FLUNUTRAC 0.5 mg/g CREAM

Introduction

Leaflet: information for the patient

Flunutrac 0.5 mg/g cream

Fluticasone propionate

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Flunutrac and what is it used for
2. What you need to know before using Flunutrac
3. How to use Flunutrac
4. Possible side effects
5. Storage of Flunutrac
6. Package contents and additional information

1. What is Flunutrac and what is it used for

Flunutrac 0.5 mg/g cream belongs to a group of medicines known as corticosteroids, which have an anti-inflammatory effect when used topically.

Fluticasone is a potent corticosteroid that, when applied to the skin, treats a wide range of inflammatory skin diseases. It is used to relieve inflamed skin, redness, and itching in numerous skin problems that are not caused by microorganisms and that respond to corticosteroids.

2. What you need to know before using Flunutrac

Do not use Flunutrac

• if you are allergic to fluticasone or any of the other components of Flunutrac (listed in section 6)
• if you have rosacea (redness and inflammation of the facial skin), acne vulgaris, or perioral dermatitis (inflammatory eruption around the mouth).
• if you have skin infections caused by viruses such as herpes simplex or chickenpox
• if you have perianal or genital pruritus (itching around the anal or genital area).

• if you have skin ulcers, atrophy (thinning of the skin), or fragility of the cutaneous blood vessels.
• if you have ichthyosis (a skin disease characterized by dryness and scaling).
• if you have juvenile dermatosis (any skin disease characterized by inflammation) or dermatosis in children under 1 year of age, including dermatitis (skin inflammation) and diaper rash.
• if you have ulcerated wounds.
• if you have infected skin lesions caused by bacterial or fungal infections

Warnings and precautions

Consult your doctor or pharmacist before using Flunutrac

• if you are pregnant or think you may be pregnant, or if you are breastfeeding (see section "Pregnancy and Breastfeeding").
• if you use this medicine on large areas of the body for extended periods, especially when treating children, as it may increase the absorption of the product and the risk of toxicity.

• if you use it on the face, as it may cause atrophic changes such as skin thinning. It is essential that you do not allow the cream to come into contact with your eyes.
• if you use it on covered areas of the body. Do not use this product under occlusive dressing; the affected area must be in contact with the air and not covered with dressing, tight clothing, or similar.
• if your doctor has prescribed the cream for psoriasis. You should visit your doctor regularly at periodic intervals to check your progress.
• if you are using other products (including cosmetics) on the affected areas of the skin, as they may have a negative effect on the product's efficacy. Consult your doctor if you have any doubts.

Contact your doctor if you experience blurred vision or other visual disturbances

Children:

Do not use this medicine in children under 1 year of age.

Tell your doctor if the symptoms do not improve after one or two weeks of treatment. Once the skin condition has improved (usually between the first and second week), you should apply the cream less frequently. Daily use of the cream for more than 4 weeks is not recommended.

Flunutrac should only be used in children to relieve inflamed skin, redness, and itching caused by atopic dermatitis, under the supervision of a specialist doctor. You should consult a dermatologist before using Flunutrac for any other type of dermatosis in children.

Other medicines and Flunutrac

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Flunutrac will only be used during pregnancy if the benefit of treatment for the mother is greater than a possible risk to the fetus.

Breastfeeding

It is not known if fluticasone propionate is excreted in breast milk. Flunutrac will only be used during breastfeeding if the benefit of treatment for the mother is greater than a possible risk to the child.

Driving and using machines

It is not known if fluticasone affects the ability to drive and use machines.

Flunutrac contains cetyl alcohol, imidurea, and propylene glycol.

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

This medicine contains imidurea, which may release traces of formaldehyde. Formaldehyde may cause local skin reactions (such as contact dermatitis).

This medicine contains 100 mg of propylene glycol in 1 gram of cream.

3. How to use Flunutrac

Your doctor will prescribe the appropriate dose for you.

Follow the instructions for administration of Flunutrac exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

For adults and children over 1 year of age, apply a thin layer of Flunutrac to the affected area of the skin once or twice a day, unless your doctor indicates otherwise. Consult your doctor for the duration of treatment.

