ACNIDUO 1 mg/g + 25 mg/g GEL

Introduction

Package Leaflet: Information for the User

Acniduo 1 mg/g + 25 mg/g gel

adapalene, benzoyl peroxide anhydrous

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Acniduo and what is it used for

Acniduo is used for the treatment of acne.

This gel combines two active substances, adapalene and benzoyl peroxide, which work together but in different ways:

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

2. What you need to know before using Acniduo

Do not use Acniduo:

• 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 to become pregnant.

Warnings and precautions

Consult your doctor or pharmacist before using Acniduo.

Do not use this medicine on areas where you have cuts, scrapes, sunburns, or eczema.

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

Avoid excessive exposure to sunlight and UV lamps.

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

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

Other medicines and Acniduo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Avoid using this medicine at the same time as irritating cosmetics, which dry or exfoliate the skin.

Pregnancy, breastfeeding, and fertility

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

Do not usethis medicine if you are pregnant or think you may become pregnant. Your doctor can give you more information.

If you become pregnant while taking this medicine, stop treatment and inform your doctor as soon as possible for follow-up.

This medicine can be used during breastfeeding. To avoid exposure of the baby by contact, application of Acniduo to the breast should be avoided.

Acniduo contains propylene glycol

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

3. How to use Acniduo

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is only designed for use in adults, adolescents, and children aged 9 years and older. This medicine is for external use only.

Apply a thin layer of gel evenly to the areas affected by acne once a day before going to bed, avoiding the eyes, lips, and nostrils. The skin should be clean and dry before application. Wash your hands well after using this medicine.

One press provides a medium weight of gel of about 0.5 g.

Your doctor will tell you how long you need to use this medicine.

If you think the effect of Acniduo is too strong or too weak, talk to your doctor or pharmacist.

If you experience persistent irritation when 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 stop using the gel altogether.

If you use more Acniduo than you should

If you use more Acniduo than you should on the skin, it will not get rid of 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 medicine
• if you accidentally swallow this medicine.

Your doctor will advise you on the measures to be taken.

If you forget to use Acniduo

Do not apply a double dose to make up for forgotten individual doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

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

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 (pruritus), sunburn.

Unknown(frequency cannot be estimated from the available data):

Swelling of the face, allergic contact reactions, swelling of the eyelids, tightness in the throat, skin pain (stinging), blisters (vesicles), difficulty breathing, skin discoloration (change in skin color), burning at the application site.

If skin irritation occurs after application of Acniduo, it is usually mild to moderate, with local signs such as redness, dryness, scaling, burning, and skin pain (stinging), which reach their peak during the first week and disappear without additional treatment.

Burning at the application site has been reported, mostly superficial but more severe cases, involving the appearance of blisters.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acniduo

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 carton and bottle after ‘EXP’. The expiry date is the last day of the month stated.

Store below 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What is in Acniduo

The active substances are adapalene and benzoyl peroxide.

One gram of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide anhydrous (as benzoyl peroxide, hydrated).

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

Appearance of Acniduo and contents of the pack

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 non-air entry pump equipped with an actuator and plastic cap, in a carton.

Not all pack sizes may be marketed.

Marketing authorisation holder

Galenicum Derma, S.L.U.

Crta N-1, Km 36,

28750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer

BELUPO lijekovi i kozmetika, d.d.

Ulica Danica 5

48 000 Croatia

This medicine is authorised in the Member States of the European Economic Area under the following names:

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

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

This leaflet was last revised in November 2022.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es