NOTICE
ANSM - Last updated: 13/06/2017
Description of the Medicine
CICATRYL, sachet-dose ointment
Allantoin, Guaiazulene, Para-chloromethacrylate, Acetate of alpha-tocopherol
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Please read this leaflet carefully before you start using this medication as it contains important information for you.
You should always use this medication carefully following the information provided in this leaflet or by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should contact your doctor if you feel uncomfortable or feel less well.
What is in this leaflet?
1. What is CICATRYL, a sachet-dose ointment and in which cases is it used?
2. What should be known before using CICATRYL, a sachet-dose ointment?
3. How to use CICATRYL, ointment in sachet-dose?
4. What are the possible undesirable effects?
5. How to store CICATRYL, a sachet-dose ointment?
6. Contents of the package and other information.
1. WHAT IS CICATRYL, a sachet-dose ointment AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code:
SKIN PROTECTOR (D. Dermatology)
Therapeutic indications:
CICATRYL ointment is used for the local treatment of short wounds and short burns.
2. WHAT TO DO ABOUT BEFORE USING CICATRYL, ointment in sachet-dose?
Never use CICATRYL, a sachet-dose ointment:
AT· If you are allergic to any of the active ingredients or to any of the other ingredients of this medication, listed in section 6.
Warnings and Precautions
Special warnings
This medicinal product contains methylated parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) and may cause allergic reactions.
These allergic reactions are described in the paragraph "What are the possible undesirable effects".
Employment Precautions
As is usual for any wound, a preliminary cleaning is advised.
Talk to your doctor or pharmacist before using CICATRYL.
children
Not applicable.
Other medicines and CICATRYL, sachet-dose ointment
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
CICATRYL, ointment in sachet-dose with food and beverages
Not applicable.
Pregnancy, breastfeeding and fertility
This medication should be used with caution during pregnancy and lactation.
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 medication.
Driving and using machines
Not applicable.
CICATRYL, sachet-dose ointment contains methylated parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).
3. HOW TO USE CICATRYL, sachet-dose 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 you are unsure.
Dosage
Wash hands thoroughly.
Apply a layer of Cicatryl on the area of the affected skin and lightly penetrate it with your fingertips.
As a general rule 1 to 2 applications per day on the area of the skin concerned depending on the nature and extent of the injury or burn.
If the edges of the wound are irritated, the application of CICATRYL should be widely displaced beyond the injury to be treated.
If the wound or burn is too painful, cover with a gauze previously coated with CICATRYL.
Route of Administration
Cutaneous route.
If you have used more CICATRYL, a sachet-dose ointment than you should have
Not applicable.
If you forget to use CICATRYL, ointment in sachet-dose
Not applicable.
If you stop using CICATRYL, ointment in sachet-dose
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
The following undesirable effects can occur:
AT· a contact eczem.
AT· an allergic reaction: discomfort, redness of the skin and / or abrupt swelling of the face and neck. If these reactions occur, you should stop treatment and seek prompt medical attention.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting undesirable effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CICATRYL, ointment in a sachet-dose?
Keep this medication out of the reach and sight of children.
Do not use this medicine after the expiration date stated on the outer packaging after EXP. The redemption date refers to the last day of that month.
Keep at a temperature not exceeding 25 ° C.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CICATRYL contains, sachet-dose ointment
AT· The active substances are:
Allantoïne ............................................... .................................................. ..................... 1.000 g
Guaiazulène ............................................... .................................................. .................. 0.007 g
Para-chloromethacrylate ............................................. .................................................. ..... 0.120 g
Alpha-Tocopherol Acetate ........................................ .................................................. .... 0.010 g
For 100 g of ointment.
AT· The other components are:
Methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), light liquid paraffin, petroleum jelly, mixtures of cationic aryl alcohol (90 percent) and ceyl sodium stearyl sulfate (10 per cent), a mixture of ce- arylic alcohol (70 per cent) and sodium ethyl sulphate (10 per cent) and ethoxylated fatty acids of organic origin (20 percent), monosodium glycerol, macrogol glycol 400, sorbitol (70 percent solution), purified water.
What is CICATRYL, ointment in sachet-dose and contents of the outer packaging
This medication is in the form of an ointment.
Box of 14, 16, 18 or 20 sachets of 1 g.
Box of 1, 12, 14, 18, 24, 28 or 140 sachets of 2 g.
Box of 6 sachets of 2 g + 10 sachets of 1 g.
Box of 8 sachets of 2 g + 8 sachets of 1 g.
Box of 3 sachets of 4 g + 14 sachets of 2 g.
Box of 2 sachets of 4 g + 10 sachets of 2 g.
Not all presentations may be marketed.
Holder of the marketing authorization
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE BILLANCOURT
Operator of the marketing authorization
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
Other
Detailed information on this medicinal product can be found on the website of the ANSM (France).