This drug is an antiseptic cream of low activity. It is indicated for the adjunctive treatment of local skin diseases, infected or likely to become infected.
CETAVLON CREAM 5% 80G
For warnings, precautions for use and contraindications, please consult the instructions for use of Cetavlon cream.
The skin can be prone to an impressive amount of infections which can be bacterial, viral, parasitic or due to fungi. In all cases, the infectious agent will be a microorganism. Antiseptic agents are not sterilizing. They temporarily reduce the number of microorganisms.
Adjunctive treatment for skin conditions that are primarily bacterial or likely to become infected.
This medication is a low activity antiseptic cream . It is indicated in the local adjunctive treatment of skin conditions that are infected or at risk of becoming infected.
DOSAGE
THIS MEDICINE WAS PROVIDED TO YOU PERSONALLY IN A SPECIFIC SITUATION:
METHOD AND ROUTE OF ADMINISTRATION
Dermal.
The active substance is :
CETRIMIDE ................................................. ...................... 0.500 g
Per 100 g of cream
The other ingredients are : alcohol, cetostearyl alcohol, liquid paraffin, parahydroxybenzoate
methyl, propyl parahydroxybenzoate, lavender essential oil, purified water.
Composition of cetostearyl alcohol : mixture of cetyl alcohol (minimum 63%) and stearyl alcohol (minimum 33%).
This medication should NOT be used in the following cases:
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
80 g tube
Please note, the Cetavlon cream medication is not like any other product. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 15/06/2017
CETAVLON cream
cetrimide
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.
1. What is CETAVLON, cream and in which cases it is used?
2. What should be known before using CETAVLON, cream?
3. How to use CETAVLON, cream?
4. What are the possible side effects?
5. How to store CETAVLON, cream?
6. Package contents and other information
1. WHAT CETAVLON, cream AND WHAT USE IS IT USED FOR?
Pharmacotherapeutic group: ANTISEPTIC (D Dermatology).
Therapeutic indications :
This medication is a low activity antiseptic cream. It is indicated in the local supplemental treatment of skin conditions, infected or at risk of becoming infected.
2. WHAT TO DO ABOUT BEFORE USING CETAVLON, cream?
Do not use CETAVLON, cream:
· on the external eye or ear canal in case of tympanic perforation,
· on the mucous membranes in particular genital,
· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· children with a history of convulsions due to fever or not (due to the presence of terpene derivatives in the formula).
Warnings and Precautions
Special warnings
Do not use premature or infant skin on a large surface under occlusive dressing on burned skin because of the risk of the active ingredient passing into the general circulation.
This specialty contains terpenic derivatives which can lead to excessive neurological convulsions in infants and children.
Observe the instructions for use:
· never apply a dose higher than recommended ( see Dosage ),
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment.
This medication should not be used unless your doctor advises otherwise during pregnancy.
Precautions for use
As soon as the tube is opened, microbial contamination is possible. Take care not to take too long an antiseptic preparation.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
Talk to your doctor or pharmacist before using CETAVLON, cream.
children
Not applicable.
Other medicines and CETAVLON, cream
With this antiseptic, avoid the simultaneous or successive use of different antiseptics such as iodized products. Prior use of soap should be followed by careful rinsing.
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
CETAVLON, cream with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
The use of this medication is not recommended unless your doctor advises otherwise during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor promptly: he alone will be able to adapt the treatment to your condition.
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.
Driving and using machines
Not applicable.
CETAVLON cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. HOW TO USE CETAVLON, cream?
Dosage
Clean the wound with soap and water, rinse off with clear water. To dry. Apply the cream, avoiding the tip of the tube directly touching the wound.
Apply the cream on the lesion 1 to 2 times a day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
· It may not be suitable for another case,
· Do not advise another person.
Route of Administration
Dermal.
If you used more CETAVLON, cream than you should have
Not applicable.
If you forget to use CETAVLON, cream
Not applicable.
If you stop using CETAVLON, cream
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 medication can cause side effects, although not everybody gets them.
· local allergic reactions (redness, irritation),
· erosions of the skin that can progress to the ulcer if the cream is applied under a closed dressing,
· use on the rectal mucosa can lead to loss of rectal tone.
Due to the presence, as excipients, of terpene derivatives, and in case of non-respect of the recommended doses :
· risk of seizure in children and infants,
· possibility of agitation, confusion in the elderly.
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 CETAVLON, cream?
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 carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature below 25 ° C.
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
· The active substance is :
Ketrimide ................................................. .................................................. ................................. 0.500 g
For 100 g of cream.
· The other components are:
Alcohol, cetostearyl alcohol, liquid paraffin, methyl parahydroxybenzoate, propyl para-hydroxybenzoate, essential oil of lavender, purified water.
What is CETAVLON, cream and contents of the pack
This medication is in the form of cream, 80 g tube.
Marketing Authorization Holder
45 PLACE ABEL GANCE
92100 BOULOGNE
Marketing Authorization Operator
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
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]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Advice
"What to do in case of superficial wound, not very extensive":
The severity of a wound is determined by its depth, its extent and its location.
· a deep wound often requires a suture, so a medical remedy within about 6 hours.
· a wound in the face, hands or genitals can lead to unsightly marks or troublesome sequelae.
Only a superficial and small wound can be treated without the advice of the doctor or the pharmacist.
The first step is to clean the wound with soap and water to remove any dirt (soil, dust, etc.).
After an abundant rinse, apply the antiseptic.
It is essential to consult a doctor quickly or even to visit an emergency medical service if:
· the wound is deep, or if it is extensive,
· the wound bleeds abundantly,
· the wound is located in a sensitive area: face, genitals, ear ...,
· the wound was caused by a dog or other animal bite,
· the wound is accompanied by an important and persistent pain,
· the evolution of the wound is not satisfactory after 2 or 3 days,
· if your tetanus vaccine is not up to date.
Any wound requires verification that your tetanus vaccination is up to date
Local antiseptic
cetrimide
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
CETAVLON 0.5%: cream; 80 g tube.
-
Laboratory Pierre Fabre Medicine
| p 100 g | |
| cetrimide | 500 mg |
| Parahydroxybenzoates of propyl and methyl | + |
Usual dosage:
1 application, 1 to 2 times a day.
