NOTICE
ANSM - Updated on : 08/11/2024
Product name
GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream
Glycerol/Vaseline/Paraffin liquid
Box
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 after 30 days.
What does this leaflet contain?
1. What is GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream and what is it used for?
2. What do I need to know before using GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream?
3. How do I use GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream?
4. What are the possible side effects?
5. How to store GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream?
6. Package contents and other information.
1. WHAT IS GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: CUTANEOUS PROTECTANT and EMOLLIENT - ATC code: D02AC.
GLYCEROL/VASELINE/PARAFFINE VIATRIS acts on the skin by increasing its moisture level, thanks to glycerol, and by restoring the skin's barrier function, thanks to vaseline and liquid kerosene. GLYCEROL/VASELINE/PARAFFINE VIATRIS restores the skin's moisture levels and protective function, and reduces irritation, itching and scratching.
The active ingredients in GLYCEROL/VASELINE/PARAFFINE VIATRIS are glycerol, vaseline and liquid kerosene.
GLYCEROL/VASELINE/PARAFFINE VIATRIS, emollient (skin-softening) and moisturizing cream, combats dry skin conditions.
Recommended for adults and children, including infants :
- as an adjunct to the treatment of dry skin in certain skin conditions, such as atopic dermatitis, ichthyosis(very dry, rough skin with dead skin flakes) and psoriasis;
- as an adjunctive treatment for superficial burns over small areas.
You should consult your doctor if you do not feel any improvement or if you feel less well after 30 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream?
Never use GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream:
- if you are allergic to any of the active ingredients or to any of the other ingredients listed in section 6.
Warnings and precautions
It is recommended not to apply GLYCEROL/VASELINE/PARAFFINE VIATRIS on an infected lesion or under an occlusive dressing.
Do not swallow.
Ask your doctor or pharmacist before using GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream.
Children and teenagers
Not applicable.
Other medicinal products and GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
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.
GLYCEROL/VASELINE/PARAFFINE VIATRIS may be used during pregnancy.
It is recommended not to apply GLYCEROL/VASELINE/PARAFFINE VIATRIS to the breast while breast-feeding, to avoid the risk of ingestion of GLYCEROL/VASELINE/PARAFFINE VIATRIS by the child.
Driving and use of machinery
Not applicable.
GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
3. HOW TO USE GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For external use only.
In adults and children, including infants, apply the cream in a thin layer to the areas to be treated, once or twice a day, or more if necessary.
Pediatric population
Do not apply to premature infants.
If you have used more GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream than you should have
Not applicable.
If you forget to use GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream
Not applicable.
If you stop using GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream
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.
Infrequently reported side effects (occurring in less than 1 in 100 patients) include urticaria, itching, redness, eczema, rash and application site reactions (irritation, redness, pain or itching).
Other effects of undetermined frequency (cannot be estimated on the basis of available data) may occur, such as eczema at the application site and burning sensation of the skin.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This applies to any side effect not mentioned in this leaflet. You can also report any adverse reaction 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: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the tube. The expiration date refers to the last day of that month.
No special storage precautions.
After first opening of tube: store for a maximum of 6 months.
Do not dispose of any medicine down the drain or in the 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 GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream contains
- The active ingredients are :
glycerol.............................................................................................................................. 15,000 g
vaseline............................................................................................................................... 8,000 g
liquid paraffin................................................................................................................... 2,000 g
per 100 g.
- The other components are :
stearic acid, glycerol monostearate, cyclomethicone, dimeticone, macrogol 600, propyl parahydroxybenzoate (E216), trolamine, purified water.
What GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2% cream is and what it contains
This medicine is in the form of a cream.
Tube of 250 g.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
DELPHARM HUNINGUE SAS
26 RUE DE LA CHAPELLE
68330 HUNINGUE
or
MISOM LABS LTD
MALTA LIFE SCIENCE PARK
LS2.01.06 INDUSTRIAL ESTATE
SAN GWANN, SGN 3000
MALTA
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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.