NOTICE
ANSM - Last updated: 19/12/2016
Name of the medicinal product
MOXYDAR, oral suspension in sachet
Aluminum oxide hydrate, aluminum phosphate, magnesium hydroxide, coated guar gum
framed
Do not use this medication for children.
What is in this leaflet?
1. What is MOXYDAR, oral suspension in sachets and in which cases is it used?
2. What should be known before taking MOXYDAR, oral suspension in sachets?
3. How to take MOXYDAR, oral suspension in sachets?
4. What are the possible side effects?
5. How to store MOXYDAR, oral suspension in sachets?
6. Package contents and other information.
1. WHAT IS MOXYDAR, oral suspension in sachets AND WHAT USES IS USED FOR?
Pharmacotherapeutic group ANTI-ACID - ATC code: A02AD01
(A: digestive system)
This medication is indicated in the pain, burning or choking of the stomach or esophagus and the symptomatic treatment of gastroesophageal reflux disease.
You should talk to your doctor if you do not feel better or feel less well.
2. BEFORE YOU TAKE MOXYDAR, oral suspension in sachet?
Never take MOXYDAR, oral suspension in sachets:
· In case of severe kidney disease (failure of the functions of the kidney).
· if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MOXYDAR, oral suspension in sachets.
Special warnings
If the disorders do not go away within 7 days, you should consult your doctor.
If the pain is associated with a fever, vomiting, consult your doctor immediately .
Precautions for use
DO NOT TAKE THIS MEDICINE WITHOUT MEDICAL ADVICE in case of chronic dialysis.
Anti-acids can decrease the effect of many drugs. You should always report any other medications you are taking to your doctor or pharmacist.
As a precaution, this drug should be taken at a distance from other medicines (2 hours apart if possible).
In addition to the use of this medication, it is recommended to follow certain hygiene-dietetic rules:
· avoid going to bed immediately after meals,
· do not sleep flat (elevate the head of the bed to decrease the frequency of night reflux);
· avoid prolonged work, bend leaning forward (cleaning, gardening ...),
· avoid over-abundant meals.
children
Not applicable.
Other medicines and MOXYDAR, oral suspension in sachet
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
MOXYDAR, oral suspension in sachets with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
This medication will only be used during pregnancy on the advice of your doctor.
feeding
This medication may be prescribed during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
MOXYDAR oral suspension in sachet contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217)
3. HOW TO TAKE MOXYDAR, oral suspension in sachet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Symptomatic treatment of pain associated with oeso-gastroduodenal disorders
The recommended dose is one sachet at the time of the painful attacks without exceeding 4 catches per day.
Symptomatic treatment of gastroesophageal reflux:
· In attack period: 1 sachet after each of the 3 meals and one additional in case of pain for 4 to 6 weeks;
· For maintenance treatment: 1 sachet at the time of the pain.
Administration mode
Oral use.
Duration of treatment
The duration of treatment varies according to the symptomatology.
Use in children
Not applicable.
If you take more MOXYDAR, oral suspension in sachet than you should:
Immediately consult your doctor or pharmacist.
High doses of aluminum may increase the risk of phosphate depletion, constipation, or even intestinal obstruction.
Patients with renal insufficiency may present a risk of hypermagnesemia.
If you forget to take MOXYDAR, oral suspension in sachet:
Not applicable.
If you stop taking MOXYDAR, oral suspension in sachet:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Constipation / Diarrhea
· Decreased phosphorus levels in the blood, in prolonged use or at high doses
· Due to the presence of parahydroxybenzoates, this drug may cause urticaria.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 MOXYDAR, oral suspension in sachets?
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 package. The expiry date refers to the last day of that month.
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 MOXYDAR contains, oral suspension in sachets
· the active substances are:
Aluminum oxide hydrate ............................................. .................................................. 500.00 mg
Aluminum phosphate .............................................. .................................................. ..... 300.00 mg
Magnesium hydroxide ............................................... .................................................. 500.00 mg
Coated guar gum ............................................... .................................................. ....... 200.00 mg
Quantity corresponding to guar gum ............................................. 198.20 mg
· The other components are:
(E219), sodium propyl parahydroxybenzoate (E217), sodium cyclamate, sodium saccharin, mint flavoring, purified water
What is MOXYDAR, oral suspension in sachet and contents of the pack
This medication is in the form of a drinkable suspension in a sachet-dose. Box of 30 bags of 20 ml.
Marketing Authorization Holder
LABORATOIRES GRIMBERG SA
19 RUE POLIVEAU
75005 PARIS
Marketing Authorization Operator
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, STREET VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
Maker
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, STREET VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
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
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).