NOTICE
ANSM - Last updated: 24/04/2017
Name of the medicinal product
CURASPOTAQUA 5%, gel
Benzoyl peroxide
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 contact your doctor if you experience no improvement or feel less well after 4 to 6 weeks.
What is in this leaflet?
1. What is Curaspotaqua 5%, gel and in which cases is it used?
2. What information should be known before using Curaspotaqua 5%, gel?
3. How to use Curaspotaqua 5%, gel?
4. What are the possible side effects?
5. How to store Curaspotaqua 5%, gel?
6. Package contents and other information.
1. WHAT IS Curaspotaqua 5%, GEL AND WHAT CASES IS IT USED FOR?
CURASPOTAQUA 5%, gel is a local anti-acne product containing Benzoyl Peroxide.
It is used in the treatment of mild to moderate acne.
2. WHAT TO DO ABOUT BEFORE USING Curaspotaqua 5%, gel?
Do not use Curaspotaqua 5%, gel:
· if you are allergic (hypersensitive) to benzoyl peroxide or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Warnings
· Patients with sensitive skin or sensitized by other preliminary treatments (retinoic acid ...) should be warned of certain side effects that may appear during the treatment. Avoid applying Curaspotaqua to heavily inflamed skin areas and open wounds.
· Only for external use, do not swallow.
· Do not use this medication in children less than 12 years of age. It is not known whether it acts on them or whether it can be used safely.
· Particular caution should be exercised in blond or redhead subjects with fragile skin and lesions in more sensitive areas (face, neck, subclavicular cavity)
· Keep out of the reach of children.
Precautions for use
· For the first applications, it is appropriate to test the individual sensitivity, to carry out a repeated test on a reduced skin surface ("test button"),
· Particularly important precautions are necessary for face applications: avoid contact with eyes and eyelids, mouth, nostrils and mucous membranes. If this is the case, it is recommended to wash thoroughly with water,
· Particular caution should be exercised when simultaneously with other preparations, especially with those which cause peeling of the skin ("peeling skin"). If, prior to treatment with CURASPOTAQUA 5%, the patient has already been treated with exfoliating preparations, it is advisable to await the recovery of the skin lesions,
· Solar radiation and ultraviolet lamps cause additional irritation, so exposure should be avoided as much as possible. Patients with erythema should wait for the signs to disappear before initiating treatment with this preparation.
· Mild irritation (burning sensation, redness and peeling skin / skin peeling) may occur, especially at the beginning of treatment).
· When the cooking sensation and the redness become too great, the stop of the treatment is advised.
· For everyday use, it is preferable to use non-irritating cleansing agents such as aqueous (lipid-free) cleansing lotion and soap-free loaves.
· Curaspotaqua can cause swelling of the skin and vesicles. If this symptom occurs, treatment should be discontinued.
CAUTION IMPORTANT:
This gel can bleach or discolor hair, nails, as well as natural or synthetic textile fibers (clothing, bedding, towels).
Children and Youth
Not applicable.
Other medicines and Curaspotaqua 5%, gel
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Curaspotaqua 5%, gel with food and beverages
Not applicable.
Pregnancy and breast feeding
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.
In the absence of data on the use of this drug in breast milk, it is preferable not to use it during breast-feeding. If you are using it while breastfeeding, to avoid accidental contact with the baby, you should not apply CURASPOTAQUA to the chest.
Driving and using machines
Not applicable.
Curaspotaqua 5% gel contains <{name excipient (s)}>
Not applicable.
3. HOW TO USE CURASPOTAQUA 5%, gel?
Reserved only for EXTERNAL USE
Administration mode
1 - Clean and dry the areas to be treated (face, back, torso ...).
2 - Gently press the tube to the base to deposit on the tip of the finger a quantity of gel sufficient to cover the areas to be treated.
3 - Apply and leave the gel in place for 1 to 5 minutes.
4 - Rinse the treated body parts thoroughly with clean water.
5 - Dry the treated areas.
6 - Wash your hands thoroughly and refill the tube.
It is important to note that after application, the gel should be RINCE.
Frequency and Timing of Use:
1 or 2 times a day, morning and evening at bedtime. In people with sensitive skin, it is recommended to apply the gel once a day.
Discreet irritation is possible, especially at the beginning of treatment; it does not indicate an intolerance or an allergy to the medication as long as it remains moderate.
