Package Insert: Information for the User

Differine 1 mg/g Gel

Adapaleno

Read this package insert carefully before starting to use this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Differine is indicated for the treatment of common acne, where comedones, papules, and pustules predominate. It is suitable for the treatment of facial, chest, and back acne.

Differine belongs to a group of medications called antiacneics.

No use Differine Gel:

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

• 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 frequency of application can be reduced, interrupted temporarily or permanently.
• Do not use Differine 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 studied in children under 12 years.

Other Medications and Differine Gel

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 antibiotics administered orally.
• If you are being treated with other anti-acne products such as 4% erythromycin solution or 1% clindamicina phosphate (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, 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 medication.

Driving and Operating Machines:

Treatment with Differine does not affect your 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 medication contains methyl parahydroxybenzoate (E218) as an excipient, which may cause allergic reactions (possibly delayed).

Follow the administration instructions provided by your doctor. Consult your doctor or pharmacist if you have any doubts. Apply the gel to the affected acne areas once a day, before going to bed:

• Before applying the gel, wash and dry the affected area
• Ensure the areas to be treated are dry before application
• Apply a thin layer of gel
• Perform a gentle massage
• Avoid letting the gel come into contact with your eyes and lips.

Use in children

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

If you use more Differine Gel 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, or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Using it excessively will not produce better or faster results and may cause intense redness, peeling, or discomfort on the skin.

If you forgot to use Differine Gel

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

If you interrupt treatment with Differine Gel

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 everyone will experience them.

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

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

Severe 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 Medicinal Products 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Differine Gel:

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

The other components are carbomer, propylene glycol (E1520), poloxamer 182, disodium edetate, methyl parahydroxybenzoate (E218), phenoxethanol, sodium hydroxide, and purified water.

Appearance of the product and content of the packaging

Differine is a white, creamy, smooth, and homogeneous aqueous gel.

Differine gel is available in plastic tubes of30 gand50 g.

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: May 2024

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