NOTICE
ANSM - Last updated: 29/05/2017
Name of the medicinal product
MELAXOSE, potted oral paste
Lactulose / Liquid Paraffin / Vaseline
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 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.
What is in this leaflet?
1. What is MELAXOSE, a potted oral paste and in which cases it is used?
2. What do you need to know before taking MELAXOSE, a potted oral paste?
3. How to take MELAXOSE, oral potted paste?
4. What are the possible side effects?
5. How to store MELAXOSE, a potted oral paste?
6. Package contents and other information.
1. WHAT IS MELAXOSE, an oral potted paste AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OSMOTIC LAXA - ATC code: A06AD61.
MELAXOSE works by softening the faeces and increasing the water content of materials in a part of the bowel called colon.
This medication is used to treat the symptoms of constipation in adults.
2. BEFORE YOU TAKE MELAXOSE, oral potted paste?
Do not take MELAXOSE, oral potted paste:
· If you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· If you suffer from chronic inflammation of the bowel and colon, such as ulcerative colitis, Crohn's disease,
· If you suffer from a complete or partial obstruction of the intestines,
· If you suffer or may suffer from a perforation of the digestive tract,
· In case of abdominal pain (stomach pains),
· In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MELAXOSE, a potted oral paste.
IN THE CONTEXT OF CONSTIPATION, NO EXTENDED USE (ABOVE 8 DAYS) WITHOUT MEDICAL ADVICE.
Do not use MELAXOSE, oral potassium in a child because this medication has been studied only in adults.
If you are at risk for electrolyte imbalance (eg if you have a kidney or liver malfunction or are treated with a drug that increases urine production), as MELAXOSE can cause diarrhea will exacerbate this risk of imbalance.
If you have to lie down or have difficulty swallowing, because the paraffin contained in MELAXOSE can pass into the lungs and cause lung disease called oily lung disease.
Occasional constipation
It may be related to a recent change in lifestyle (eg travel).
The drug may be an aid in short treatment. Any recent constipation unexplained by the change of lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation)
It can be linked to two causes:
· Either a bowel disease that requires management by the doctor,
· Either an imbalance of intestinal function due to eating habits and lifestyle.
Treatment includes:
· Increased dietary intakes of vegetable products (green vegetables, raw vegetables, whole-wheat bread, fruit);
· Increased consumption of water and fruit juices;
· Increased physical activity (sports, walking);
· Rehabilitation of the defecation reflex;
· Sometimes the addition of sound to the diet.
The administration of paraffin oil in persons who are elongated or have difficulty in swallowing should be cautious because of the risk of bronchial inhalation.
Precautions for use
This medication should be used with caution in case of liver or kidney disease and in parents treated with diuretics.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other medicines and MELAXOSE, potted oral paste
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
Prolonged use of MELAXOSE may decrease the absorption of fat-soluble vitamins (vitamins A, D, E, K).
MELAXOSE, oral potted paste with food and beverages
Not applicable.
Pregnancy and breast feeding
It is best not to use MELAXOSE during pregnancy. 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.
Driving and using machines
Not applicable.
MELAXOSE, potted oral paste contains Aspartam (E951).
3. HOW TO TAKE MELAXOSE, potted oral paste?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Dosage
Reserved for adults only.
The recommended dose is 1 to 3 measuring spoons (teaspoons), in a single dose preferably in the evening.
Attack treatment: 2 to 3 measuring spoons (teaspoons) per day.
Maintenance treatment: 1 to 3 measuring spoons (teaspoons) per day.
Adjust the number of measuring spoons according to your symptomatology.
The effects of MELAXOSE usually occur within 6 to 8 hours of dosing.
If you see no improvement, consult your doctor or pharmacist.
If diarrhea occurs, decrease the amount of MELAXOSE you are taking. If the diarrhea does not stop, stop taking MELAXOSE and consult your doctor.
If you feel that the effect of MELAXOSE is too strong or too weak, talk to your doctor or pharmacist.
The duration of treatment varies according to the symptomatology.
Method and route of administration
Oral use.
Do not take MELAXOSE while you are lying down or just before going to bed.
If you have taken more MELAXOSE, potted oral paste than you should have
Consult your doctor or pharmacist.
If you forget to take MELAXOSE, oral potted paste
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you stop taking MELAXOSE, orally potted
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Bloating, semi-fluid stools. These phenomena can occur at the beginning of treatment but they generally cease after adjustment of the dosage.
· Rare cases of pruritus, anal pain and moderate weight loss.
· The use of paraffin oil exposes the risk of anal seepage and sometimes peri-anal irritation.
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 MELAXOSE, potted oral paste?
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 outer packaging after EXP. The expiry date refers to the last day of that month .
Store 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 MELAXOSE Contains, Potted Oral Paste
· The active substances are:
Lactulose ................................................. .................................................. .................. 35.00 g
Quantity corresponding to:
Vaseline ................................................. .................................................. .................... 21.45 g
Liquid paraffin ................................................ .................................................. ......... 42.91 g
For 100 g of oral paste
· The other components are:
Aspartam (E951), cholesterol, lactic acid, bixin oil, mandarin essential oil, lemon essential oil, sweet orange essential oil.
What is MELAXOSE, oral paste in pot and contents of the pack
This medication is in the form of bright, yellow to orange-yellow, opaque, compact, finely granular oral paste.
This medication is available in 100 g, 150 g or 200 g jars with or without measuring spoon graduated to 2.5 ml and 5 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Marketing Authorization Operator
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Maker
BIOCODEX
1, AVENUE BLAISE PASCAL
60000 BEAUVAIS
LA FRANCE
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]
Other
Detailed information on this medicine is available on the ANSM website (France).