NOTICE
ANSM - Last updated: 19/06/2017
Name of the medicinal product
DERMOCUIVRE, ointment
Copper sulphate, zinc oxide
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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is DERMOCUIVRE, Ointment and in which cases it is used?
2. What do you need to know before using DERMOCUIVRE, ointment?
3. How to use DERMOCUIVRE, ointment?
4. What are the possible side effects?
5. How to preserve DERMOCUIVRE, ointment?
6. Package contents and other information.
1. WHAT IS DERMOCUIVRE, Ointment AND WHAT IT IS USED FOR?
Pharmacotherapeutic group CUTANEOUS PROTECTOR (D. Dermatology) - ATC code: D02AB
This medication is recommended in the treatment of skin irritations.
2. WHAT TO DO ABOUT BEFORE USING DERMOCUIVRE, ointment?
Do not use DERMOCUIVRE, Ointment:
· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· Infected lesions.
· Oozing lesions.
Warnings and Precautions
Talk to your doctor or pharmacist before using DERMOCUIVRE, ointment.
Avoid application on the mucous membranes.
This medication contains wool fat (Lanolin) and may cause local skin reactions (eg eczema).
children
Not applicable.
Other medicines and DERMOCUIVRE, ointment
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DERMOCUIVRE, ointment with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
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 medicine.
This medication should be used with caution during pregnancy or lactation.
Driving and using machines
Not applicable.
DERMOCUIVRE, ointment contains wool fat (Lanolin).
3. HOW TO USE DERMOCUIVRE, Ointment?
Always use 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.
Dosage
Apply locally 2 to 3 times a day.
Method and route of administration
Dermal.
If you used more DERMOCUIVRE, ointment than you should:
Immediately consult your doctor or pharmacist.
If you forget to use DERMOCUIVRE, ointment:
Not applicable.
If you stop using DERMOCUIVRE, ointment:
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.
Especially :
· allergy to any of the constituents of the product (wool fat or lanolin, ...).
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 DERMOCUIVRE, Ointment?
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 outer packaging after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
Keep the tube in the outer carton, protected from light.
Do not use this medication if you notice any signs of deterioration.
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 DERMOCUIVRE contains, ointment
· The active substances are:
Copper sulphate pentahydrate .............................................. ............................................ 0.20 g
Zinc oxide............................................... .................................................. 10.00 g
For 100 g of ointment.
· The other excipients are:
Liquid paraffin, petroleum jelly, wool grease, purified water.
What is DERMOCUIVRE, ointment and contents of the pack
This medication is in the form of an ointment.
Tube of 25 g or 100 g.
Not all pack sizes may be marketed.
Marketing Authorization Holder
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER CEDEX 2
Marketing Authorization Operator
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER CEDEX 2
Maker
CHAUVIN LABORATORY
ZI RIPOTIER HAUT
07200 AUBENAS
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]
{MM / YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).