Acniduo 1 mg/g + 25 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Acniduo 1 mg/g + 25 mg/g gel
adapalene, anhydrous benzoyl peroxide
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Acniduo is and what it is used for
- What you need to know before using Acniduo
- How to use Acniduo
- Possible side effects
- How to store Acniduo
- Contents of the pack and other information
1. What Acniduo is and what it is used for
Acniduo is used for the treatment of acne.
This gel combines two active substances, adapalene and benzoyl peroxide, which work together in different ways:
Adapalene belongs to a group of medicines known as retinoids and specifically targets the skin processes that cause acne. The other active substance, benzoyl peroxide, acts as an antimicrobial agent and softens and peels 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 components of this medicine (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 medicine on areas with cuts, scrapes, sunburns, or eczema.
Ensure that this medicine does not come into contact with the eyes, mouth, nostrils, or other highly sensitive areas of the body. If this occurs, rinse these areas immediately with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of this medicine with hair or colored fabrics, as it may cause discoloration. Wash your hands thoroughly after using the medicine.
The use of Acniduo in children under 9 years of age is not recommended.
Other medicines and Acniduo
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not use other acne treatments (containing benzoyl peroxide or retinoids) at the same time as this medicine.
Avoid using this medicine simultaneously with irritating cosmetics that 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 use this medicine if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using this medicine, you must stop treatment and inform your doctor as soon as possible for follow-up.
This medicine may be used during breastfeeding. To avoid exposing the baby to the medicine through contact, application of Acniduo on the breast area must 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. Consult your doctor or pharmacist if you are unsure.
This medicine is intended for use only in adults, adolescents, and children aged 9 years and older. This medicine is for external use only.
Apply a thin, even layer of gel to the acne-affected areas once daily before bedtime, avoiding the eyes, lips, and nostrils. The skin should be clean and dry before application. Wash your hands thoroughly after using this medicine.
One pump press delivers an average weight of approximately 0.5 g of gel.
Your doctor will advise you on how long you need to use this medicine.
If you think the effect of Acniduo is too strong or too weak, consult your doctor or pharmacist.
If you experience persistent irritation when applying Acniduo, contact your doctor.
You may be advised to apply a moisturizing cream, to use the gel less frequently, to stop using it temporarily, or to discontinue use of the gel completely.
If you use more Acniduo than you should
Using more Acniduo than recommended will not clear acne faster, but may cause skin irritation and redness.
Contact your doctor or hospital:
- if you have used more Acniduo than you should
- if a child has accidentally ingested this medicine
- if you have accidentally swallowed this medicine.
Your doctor will advise you on the necessary steps to take.
If you forget to use Acniduo
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop using the product and seek immediate medical attention if you experience throat tightness or swelling of the eyes, face, lips, or tongue, feel faint, or have difficulty breathing. Discontinue use of the product if you develop hives or itching of 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, peeling.
Uncommon adverse effects (may affect up to 1 in 100 people):
Itching of the skin (pruritus), sunburn.
Unknown frequency (frequency cannot be estimated from available data):
Facial swelling, allergic contact reactions, eyelid swelling, throat tightness, skin pain (stabbing pain), 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, peeling, burning, and skin pain (stabbing pain), which typically peak during the first week and resolve without additional treatment.
Application site burns have been reported, mostly superficial cases, but also more severe cases involving blister formation.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage instructions for Acniduo
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 the month indicated.
Store below 30°C.
After first opening, 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. Return any unused medicines and their containers to your pharmacy's SIGRE point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Contents of Acniduo
The active substances are adapalene and benzoyl peroxide.
One gram of gel contains 1 mg of adapalene and 25 mg of anhydrous benzoyl peroxide (in the form of hydrated benzoyl peroxide).
The other components are disodium edetate; sodium docusate; poloxamer 124; glycerol; propylene glycol (E1520); sorbitan oleate; Sepineo P 600 (acrylamide/sodium acryloyldimethyl taurate 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 an opaque gel, white to very pale yellow in color.
Acniduo 1 mg/g + 25 mg/g gel is available in the following pack sizes:
30 g, 45 g and 60 g of gel in white polypropylene bottle with airless pump equipped with actuator and plastic cap, in a carton.
Not all pack sizes may be marketed.
Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es