Microlax for Infants and Children is a laxative that softens stools and triggers the urge to have a bowel movement (defecation). Microlaxfor Infants and Children is used to treat occasional constipation.
For warnings, precautions, and contraindications, please refer to the package insert.
Microlax Baby and Child is a laxative specially formulated for young children to soften stools and trigger the bowel movement reflex (defecation). It is used to treat occasional constipation in babies and children.
Gentle Relief: Occasional constipation can be uncomfortable for young children. Microlax Baby and Child offers gentle relief by helping to soften stools and trigger the bowel movement reflex.
Ease of Use: Microlax for Babies and Children is easy to use, providing a solution tailored to the needs of the youngest children.
Appropriate Dosage: Follow the instructions on the package for the dosage appropriate for your child’s age. In general, Microlax for Infants and Children is effective in treating occasional constipation.
Quick Relief: This laxative works quickly to help your child regain bowel comfort.
Microlax Baby is recommended as a symptomatic treatment for certain forms of constipation, in addition to lifestyle and dietary measures, and as preparation for certain medical procedures (rectoscopy).
In most cases, constipation in children is benign. It is simply due to a slowing of bowel transit, meaning stools move too slowly through the colon. It may be related to:
Rectal administration
Read the package insert carefully
Box of 4 single-dose containers.
Please note: This medication is not like other products. Read the package insert carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated: 21/09/2015
Description of the Medicine
MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose recipient
70% Sorbitol crystallizable / sodium citrate / sodium laurilsulfoacetate 70%
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Please read this leaflet carefully before you start using this medication. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
AT· Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
AT· If symptoms worsen or persist, consult a physician.
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 MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose recipient AND WHAT IT IS USED FOR?
2. BEFORE YOU USE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose recipients?
3. HOW TO USE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in unidose recipient?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose?
6. ADDITIONAL INFORMATION
1. WHAT IS MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose recipient AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ENEMA
Therapeutic Indications
This medication is prescribed as a symptomatic treatment for certain forms of constipation and as a preparation for certain examinations (rectoscopy).
2. BEFORE YOU USE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose recipients?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE Rectal solution in single dose in the following case:
AT· If your child is allergic (hypersensitive) to any of the active ingredients (sorbitol, sodium citrate or sodium lauryl sulfate) or any of the other ingredients of this medication,
AT· or if your child is suffering from abdominal pain, the cause of which is unknown.
IN CASE OF DOUBT, IT IS NECESSARY TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Employment precautions; special warnings
Take special care with MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose :
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE
Occasional constipation
It may be related to a recent change in lifestyle (travel). The medication can be an aid in short treatment. Any recent constipation unexplained by lifestyle change, any constipation accompanied by pain, fever, swelling of the belly should have the physician's opinion sought.
Chronic constipation (long-lasting constipation)
It can be related to two causes:
AT· a disease of the intestine that requires management by the physician,
AT· or to an imbalance in intestinal function due to eating habits and lifestyle.
Treatment includes:
AT· an increase in dietary intakes of products of vegetable origin (green vegetables, raw vegetables, whole bread, fruits ...);
AT· increased consumption of water and fruit juices;
AT· an increase in physical activities (sports, walking, etc.);
AT· a re-education of the defecation reflex;
AT· sometimes, the addition of his to the diet.
It is helpful to seek advice from your doctor or pharmacist.
Employment Precautions
Use this medication WITH CAUTION if:
AT· hemorrhoidal thrust,
AT· anal fissure,
AT· Hemorrhagic rectocolitis.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Taking or using other medicines:
MICROLAX BEBE is disinfectant in combination with catoresine sulfo sodium (oral and rectal).
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
MICROLAX BEBE is not intended for the adult.
However, when used in exceptional circumstances in women of childbearing age, the following points should be recalled:
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor.
If you are pregnant or nursing, planning to become pregnant or planning a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Ask your doctor or pharmacist for advice before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
This medication has no or negligible effect on the ability to drive and use machines.
List of excipients with known effect
Not applicable
3. HOW TO USE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in unidose recipient?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
Treatment of constipation: 1 single dose per day.
Preparation for endoscopic examinations of the rectum: 1 unidose recipient administered 5 to 20 minutes before the chosen time for the saddle.
Method and route of administration
This medication is administered rectally.
Manual :
It is not necessary to be stretched to administer the product or to wait until it produces its effect.
This medication usually works in 5 to 20 minutes ; a longer delay (greater than 1 hour) can be observed in the altered subjects.
Duration of treatment
No prolonged use without medical advice.
Symptoms and Instructions for Overdose
If you have used more MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in unidose recipe that you should not have:
Prolonged use can give rise to sensations of anal burns and exceptionally, congestive rectitions.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
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 unknown frequency:
AT· Abdominal pain
AT· Anorectal and / or rectal abnormalities
AT· Liquid stools
AT· Allergic reactions (urticaria)
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 Pharmacovigilance Regional Centers
By reporting undesirable effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose?
Keep out of sight and reach of children.
Date of filing
Do not use MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose after the expiration date stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
Storage conditions
Keep at a temperature not exceeding 25Â ° C.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away or washed away 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 MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE contain rectal solution in single dose?
The active substances are :
Sorbitol with 70% crystallizable ............................................. .................................................. ............ 2.6790 g
Sodium citrate ............................................... .................................................. .......................... 0.2700 g
Sodium Laurilsulfoacetate 70% .......................................... .................................................. ..... 0.0387 g
For a single-dose recipient
The other components are :
Sorbic acid, glycerol, purified water.
Pharmaceutical form and content
What is MICROLAX BABY SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single doses and contents of the outer packaging?
This medication is in the form of a rectal solution in single-dose recipients; box of 4, 6, 50 or 200 single dose receptacles.
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
FAMAR ORLEANS
5, avenue de Concyr
45071 ORLEANS CEDEX 2
Names of medicines in the Member States of the European Economic Area
In compliance with the regulations in force.
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 medication can be found on the website of the ANSM (France).
Information for health professionals
Not applicable.
Other
Not applicable.
Rectal Laxative
sorbitol, sodium citrate, sodium lauryl sulphoacetate
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
MICROLAX: rectal solution; box of 4 single-dose containers of 5 ml.
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MICROLAX: rectal solution; box of 12 single-dose containers of 5 ml.
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MICROLAX BAB: rectal solution; box of 4 single-dose containers of 3 ml.
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Laboratory
| AT | p unidose | p unidose Baby |
| Sorbitol (70% solution) | 4,465 g | 2,679 g |
| Sodium citrate | 450 mg | 270 mg |
| Sodium Lauryl Sulfoacetate | 64.5 mg | 38.7 mg |
Usual dosage:
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