Package Insert: Information for the User

Acniduo 1 mg/g + 25 mg/g gel

adapaleno, peróxido de benzoílo anhidro

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Acniduo and for what it is used

2. What you need to know before starting to take Acniduo

3. How to use Acniduo

4. Possible adverse effects

5. Storage of Acniduo

6. Contents of the package and additional information

Acniduo is used for the treatment of acne.

This gel combines two active principles, adapaleno and benzoyl peroxide, which act together, but in different ways:

The adapaleno belongs to a group of products known as retinoids and acts specifically on the cutaneous processes that cause acne. The other active principle, benzoyl peroxide, acts as an antimicrobial agent and softens and exfoliates the outer layer of the skin.

Do not use Acniduo :

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• if you are pregnant
• if you plan to become pregnant.

Warnings and precautions

Consult your doctor or pharmacist before using Acniduo.

Do not use this medication in areas where you have cuts, scrapes, sunburn, or eczema.

Make sure this medication does not come into contact with your eyes, mouth, nostrils, and other sensitive areas of the body. If this occurs, wash these areas immediately with plenty of warm water.

Avoid excessive exposure to sunlight and UV lamps.

Avoid this medication coming into contact with your hair or colored fabrics, as it may discolor them, and wash your hands thoroughly after using the medication.

The use of Acniduo in children under 9 years old is not recommended.

Other medications and Acniduo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use other acne products (containing benzoyl peroxide or retinoids) at the same time as this medication.

Avoid using this medication at the same time as irritating cosmetics, those that dry out or exfoliate the skin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use this medication if you are pregnant or plan to become pregnant. Your doctor may provide you with more information.

If you become pregnant while taking this medication, you must discontinue treatment and inform your doctor as soon as possible for further follow-up.

This medication can be used during breastfeeding. To avoid exposing the baby to contact, avoid applying Acniduo to the breast.

Acniduo contains propylene glycol

Acniduo contains 40 mg of propylene glycol per 1 g of gel, which may cause skin irritation.

Use this medication exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

This medication is only designed for use in adults, adolescents, and children 9 years of age or older. This medication is only for external use.

Apply a thin, uniform layer of gel to the affected areas of acne once a day before bedtime, avoiding the eyes, lips, and nostrils. The skin must be clean and dry before application. Wash your hands thoroughly after using this medication.

A single press provides a medium weight of gel of approximately 0.5 g.

Your doctor will inform you of how long you need to use this medication.

If you believe the effect of Acniduo is too strong or too weak, consult your doctor or pharmacist.

If you experience persistent irritation after applying Acniduo, contact your doctor.

You may be asked to apply a moisturizing cream, use the gel less frequently, or stop using it for a short time, or to stop using the gel completely.

If you use more Acniduo than you should

If you use more Acniduo than you should on your skin, it will not clear up your acne faster, but your skin may become irritated and red.

Contact your doctor or hospital:

-if you have used more Acniduo than you should

-if a child has accidentally taken this medication

-if you have accidentally ingested this medication.

Your doctor will advise you on the necessary measures.

If you forgot to use Acniduo

Do not apply a double dose to compensate for the missed doses.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Stop using the product and seek medical attention immediately if you experience throat constriction or swelling of the eyes, face, lips, or tongue, feel faint, or have difficulty breathing. Stop using the product if you experience urticaria or itching on the face or body. The frequency of these side effects is unknown.

Frequent Adverse Effects(may affect up to 1 in 10 people);

Dry skin, local skin rash (irritant contact dermatitis), burning sensation, skin irritation, redness, flaking.

Less Frequent Adverse Effects(may affect up to 1 in 100 people)

Skin itching (pruritus), sunburn.

Unknown(frequency cannot be estimated from available data):

Swelling of the face, contact allergy reactions, eyelid swelling, throat constriction, skin pain (stabbing pain), blisters (vesicles), difficulty breathing, skin discoloration (change in skin color), burn at the application site.

If skin irritation occurs after applying Acniduo, it is usually mild to moderate, with local signs such as redness, dryness, flaking, burning sensation, and skin pain (stabbing pain), which reach their peak during the first week and resolve without additional treatment.

Superficial burns at the application site have been reported, mostly cases, but more severe, which involve the appearance of blisters.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle after «CAD». The expiration date is the last day of the month indicated.

Store below 30°C.

After opening it for the first time, this medication can be used for 6 months if stored at a temperature below 25°C.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Content of Acniduo

The active principles are adapaleno and benzoyl peroxide.

One gram of gel contains 1 mg of adapaleno and 25 mg of anhydrous benzoyl peroxide (in the form of benzoyl peroxide, hydrated).

The other components are disodium edetate; sodium docusate; poloxamer 124; glycerol; propylene glycol (E1520); sorbitan oleate; Sepineo P 600 (acrylamide/acrylodimethyltaurato sodium copolymer in isohexadecane with polysorbate 80); purified water.

Appearance of Acniduo and content of the container

Acniduo 1 mg/g + 25 mg/g gel is a white to very pale yellow opaque gel.

Acniduo 1 mg/g + 25 mg/g gel can be packaged as:

30 g, 45 g, and 60 g of gel in a white polypropylene bottle with a pump without air entryequipped with a plastic actuator and cap, in a box.

Not all container sizes may be marketed.

Marketing Authorization Holder

Galenicum Derma, S.L.U.

Crta N-1, Km 36,

28750 San Agustín del Guadalix (Madrid)

Spain

Responsible for manufacturing

BELUPO lijekovi i kozmetika, d.d.

Ulica Danica 5

48 000 Croatia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Croatia Acniduo 1 mg/g + 25 mg/g gel

SpainAcniduo 1 mg/g + 25 mg/g gel

This leaflet was last revised in November 2022.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es