Prospecto: Information for the User

Retirides 0.5 mg/g Cream

Tretinoin

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should 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 not listed in this prospect. See section 4.

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

2.What you need to know before starting touse Retirides 0.5 mg/g Cream

3.How to use Retirides 0.5 mg/g Cream

4.Possible adverse effects

5Storage of Retirides 0.5 mg/g Cream

6.Contents of the package andadditional information

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

Retirides 0.5 mg/g is a cream that contains tretinoin as its active ingredient, a derivative of Vitamin A, indicated for the topical treatment of mild to moderate acne, and for the reduction of signs of photo-aging (premature skin aging with the appearance of wrinkles, spots, and/or facial roughness due to prolonged sun exposure).

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

Do not use Retirides 0.5mg/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 0.5 mg/g cream

• be especially careful if you have eczema, as this medication may cause skin irritation. If your skin is irritated, it is recommended to wait for the irritation to recover before starting treatment with Retirides 0.5 mg/g cream.
• be careful to avoid contact with the eyes, eyelids, nose corners, mouth, and mucous membranes or other areas where treatment is not indicated, to minimize potential additional skin irritation. You should take precautions to avoid leaving medication accumulated in skin folds. In sensitive skin areas such as the neck and forearms, there is a higher risk of irritation, so it is recommended to reduce the frequency of application.
• avoid or reduce exposure to sunlight, including ultraviolet A (UVA) lamps, during the use of tretinoin. Patients with sunburns should be advised not to use the product until their skin has fully recovered. When it is not possible to avoid sun exposure, use products with solar filters (minimum sun protection factor FPS 15) and protective clothing over treated areas.
• if you experience persistent or severe irritation, you should completely discontinue the application of Retirides 0.5 mg/g cream and, if necessary, consult a doctor

Other medications and Retirides 0.5 mg/g cream

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

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

Use Retirides 0.5 mg/g cream with caution in the presence of:

• medications used in topical 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, such as perfumes, pre- and post-shaving lotions, etc.), treatment shampoos or soaps, permanent hair dyes, electrolysis, depilatory creams or waxes, or processes that may irritate the skin, unless the treatment is performed under medical supervision.

Pregnancy, breastfeeding, and fertility

DO NOT use Retirides 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 necessary precautions will be taken when using it in breastfeeding mothers.

Consult your doctor or pharmacist before using any medication.

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 old

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

Driving and operating machinery

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

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

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

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medication contains perfume with the allergens benzyl salicylate, geraniol, amyl cinnamaldehyde, 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 perfume with butylhydroxytoluene (E-321).

For Acne Treatment

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts, consult your doctor again.

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

It is recommended to start treatment with the cream of the lowest concentration (0.25 mg/g) and apply it once a day. Subsequently, and in accordance with the patient's individual 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 drying without rubbing.

Do not apply the cream until 30 minutes after washing the face.

Apply a sufficient amount of cream to cover the area to be treated and perform a gentle massage, avoiding contact with the eyes, eyelids, nose angles, 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, the irritation phenomenon is directly linked to the effectiveness of the product and disappears by spacing the applications. 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 a matter of accelerated elimination of microorganisms that were forming in the depth of the skin.

Excessive application of Retirides 0.5 mg/g cream does not improve treatment results and may even induce marked irritation with redness, peeling, itching, etc.

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

For Photoaging Treatment

Apply once a night after skin cleansing, only in sufficient quantity to lightly cover the areas to be treated (face, arms, etc.), avoiding contact with the eyes, eyelids, nose angles, mouth, and mucous membranes.

The treated areas with Retirides 0.5 mg/g cream must be completely cleaned. A mild non-medical soap is recommended. Gently pat the area without rubbing. Leave the area to dry for at least 20-30 minutes before applying Retirides 0.5 mg/g cream to the skin. It is more than enough to wash the treated area twice a day.

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

The improvements in photoaging signs with Retirides 0.5 mg/g cream are not immediate, but rather occur gradually during the course of therapy. Visible improvements begin to appear 3-4 months after starting treatment, and may require up to 6 months to observe defined beneficial effects.

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 you should, 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 ingestion of vitamin A, such as itching, skin dryness, arthralgias (neuralgias 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 Tel. 91 5620420, indicating the medication and the amount ingested.

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

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

The topical application ofRetirides 0.5 mg/g creamcan produce transient itching, sensation of heat, mild redness, and skin peeling similar to mild sunburn, dryness, severe local erythema, appearance of edema at the application site, burns, blisters, scabs, and pruritus. Thedryness or skin peeling may persist throughout the entire therapy, although they generally decrease during the course of treatment.

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

In the case of photoaging treatment. If local irritation appears, patients should use the cream less frequently, temporarily stop using it, or if necessary, completely discontinue administration.

Allergic contact dermatitis may rarely occur with the topical use of tretinoin.

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

Up to the present, all adverse effects of Retirides 0.5 mg/g cream have been reversible upon discontinuing treatment.

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 throughthe Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 the packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Retirides 0.5 mg/g cream

-The active ingredient istretinoin in the amount of 0.05 g per each100 gof cream.

• The other components are:decyl oleate, isopropyl myristate, monoestearate of glycerol, acetylated lanolin alcohol, ceteareth-30, cetyl alcohol, proline, polyethylene glycol 400 monoestearate, urea, collagen, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), lactic acid, sodium citrate, sodium hydroxide, acetate of tocopherol, vertalina 72 fragrance (contains benzyl salicylate, geraniol, amyl cinnamaldehyde, linaloolandbutilhydroxytoluene E-321) and purified water.

Appearance of the product and content of the packaging

Retirides 0.5mg/g creamis an oil-in-water emulsion for cutaneous use presented in a 30 ml tube.

Holder of the marketing authorization

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:October 2018

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