NOTICE
ANSM - Last updated: 17/08/2017
Name of the medicinal product
GELOX, oral suspension in sachet
Monmectite, Aluminum Hydroxide, Magnesium Hydroxide
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 contact your doctor if you experience no improvement or feel less well after 7 days of treatment.
What is in this leaflet?
1. What is GELOX, oral suspension in sachets and in which cases it is used?
2. What should I know before taking GELOX oral suspension in sachets?
3. How to take GELOX, oral suspension in sachets?
4. What are the possible side effects?
5. How to store GELOX, oral suspension in sachets?
6. Package contents and other information.
1. WHAT IS GELOX, oral suspension in sachets AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: Antacid, other combination - ATC code: A02AX.
This medication is indicated in the pain, burns or chills of the stomach or esophagus in adults.
2. BEFORE YOU TAKE GELOX, oral suspension in sachet?
Do not take GELOX, oral suspension in sachets:
· If you are allergic to monmectite, aluminum hydroxide (expressed as Al 2 O 3 ) or magnesium hydroxide (expressed as MgO) or any of the other ingredients of this medication mentioned in 6.
· If you have severe renal insufficiency (kidney function failure)
· If you suffer from stenosis (narrowing) of the digestive tract.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking GELOX, oral suspension in sachets .
Drug use is discouraged in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicinal product contains 2.5 g of sucrose per sachet which must be taken into account in the daily diet in the case of a low-sugar diet or diabetes.
This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and may cause allergic reactions.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary diseases).
This drug contains 2.4% ethanol (alcohol), ie up to 230 mg per sachet, equivalent to 7.2 ml of beer, 3 ml of wine per sachet. The use of this medication is dangerous in alcoholics and should be taken into account in pregnant or lactating women, children and high risk groups such as hepatic insufficiency or epileptics.
If you take this medication without a prescription and your symptoms persist after 7 days of treatment take the advice of your doctor.
Tell your doctor if you have kidney dialysis.
Other medicines and GELOX, oral suspension in sachet
Antacids can decrease the effect of many other drugs. You should always report any other medications you are taking to your doctor or pharmacist.
As a precaution, antacid and other medicines should not be taken at the same time. This other medication can be taken at a distance from the antacid (for example 2 hours before).
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including quinidine medicines.
Gelox, oral suspension in sachets with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication may be prescribed during pregnancy and lactation, if necessary.
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.
Driving and using machines
Not applicable.
GELOX, oral suspension in sachet contains: sucrose, sorbitol, ethanol (alcohol), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
3. HOW TO TAKE GELOX, oral suspension in sachets?
Dosage
1 sachet to take at the time of the pains.
Method and route of administration
Oral use.
Mix well before opening the sachet. The contents of the sachet can be swallowed pure or diluted in half a glass of water.
Frequency and Timing of Medication
This medicine should be taken at the time of the pain, without exceeding 6 catches per day.
The duration of treatment should not exceed 7 days without medical advice.
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.
If you take more GELOX, oral suspension in sachet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take GELOX, oral suspension in sachet
Not applicable.
If you stop taking GELOX, 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.
· In case of prolonged use or in high doses, a decrease in the level of phosphorus in the blood may occur.
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 GELOX, oral suspension in sachet?
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 after EXP. The expiry date refers to the last day of that month.
Do not throw any medication into drains < or with household garbage>. 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 GELOX contains, oral suspension in sachets
· The active substances are:
Monmectite ................................................. .................................................. 2,500 g
Aluminum hydroxide (expressed as Al 2 O 3 ) ...................................... ................................ 0.425 g
Magnesium hydroxide (expressed in MgO) .......................................... ........................ 0.450 g
For a bag
· The other components are: Sucrose, 70% sorbitol crystallizable, flavor, alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), levomenthol, purified water.
What is GELOX, oral suspension in sachet and contents of the pack
This medication is in the form of a drinkable suspension in a sachet. Box of 24, 30, 60, 90 or 120 sachets.
Marketing Authorization Holder
IPSEN PHARMA
65, quai georges gorse
92100 boulogne-billancourt
Marketing Authorization Operator
IPSEN PHARMA
65, quai georges gorse
92100 boulogne-billancourt
Maker
BEAUFOUR IPSEN PHARMA
Rue ethe virton
28100 dreux
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:
month YYYY.
Other
Detailed information on this medicine is available on the ANSM website (France).