DIASTROLIB 2MG LYOPHILISAT ORAL is an over-the-counter medication, available in our online pharmacy
For warnings, precautions for use and contraindications, please consult the instructions for use.
DIASTROLIB
Updated: Thursday, August 22, 2013.
What is DIASTROLIB prescribed for ?
This medication is an antidiarrheal that works by slowing intestinal transit and reducing intestinal secretions. It is used in the symptomatic treatment of acute diarrhea in adults , in addition to dietary measures.
You can consult the following article (s):
Diarrhea and gastroenteritis in adults
p lyoph
Loperamide hydrochloride 2 mg
Aspartame +
Sorbitol +
Lactose +
Active substance : Loperamide hydrochloride
Excipients : Aspartame, Dextran 70, Raspberry flavor, Glucose, Xanthan gum, Lactose monohydrate, Maltodextrin, Anhydrous disodium phosphate, Polysorbate 60, Propylene glycol, Sorbitol
This medication should not be used in the following cases :
Warning
Fertility, pregnancy and lactation
Possible side effects of DIASTROLIB
Constipation, bloating, abdominal pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, allergic reaction.
Exceptionally: severe constipation, especially in case of excessive dosage.
You have experienced an undesirable effect likely to be due to this medicine, you can report it by downloading the form.
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 stool, without exceeding 6 lyophilisates per day and 2 days of treatment; beyond, if the troubles persist, consult the doctor.
Strictly follow the dosage recommended by your pharmacist.
Diarrhea can cause dehydration, especially in the elderly. This loss of water by the body must be compensated by rehydration solutions or abundant drinks (salty broth, sugary drinks) because it can cause fatigue, discomfort or confusion of ideas.
The diet to follow in case of diarrhea is based on a light diet, based on:
Should be avoided : fruit juices and raw fruits, high-fiber vegetables, meats, eggs, dairy products and frozen drinks.
Téva Santé Laboratory
DIASTROLIB 2 mg: oral lyophilisate (raspberry flavor); box of 10
- Not refunded - Free price
DIASTROLIB picture
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.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 19/05/2017
DIASTROLIB 2 mg oral lyophilisate
Loperamide Hydrochloride
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 experience no improvement or feel less well after 2 days.
Do not use this medication for children.
1. What is DIASTROLIB 2 mg, oral lyophilisate and in which cases it is used?
2. What should I tell you before taking DIASTROLIB 2 mg oral lyophilisate?
3. How to take DIASTROLIB 2 mg oral lyophilisate?
4. What are the possible side effects?
5. How to store DIASTROLIB 2 mg oral lyophilisate?
6. Package contents and other information.
1. WHAT IS DIASTROLIB 2 mg oral lyophilisate AND WHAT IT IS USED FOR?
This medication is a complement to dietary measures: read carefully "Precautions for use; special warnings ".
2. BEFORE YOU TAKE DIASTROLIB 2 mg oral lyophilisate?
Do not take DIASTROLIB 2 mg oral lyophilisate:
· If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
· If you have a chronic bowel and colon disease, especially during acute outbreaks of ulcerative colitis
· If you have a high fever or if you have blood in the stool,
· If your diarrhea occurs after taking antibiotics,
· If you are constipated or in case of abdominal swelling,
· If you have phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame (E951).
· In children under 15 years of age.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking DIASTROLIB 2 mg, oral lyophilisate .
Warnings
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).
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
Precautions for use
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 stool.
· in the absence of improvement after 2 days of treatment.
· 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.
· if your diarrhea occurs during an antibiotic treatment (risk of severe bowel disease).
· if you are carrying the AIDS virus and your belly is swelling, stop the treatment immediately and contact your doctor.
TAKE ADVICE OF YOUR DOCTOR in case of liver disease because medical supervision during treatment is necessary.
If you are suffering from inflammatory bowel disease, check with your doctor before taking this medication.
Diarrhea causes loss of liquids and mineral salts. It is necessary that :
· rehydrate with abundant, salty or sugary drinks 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.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Other medicines and DIASTROLIB 2 mg oral lyophilisate
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Tell your doctor or pharmacist if you are taking any other medicines including:
· Quinidine (used to treat heart rhythm abnormalities and malaria);
· Itraconazole, Ketoconazole (medicines used for fungal infections);
· Gemfibrozil (used to treat high cholesterol);
· Ritonavir (used to treat HIV infections);
· Desmopressin (medication used in diabetes or in nocturnal urinary disorders).
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 DIASTROLIB 2 mg, oral lyophilisate?). |
DIASTROLIB 2 mg, oral lyophilisate with food and beverages and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
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.
