RETIRIDES 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Retirides 1 mg/g Cream

Tretinoin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Retirides 1 mg/g Cream and what is it used for
2. What you need to know before using Retirides 1 mg/g Cream
3. How to use Retirides 1 mg/g Cream
4. Possible side effects
5. Storage of Retirides 1 mg/g Cream
6. Package Contents and Additional Information

1. What is Retirides 1 mg/g Cream and what is it used for

This cream belongs to the group of medications called anti-acne agents.

Retirides is a cream that contains tretinoin as the active ingredient, a derivative of Vitamin A, indicated for the topical treatment of acne, from mild to moderate.

Retirides will be used under medical supervision.

2. What you need to know before using Retirides 1 mg/g Cream

Do not use Retirides 1 mg/g Cream

• if you are allergic to tretinoin or any of the other components of this medication (listed in section 6)
• if you have a family or personal history of cutaneous epithelioma (skin cancer)
• if you are pregnant
• if you plan to become pregnant
• if you are using photosensitizing medications

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Retirides 1 mg/g Cream

• be particularly careful if you have eczema, as this medication may cause skin irritation. If the skin is irritated, it is recommended to wait for the irritation to heal before starting treatment with Retirides 1 mg/g Cream.
• care should be taken to avoid contact with the eyes, eyelids, corners of the nose, mouth, and mucous membranes or other areas where treatment is not indicated, to minimize potential additional skin irritation. Precautions should be taken to avoid leaving medication accumulated in skin folds. In areas of the skin that are more sensitive, such as the neck and forearms, there is a higher risk of irritation, so it is recommended to reduce the frequency of application.
• exposure to sunlight, including ultraviolet lamps (UVA), should be avoided or reduced during the use of tretinoin. Patients with sunburn should be warned not to use the product until they have fully recovered. When sun exposure cannot be avoided, products with sunscreens (minimum sun protection factor FPS 15) and protective clothing should be used over the treated areas.
• If you experience persistent or severe irritation, you should completely discontinue the application of Retirides 1 mg/g Cream and, if necessary, consult your doctor.

Other Medications and Retirides 1 mg/g Cream

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not use Retirides 1 mg/g Cream if you are taking photosensitizing medications (medications that increase skin sensitivity to sunlight), such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides.

Use Retirides 1 mg/g Cream with caution in the presence of:

• Topical medications used in skin treatments for acne and/or photoaging.
• Cosmetic products with abrasive, drying, or peeling effects, including soaps, shampoos, cosmetics, and astringents (especially those containing alcohol or fragrances, e.g., colognes, pre- and post-shave lotions, etc.), treatment shampoos or soaps, permanent wave liquids, electrolysis, depilatory creams and waxes, or preparations or processes that may irritate the skin, unless the treatment is performed under medical supervision.

Pregnancy, Breastfeeding, and Fertility

DO NOT use Retirides 1 mg/g Cream if you are pregnant or plan to become pregnant.Your doctor may provide you with more information.

It is not known whether tretinoin is excreted in breast milk, so precautions should be taken when used by breastfeeding mothers.

Consult your doctor or pharmacist before using any medication.

Use in Children

The safety and efficacy of Retirides 1 mg/g Cream have not been established in this population.

Use in People Over 50 Years Old

The safety and efficacy of Retirides 1 mg/g Cream have not been established in this population.

Driving and Using Machines

No effects on the ability to drive or use machines have been described.

Retirides 1 mg/g Cream contains cetyl alcohol, lanolin, methylparaben, propylparaben, benzyl salicylate, geraniol, amylcinnamaldehyde, linalool, and butylhydroxytoluene.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and lanolin.

It may cause allergic reactions (possibly delayed) because it contains methylparaben and propylparaben.

This medication contains vertaline perfume with allergens benzyl salicylate, geraniol, amylcinnamaldehyde, and linalool, which may cause allergic reactions.

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains vertaline perfume (contains butylhydroxytoluene E-321).

