RETIRIDES 0.25 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Retirides 0.25 mg/g Cream

Tretinoin

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.

• Keep this leaflet, as 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. What is Retirides 0.25 mg/g cream and what is it used for
2. What you need to know before you use Retirides 0.25 mg/g cream
3. How to use Retirides 0.25 mg/g cream
4. Possible side effects
5. Storage of Retirides 0.25 mg/g cream
6. Contents of the pack and other information

1. What is Retirides 0.25 mg/g cream and what is it used for

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

Retirides 0.25 mg/g is a cream that contains the active ingredient tretinoin, a derivative of Vitamin A, indicated for the topical treatment of acne, from mild to moderate.

Retirides 0.25 mg/g cream will be used under medical supervision.

2. What you need to know before you use Retirides 0.25 mg/g cream

Do not use Retirides 0.25 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 personal or family history of skin epithelioma (skin cancer).
• if you are pregnant
• if you are planning to become pregnant
• if you are using photosensitizing medications

Warnings and precautions

Consult your doctor or pharmacist before starting to use Retirides 0.25 mg/g cream

• be careful if you have eczema, as this medicine may cause skin irritation. If the skin is irritated, it is recommended to wait for the irritation to heal before starting treatment with Retirides 0.25 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 more 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.
• exposure to sunlight, including ultraviolet sunlamps (UVA), should be avoided or reduced during the use of tretinoin. Patients with sunburn should be advised 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 stop applying Retirides 0.25 mg/g cream and, if necessary, consult your doctor.

Other medicines and Retirides 0.25 mg/g cream

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not use Retirides 0.25 mg/g cream if you are taking photosensitizing medications (medicines that increase skin sensitivity to sunlight), such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides.

Use Retirides 0.25 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 IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT.Your doctor may give you 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 medicine.

Use in children

The safety and efficacy of Retirides 0.25 mg/g cream have not been established in this population.

Use in people over 50 years old

The safety and efficacy of Retirides 0.25 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 0.25 mg/g cream contains cetyl alcohol, lanolin, methylparaben, propylparaben, benzyl salicylate, geraniol, amylcinnamaldehyde, linalol, 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 methylparaben, propylparaben, and Vertalina perfume (contains benzyl salicylate, geraniol, amylcinnamaldehyde, and linalol).

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

3. How to use Retirides 0.25 mg/g cream

Follow the instructions for administration of this medicine indicated by your doctor. If you have any doubts, consult your doctor again.

According to the skin type and severity of the condition, the doctor will prescribe the cream of the suitable concentration (since Retirides is available in concentrations of 0.25 mg/g, 0.50 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 a sufficient amount of 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 0.25 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 0.25 mg/g cream does not improve treatment results and may even induce marked irritation with redness, peeling, 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 0.25 mg/g cream than you should

If you have used more Retirides 0.25 mg/g cream than you should, consult your doctor or pharmacist immediately.

Oral ingestion of Retirides 0.25 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 Tel. 91 5620420.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Topical application of Retirides 0.25 mg/g cream may cause transient itching, sensation of heat, mild redness, and skin peeling similar to that of mild sunburn, dryness, severe local erythema, edema at the application site, burns, blisters, eschars, and pruritus. Skin dryness or peeling 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 0.25 mg/g cream have been reversible upon discontinuation of treatment.

Reporting of side effects

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

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

5. Storage of Retirides 0.25 mg/g cream

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Retirides 0.25 mg/g cream

• The active ingredient is tretinoin in the amount of 0.025 g per 100 g of cream.
• The other ingredients 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, Vertalina perfume 72 (contains benzyl salicylate, geraniol, amylcinnamaldehyde, linalol, and butylhydroxytoluene E-321), and purified water.

Appearance of the product and contents of the pack

Retirides 0.25 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 leaflet:October 2018.

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.gob.es/.