Differine 1 mg/g cream
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Differine 1mg/g cream
Adapalene
Read all of this 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. It may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Package leaflet contents
- What Differine cream is and what it is used for
- What you need to know before using Differine cream
- How to use Differine cream
- Possible side effects
- Storage of Differine cream
Contents of the pack and other information
1. What Differine cream is and what it is used for
Differine cream is indicated for the treatment of acne vulgaris, in which comedones, papules and pustules predominate. It is suitable for the treatment of facial, chest and back acne.
Differine cream belongs to a group of medicines called anti-acne agents.
2. What you need to know before using Differine cream
Do not use Differine cream:
- If you are pregnant.
- If you plan 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 cream.
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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.
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If after applying the product you experience irritation (redness and itching) at the application site, treatment should be stopped. Consult your doctor to determine whether the frequency of application can be reduced, or whether treatment should be temporarily or permanently discontinued.
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Do not use Differine cream on damaged skin (cuts or wounds), sunburned skin, or on eczematous skin (skin that is scaly, red, blistered, and painful).
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Avoid excessive exposure to sunlight or ultraviolet (UV) radiation.
If you use cosmetics, they should be non-greasy and non-drying to the skin.
Children and adolescents
Safety and efficacy have not been established in children under 12 years of age.
Other medicines and Differine cream
Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.
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Do not use other acne treatments (containing retinoids) at the same time as Differine.
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Avoid using Differine simultaneously with cosmetics that are irritating, drying, or exfoliating to the skin.
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Treatment with Differine does not affect the effectiveness of oral contraceptives or orally administered antibiotics.
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If you are being treated with other anti-acne products such as 4% erythromycin or 1% clindamycin phosphate solutions (as base), 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 further information.
Differine may be used during breastfeeding. To avoid exposure of the infant through contact, 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 cream contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) as excipients, which may cause allergic reactions (possibly delayed).
3. How to use Differine cream
Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply the cream to the affected acne areas once daily, before going to bed:
- Before applying the cream, wash and dry the affected area
- Make sure the areas to be treated are dry before application
- Apply a thin layer of cream
- Gently massage in
- Avoid contact of the cream 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 Cream than you should
This medicine is not for ingestion. It is for external use only.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
Excessive use will not produce better or faster results, and may instead cause intense redness, peeling, or skin irritation.
If you forget to use Differine Cream
Do not apply a double dose to make up for missed doses.
If you stop using Differine Cream
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; you may require urgent medical treatment: Swelling of the face, lips, or throat causing difficulty 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).
Frequent 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)
- Contact allergic reactions
- Pain or swelling of the skin
- Irritation, redness, itching, or swelling of the eyelids
- Darkening of light skin
- Lightening of dark skin
- Burn at the application site
Burns at the application site have been reported (mainly superficial burns, but also second-degree burns or severe 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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Differine cream
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after EXP or CAD. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Differine cream
The active substance is adapalene. Each gram of cream contains 1 milligram of adapalene.
The other ingredients are carbomer 934P, polyethylene glycol-20 methylglucose sesquistearate, methylglucose sesquistearate, glycerol, squalene, methylparaben (E218), propylparaben (E216), disodium edetate, phenoxyethanol, cyclomethicone, sodium hydroxide, and purified water.
Appearance of the product and contents of the container
Differine is a white, smooth cream.
Differine cream is available in containers containing 30 g and 50 g of cream.
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: 07/2019
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.gob.es