Retirides 0.5 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Retirides 0.5 mg/g cream

Tretinoin

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Retirides 0.5 mg/g cream is and what it is used for

2. What you need to know before using Retirides 0.5 mg/g cream

3. How to use Retirides 0.5 mg/g cream

4. Possible side effects

5. Storage of Retirides 0.5 mg/g cream

6. Contents of the pack and other information

1. What Retirides 0.5 mg/g cream is and what it is used for

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

Retirides 0.5 mg/g is a cream containing the active substance tretinoin, a derivative of Vitamin A, indicated for the topical treatment of mild to moderate acne, and for reducing the clinical signs of photoaging (premature skin aging with the appearance of wrinkles, spots, and/or facial roughness due to prolonged sun exposure).

Retirides 0.5 mg/g cream should be used under medical supervision.

2. What you need to know before starting to use Retirides 0.5 mg/g cream

Do not use Retirides 0.5 mg/g cream

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Retirides 0.5 mg/g cream

• take special care if you have eczema, as this medicine may cause skin irritation. If your skin is irritated, it is advisable to wait until the irritation has resolved before starting treatment with Retirides 0.5 mg/g cream.
• care must be taken to avoid contact with the eyes, eyelids, corners of the nose, mouth, mucous membranes, or other areas where treatment is not indicated, in order to minimize additional skin irritation. Precautions should be taken to avoid accumulation of the medication in skin folds. Areas of more sensitive skin, such as the neck and forearms, carry a higher risk of irritation; therefore, it is recommended to reduce the frequency of application.
• exposure to sunlight, including ultraviolet (UVA) sunlamps, should be avoided or minimized during treatment with tretinoin. Patients with sunburn should be advised not to use the product until fully recovered. When sun exposure cannot be avoided, sunscreen products (minimum sun protection factor SPF 15) and protective clothing should be used on treated areas.
• if persistent or severe irritation occurs, application of Retirides 0.5 mg/g cream should be discontinued completely and, if necessary, medical advice should be sought.

Other medicines and Retirides 0.5 mg/g cream

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not use Retirides 0.5 mg/g cream if you are taking photosensitizing medicines (medicines that increase skin sensitivity to sunlight), such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, or sulfonamides.

Use Retirides 0.5 mg/g cream with caution if you are using:

• topical medications for acne and/or photoaging.
• abrasive, drying, or exfoliating cosmetic products, including soaps, shampoos, cosmetics, and astringents (especially those containing alcohol or fragrances, e.g., colognes, pre- and post-shaving lotions, etc.), medicated shampoos or soaps, permanent wave lotions, electrolysis, depilatory creams or waxes, or other preparations or procedures that may irritate the skin, unless performed under medical supervision.

Pregnancy, breastfeeding, and fertility

DO NOT use Retirides if you are pregnant or planning to become pregnant. Your doctor can provide further information.

It is not known whether tretinoin is excreted in human breast milk; therefore, appropriate precautions should be taken when using this medicine during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Use in children

The safety and efficacy of Retirides 0.5 mg/g cream have not been established in this population.

Use in people over 50 years of age

The safety and efficacy of Retirides 0.5 mg/g cream have not been established in this population.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Retirides 0.5 mg/g cream contains cetyl alcohol, lanolin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl salicylate, geraniol, amyl cinnamaldehyde, linalool, and butylhydroxytoluene.

This medicine 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 methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine contains Vertaline fragrance containing the allergens benzyl salicylate, geraniol, amyl cinnamaldehyde, and linalool, which may cause allergic reactions.

This medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains Vertaline fragrance (containing butylhydroxytoluene E-321).

3. How to use Retirides 0.5 mg/g cream

For the treatment of acne

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Depending on the skin type and severity of the condition, at the physician's discretion, the cream with the appropriate concentration will be prescribed (since Retirides is available in concentrations of 0.25 mg/g, 0.5 mg/g, and 1 mg/g), and the number of daily applications will be recommended.

