Patient Information

Differine 1mg/g Cream

Adapaleno

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Differine creamis indicated for the treatment of mild to moderate acne, characterized by blackheads, papules, and pustules. It is suitable for treating facial, chest, and back acne.

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

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 medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Differine cream.

• Ensure that Differine does not come into contact with your eyes, lips, nose wings, or mucous membranes. If it accidentally comes into contact with your eyes, wash them immediately with warm water.

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

The safety and efficacy have not been established in children under 12 years.

Other medications and Differine Cream

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those obtained 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 peeling the skin.
• Treatment with Differine does not affect the efficacy of oral contraceptives or oral antibiotics.

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

Pregnancy and breastfeeding:

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

Differine can be used during breastfeeding. To avoid exposure through contact with the infant, Differine should not be applied to the breast, as it is not known whether Differine passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Treatment with Differine does not affect your ability to drive or operate machinery.

Differine cream containsparahidroxibenzoato de metilo(E218) and parahidroxibenzoato de propilo (E216)as excipients, which may cause allergic reactions (possibly delayed).

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

Apply the cream to the affected areas of acne once a day, before going to bed:

• Before applying the cream, wash and dry the affected area
• Ensure the areas to be treated are dry before application

• Apply a thin layer of cream

• Perform a gentle massage

• Avoid 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 medication should not be ingested. It is only for external use.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Excessive use will not produce better or faster results and may cause intense redness, peeling, or discomfort on the skin.

If you forgot to useDifferine Cream

Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Differine Cream

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Immediately contact your doctor if you notice any of the following symptoms, you may need emergency medical treatment: Swelling of the face, lips, or throat that makes it difficult to swallow or breathe, skin rash, itching, urticaria, and dizziness. This could be a sign of angioedema or a severe allergic reaction (frequency unknown, 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)

Less Frequent Adverse Effects (may affect up to 1 in 100 people)

- Local skin reaction (contact dermatitis)

- Skin discomfort

- Sunburn

- Itching on 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 fair skin

- Lightening of darker skin

- Burn at the application site

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above25°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Differine cream

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

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

Appearance of the product and content of the packaging

Differine is a white and shiny cream.

Differine cream is available in containers containing 30 g and 50 g of cream.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratoires Galderma

Alby-sur-Chéran

(France)

Last review date of this leaflet:07/2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es