Label: information for the user

Retirides 1 mg/g cream

Tretinoin

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyto youand should not be given to others, 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 label. See section 4.

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

2. What you need to know before starting to use Retirides 1 mg/g cream

3. How to use Retirides 1 mg/g cream

4. Possible adverse effects

5. Storage of Retirides 1 mg/g cream

6. Contents of the package and additional information

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

Retirides 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.

Retirides will be used under medical supervision.

Do not use Retirides 1 mg/g cream

• if you are allergic to tretinoin or any of the other ingredients of this medicine (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 medicines

Warnings and precautions

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

• be especially careful if you have eczema, as this medicine may cause skin irritation. If your skin is irritated, it is recommended to wait for the irritation to recover before starting treatment with Retirides 1 mg/g cream.
• take care to avoid contact with the eyes, eyelids, angles of the nose, 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 full recovery. When exposure to the sun cannot be avoided, use products with solar filters (minimum sun protection factor SPF 15) and protective clothing over 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 medicines and Retirides 1 mg/g cream

inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medicine.

Do not use Retirides 1 mg/g cream if you are taking photosensitizing medicines (medicines that increase the sensitivity of the skin 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, such as perfumes, pre- and post-shaving lotions, etc.), treatment shampoos or soaps, permanent liquid, electrolysis, depilatory creams and waxes, 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 intend 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 lactating mothers.

Consult your doctor or pharmacist before using any medicine.

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 operating machinery

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

Retirides 1 mg/g cream contains cetomacrogol, 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 cetomacrogol and lanolin.

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

This medicine contains perfume with 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 irritation of the eyes and mucous membranes because it contains perfume with butylhydroxytoluene (E-321).

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 the severity of the condition, at the doctor's discretion, the cream of the suitable concentration (since Retirides is available in concentrations of 0.25mg/g, 0.5mg/g, and 1mg/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 (0.25mg/g) and apply it once a day. Subsequently, and according to 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 enough 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, nasal angles, mouth, and mucous membranes.

In any case, your doctor must indicate the duration of your treatment withRetirides 1 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 rapid elimination of the microorganisms that were forming in the depth of the skin.

Excessive application of Retirides 1mg/gcream 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 theskin at the same time.

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

If you have used moreRetirides 1mg/gcreamthan you should, consult your doctor or pharmacist immediately.

Oral ingestion of Retirides 1mg/gcream 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 Toxicological Information Service Tel. 91 5620420.

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

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

The topical application ofRetirides 1mg/gcreammay 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. Skin dryness or peeling may persist throughout the therapy, although they generally decrease during the course of treatment.

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

Rarely, contact allergies occur with the topical use of tretinoin.

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

Up to the current date, all side effects of Retirides 1mg/gcreamhave been reversible upon interrupting 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 conservation 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 1 mg/g cream

-The active ingredient istretinoin in the amount of 0.1 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 perfume (contains benzyl salicylate, geraniol, amyl cinnamaldehyde, linalolandbutilhydroxytoluene E-321) and purified water.

Appearance of the product and contents of the packaging

Retirides 1mg/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

O

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/.