NOTICE
ANSM - Updated on : 01/08/2023
Name of medicinal product
MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule
Manganese gluconate / Cobalt gluconate
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any undesirable 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 do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule and what is it used for?
2. What do I need to know before taking MANGANESE-COBALT OLIGOSOL, solution for drinking in phials?
3. How should MANGANESE-COBALT OLIGOSOL be taken?
4. What are the possible side effects?
5. How should MANGANESE-COBALT OLIGOSOL be stored?
6. Package contents and other information.
1. WHAT IS MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OLIGOTHERAPY (V: miscellaneous).
This drug is used in adults as a ground modifier, particularly during states of neurovegetative dystonia.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING MANGANESE-COBALT OLIGOSOL, oral solution in ampoule?
Never take MANGANESE-COBALT OLIGOSOL, solution for drinking in phials:
- If you are allergic to manganese gluconate, cobalt gluconate or any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking MANGANESE-COBALT OLIGOSOL, solution for drinking in phials.
This medicine is not recommended for patients with glucose-galactose malabsorption syndrome.
Children
Not applicable.
Other medicinal products and MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MANGANESE-COBALT OLIGOSOL, solution for drinking in phials with food and drink
Not applicable.
Pregnancy and breast-feeding
As a precautionary measure, this drug should not be used during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
MANGANESE-COBALT OLIGOSOL, solution buvable en ampoule contains glucose.
3. HOW SHOULD MANGANESE-COBALT OLIGOSOL be taken?
FOR ADULTS ONLY.
1 to 2 phials per day.
To be taken orally.
Sublingual administration is recommended.
Ampoules should be taken :
- preferably in the morning on an empty stomach,
- 15 minutes before a meal or in the evening at bedtime.
Keep the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing.
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Instructions for opening ampoule :
Break off the 2 tips at the coloured ring.
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If you have taken more MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule than you should have :
No case of overdosage has been reported.
If you forget to take MANGANESE-COBALT OLIGOSOL, oral solution in ampoule :
Not applicable.
If you stop taking MANGANESE-COBALT OLIGOSOL, oral solution in ampoule :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE MANGANESE-COBALT OLIGOSOL, oral solution in ampoule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Store at temperatures below 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What MANGANESE-COBALT OLIGOSOL ampoule contains
- The active ingredients are :
Manganese gluconate.................................................................................................. 0.590 mg
(Corresponding manganese quantity......................................................................... 0.0728 mg)
Cobalt gluconate.......................................................................................................... 0.553 mg
(Corresponding cobalt quantity................................................................................. 0.0726 mg)
For one 2-ml ampoule.
- Other components: anhydrous glucose and purified water.
What MANGANESE-COBALT OLIGOSOL is and what it contains
This medicine comes in the form of an oral solution in 2 ml ampoules, in boxes of 14 or 28 ampoules.
Marketing authorization holder
LABCATAL
1198 AVENUE DU DOCTEUR MAURICE DONAT
ZAC DU FONT DE LORME
06250 MOUGINS
Marketing authorization holder
LABORATOIRE DES GRANIONS
LE PARADOR II
5 ALLEE CROVETTO FRERES
98000 MONACO
Manufacturer
LABCATAL
ZONE INDUSTRIELLE DU MONT-BLANC
1, RUE DE LINDUSTRIE
74106 ANNEMASSE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.