DIFFERINE 1 mg/g CREAM

Introduction

P

Differine 1mg/g cream

Adapalene

Read the entire leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Differine cream and what is it used for
2. What you need to know before starting to use Differine cream
3. How to use Differine cream
4. Possible side effects
5. Storage of Differine cream

Contents of the package and additional information

1. What is Differine cream and what is it used for

Differine cream is indicated for the treatment of vulgar acne, where comedones, papules, and pustules predominate. It is suitable for the treatment of acne on the face, chest, and back.

Differine cream belongs to a group of medicines called anti-acne agents.

2. What you need to know before starting to use Differine cream

Do not use Differine cream:

• If you are pregnant.
• If you plan to become pregnant.
• If you are allergic to the active ingredient 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.

• Make sure Differine does not come into contact with the eyes, lips, nostrils, or mucous membranes. If it accidentally comes into contact with the eyes, rinse them immediately with warm water.

• If after applying the product you experience irritation (redness and itching) at the application site, you should interrupt treatment, consult your doctor to see if the application frequency can be reduced, or the medication temporarily or permanently discontinued.
• Do not use Differine cream on damaged skin (cuts or wounds), sunburned skin, or eczematous skin (scaly, red, blistered, and painful skin).
• 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

Safety and efficacy have not been established in children under 12 years of age.

Other medicines and Differine cream

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those purchased without a prescription.

• Do not use other acne products (containing retinoids) at the same time as Differine.
• Avoid using Differine at the same time as cosmetics that are irritating, drying, or scaling to the skin.
• Treatment with Differine does not affect the efficacy of oral contraceptives or antibiotics administered orally.

• If you are being treated with other anti-acne products such as 4% erythromycin solutions or 1% clindamycin phosphate (as a base), or aqueous-based gels of benzoyl peroxide up to 10%, you can apply these products in the morning and Differine at night.

Pregnancy and breastfeeding:

DO NOT use Differine if you are pregnant or plan to become pregnant. Your doctor may provide more information.

Differine can be used during breastfeeding. To avoid contact exposure to the infant, you should avoid applying Differine to the breast, as it is not known 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 use machinery.

Differine creamcontainsmethylparaben (E218) and propylparaben (E216)as excipients, which may cause allergic reactions (possibly delayed).

3. How to use Differine cream

Follow the administration instructions for this medicine exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Apply the cream to the affected acne areas once a day, before bedtime:

• 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

• Perform a gentle massage

• Avoid getting the cream into contact with the eyes and lips.

Use in children

It cannot be used in children under 12 years of age.

If you use more Differine cream than you should

This medicine should not be ingested. 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If it is used excessively, it will not produce better or faster results, and it may cause intense redness, scaling, or discomfort on the skin.

If you forget to use Differine cream

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

If you interrupt treatment with Differine cream

If you have any other doubts about using this leaflet, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Differine may cause the following side effects at the application site.

Contact your doctor immediately if you notice any of the following symptoms, as you may need urgent medical treatment: Swelling of the face, lips, or throat that makes swallowing or breathing difficult, 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 side effects (may affect up to 1 in 10 people) - Dryness of the skin

• Skin irritation
• Burning sensation on the skin
• Redness of the skin (erythema)

Uncommon side effects (may affect up to 1 in 100 people)

• Local skin reaction (contact dermatitis)
• Discomfort on the skin
• Sunburn
• Itching on the skin (pruritus)
• Worsening of acne

Side 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 darker skin
• Burn at the application site

Burns have been reported at the application site (mainly superficial but also second-degree or severe burns).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Differine cream

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiration date stated on the box after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Contents of the package and additional information

Composition of Differine cream

The active ingredient is adapalene. Each gram of cream contains 1 milligram of adapalene.

The other excipients are carbomer 934P, polyethylene glycol-20 methylglucose sesquiestearate, methylglucose sesquiestearate, glycerol, squalene, methylparaben (E218), propylparaben (E216), disodium edetate, phenoxyethanol, cyclomethicone, sodium hydroxide, and purified water.

Appearance of the product and contents of the package

Differine is a cream, white and shiny.

Differine cream is available in packages 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 last revision of this leaflet:07/2019

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