NOTICE
ANSM - Updated on: 16/09/2015
Name of the medicinal product
LANSOYL FRAMBOISE oral gel in single dose container
Liquid Paraffin
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· 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 or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Review summary
In this notice :
1. WHAT IS LANSOYL RASPBERRY, oral gel in single-dose containers AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE LANSOYL FRAMBOISE oral gel in single dose container?
3. HOW TO TAKE LANSOYL FRAMBOISE oral gel in a single dose container?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LANSOYL RASPBERRY, oral gel in single dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS LANSOYL RASPBERRY, oral gel in single-dose containers AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
LUBRICANTS LUBRICANTS
(A: digestive system and metabolism)
Liquid paraffin acts by mechanical action by lubricating the contents of the colon and by softening the stools.
Therapeutic indications
Treatment of occasional constipation.
2. BEFORE YOU TAKE LANSOYL FRAMBOISE oral gel in single dose container?
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 LANSOYL FRAMBOISE oral gel in single dose containers:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6,
· if you suffer from abdominal pain that you do not know the cause,
· if you have swallowing difficulties (swallow properly) due to 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.
Precautions for use; special warnings
Take special care with LANSOYL FRAMBOISE oral gel in single dose container:
Special warnings
Warnings
In children the administration of laxatives should be exceptional, consult your doctor.
Do not use this medication for long periods of time. the prolonged use of liquid paraffin is likely to reduce the absorption of fat-soluble vitamins (A, D, E, K).
The drug treatment of constipation is only an adjunct to the hygiene-dietetic treatment which consists of:
· an enrichment of the diet of vegetable fibers and drinks,
· the practice of physical activity,
· the rehabilitation of the defecation reflex.
In case of chronic constipation, which may be related to bowel disease or an imbalance of intestinal function due to eating habits and lifestyle, TAKE ADVICE OF YOUR DOCTOR.
Precautions for use
The administration of liquid paraffin in young children, bedridden patients or those with difficulty in swallowing should be cautious as it may cause bronchial passage and respiratory problems.
· This medication contains an azo dye (cochineal red A, E124) and may cause allergic reactions.
· The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases). This medicinal product contains 2.3 g of sucrose per single-dose container (9 Kcal / unidose), which must be taken into account in the daily diet in the case of a low-sugar diet or diabetes.
Interaction with other medicines
Use of other medicines
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
Not applicable.
Interactions with Herbal Medicines 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 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 medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
LANSOYL FRAMBOISE has no or negligible influence on the ability to drive and use machines.
List of excipients with known effect
Important information about some of the ingredients of LANSOYL FRAMBOISE oral gel in a single-dose container: sucrose (2.3 g per unidose), cochineal red A (E 124)
3. HOW TO TAKE LANSOYL FRAMBOISE oral gel in a single dose container?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN FROM 12 YEARS.
· Adult: unidose to be renewed if necessary 1 to 3 times per 24 hours, without exceeding the maximum dose of 3 unidoses per 24 hours.
· Child: according to medical opinion.
If the treatment fails, do not increase the dose, but take the advice of your doctor.
Method and route of administration
Oral use.
Frequency of Administration
The intake will be at a distance from meals:
· preferably in the morning on an empty stomach;
· 2 hours before or after meals;
· if you take it in the evening, you should avoid being treated 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 15 days.
Symptoms and Instructions for Overdose
If you take more LANSOYL RASPBERRY, oral gel in a single dose container you should not have:
Stop treatment and see your doctor or pharmacist immediately.
An overdose may cause an excessive laxative effect and adverse effects as mentioned in section 4.
Instructions for omission of one or more doses
If you have forgotten to take LANSOYL FRAMBOISE oral gel in a single dose container:
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, this medicine may cause side effects, although not everybody gets them.
The following adverse reactions have been reported with an indeterminate frequency (can not be estimated from the available data):
· Diarrhea,
· Oily flow at the anus,
· Irritation in the anus.
In exceptional conditions or because of misuse, possibilities for respiratory problems ( see section "Precautions for use, special warnings" ).
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. 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 LANSOYL RASPBERRY, oral gel in single dose container?
Keep out of the reach and sight of children.
Expiration date
Do not use LANSOYL RASPBERRY, oral gel in single dose container after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month.
Storage conditions
This medicine should be stored at a temperature below 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 LANSOYL FRAMBOISE contain, oral gel in a single dose container?
The active substance is :
Liquid paraffin ................................................ .................................................. ... 11734 g
For a single-dose container.
The other components are :
Sucrose, citric acid monohydrate, gelatin, cochineal red A (E 124), aromatic composition, drinking water
Pharmaceutical form and content
What is LANSOYL FRAMBOISE oral gel in single-dose containers and contents of the pack?
This medicinal product is in the form of an oral gel in single-dose containers. Boxes of 9, 10, 100 and 220 unidose containers.
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 BOUCHE THOMAS
ZAC D'ORGEMONT
49007 ANGERS CEDEX 01
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).
Information for health professionals only
Not applicable.
Other
Not applicable.