Package Insert: Information for the Patient

Flunutrac 0.5 mg/g Cream

Fluticasone Propionate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Flunutrac and how is it used

2. What you need to know before starting to use Flunutrac

3. How to use Flunutrac

4. Possible adverse effects

5. Storage of Flunutrac

6. Contents of the package and additional information

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

Fluticasona is a potent corticosteroid that, when applied to the skin, treats a wide variety 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 respond to corticosteroids.

Do not use Flunutrac

Warnings and precautions

Consult your doctor or pharmacist before using Flunutrac

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

Children:

Do not use this medication in children under 1 year.

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

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 other types of dermatosis in children.

Other medications and Flunutrac

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

Pregnancy, breastfeeding and fertility

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

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

The propionate of fluticasone is unknown to be 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 operating machinery

The effect of fluticasone on the ability to drive and operate machinery is unknown.

Flunutrac contains alcohol cetoestearílico, imidurea and propilenglicol.

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

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

This medication contains 100 mg of propilenglicol per 1 gram of cream.

Your doctor will prescribe the appropriate dose for you.

Follow exactly the administration instructions for Flunutrac 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 skin area one or two times a day, unless your doctor tells you otherwise. Consult your doctor about the duration of treatment.

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

If after recovery the symptoms appear again, 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 interrupt treatment in some skin diseases such as psoriasis or atopic dermatitis. You must consult with your doctor about the most suitable way to end treatment.

Usage instructions:

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 skin areas 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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount administered.

If you forget to use Flunutrac

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

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

If you interrupt treatment with Flunutrac

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects(affects more than 1 in 100 patients but less than 1 in 10 patients)

• Itching(pruritus)

Less frequent side effectsfrequent(affects more than 1 in 1,000 patients but less than 1 in 100 patients)

• Local burning sensation

Very rare side effects(affects less than 1 in 10,000 patients)

• Secondary infections (infection that occurs during or after treatment of an existing infection), especially when using occlusive dressings or when skin folds are involved.
• Hypersensitivity. Discontinue use of Flunutrac in case of signs of hypersensitivity.
• Hypercortisolism (elevated 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 using occlusive dressings.

• Superficial blood vessel dilation due to prolonged and intensive treatment with potent corticosteroid preparations.
• Contact dermatitis (allergic skin 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 skin atrophy changes such as thinning, striae, hypertrichosis (excessive hair growth in a specific area) and hypopigmentation (skin discoloration) caused by prolonged and intensive treatment with potent corticosteroid preparations.

Unknown(frequency cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it ispossible side effects that do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano http://www.notificaRAM.es.

By reporting side effects, you can contribute toproviding more information on the safety of this medicine

Keep out of sight and reach of children.

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

Do not store above30°C.

Shelf life after first opening: 6 months

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Do not use this medication if you observe any visible signs of deterioration.

Composition of Flunutrac

The active ingredient is fluticasone propionate. Each100 gof cream contains0.05 gof fluticasone propionate.

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

Appearance of the product and contents of the packaging

Flunutrac is a white viscous cream contained in an aluminum tube of30 gwith a screw cap.

Holder of the marketing authorization

ISDIN SA

Provençals 33

08019 Barcelona

Spain

Responsible for manufacturing

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 with the following names:

SpainFlunutrac 0.5 mg/g cream

NetherlandsCortifil 0.5 mg/g crème

ItalyFlunutrac 0.05% cream

PortugalFlunutra 0.5 mg/g creme

United KingdomFluticasone propionate 0.05% cream

Revision date of this prospectus: July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.es/