NOTICE
ANSM - Updated on: 16/09/2015
Description of the Medicine
LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin
Liquid paraffin
© framed
Please read this leaflet carefully before you start taking this medication because it contains important information for you.
This is an authorized and controlled medication (see External Packaging ID):
AT· This medication can be used in self-treatment, ie without consultation or prescription of a doctor.
AT· If symptoms persist beyond 10 days, if they become worse or if new symptoms appear, seek advice from your pharmacist or your doctor.
AT· This leaflet is designed to help you use this medication properly. Keep it there, you might need to re-read it.
AT· Do not allow this medication to reach children.
AT· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
Summary sheet
In this notice :
1. WHAT IS LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin?
3. HOW TO TAKE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium?
6. ADDITIONAL INFORMATION
1. WHAT IS LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
LUBRICANTS
Liquid paraffin acts mechanically by lubricating the contents of the bowel, and by softening the stools.
Therapeutic Indications
Treatment of occasional constipation.
2. BEFORE YOU TAKE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin?
List of information needed before taking the medication
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
Cons-indications
Never take LANSOYL WITHOUT SUGAR 78.23 g PERCENT, Oral Jelly Sweetened with Saccharin Sodium:
AT· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
AT· if you suffer from abdominal pain that you do not know the cause,
AT· if you have difficulty swallowing (swallow properly) because of the risk of bronchial inhalation and lipoid pneumonitis.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment precautions; special warnings
Take special care with LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium:
Special warnings
AT· Do not use this medication prolonged; prolonged use of liquid paraffin is likely to reduce the absorption of fat-soluble vitamins (A, D, E, K).
AT· The medication of constipation is only an adjuvant to the hygienic treatment no-dietetic which consists of:
o an enrichment of the supply of vegetable fibers and beverages,
o the practice of physical activity,
o the re-education of the exemption.
AT· In case of chronic constipation, which can be related to bowel disease or an imbalance of intestinal function due to eating habits and lifestyle, TAKE ADVICE OF YOUR DOCTOR.
Employment Precautions
The administration of liquid paraffin in patients with asthma or having difficulty swallowing should be cautious as it may cause bronchial passages and respiratory disorders.
This medication contains an azo dye (E 124) and may cause allergic reactions.
This medicine contains sorbitol. Its use is discouraged in patients with fructose intolerance (rare hereditary disease).
Interactions with other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, speak to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy because it may cause a defect in the absorption of certain vitamins essential for your child.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
LANSOYL WITHOUT SUGAR 78.23 g PERCENT has no effect or negligible effect on the ability to drive and use machines.
List of excipients with known effect
Important information about some of the ingredients of LANSOYL SANS SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin
sorbitol
Red cochineal A (E 124).
3. HOW TO TAKE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
Reserved for adults and children over 15 years old: one tablespoon to be renewed if necessary 1 to 3 times per 24 hours, without exceeding the maximum dosage of 3 spoon tables per 24 hours.
If treatment fails, do not increase the dosage, but take the advice of your doctor.
Method and route of administration
Oral use
Frequency of administration
Meals will be taken at a distance:
AT· Either preferably in the morning on an empty stomach;
AT· Either 2 hours before or after meals;
AT· If you take it in the evening, you should avoid alert yourself within two hours and take into account the risk of the laxative effect in the night.
Duration of treatment
The duration of use is limited to 10 days.
Symptoms and Instructions for Overdose
If you take more LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin you should not have:
Discontinue treatment and immediately consult your doctor or pharmacist.
An overdose may cause an excessive laxative effect and undesirable effects as mentioned in section 4.
Instructions for omission of one or more doses
If you forget to take LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharine sodium:
Do not take a double dose to make up for the missed dose.
Risk of withdrawal syndrome
If you stop taking LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium: not applicable.
If you have any further questions on the use of this medication, ask your pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, this medication can cause side effects, although not everybody gets them.
The following undesirable effects have been reported with an undefined frequency (can not be estimated on the basis of available data):
AT· Diarrha © e,
AT· Oily flow at the anus,
AT· Irritation in the anus.