3. How to Use Retirides 1 mg/g Cream

Follow your doctor's instructions for administering this medication exactly. If you have any doubts, consult your doctor again.

According to the skin type and severity of the condition, your doctor will prescribe the cream with the appropriate concentration (since Retirides is available in concentrations of 0.25 mg/g, 0.5 mg/g, and 1 mg/g) and recommend the number of daily applications.

It is recommended to start treatment with the lowest concentration cream (0.25 mg/g) and apply it once a day. Subsequently, and according to the patient's particular response, the concentration of the cream and/or the number of applications may be increased.

Avoid frequent washing of the face. It is sufficient to wash it two or three times a day, using a neutral soap and trying to dry without rubbing.

Do not apply the cream until half an hour after washing the face.

Apply enough cream to cover the area to be treated and perform a gentle massage, avoiding contact with the eyes, eyelids, corners of the nose, mouth, and mucous membranes.

In any case, your doctor should indicate the duration of your treatment with Retirides 1 mg/g Cream.

In acne treatments, the phenomenon of skin irritation is directly related to the efficacy of the product and disappears when applications are spaced out. In the first weeks of treatment, an apparent increase in symptoms and signs of irritation may be observed. This reaction is normal, as it is the accelerated elimination of microcomedones that were forming in the depth of the skin.

Excessive application of Retirides 1 mg/g Cream does not improve treatment results and may even induce marked irritation with redness, desquamation, itching, etc.

During treatment, cosmetics can be used, especially moisturizing products, but they should not be applied to the skin at the same time.

If you use more Retirides 1 mg/g Cream than you should

If you have used more Retirides 1 mg/g Cream than you should, consult your doctor or pharmacist immediately.

Oral ingestion of Retirides 1 mg/g Cream may lead to effects similar to those associated with excessive oral intake of vitamin A, such as itching, dry skin, arthralgias (neuralgias or joint pain), anorexia, vomiting, etc.

In case of overdose or accidental ingestion, consult the National Toxicology Information Service at 91 5620420.

If you have any other questions about using this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Topical application of Retirides 1 mg/g Cream may cause transient itching, sensation of heat, mild redness, and skin desquamation similar to that of mild sunburn, dryness, severe local erythema, edema at the application site, burns, blisters, eschars, and pruritus. Skin dryness or desquamation may persist throughout therapy, although they generally decrease during the course of treatment.

In acne treatments, the phenomenon of skin irritation is directly related to the efficacy of the product based on tretinoin and disappears when applications are spaced out.

Rarely, contact allergies have been reported with the topical use of tretinoin.

Some cases of temporary increase and decrease in pigmentation have been described due to repeated application. An increased sensitivity to sunlight or other UVB light sources has been noted.

To date, all side effects of Retirides 1 mg/g Cream have been reversible upon discontinuation of treatment.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Retirides 1 mg/g Cream

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

This medication does not require special storage conditions. Keep the tube perfectly closed.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Retirides 1 mg/g Cream

• The active ingredient is tretinoin in an amount of 0.1 g per 100 g of cream.
  • The other components are: decyl oleate, isopropyl myristate, glycerol monostearate, acetylated lanolin alcohol, ceteareth-30, cetyl alcohol, proline, polyethylene glycol 400 monostearate, urea, collagen, methylparaben (E-218), propylparaben (E-216), lactic acid, sodium citrate, sodium hydroxide, tocopherol acetate, vertaline perfume 72 (contains benzyl salicylate, geraniol, amylcinnamaldehyde, linalool, and butylhydroxytoluene E-321), and purified water.

Appearance of the Product and Package Contents

Retirides 1 mg/g Cream is an oil-in-water emulsion for topical use, presented in a 30 ml tube.

Marketing Authorization Holder

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9, Sant Cugat del Valles (Barcelona)

Spain

Or

LABORATORIOS ERN, S.A.

Polígono Industrial Can Salvatella. Calle Gorcs i Lladó, 188

Barberá del Vallés (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet:October 2018.

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