However, individual sensitivity should be tested prior to initiation of treatment with a "test touch" (repeat applications on a small area of skin for about ten consecutive days).
The improvement is visible in most cases after 4 to 6 weeks of treatment. However, longer use may be necessary.
Due to the risk of discoloration of natural or synthetic textile fibers, it is advisable to use light colored linen (pillows, towels, towels), to wash hands after application and to rinse thoroughly the parts of the body processed.
If you used more than Curaspotaqua 5% gel you should not have
Curaspotaqua 5%, gel is indicated for external use only. If you apply more gel than necessary, the results will not be better or faster; on the other hand, a more severe irritation may develop.
Immediately consult your doctor or pharmacist.
If you forget to use Curaspotaqua 5% gel
Not applicable.
If you stop using Curaspotaqua 5%, gel
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Very common side effects (affecting more than 1 in 10 people):
o Dry skin
o Redness of the skin
o Desquamation (peeling skin)
o Burning sensation of the skin.
These effects are generally reversible if the frequency of application is decreased or if the treatment is stopped.
· Common side effects (affecting less than 1 in 10 people):
o Itching (pruritus)
o Irritation of the skin (irritant contact dermatitis)
· Frequency of occurrence not known (can not be determined with available data):
o Swelling of the face
o Swelling of the eyelids
o Rash on the skin
o Skin pain (tingling)
o Sensitivity to sunlight
o Allergic Skin Dermatitis
o Allergic reactions: difficulty breathing, sudden swelling of the face, mouth or neck (angioedema), allergic shock. If you experience any of these symptoms, stop using the product and contact a doctor immediately.
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 CURASPOTAQUA 5%, gel?
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 not exceeding + 25 ° C.
Ask your pharmacist or doctor:
· If you need additional information or advice,
· If you are not sure whether this medication is appropriate for you, in particular,
· If you are pregnant or breastfeeding,
· If you have, besides what you want to treat with this medication, another disease,
· If you are taking other medicines at the same time, even if they are sold without a prescription,
· If you have ever been allergic to a drug,
· If you notice any side effects not listed above, contact your doctor or pharmacist.
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 Curaspotaqua contains 5%, gel
· The active substance is:
Benzoyl peroxide ............................................... .................................................. ..... 5.00 g
For 100 g of gel.
· The other components are: methacrylic copolymer (POLYTRAP 6603), glycerol, carbomer 940, sodium olefin sulfonate (C14-C16), sodium hydroxide solution
10%, and purified water.
What is Curaspotaqua 5%, gel and contents of the pack
This medication is in the form of a gel. Tube (PE) of 50 or 100 g, with a capsule in white polypropylene.
Marketing Authorization Holder
GALDERMA INTERNATIONAL
TOUR EUROPLAZA - THE DEFENSE 4
20, AVENUE ANDRE PROTHIN
92927 LA DEFENSE CEDEX
Marketing Authorization Operator
GALDERMA INTERNATIONAL
TOUR EUROPLAZA - THE DEFENSE 4
20, AVENUE ANDRE PROTHIN
92927 LA DEFENSE CEDEX
Maker
GALDERMA LABORATORY
ZI MONTDESIR
74540 ALBY SUR CHERAN
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
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Acne is a condition characterized by the appearance of pimples related to the excessive production of sebum
("Oily skin") and comedones ("blackheads").
It usually occurs in adolescence from where its frequent designation under the name of juvenile acne, but in fact it can occur at other periods of life.
It is usually limited to the face (nose, cheeks and forehead) but can also reach the shoulders, thorax and back.
It is necessary to have a good normal skin hygiene and not very aggressive.
Clean your skin gently: use non-aggressive soaps (dermatological rolls, milks or cleansing gels) and always dry the facial skin after washing. Hygiene products remove impurities on the skin surface.
Avoid irritating the skin by rubbing it during cleaning.
Thoroughly moisturize the skin, taking care to use non-comedogenic creams, ie tested to avoid inducing comedones (blackheads).
Acne and Makeup
Make-up is possible, but on condition of using non-comedogenic products suitable for acne skins.
It is advisable not to touch his acne.
If the acne lesions are affected, you can cause permanent scarring and promote the development of new pimples.
Acne and sun
Exposure to the sun sometimes reduces the inflammatory character in a transitory way (one gets the impression that acne improves in the summer) but then, one sees a more important crisis.
The sun should therefore be avoided and the application of a sunscreen with a high degree of protection is recommended in case of exposure.