In exceptional circumstances or because of misuse, possibilities of breathing problems ( see section "Precautions for use, special warnings" ).
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with saccharin sodium?
Keep out of the reach and sight of children.
Date of filing
Do not use LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral oral gel in saccharine sodium saccharin after the date of expiration mentioned on the carton. The expiry date refers to the last day of the month.
Storage conditions
This medication should be stored at a temperature not exceeding 25 ° C.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away at the sewer or with household garbage. Ask your pharmacist what to do with unused medications. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does LANSOYL WITHOUT SUGAR contain 78.23 g PERCENT, oral saccharine gel with saccharin sodium?
The active substance is:
Liquid paraffin ................................................ .................................................. 78.230 g
The other components are:
Lactulose syrup, sorbitol, citric acid monohydrate, gelatin, cochineal red A (E 124), aromatic composition, sodium saccharin, drinking water.
Pharmaceutical form and content
What is LANSOYL WITHOUT SUGAR 78.23 g PERCENT, oral saccharine gel with sodium saccharin and contents of the outer packaging?
This medication is in the form of an oral gel. Pot of 180 g or 215 g.
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
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
exploiting
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
Maker
FARMEA
10, RUE BOUCHER THOMAS
ZAC D'ORGEMONT
49007 ANGERS CEDEX 01
Names of medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicinal product can be found on the website of the ANSM (France).
Information for health professionals
Not applicable.
Other
SANITARY EDUCATION COUNCILS
What there is to know
Constipation is defined as decreased stool frequency below 3 per week.
This definition is not an absolute rule. Indeed, the usual duration of transit (feeding through the intestine) and therefore the frequency of stools varies greatly from one individual to another. It is therefore important to take into account the feeling of malaise or the disorders associated with this slowing of transit.
In the case of constipation, there may be discomfort in the abdomen (belly). It is difficult, if not painful, to go to the saddle. The expulsion of the stool seems incomplete. The stools are hard, scanty. Cramping or bloating may occur.
Occasional constipation is usually due to a change in daily habits (travel abroad, changes in diet, stress, ...), or to "self-restraint".
Eating habits and lifestyle (sedentariness) can also cause an imbalance in intestinal function that can lead to constipation over a longer period of time ( chronic constipation).
Other situations are likely to lead to constipation: taking certain medications (some anti-pain, antidepressants, antitussives, antacids based on aluminum ...); in women: certain periods of the menstrual cycle, pregnancy or menopause.
What you should not do
â ‡ ' You should not take yourself to treat constipation if:
AT· You are suffering from a bowel or colon disease (eg Crohn's disease, hemorrhagic rectocolitis),
AT· You have severe kidney disease, severe dehydration,
AT· You suffer from a pain in the belly whose cause is not determined,
AT· You are pregnant or nursing,
AT· You assume that your constipation is related to taking certain medications.
• Constipation should not be continued if symptoms persist or when constipation is accompanied by other conditions such as persistent pain in the abdomen, alternating episodes of constipation / diarrhea, mucus, involuntary defect (involuntary loss of stool).
In all these cases, seek the advice of your pharmacist or your doctor.
WARNINGS: if constipation is accompanied by: blood in the stool, vomiting and stopping of gas emission (occlusion), severe pain in the stomach, fever, weight loss. It is necessary to consult your doctor, indeed these signs can be symptoms of a more serious illness. |
What you can do yourself
Isolated constipation, although disagreeable, is trivial.
A few simple hygiene tips allow most often to facilitate intestinal transit and stool delivery:
â ‡ ' Eat green vegetables, rich in fiber, and fresh fruits, which promote transit.
You can also consume bread or biscuits to the full sound or cereals gradually and without abuse.
â Avoid food that is too greasy and too sweet.
‡ Drink sufficiently and regularly during the day (at least 1.5 liters / day): consume water, fruit juice and soups at will;
â € ¢ Put yourself in the bathroom at a fixed time (usually 30 to 60 minutes after meals) without making too much effort to "push". Your organization will get used to a regular schedule. It is also important that you take your time.
â ‡ ' Do not forget gymnastics and physical exercise like walking, excellent ways to fight against constipation.