Differine 1 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Differine 1 mg/g Gel
Adapalene
Read the entire leaflet carefully before you start using this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
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- What Differine Gel is and what it is used for
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- What you need to know before using Differine Gel
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- How to use Differine Gel
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- Possible side effects
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- How to store Differine Gel
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Contents of the pack and other information
1. What Differine Gel is and what it is used for
Differine is indicated for the treatment of acne vulgaris where comedones, papules and pustules predominate. It is suitable for the treatment of acne affecting the face, chest and back.
Differine belongs to a group of medicines called anti-acne agents.
2. What you need to know before starting to use Differine Gel
Do not use Differine Gel:
- If you are pregnant.
- If you are planning to become pregnant.
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Differine Gel.
- Make sure that Differine does not come into contact with the eyes, lips, nostrils, or mucous membranes. If accidental contact occurs with the eyes, rinse immediately with lukewarm water.
- If you experience irritation (redness and itching) at the application site after using the product, treatment should be discontinued. Consult your doctor to determine whether the frequency of application should be reduced or whether treatment should be temporarily or permanently interrupted.
- Do not use Differine on damaged skin (cuts or wounds), sunburned skin, or on eczematous skin (skin that is scaly, red, blistered, and painful).
- Avoid excessive exposure to sunlight or UV radiation.
If you use cosmetics, they should be non-greasy and non-drying for the skin.
Children and adolescents
The safety and efficacy of Differine have not been studied in children under 12 years of age.
Other medicines and Differine Gel
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
- Do not use other acne products (containing retinoids) at the same time as Differine.
- Avoid using Differine simultaneously with cosmetics that are irritating, drying, or exfoliating to the skin.
- Treatment with Differine does not affect the effectiveness of oral contraceptives or orally administered antibiotics.
- If you are being treated with other anti-acne products such as 4% erythromycin solutions or 1% clindamycin phosphate solutions, or aqueous gels containing up to 10% benzoyl peroxide, you may apply these products in the morning and Differine at night.
Pregnancy and breastfeeding:
DO NOT use Differine if you are pregnant or planning to become pregnant. Your doctor can provide you with further information.
Differine may be used during breastfeeding. To avoid contact exposure to the infant, avoid applying Differine to the breast area, as it is unknown whether Differine passes into breast milk.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines:
Treatment with Differine does not affect the ability to drive or operate machinery.
Differine Gel contains:
40 mg of propylene glycol (E1520) per gram, equivalent to 40 mg/g, which may cause skin irritation.
This medicine contains methyl parahydroxybenzoate (E218) as an excipient, which may cause allergic reactions (possibly delayed).
3. How to use Differine Gel
Follow these administration instructions provided by your doctor. Consult your doctor or pharmacist if you have any questions. Apply the gel to the affected acne areas once daily, before going to bed:
- Before applying the gel, wash and dry the affected area
- Make sure the areas to be treated are dry before application
- Apply a thin layer of gel
- Gently massage in
- Avoid contact of the gel with the eyes and lips.
Use in children
This medicine must not be used in children under 12 years of age.
If you use more Differine Gel than you should
This medicine is not for ingestion. It is for external use only.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
Excessive use will not produce better or faster results and may instead cause intense redness, peeling, or skin discomfort.
If you forget to use Differine Gel
Do not apply a double dose to make up for missed doses.
If you stop using Differine Gel
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 experiences them.
Differine may cause the following adverse effects at the site of application.
Contact your doctor immediately if you notice any of the following symptoms, as you may require urgent medical treatment: Swelling of the face, lips or throat causing difficulty in swallowing or breathing, skin rash, itching, hives, and dizziness. This could be a sign of angioedema or a severe allergic reaction (frequency not known, cannot be estimated from available data).
Common adverse effects (may affect up to 1 in 10 people)
- Dry skin
- Skin irritation
- Burning sensation on the skin
- Redness of the skin (erythema)
Uncommon adverse effects (may affect up to 1 in 100 people)
- Local skin reaction (contact dermatitis)
- Skin discomfort
- Sunburn
- Itching of the skin (pruritus)
- Worsening of acne
Adverse effects of unknown frequency (cannot be estimated from available data)
- Allergic contact reactions
- Pain or swelling of the skin
- Irritation, redness, itching, or swelling of the eyelids
- Darkening of light skin
- Lightening of dark skin
- Burning at the site of application
Burns at the application site have been reported (mainly superficial burns, but also second-degree burns or serious burns).
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 of Differine Gel
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the pack after CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, 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
Composition of Differine Gel:
The active substance is adapalene. Each gram of gel contains 1 milligram of adapalene.
The other components are carbomer, propylene glycol (E1520), poloxamer 182, disodium edetate, methyl parahydroxybenzoate (E218), phenoxyethanol, sodium hydroxide, and purified water.
Appearance of the product and contents of the pack
Differine is a white, creamy, soft, homogeneous aqueous gel.
Differine gel is available in plastic tubes of 30 g and 50 g.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Laboratoires Galderma
Alby-sur-Chéran
(France)
Date of the most recent revision of this leaflet: May 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es