Retirides Tretinoin 0.1% Cream

Purified water, Lactic acid, Cetyl alcohol, Isopropyl myristate, Glycerol monostearate, Sodium hydroxide, Acetylated lanolin alcohol, Perfume vertalina 72 (containing Butylhydroxytoluene E-321), Ceteareth-30, Proline, Polyethylene glycol 400 monostearate, Urea, Hydrolyzed collagen, Sodium citrate, Methyl parahydroxybenzoate (E-218), Propyl parahydroxybenzoate (E-216), Tocopherol acetate, Decilum oleate.

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

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

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).

30g

According to the type of skin and severity of the condition, at medical discretion, the cream of the ideal concentration will be prescribed (concentrations of 0.25 mg/g, 0.5 mg/g and 1.00 mg/g are available) and the number of daily applications will be recommended. It is recommended to start treatment with a low concentration cream and apply it once a day. Subsequently, and according to the particular response of the patient, the concentration of the cream and/or the number of applications can be increased.

Method of administration:

For the correct application of Retiroides, avoid frequent washing of the face. Wash twice a day using a neutral soap and try to dry without rubbing. Removers 0.25 mg/g should not be applied until half an hour after washing the face.

Subsequently, a quantity of cream will be spread that exclusively covers the affected area, with the frequency indicated by your doctor.

Avoid contact with eyes, eyelids, angles of the nose and mouth, and other mucous membranes of the body or other areas where treatment is not indicated. Patients should be informed of the importance of sun protection, the use of sunscreens, moisturizing products and appropriate clothing.

The application of Retiraides cream can produce transient itching and a feeling of heat. More frequent application or use of large amounts of Retiroides cream will not improve the result of the treatment and may induce marked irritation of the skin, e.g. erythema, pruritus, exfoliation, etc.

Cosmetics and moisturizing products may be used together during treatment, but should not be applied to the skin at the same time. Neither the safety nor the efficacy of daily use of topical tretinoin for a period exceeding 48 weeks has been established. The safety and efficacy of topical tretinoin in children and those over 50 years had not been established.

Special warnings and precautions for use:

Local irritation;

In the case of acne treatments, this phenomenon of irritation is directly linked to the effectiveness of the product and disappears when spacing the applications. In the first few weeks of treatment, an apparent flare-up of the condition may be observed. This reaction is normal since it is the accelerated removal of micro cysts that were in formation from the depth of the skin.

The use of Retiroides cream in certain sensitive individuals (e.g. those with eczema, sunburn etc.) may induce severe local erythema, itchy inflammation, burning, burning or itching blisters, scabs and/or peeling of the skin at the application site. Tretinoin has been reported to cause severe irritation to eczematous skin and should be used with the utmost caution in those with this condition.

If you have persistent or severe irritation, you should be advised to completely stop the use of Retiroides and speak to your doctor.

Care should be taken with the use of other local irritants at the same time, especially those having an abrasive, desiccant or flaking effect.

Some extreme weather conditions such as wind, cold and low humidity can also be irritating to the skin treated with tretinoin and may increase its dryness.

Exposure to sunlight;

Exposure to sunlight (even if cloudy), including ultraviolet (UVA) sunlamps, should be avoided or reduced during the use of tretinoin.

Those with sunburn should be warned not to use the product until full recovery, due to the potential for serious irritation it can cause to sensitive skin. Those experiencing considerable sun exposure due to their jobs and/or skin sensitivity to the sun should take special precautions. When sun exposure cannot be avoided, products with sunscreens (minimum sun protection factor SPF 50) and protective clothing should be used on the treated areas.

General precautions for use;

Tretinoin should be used under medical supervision as part of a comprehensive skincare program, including patient education on sun avoidance and general skincare, using sunscreens, moisturizers, and protective clothing.

Care should be taken 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 the potential for additional skin irritation. Caution should be taken not to leave medication accumulated in the folds of the skin. In the most sensitive areas of the skin such as the forearm neck there is a greater risk of irritation so it is recommended to reduce the frequency of application.

Interaction with other medicinal products and other forms of interaction:

Use tretinoin with caution in the presence of:

Concomitant topical medications.
Products with abrasive, desiccant or flaking effect including soaps, shampoos, cosmetics and astringents (especially those containing alcohol, lime or aromas). Treatment shampoos or soaps, permanent fluids, electrolysis hair removal, depilatory creams and waxes or preparations or processes that may dry or irritate the skin, unless the treatment is performed under medical supervision.
Do not apply tretinoin if photosensitizing medications (such as thiazides, tetracyclines, fluoroquinolones, phenothiazides, sulfonamides) are being taken due to the possibility of increased toxicity.

Fertility, pregnancy and lactation:

Orally administered retinoids have been associated with congenital anomalies. It is generally assumed that topically administered retinoids produce low systemic exposure because dermal absorption is minimal, provided that they are used in accordance with the information contained in the smPC. However, individual factors (e.g., skin barrier damage, overuse) may occur that contribute to increased systemic exposure.

Pregnancy and breastfeeding

Retirides is contraindicated in women who are breastfeeding, pregnant or planning to become pregnant. If the product is used during pregnancy or if the patient becomes pregnant while using this medication, treatment should be discontinued.

Adverse reactions:

Aluminium tubes coated with a LATEX band.

The most frequent local reactions reported during therapy are dryness or peeling skin, burns, itching, burning, severe local erythema, oedema, blisters, bedsores, pruritus and hiccups and transient hyperpigmentation.

These skin reactions were generally mild to moderate and generally well tolerated. They normally occurred at the beginning of treatment except in the case of dryness or peeling of the skin, which persisted during therapy, although they generally decrease during the course of treatment (see section 4.4, section "Local irritation"). The frequency of these reactions is not known (it cannot be estimated from the available data).

Clinical studies with tretinoin showed no incidences of true allergic sensitivity to contact. An increase in sensitivity to sunlight or other UVB light sources has been noted.

Overuse:

Excessive application of Retiroides 0.25 mg/g cream does not improve the results of the treatment and can induce marked irritation, for example, erythema, peeling, pruritus etc. Oral ingestion of Retiroides 0.25 mg/g cream may lead to effects similar to those associated with excessive oral intake of vitamin A (e.g. pruritus, dry skin, arthralgia, anorexia, vomiting, etc.). Contact your doctor if you have accidentally ingested the product.