CASARENEL 1 mg /G + 25 Mg/G Gel

Зміст інструкції

1. Casarenel 0.1%/2.5% gel
   1. What is Casarenel and what is it used for
   2. What you need to know before using Casarenel
   3. How to use Casarenel
   4. Possible side effects
   5. How to store Casarenel
   6. Contents of the pack and other information

Casarenel 0.1%/2.5% gel

adapalene, benzoyl peroxide anhydrous
Generic medicine

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Casarenel is and what it is used for
• 2. What you need to know before you use Casarenel
• 3. How to use Casarenel
• 4. Possible side effects
• 5. How to store Casarenel
• 6. Contents of the pack and other information

1. What is Casarenel and what is it used for

Casarenel is indicated for the treatment of acne.
This gel contains two active ingredients, adapalene and benzoyl peroxide, which act
together but in different ways:
Adapalene belongs to a group of substances known as retinoids and acts specifically on the
skin processes that cause acne. The other active ingredient, benzoyl peroxide, acts as
an antimicrobial and exerts a soothing and exfoliating action on the outermost layer of the skin.

2. What you need to know before using Casarenel

Do not use Casarenel:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant
• if you are planning a pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before using Casarenel.
Do not use Casarenel on areas where there are cuts, scratches, sunburn or eczema.
Avoid contact of Casarenel with the eyes, mouth, nostrils and with other very sensitive areas of the body.
If it comes into contact with one of these areas, immediately rinse the affected area with plenty of
lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of Casarenel with hair or colored fabrics as it may discolor them, and wash
your hands thoroughly after using the medicine.

Children
The use of Casarenel in children under 9 years of age is not recommended.

Other medicines and Casarenel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use other products for acne (containing benzoyl peroxide and/or retinoids) at the same time as
Casarenel .
Avoid using Casarenel at the same time as cosmetic products that have irritating, drying
or exfoliating effects on the skin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
DO NOT USE Casarenel if you are pregnant, or if you are planning a pregnancy. Your doctor will be able to
give you more information.
If you become pregnant while using Casarenel, stop treatment and inform your doctor as soon as
possible for further monitoring.
Casarenel can be used during breastfeeding. To avoid contact exposure of the
infant, do not apply Casarenel to the chest area.

Casarenel contains propylene glycol.
Casarenel contains 40 mg of propylene glycol per g of gel.

3. How to use Casarenel

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Casarenel is indicated for use only in adults and adolescents and in children aged 9 years or older.
This medicine is for external use only.
Apply a thin layer of gel to the areas affected by acne once a day at bedtime,
avoiding contact with the eyes, lips and nostrils. You must wash and dry the skin before each
application. You should wash your hands thoroughly after applying Casarenel.
With pressure, you obtain an amount of gel equal to approximately 0.5 g.
Your doctor will tell you how long you will need to use Casarenel.
If you should notice that the effect of Casarenel is too strong or too weak, consult your doctor or
pharmacist.
If the application of Casarenel should cause persistent irritation, contact your doctor.
Your doctor may ask you to apply a moisturising cream, to use the gel less
frequently, to suspend treatment for a short period or to stop it permanently.

If you use more Casarenel than you should
If you apply more Casarenel than you should to the skin, your acne will not disappear faster but your
skin may become irritated and reddened.
Please, contact your doctor or hospital if:

• you have used more Casarenel than you should
• a child has accidentally taken the product
• you have accidentally ingested the product. Your doctor will advise you on the measures to take.

If you forget to use Casarenel
Do not apply a double dose to compensate for forgotten applications.

Consult your doctor or pharmacist if you have further questions on the use of this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the product and seek medical advice immediately if you experience tightness of the throat or
swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty breathing.
Stop using the product if you develop hives or feel an itching sensation on your face or body. The frequency with which these adverse events may occur is not known.

Common side effects(may affect up to 1 in 10 people):
Dry skin, local skin rash (irritant contact dermatitis), burning sensation,
skin irritation, redness, scaling.

Uncommon side effects(may affect up to 1 in 100 people):
Skin itching, sunburn.

Frequency not known(cannot be estimated from the available data):
Facial swelling, allergic contact reactions, eyelid swelling, tightness of the throat, skin pain (stinging pain), blisters (vesicles), difficulty breathing, skin discoloration (alteration of
skin color), burning sensation at the application site.
If skin irritation occurs following application of Casarenel, it is
generally mild or moderate, with local signs such as redness, dryness, scaling,
burning and skin pain (stinging pain), which peak during the first week
and then disappear without additional treatment.
Cases of burning at the application site have been reported, mostly superficial but also more serious cases with blisters.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Casarenel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the vial after
“EXP”. The expiry date refers to the last day of that month.
Store below 30  C.
After first opening, this medicine can be used for 6 months if stored at a temperature below
25  C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Casarenel contains
The active ingredients are adapalene and benzoyl peroxide.
1 g of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide anhydrous (as benzoyl peroxide
hydrate).
The other ingredients are disodium edetate; sodium docusate; poloxamer 124; glycerol; propylene glycol
(E1520); sorbitan oleate; SepineoP 600 (acrylamide and sodium acryloyl-dimethyltaurate copolymer in
isohexadecane with polysorbate 80); purified water.

Description of the appearance of Casarenel and contents of the pack
Casarenel is an opaque gel from white to very pale yellow.
Casarenel is available in:
white vacuum tubes made of polypropylene with a snap-on airtight pump in plastic equipped with an
actuator and a plastic cap, containing 30 g, 45 g and 60 g of gel, in cardboard.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Laboratoires Medgen SAS
24 rue Erlanger, 75016 Paris - France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
CROATIA Adapalen/benzoilperoksid Laboratoires Medgen
1 mg/g + 25 mg/g gel
FRANCE Desarena 0.1%/2.5%, gel
BELGIUM Aknadue 1 mg/g + 25 mg/g gel
ITALY Casarenel 0.1%/2.5% gel
GREECE Adapalene + Benzoyl peroxide/Laboratoires
Medgen1 mg/g + 25 mg/g Γέλη