DIASTROLIB 2 mg, oral lyophilisate is not recommended if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Caution, this medication sometimes causes fatigue, discrete and transient somnolence or dizziness that may be dangerous when driving vehicles and using certain machines.
DIASTROLIB 2 mg, oral lyophilisate contains aspartame (E951): source of phenylalanine, maltodextrin (glucose), lactose, sorbitol.
3. HOW TO TAKE DIASTROLIB 2 mg oral lyophilisate?
Do not use this medication in children (less than 15 years of age). |
RESERVED FOR ADULTS and CHILDREN from 15 years.
Dosage
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 .
Start with 2 lyophilisates in a single dose (4 mg loperamide).
If diarrhea continues: after each unmolded saddle, take 1 extra lyophilisate, but:
· never exceed 6 lyophilisates per day,
· never exceed 2 days of treatment.
If you feel that the effect of DIASTROLIB 2 mg oral lyophilisate is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
Oral lyophilisate should be placed on the tongue. It will dissolve and must be swallowed with saliva. No liquid is needed with the orodispersible tablet.
Duration of treatment
The duration of treatment is limited to 2 days. |
If you take more DIASTROLIB 2 mg oral lyophilisate than you should:
Immediately consult your doctor or pharmacist.
In case of overdose, depression of the central nervous system may occur (decreased vigilance, drowsiness, shrinking pupil, difficulty breathing, difficulty in coordinating its movements, ...). In this case, an antidote (naloxone) should be administered. Hospital supervision should be maintained for at least 48 hours.
If you forget to take DIASTROLIB 2 mg oral lyophilisate:
Do not take a double dose to make up for a missed dose .
If you stop taking DIASTROLIB 2 mg, oral lyophilisate:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
In clinical trials
The following adverse reactions have been reported with loperamide hydrochloride in acute diarrhea:
Common side effects (less than 1 in 10 patients but more than 1 in 100 patients):
· Headache,
· Constipation, nausea, flatulence.
Uncommon side effects (less than 1 in 100 patients but more than 1 in 1,000 patients):
· Dizziness,
· Abdominal pain, abdominal discomfort, dry mouth,
· High abdominal pain, vomiting,
· Rashes.
Rare side effects (less than 1 in 1,000 patients but more than 1 in 10,000 patients):
· Abdominal distension.
In addition, the following effects have been reported since loperamide hydrochloride is marketed (indeterminate frequency):
Immune system disorders: hypersensitivity reactions, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction.
Nervous system disorders: drowsiness, loss of consciousness, stupor, decreased level of consciousness, hypertonia, disorders of coordination.
Eye disorders: myosis (narrowing of the pupil).
Gastrointestinal disorders: ileus including paralytic ileus (intestinal occlusion), megacolon (manifested by rebellious constipation) including toxic megacolon, glossodynia (tongue pain).
Skin and subcutaneous tissue disorders: bullous eruption (including Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, itching.
Renal and urinary disorders: urinary retention.
General disorders and administration site conditions: fatigue.
Declaration of side effects
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. 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 DIASTROLIB 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 EXP MM / YYYY box. The expiry date refers to the last day of that month.
Store in the original package.
After opening the sachet: keep away from moisture and 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 DIASTROLIB 2 mg contains, oral lyophilisate
· The active substance is:
Loperamide Hydrochloride ............................................... .................................................. .......... 2 mg
For an oral lyophilisate.
The other ingredients are lactose monohydrate, raspberry flavor (contains maltodextrin and sorbitol), dextran 70, aspartame (E951), anhydrous disodium phosphate, xanthan gum, polysorbate 60.
What is DIASTROLIB 2 mg, oral lyophilisate and contents of the pack
This medication is in the form of an oral lyophilisate. Box of 6, 10 or 12 lyophilisates.
Marketing Authorization Holder
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Marketing Authorization Operator
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165 AULAGNIER QUARTER
92600 ASNIERES-SUR-SEINE
22 RUE EDME LABORDE
NEVERS SAINT ELOI ACTIVITY PARK
58000 NEVERS
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]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Diarrhea causes loss of liquids and mineral salts.
This treatment against the symptoms of acute diarrhea, does not dispense with significant rehydration, accompanied by a dietary hygiene if necessary (prefer sugary drinks, salted broths, avoid milk, green vegetables, raw vegetables, fruits, spices) until disappearance of diarrhea.
antidiarrheal
loperamide
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DIASTROLIB 2 mg: oral lyophilisate (raspberry flavor); box of 10.
-
Laboratoire Procter and Gamble Pharmaceuticals France
| p lyoph | |
| Loperamide hydrochloride | 2 mg |
| aspartame | + |
| sorbitol | + |
| Lactose | + |
Usual dosage:
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