It is recommended to start treatment with the lowest concentration cream (0.25 mg/g), applied once daily. Subsequently, depending on the individual patient's 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 taking care to dry without rubbing.

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

Apply a sufficient amount of cream to cover the area to be treated and gently 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 0.5 mg/g cream.

In acne treatments, irritation is directly related to the product's efficacy and subsides when applications are spaced out. During the first weeks of treatment, an apparent increase in symptoms and signs of irritation may be observed. This reaction is normal, as it reflects the accelerated elimination of microcysts forming deep within the skin.

Excessive application of Retirides 0.5 mg/g cream does not improve treatment outcomes and may instead cause marked irritation with redness, desquamation, itching, etc.

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

For the treatment of photoaging

Apply once nightly after cleansing the skin, using only enough to lightly cover the areas to be treated (face, arms, etc.), avoiding contact with the eyes, eyelids, corners of the nose, mouth, and mucous membranes.

The areas treated with Retirides 0.5 mg/g cream should be thoroughly cleansed. The use of a mild, non-medicated soap is recommended. Gently pat the area without rubbing. Allow the area to dry for at least 20–30 minutes before applying Retirides 0.5 mg/g cream to the skin. Washing the treated area twice daily is more than sufficient.

Application of Retirides 0.5 mg/g cream may cause transient itching, a sensation of warmth, and mild transient redness, similar to that of a mild sunburn.

Improvements in signs of photoaging with Retirides 0.5 mg/g cream are not immediate but appear gradually during the course of therapy. Visible improvements typically begin 3–4 months after starting treatment, and up to 6 months may be needed before definite beneficial effects are observed.

If you use more Retirides 0.5 mg/g cream than you should

If you have used more Retirides 0.5 mg/g cream than prescribed, consult your doctor or pharmacist immediately.

Oral ingestion of Retirides 0.5 mg/g cream may lead to effects similar to those associated with excessive oral intake of vitamin A, for example, itching, skin dryness, arthralgia (neuralgia or joint pain), anorexia, vomiting, etc.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the National Toxicology Information Service at Tel. 91 5620420, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Topical application of Retirides 0.5 mg/g cream may cause transient pruritus, sensation of warmth, slight redness, and skin peeling similar to mild sunburn, dryness, severe local erythema, development of edema at the application site, burns, blisters, ulcers, and pruritus. Skin dryness or desquamation may persist throughout the therapy, although they generally decrease during the course of treatment.

In acne treatment, skin irritation is directly related to the efficacy of tretinoin-containing products and resolves when applications are spaced out.

In the case of photoaging treatment, if local irritation occurs, patients should use the cream less frequently, temporarily discontinue use, or, if necessary, completely interrupt administration.

Allergic contact reactions with topical use of tretinoin are rare.

There have been reports of some cases of temporary increase and decrease in pigmentation due to repeated application. Increased sensitivity to sunlight or other sources of UVB radiation has been observed.

To date, all side effects of Retirides 0.5 mg/g cream have been reversible upon discontinuation of treatment.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Retinides 0.5 mg/g cream storage

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

This medicine does not require special storage conditions. Keep the tube tightly closed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Retirides 0.5 mg/g cream

• The active substance is tretinoin, 0.05 g per 100 g of cream.
  • The other components are: decyl oleate, isopropyl myristate, glyceryl 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, tocopheryl acetate, vertalina 72 fragrance (contains benzyl salicylate, geraniol, amyl cinnamaldehyde, linalool and butylated hydroxytoluene E-321) and purified water.

Appearance of the product and contents of the container

Retirides 0.5 mg/g cream is an oil-in-water emulsion for topical use, supplied 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

LABORATORIOS ERN, S.A.

Polígono Industrial Can Salvatella. Calle Gorcs i Lladó, 188

Barberá del Vallés (Barcelona)

Spain

Date of the most recent revision of this package leaflet: October 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.