Leaflet: information for the user

Neocare 4 mg/g cream

Tretinoin

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What Neocare cream is and what it is used for

2. What you need to know before using Neocare cream

3. How to use Neocare cream

4. Possible side effects

5. Storage of Neocare cream

6. Contents of the pack and additional information

Neocare is a medication that belongs to the group of medications known as topical antiacneics.

Neocare is a cream indicated for the topical treatment of mild to moderate common acne.

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 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 linked to the effectiveness of the product and disappears by spacing out 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 the accelerated elimination of the microquists that were forming in the deeper layers of the skin.

If persistent or severe irritation occurs, your doctor will evaluate the possible interruption of treatment.

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

During treatment with Neocare cream, be careful with concomitant treatments with other medications that may cause local irritation, especially those with abrasive, drying, or desquamating effects.

Treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet A (UVA) lamps during treatment with Neocare cream. Patients with sunburns should be advised not to use the product until full recovery.

When sun exposure cannot be avoided, it is recommended to use sun protection products and protective clothing on treated areas.

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

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

Administration should be avoided in case of infection of the affected area. Be careful 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 of skin irritation, it is advisable to wait for the skin to fully recover before starting treatment with Neocare cream.

Interaction of Neocare cream with other medications

Inform your doctor or pharmacist that you are using or have used recently 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 drying or desquamating effects, including soaps, shampoos, cosmetics, and astringents (especially those containing alcohol or fragrances, such as perfumes, pre- and post-shaving lotions, etc.), shampoos or treatment soaps, permanent hair dyes, electrolysis, depilatory creams or waxes, or processes that may irritate the skin, unless 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 may provide more information.

It is not known whether tretinoin is excreted in breast milk, so necessary precautions will be taken when using it in lactating women.

Driving and operating machinery

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

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

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

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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Your doctor will recommend the suitable dose for your treatment. Depending on the type of skin and the 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.

Treatment will usually begin with the lowest concentration (0.1 mg/g) and, according to the response, it will be gradually increased to higher concentrations, 0.25 and 0.5 mg/g, and finally end with a concentration of 4 mg/g.

Before applying, the skin will be washed with water and a mild soap, and left to dry without rubbing for at least 20-30 minutes. Then, a sufficient amount of cream will be applied to cover only the affected area, twice a day, although the amount and applications should be adjusted according to individual needs. Avoid contact with the eyes, eyelids, nose angles, and mouth, and other mucous membranes of the body.

In any case, your doctor should inform you of 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 intake 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Neocare cream

Do not use a double dose to compensate for the missed dose.

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 the use of this medication, ask your doctor or pharmacist.

Like all medications, Neocare cream may produce adverse effects, although not all people will experience them.

The topical application of Neocare cream may produce transient itching, sensation of heat, mild redness, and peeling similar to a mild sunburn, dryness, severe local erythema, and the appearance of edemas 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.

To date, all adverse effects of Neocare cream have been reversible upon interrupting treatment.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this prospectus.

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

No special storage conditions are required.

Closely close the container 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 drains or in the trash. Dispose of containers and unused medications at the PHARMACY TAKE-BACK POINT. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

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 salt of methyl parahydroxybenzoate (E-219), sodium salt of propyl parahydroxybenzoate (E-217), and deionized water.

Appearance of the product and content of the packaging

Viscous and homogeneous yellow-colored cream.

20 g aluminum tube.

Holder of the marketing authorization and responsible for manufacturing

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Ctra. Cazoña-Adarzo s/n

39011 Santander (Spain)

This leaflet was approved in November 2020

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