NOTICE
ANSM - Updated on : 01/08/2023
Product name
LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container
Lithium gluconate
Sidebar
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 LITHIUM OLIGOSOL, drinkable solution in ampoule or single-dose container and what is it used for?
2. What do I need to know before taking LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container?
3. How should LITHIUM OLIGOSOL be taken?
4. What are the possible side effects?
5. How to store LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container?
6. Package contents and other information.
1. WHAT IS LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OLIGOTHERAPY (V: miscellaneous).
This drug is used as a ground modifier, particularly for minor psychic or psychosomatic symptoms in children over 6 and adults (mild sleep disorders, irritability).
2. WHAT DO I HAVE TO KNOW BEFORE taking LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container?
Never take LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container:
- If you are allergic (hypersensitive) to lithium gluconate or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Certain character or behavioral disorders require high doses of lithium. Lithium in trace element form has no place in the treatment of these disorders.
Renal tumours: Patients with severe renal insufficiency who have received lithium for more than 10 years may be at risk of developing malignant or benign renal tumours (microcysts, oncocytomas and renal tubular carcinomas).
LITHIUM OLIGOSOL, oral solution in ampoules or single-dose containers should not generally be used during pregnancy(see Pregnancy and breast-feeding).
Treatment with this trace mineral does not dispense with any specific treatment.
Ask your doctor or pharmacist before taking LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container.
Children
In children, behavioural or sleep disorders should be discussed with your doctor.
Other medicinal products and LITHIUM OLIGOSOL, solution for drinking in phials or single-dose containers
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container 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 breastfeeding, 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.
LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container contains glucose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
3. HOW TO TAKE LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container?
FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE ONLY.
Adults: 2 to 4 ampoules or single-dose containers per day.
Children: 1 to 2 ampoules or single-dose containers per day.
Oral administration.
Sublingual administration is recommended: keep the contents of the ampoule or single-dose container under the tongue for 1 to 2 minutes before swallowing.
Ampoules or single-dose containers should be taken :
- preferably in the evening at bedtime,
- 15 minutes before a meal or in the morning on an empty stomach.
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Instructions for opening the ampoule :
Break off the 2 tips at the colored ring.
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Instructions for opening single-dose container :
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1. Detach single-dose container from clip.
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2. Open one dose by turning the tip.
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3. Squeeze the contents of the single-dose container firmly into the mouth, under the tongue (2 squeezes are usually required).
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If you have taken more LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container than you should have :
No case of overdose has been reported.
If you forget to take LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container
Not applicable.
If you stop taking LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container
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.
The following effects may occur:
Undetermined frequency:
- Skin or mucous membrane rash (drug-induced lichenoid reaction)
- Benign/malignant renal tumors (microcysts, oncocytoma and renal tubular cell carcinoma) (in long-term therapy).
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 Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE LITHIUM OLIGOSOL, oral solution in ampoule or single-dose container?
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.
Glass ampoule packaging: Store at temperatures not exceeding 25°C.
Single-dose container (polyethylene): store at a temperature not exceeding 30°C.
Do not dispose of any medication in the sewer or with household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What LITHIUM OLIGOSOL oral solution in ampoule or single-dose container contains
- The active substance is :
Lithium gluconate............................................................................................................ 8.14 mg
(Corresponding lithium quantity................................................................................ 0.2796 mg)
For one ampoule or single-dose container of 2 ml.
- Other ingredients: glucose, purified water.
What LITHIUM OLIGOSOL is and what it contains
This medicine comes in the form of an oral solution in ampoules or 2 ml single-dose containers.
Box of 14 or 28 ampoules.
Box of 30 single-dose containers.
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 subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.