NADONA 20 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Nadona 20 mg/g Cream

Hydroquinone

Read all of this leaflet carefully before use because it contains important information for you.

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

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

• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after two months, you should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is Nadona and what is it used for
2. Before using Nadona
3. How to use Nadona
4. Possible side effects
5. Storage of Nadona
6. Additional information

1. What is NADONA and what is it used for

Nadona is a cream that acts by gradually reducing the production of excess melanin that causes dark spots on the skin.

This medicine is indicated for the reduction of the color of small dark spots that occasionally appear on the skin, such as freckles and age spots in adults and children over 12 years old.

2. BEFORE USING NADONA

This medicine is for cutaneous use, so it should be applied exclusively to the skin spots. It should not be ingested.

Do not use Nadona

• If you are allergic (hypersensitive) to hydroquinone or any of the other components of Nadona
• On an open wound
• On irritated skin
• On mucous membranes or sunburns

Be careful with Nadona

• It should only be applied to intact skin and on small surfaces.
• You should avoid contact of the product with the eyes and mucous membranes. If accidental contact with the eyes occurs, they should be rinsed with plenty of water and a doctor should be consulted. In case of contact with the lips, a bitter taste and a slight anesthetic effect in the area may be noticed.
• The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet lamps (UVA). During Nadona treatment, it protects because it contains solar filters with a protection factor of 12. When the treatment is finished, the area should continue to be protected with a high-protection sun filter or covered with clothing.
• This medicine cannot be used to prevent sunburn.
• If you have very dark skin, you may not notice the effects of the product.
• If you have sensitive skin, the application of the product may cause an allergic reaction. To prevent it, apply a small amount of product to the inner arm for at least 24 hours. If you notice that the area is irritated, do not use this medicine.
• In some cases, a temporary darkening or irritation of the skin may appear. If it persists, the treatment should be interrupted.

Keep in mind that the reduction of the color of the spot in the affected skin area is not immediate and is only temporary, since when the treatment is interrupted, melanin production resumes, and the effect may last between 2 and 6 months after finishing the treatment.

In some cases, the spots may not completely disappear with treatment.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicine on the same skin area to be treated, including those purchased without a prescription.

Do not use cutaneous preparations with peroxides (e.g., hydrogen peroxide, benzoyl peroxide) on the same skin area where Nadona is being applied, as temporary darkening may occur in the skin area where they have been applied together. If this happens, the use of one of these medicines should be interrupted and the application area should be washed with a mild soap.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine does not alter the ability to drive vehicles or use machines.

Important information about some of the components of Nadona

This medicine may cause local reactions on the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole.

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

This medicine may be slightly irritating to the skin, eyes, and mucous membranes because it contains C12-C15 alkyl benzoate.

3. HOW TO USE NADONA

Nadona is a cutaneous medicine (exclusively for the skin).

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have doubts.

Adults and children over 12 years old:

Wash the affected skin area and dry it afterwards.

Apply a small amount of product 2 times a day (morning and night) exclusively to the spot, until the desired effect is achieved, which may require several weeks of treatment. Protect the treated area from the sun (see "Be careful with Nadona" section). You should wash your hands with soap after applying the product, as hydroquinone can cause brown spots on the nails that disappear over time.

Use in children

Do not administer this medicine to children under 12 years old.

Never use the product for more than 6 months.

If you do not notice improvement after 2 months of treatment, you should interrupt it and consult a doctor.

Nadona includes solar filters with a protection factor of 12 in its formulation. When you finish the treatment, apply a high-protection sun filter to the spot or cover the area with clothing to avoid the spots from reappearing.

Interrupt the application of Nadona when the spots disappear.

If you think the action of Nadona is too strong or too weak, inform your doctor or pharmacist.

If you use more Nadona than you should

Due to its cutaneous use, it is unlikely that intoxication will occur.

In case of accidental ingestion, convulsions, tremors, and anemia may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915.620.420, indicating the medicine and the amount ingested.

If you forget to use Nadona

Continue the treatment with the recommended dosage.

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

4. Possible side effects

Like all medicines, Nadona can cause side effects, although not everyone will experience them.

The side effects listed below are classified according to their frequency and the classification by organs and systems. The frequency categories are defined by the following convention: very common (affects more than 1 in 10 patients); common (affects up to 1 in 100 patients); uncommon (affects up to 1 in 1000 patients); rare (affects 1 in 10,000 patients); very rare (affects less than 1 in 10,000 patients); frequency not known (cannot be estimated from the available data).

Uncommon: inflammation and redness of the skin (erythema) and itching.

Rare: increased skin sensitivity (increased cutaneous sensitivity) and skin spots (cutaneous hyperpigmentation).

Very rare: blue-black discoloration of cartilages, tendons, and some areas of the face (ochronosis) and skin discoloration (leucoderma).

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of NADONA

Keep out of the reach and sight of children.

Keep the container tightly closed.

Expiry date of Nadona

Do not use Nadona after the expiry date stated on the container after CAD. The expiry date is the last day of the month indicated.

Do not use Nadona if you notice a dark color, even if it is within the validity period.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Nadona

The active ingredient is Hydroquinone.

The other components are: Sorbitan-glycerol isoestearates and beeswax, cyclomethicone dimethicone copolyol, cyclomethicone dimethiconol, C12-C15 alkyl benzoate, 4-methylbenzylidene-borneanone, avobenzone, sodium chloride, disodium edetate, ascorbic acid (E-300), methylparaben sodium (E-219), propylparaben sodium (E-217), sodium metabisulfite (E-223), butylhydroxyanisole (E-320), glycolic acid, hydroxypropyl-β-cyclodextrin, and purified water.

Appearance of the product and container contents

Nadona is a white cream presented in aluminum tubes containing 30 grams of cream.

Marketing authorization holder and manufacturer

Laboratorio Reig Jofré, SA

C/ Gran Capitán, 10

08970 Sant Joan Despí

Barcelona, Spain

This leaflet was approved in: May 2011

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.es/