NOTICE
ANSM - Updated on: August 1, 2023
Drug Name
ZINC-COPPER OLIGOSOL, oral solution in ampoules
Zinc gluconate / Copper gluconate
Box
Please read this package insert carefully before taking this medication, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this package insert. You may 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 listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What is in this package insert?
1. What is ZINC-COPPER OLIGOSOL, oral solution in ampoules, and what is it used for?
2. What should you know before taking ZINC-COPPER OLIGOSOL, oral solution in ampoules?
3. How should you take ZINC-COPPER OLIGOSOL, oral solution in ampoules?
4. What are the possible side effects?
5. How should you store ZINC-COPPER OLIGOSOL, an oral solution in ampoules?
6. Package contents and other information.
1. WHAT IS ZINC-COPPER OLIGOSOL, an oral solution in ampoules, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OLIGOTHERAPY (V: miscellaneous).
This medication is used as a constitutional regulator, particularly for functional disorders associated with puberty in children over 12 years of age, menopause, and premenstrual syndrome.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE taking ZINC-COPPER OLIGOSOL, oral solution in ampoules?
Never take ZINC-COPPER OLIGOSOL, oral solution in ampoules:
· If you are allergic (hypersensitive) to zinc gluconate, copper gluconate, or any of the other ingredients in this medication listed in Section 6.
Warnings and Precautions
Treatment with these trace minerals does not replace any specific treatment that may be necessary.
Consult your doctor or pharmacist before taking ZINC-COPPER OLIGOSOL, oral solution in ampoules.
Children
For adults and children over 12 years of age only.
Other Medications and ZINC-COPPER OLIGOSOL, Oral Solution in Ampoules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
ZINC-COPPER OLIGOSOL, oral solution in ampoules, with food and beverages
Not applicable.
Pregnancy and breastfeeding
As a precaution, avoid using this medication during pregnancy and while breastfeeding.
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medication.
Driving and operating machinery
Not applicable.
ZINC-COPPER OLIGOSOL, oral solution in ampoules, contains glucose
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication.
3. HOW should you take ZINC-COPPER OLIGOSOL, oral solution in ampoules?
FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE ONLY.
The recommended dose is 1 to 3 ampoules per day, usually 2 ampoules per day.
Oral use.
Sublingual administration is recommended: hold the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing.
The ampoules should be taken:
· preferably in the morning on an empty stomach,
· , if necessary, 15 minutes before a meal or at bedtime.
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Instructions for opening the ampoule:
Snap off both ends at the colored ring.
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If you have taken more ZINC-COPPER OLIGOSOL oral solution in ampoules than you should have:
No cases of overdose have been reported.
If you forget to take ZINC-COPPER OLIGOSOL, oral solution in ampoules
Not applicable.
If you stop taking ZINC-COPPER OLIGOSOL, oral solution in ampoules
Not applicable.
If you have any other questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package insert. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: www.signalement.sante.gouv.fr
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD ZINC-COPPER OLIGOSOL, oral solution in ampoules, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date printed on the packaging after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25 °C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ZINC-COPPER OLIGOSOL, oral solution in ampoules, contains
· The active ingredients are:
Zinc gluconate.............................................................................................................. 0.470 mg
(Corresponding amount of zinc..................................................................................... 0.0674 mg)
Copper gluconate........................................................................................................... 0.518 mg
(Corresponding amount of copper ................................................................................. 0.0726 mg)
Per 2-mL ampoule.
· The other ingredients are: anhydrous glucose, purified water.
What is ZINC-COPPER OLIGOSOL, oral solution in ampoules, and contents of the outer packaging
This medication is available as an oral solution in 2-mL ampoules, packaged 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 Allée Crovetto Frères
98000 MONACO
Manufacturer
LABCATAL
MONT-BLANC INDUSTRIAL PARK
1, RUE DE LINDUSTRIE
74106 ANNEMASSE CEDEX
Drug Names in Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information about this medication is available on the ANSM (France) website.