In some diseases (psoriasis, atopic dermatitis...), it is not recommended to stop treatment abruptly; you should gradually reduce the number of applications. Follow your doctor's instructions exactly.

If symptoms recur after recovery, your doctor will indicate the appropriate dose for you. The usual dose is one application per day, two days a week.

It is not recommended to stop treatment in some skin diseases such as psoriasis or atopic dermatitis. You should consult your doctor for the most suitable way to end treatment.

Instructions for use:

1. Wash your hands
2. Apply a thin layer of cream and spread it carefully until it is completely absorbed
3. Wash your hands, unless the cream is used to treat the hands

If your skin problems do not improve during the first or second week of treatment, inform your doctor.

If you use more Flunutrac than you should

If you use more Flunutrac than you should, especially in children, wash the affected areas of the skin carefully to remove all the cream and consult your doctor or pharmacist.

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 medicine and the amount administered.

If you forget to use Flunutrac

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

If you forget to apply the cream, do so in the correct dose as soon as you remember, or wait until the next application if it is soon.

If you stop using Flunutrac

Do not stop using the medicine even if you feel well, unless your doctor tells you to.

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

4. Possible side effects

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

Common side effects (affect more than 1 in 100 patients but less than 1 in 10 patients)

• Itching (pruritus)

Uncommon side effects (affect more than 1 in 1000 patients but less than 1 in 100 patients)

• Local burning sensation

Rare side effects (affect less than 1 in 10,000 patients)

• Secondary infections (infections that occur during or after treatment of another existing infection), especially when occlusive dressings are used or when skin folds are involved.
• Hypersensitivity. Flunutrac should be discontinued in case of signs of hypersensitivity
• Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids or treatment of extensive areas of the skin.

The adverse reaction is more likely to occur in infants and children, and when occlusive dressings are used.

• Dilation of superficial blood vessels due to prolonged and intensive treatment with potent corticosteroid preparations.
• Allergic contact dermatitis (skin allergic reactions).
• Worsening of signs and symptoms of dermatosis (skin reaction characterized by inflammation).
• Pustular psoriasis caused by the treatment itself or by its interruption.
• Local atrophic changes of the skin such as thinning, stretch marks, hirsutism (excessive hair growth in a particular area), and hypopigmentation (skin discoloration) caused by prolonged and intensive treatment with potent corticosteroid preparations.

Unknown frequency (frequency cannot be estimated from available data):

• Vascular purpura (a group of skin disorders characterized by purple or reddish-purple discoloration).
• Skin fragility.
• Perioral dermatitis (inflammation of the skin around the mouth).
• Rosacea (redness and inflammation of the facial skin).
• Crusts
• Leg ulcers
• Acne
• Healing disorders
• Blurred vision

Reporting of side effects

If you experience any side effects, consult 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 http://www.notificaRAM.es.

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

5. Storage of Flunutrac

Keep out of sight and reach of children.

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

Do not store above 30°C.

Shelf life after first opening: 6 months

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

Do not use this medicine if you notice any visible signs of deterioration.

6. Package contents and additional information

Composition of Flunutrac

The active ingredient is fluticasone propionate. Each 100 g of cream contains 0.05 g of fluticasone propionate.

The other ingredients are macrogol, cetyl ether, cetyl alcohol, isopropyl myristate, liquid paraffin, purified water, propylene glycol (E-1520), citric acid monohydrate, anhydrous disodium phosphate, imidazolinyl urea.

Appearance and package contents

Flunutrac is a viscous white cream contained in a 30 g aluminum tube with a screw cap.

Marketing authorization holder

ISDIN SA

Provençals 33

08019 Barcelona

Spain

Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950.

Esplugues de Llobregat

Barcelona - Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Flunutrac 0.5 mg/g cream

Netherlands Cortifil 0.5 mg/g cream

Italy Flunutrac 0.05% cream

Portugal Flunutra 0.5 mg/g cream

United Kingdom Fluticasone propionate 0.05% cream

Date of last revision of this leaflet: July 2020

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/