Package leaflet: Information for the user

Casarenel 0.1%/2.5% gel

adapalene, anhydrous benzoyl peroxide
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Casarenel is and what it is used for
What you need to know before using Casarenel
How to use Casarenel
Possible side effects
How to store Casarenel
Contents of the pack and other information

1. What Casarenel is and what it is used for

Casarenel is indicated for the treatment of acne.
This gel contains two active substances, 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 substance, benzoyl peroxide, acts as an antimicrobial and has a soothing and exfoliating effect 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 substances or to 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
Talk to your doctor or pharmacist before using Casarenel.
Do not apply Casarenel on areas of skin with cuts, scratches, sunburn or eczema.
Avoid contact of Casarenel with eyes, mouth, nostrils and other highly sensitive areas of the body.
If contact occurs, rinse the affected area immediately with plenty of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of Casarenel with hair or coloured fabrics, as it may bleach 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with Casarenel.
Avoid using Casarenel together with 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
DO NOT USE Casarenel if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using Casarenel, stop treatment immediately and inform your doctor as soon as possible for further evaluation.
Casarenel may be used during breastfeeding. To avoid contact exposure to 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 exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Casarenel is indicated for use only in adults and adolescents and children aged 9 years and older. This medicine is for external use only.
Apply a thin layer of gel to the acne-affected areas once daily at bedtime, avoiding contact with the eyes, lips, and nostrils. Wash and dry the skin before each application. Wash your hands thoroughly after applying Casarenel.
By applying gentle pressure, approximately 0.5 g of gel is dispensed.
Your doctor will inform you how long you should use Casarenel.
If you notice that the effect of Casarenel seems too strong or too weak, consult your doctor or pharmacist.
If application of Casarenel causes persistent irritation, contact your doctor.
Your doctor may advise you to apply a moisturizing cream, use the gel less frequently, suspend treatment for a short period, or discontinue treatment altogether.

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

you have used more Casarenel than you should have
a child has accidentally ingested the product
you have accidentally swallowed the product. Your doctor will advise you on the necessary steps to take.

If you forget to use Casarenel
Do not apply a double dose to make up for missed applications.
Consult your doctor or pharmacist if you have any further questions about the use of this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using the product and contact your doctor immediately if you experience throat tightness or
swelling of the eyes, face, lips, or tongue, if you feel faint, or if you have difficulty breathing.
Discontinue use of the product if you develop hives or experience itching of the face or body.
The frequency with which these adverse events may occur is unknown.
Common side effects (may affect up to 1 in 10 people):
Dry skin, localised skin rash (irritant contact dermatitis), burning sensation, skin irritation, redness, peeling.
Uncommon side effects (may affect up to 1 in 100 people):
Skin itching, sunburn.
Frequency not known (cannot be estimated based on available data):
Facial swelling, allergic contact reactions, eyelid swelling, throat tightness, skin pain (pricking pain), blisters (vesicles), breathing difficulties, skin discoloration (change in skin colour), burning at the application site.
In cases where skin irritation occurs following the application of Casarenel, it is generally mild or moderate, with local signs such as redness, dryness, peeling, burning, and skin pain (pricking pain), which usually peak during the first week and then resolve without additional treatment.
Cases of burning at the application site have been reported, mostly superficial, but also more severe cases with blistering.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 stated on the carton and bottle 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 below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Casarenel and contents of the pack
Casarenel is an opaque gel, white to very pale yellow.
Casarenel is available in:
white polypropylene vacuum bottles with a plastic, air-tight, snap-action pump dispenser equipped with an actuator and a plastic cap, containing 30 g, 45 g or 60 g of gel, packed in cardboard cartons.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Laboratoires Medgen SAS
24 rue Erlanger, 75016 Paris - France

This medicinal product is authorized in the European Economic Area countries 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 Medgen 1 mg/g + 25 mg/g gel