
The active substance is:
Loperamide Hydrochloride ............................................... .................................................. 2.00 mg
Amount corresponding to loperamide base ............................................. ........................................... 1.86 mg
For a capsule.
The other components are:
Lactose monohydrate, rice starch, talc, magnesium stearate.
Envelope of the capsule: gelatin, titanium dioxide (E171)
Pharmaceutical form and content
What is LOPERAMIDE BIOGARAN CONSEIL 2 mg, hard capsules and contents of the pack?
This medication is in the form of a capsule.
Box of 6 or 12 capsules.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
Biogaran
15 boulevard charles de gaulle
92700 colombes
exploiting
Biogaran
15 boulevard charles de gaulle
92700 colombes
Maker
btt laboratories
zi de krafft
67150 erstein
la France
AND
LABORATOIRES SERVIER INDUSTRIE
905 route de saran
45520 gidy
la France
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France) www.ansm.sante.fr .
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION
Diarrhea causes loss of liquids and mineral salts.
This medication treats the symptoms of acute diarrhea in adults, but does not relieve moisture, 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.