NEOCARE 4 mg/g CREAM

2. What you need to know before starting to use Neocare cream

Do not use Neocare cream:

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• if you are pregnant.
• if you plan to become pregnant.
• if you have a family history or personal history of cutaneous epithelioma (a type of skin cancer).
• on areas of the skin with wounds, abrasions, and eczema (a skin disease with inflammation, redness, and exudation), as it may cause skin irritation.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Neocare cream.

The irritation caused by this medication is directly related to its efficacy and disappears when applications are spaced out. In the first few 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 deeper part of the skin.

In case of persistent or severe irritation, your doctor will assess the possible interruption of treatment.

Excessive application of Neocare cream does not improve treatment results and may even induce marked irritation with redness, desquamation, itching, etc.

During treatment with Neocare cream, caution should be exercised when using concomitant treatments with other medications that may cause local irritation, especially those with an abrasive, drying, or desquamating effect.

The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet (UVA) lamps during treatment with Neocare cream. Patients with sunburn should be advised not to use the product until they have fully recovered.

When sun exposure cannot be avoided, it is recommended to use products with sun filters and protective clothing over the treated areas.

During treatment with Neocare cream, cosmetics can be used concurrently, but they should not be applied to the skin at the same time.

Avoid contact with the eyes, eyelids, corners of the nose, mouth, and mucous membranes.

Administration should be avoided in case of infection of the affected area. You should take care not to leave cream accumulated between skin folds.

In areas such as the neck and forearms, there is a higher risk of irritation, so it is recommended to reduce the frequency of application.

In case the skin is irritated, it is advisable to wait for the skin to fully recover before starting treatment with Neocare cream.

Interaction of Neocare cream with other medications

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Do not use Neocare cream if you are taking photosensitizing medications (medications that increase skin sensitivity to sunlight) such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides.

Use this medication with caution in the presence of:

• medications used in topical treatments for acne.
• products with a drying or desquamating effect, including soaps, shampoos, cosmetics, and astringents (especially those containing alcohol or fragrances, e.g., perfumes, aftershave lotions, etc.), shampoos or soaps for treatment, 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 Neocare cream if you are pregnant or plan to become pregnant. Your doctor can provide more information.

It is not known whether tretinoin is excreted in breast milk, so precautions should be taken when used by breastfeeding mothers.

Driving and Using Machines

No effects on the ability to drive or use machines have been described.

Neocare cream contains cetyl alcohol, propylene glycol, butylhydroxytoluene, sodium propylparaben, and sodium methylparaben.

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

This medication contains 50 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

It may cause allergic reactions (possibly delayed) because it contains sodium propylparaben and sodium methylparaben.

3. How to use Neocare cream

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Neocare cream.

Your doctor will recommend the appropriate dose for your treatment. Depending on the skin type and severity of the condition, the doctor will prescribe the appropriate concentration. The following presentations are available on the market: 4 mg/g, 0.5 mg/g, 0.25 mg/g, and 0.1 mg/g.

Normally, treatment will start with the lowest concentration (0.1 mg/g) and then, according to the response, will gradually increase to higher concentrations, 0.25 and 0.5 mg/g, and finally end with the 4 mg/g concentration.

Before application, wash the skin with water and a mild soap, letting it dry without rubbing for at least 20-30 minutes. Then, apply a amount of cream that covers only the affected area, 2 times a day, although the amount and applications should be adjusted to individual needs. Avoid contact with the eyes, eyelids, corners of the nose, and mouth, and other mucous membranes of the body.

In any case, your doctor should indicate the duration of treatment with Neocare cream.

General precautions for use

For more detailed information on general precautions for use, consult section 2, "Warnings and Precautions".

Use in Children

The safety and efficacy of Neocare cream in children have not been established.

If you use more Neocare cream than you should

Accidental oral ingestion of Neocare cream may lead to effects similar to those associated with excessive oral ingestion of vitamin A, such as dry skin, joint pain, loss of appetite, vomiting, etc.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Neocare cream

Do not use a double dose to make up for forgotten doses.

If you interrupt treatment with Neocare cream

Do not interrupt treatment unless your doctor advises you to do so.

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

4. Possible Side Effects

Like all medications, Neocare cream can cause side effects, although not everyone will experience them.

Topical application of Neocare cream may cause transient itching, sensation of heat, mild redness, and desquamation similar to that of a mild sunburn, dryness, severe local erythema, and edema at the application site.

The efficacy of the tretinoin-based product is almost always accompanied by skin irritation phenomena that disappear when applications are spaced out.

So far, all side effects of Neocare cream have been reversible upon interruption of treatment.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Neocare cream

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

No special storage conditions are required.

Close the container tightly after use.

Do not use Neocare cream after the expiration date shown on the container. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Neocare cream:

• The active ingredient is tretinoin. Each gram of cream contains 4 mg of tretinoin.
• The other components (excipients) are: Xalifin-15 (PEG-8-C12-C18 Alkyl ether), cetyl alcohol, glycerol, propylene glycol, Oxynex 2004 (propylene glycol, butylhydroxytoluene (E-321), ascorbyl palmitate, glyceryl stearate, citric acid), sodium methylparaben (E-219), sodium propylparaben (E-217), and deionized water.

Appearance of the Product and Package Contents

Viscous and homogeneous cream of yellow color.

20 g aluminum tube.

Marketing Authorization Holder and Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Ctra. Cazoña-Adarzo s/n

39011 Santander (Spain)

This package leaflet was approved in November 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/