DIFFERINE 1 mg/g GEL

Introduction

Package Leaflet: Information for the User

Differine 1 mg/g Gel

Adapalene

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. Contents of the pack and further 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 on the face, chest, and back.

Differine belongs to a group of medicines called anti-acneics.

2. What you need to know before you 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Differine gel.

• 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, treatment should be discontinued. Consult your doctor to determine if the frequency of application can be reduced or if the medication should be temporarily or permanently discontinued.
• Do not use Differine 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 to the skin.

Children and adolescents

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

Other medicines and Differine gel

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 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 solutions (as a base), or aqueous-based gels of benzoyl peroxide up to 10%, you can apply these products in the morning and Differine in the evening.

Pregnancy and breastfeeding:

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

Differine can be used during breastfeeding. To avoid contact exposure to 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 medicine.

Driving and using machines:

Treatment with Differine does not affect the ability to drive or use machinery.

Differine gelcontains:

40 mg of propylene glycol (E1520) per gram, equivalent to 40 mg/g, which may cause skin irritation.

This medicine contains methylparaben (E218) as an excipient, which may cause allergic reactions (possibly delayed).

3. How to use Differine Gel

Follow these instructions for administration as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Apply the gel to the affected areas of acne, once a day, before bedtime:

• 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.
• Avoid getting the gel in 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 Gel than you should

This medicine is not to be ingested. It is for external use only.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or 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 Gel

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

If you stop treatment with Differine Gel

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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, 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 the 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

Rare side effects (cannot be estimated from the 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 darker skin
• Burning at the application site

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Differine Gel

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 CAD or EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Differine Gel:

The active substance is adapalene. Each gram of gel contains 1 milligram of adapalene.

The other ingredients are carbomer, propylene glycol (E1520), poloxamer 182, disodium edetate, methylparaben (E218), phenoxyethanol, sodium hydroxide, and purified water.

Appearance of the product and contents of the pack

Differine is a white, creamy, smooth, and 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 last revision of this leaflet: May 2024

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.es