NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
SORBITOL DELALANDE 5 g, powder for oral solution in sachet-dose
framed
This is an authorized and controlled medicinal product (see Identification No on the outer packaging)
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from 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 SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose?
3. HOW TO TAKE SORBITOL DELALANDE 5 g, powder for oral solution in sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SORBITOL DELALANDE 5 g powder for oral solution in a sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
OSMOTIC LAXATIVE.
Therapeutic indications
This medication is indicated in adults for the treatment of occasional constipation and in case of difficult digestion (slowness to digestion, bloating).
2. BEFORE YOU TAKE SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose?
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
Never take SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose in the following cases:
· certain diseases of the intestine and colon (ulcerative colitis, Crohn's disease ...),
· abdominal pain of indeterminate cause,
· your constipation follows the taking of certain medications.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
Occasional constipation
It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment.
Patients are advised to seek medical advice before starting or continuing treatment if:
· unexplained recent constipation by changing lifestyle,
· constipation accompanied by vomiting and stopping the emission of gases (occlusion), pain in the abdomen, fever, bloating (stomach swelling), blood in the stool, weight loss.
Indeed these signs can be the symptoms of a more serious disease.
Digestion difficult
Patients are advised to seek medical advice before starting or continuing treatment if:
· diarrhea,
· abdominal pain,
· vomiting.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use
Do not take this medicine if you have biliary tract obstruction.
In patients who are usually bedridden or whose physical activity is very low, a medical examination is necessary before any treatment with this drug.
In elderly people, ensure that the daily intake of water is sufficient.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, and in particular Kayexalate (a medicine used in the treatment of hyperkalaemia), IT SHOULD BE INFORMED SYSTEMATICALLY OF ANY OTHER PROCESSING IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE SORBITOL DELALANDE 5 g, powder for oral solution in sachet-dose?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
In case of occasional constipation in adults :
· 1 sachet in the morning on an empty stomach.
In case of difficult digestion in adults :
· 1 to 3 sachets per day to be taken before meals or at the time of the troubles.
Method and route of administration
Oral use.
Dissolve the contents of the sachet in half a glass of water.
Duration of the treatment
Occasional constipation in adults:
Do not continue treatment without medical advice after 1 week.
Digestion difficult (slow digestion, bloating):
Do not continue treatment without medical advice after 1 week.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, SORBITOL DELALANDE 5 g, powder for oral solution in sachet-dose is likely to have undesirable effects, although not everyone is subject to it.
· risk of diarrhea and abdominal pain, especially in patients with functional colopathies,
· possibility of abdominal bloating.
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 SORBITOL DELALANDE 5 g powder for oral solution in a sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use SORBITOL DELALANDE 5 g powder for oral solution in a sachet-dose after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
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 SORBITOL DELALANDE 5 g contain, powder for oral solution in sachet-dose?
The active substance is:
Sorbitol ................................................. .................................................. ............................................... 5 g
For a sachet-dose.
Pharmaceutical form and content
What is SORBITOL DELALANDE 5 g powder for oral solution in sachet-dose and contents of the pack?
This medication is in powder form for oral solution.
Box of 20 sachets-doses.
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
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI WINTHROP INDUSTRIE
196, AVENUE DU MARECHAL JUNE
45200 AMILLY
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS
This medication is intended to relieve occasional constipation of the adult or a difficult digestion (slowness to digestion, bloating).
Do not hesitate to talk to your doctor or pharmacist.
In order to limit the onset of symptoms, observe as much as possible the following hygiene rules:
If you suffer from occasional constipation:
· increase the dietary intakes of vegetable products rich in fiber (green vegetables, raw vegetables, whole bread, fruits ...),
· increase the consumption of water and fruit juices,
· increase physical activities (sports, walking ...),
· perform a rehabilitation of the defecation reflex,
· sometimes add sound to your diet.
If you suffer from difficult digestion:
· vary your diet,
· avoid the practice of an important effort just after the meal,
· avoid tobacco and limit alcohol consumption,
· avoid abundant meals rich in fats or sugars,
· normalize your weight and do physical exercise like walking.
YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM.
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.