NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
VASELINE OFFICINALE COOPER, ointment
vaseline
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use 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 VASELINE OFFICINALE COOPER, ointment and in which cases it is used?
2. What should be known before using VASELINE OFFICINALE COOPER, ointment?
3. How to use VASELINE OFFICINALE COOPER, ointment?
4. What are the possible side effects?
5. How to store VASELINE OFFICINALE COOPER, ointment?
6. Package contents and other information.
1. WHAT IS VASELINE OFFICINALE COOPER, Ointment AND WHAT IT IS USED FOR?
Supplemental treatment of irritation and dryness lesions.
Pharmacotherapeutic group CUTANEOUS PROTECTOR (D. Dermatology) - ATC code: D02AC
2. BEFORE YOU USE VASELINE OFFICINALE COOPER, Ointment?
Never use VASELINE OFFICINALE COOPER, ointment in the following cases:
· Infected lesions.
Warnings and Precautions
External use.
The persistence of the symptoms, the aggravation or the appearance of new disorders require to take a medical opinion.
Other medicines and VASELINE OFFICINALE COOPER, ointment
This medication MUST NOT BE ADMINISTERED in combination with latex condoms.
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
VASELINE OFFICINALE COOPER, ointment with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This medication under normal conditions of use can be used during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or your pharmacist before using this medication.
Driving and using machines
Not applicable.
VASELINE OFFICINALE COOPER, ointment contains:
Not applicable.
3. HOW TO USE VASELINE OFFICINALE COOPER, Ointment?
Dosage
2 to 3 applications per day.
Method and route of administration
DERMAL
If you used more than VASELINE OFFICINALE COOPER, ointment you should not have
Not applicable.
If you forget to use VASELINE OFFICINALE COOPER, ointment
Not applicable.
If you stop using VASELINE OFFICINALE COOPER, ointment
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
· Possible allergic reaction
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 COASTAL OFFICIAL VASELINE, 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.
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 VASELINE OFFICINALE COOPER contains, ointment
· The active substance is:
Vaseline ................................................. .................................................. ........................ 100 g
For 100 g of ointment
· The other components are:
Not applicable.
What is VASELINE OFFICINALE COOPER, ointment and contents of the pack
This medication is in the form of an ointment, a tube of 20 g, 45 g, 80 g and 100 g.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
LIPHA LABORATORIES
115 AVENUE LACASSAGNE
69003 LYON
or
FRENCH PHARMACEUTICAL COOPERATION
2 RUE DE LA SAUSSAIE
77310 SAINT FARGEAU PONTHIERRY
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]
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).