Leaflet: information for the user

Fluticrem 0.5 mg/g cream

Fluticasone propionate

Read this leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of the disease, 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 Fluticrem is and what it is used for

2. What you need to know before using Fluticrem

3. How to use Fluticrem

4. Possible side effects

5. Storage of Fluticrem

6. Contents of the pack and additional information

Fluticrem 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 various skin problems that are not caused by germs and respond to corticosteroids.

Do not use Fluticrem

• If you are allergic to fluticasone or any of the other components of this medication listed in section 6.
• If you have rosacea (redness and inflammation of the skin of the face), acne vulgar or perioral dermatitis (inflammatory eruption around the mouth).
• If you have anal or genital pruritus (itching around the anal and genital area).
• If you have skin ulcers, atrophy (thinning of the skin) or fragile skin vessels.
• If you have ichthyosis (skin diseases characterized by dryness and scaly skin like a fish).
• 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 skin infections caused by fungi or bacteria.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fluticrem.

• If you are pregnant or think you may be pregnant, or if you are breastfeeding (see section “Pregnancy and breastfeeding”).
• If you use this medication on extensive areas of the body for prolonged periods of time, 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 be covered with the dressing, tight clothing or similar. In babies, the diaper can act as an occlusive dressing. Before changing the dressing, the skin should be washed.
• If your doctor has prescribed the cream for psoriasis. You should visit your doctor regularly at periodic intervals of time to check your progress.

• If you are using other products (including cosmetics) on the affected skin areas, as they may have a negative effect on the product's efficacy. Consult your doctor if you are unsure.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Do not use this product in children under 1 year.

If symptoms do not improve during the first or second week of starting treatment, inform your doctor. Once the skin disease has improved (usually between 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.

Fluticrem should only be used in children to relieve inflamed, red and itchy skin caused by atopic dermatitis, under the supervision of a specialist doctor. You should consult a dermatologist before using Fluticrem for other types of dermatosis in children.

Other medications

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

Fluticrem should only be used during pregnancy if the expected benefit for the mother outweighs the possible risk to the fetus.

Breastfeeding

The excretion of fluticasone in breast milk is unknown.Fluticrem should only be used during breastfeeding if the expected benefit for the mother outweighs the possible risk to the child.

Driving and operating machinery

The effect of fluticasone on driving and operating machinery is unknown.

Fluticrem contains alcohol cetoesterarílico, imidurea and propilenglicol

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

This product contains imidurea as a preservative. Imidurea breaks down, releasing small amounts of a chemical called formaldehyde. Formaldehyde can cause an allergic reaction such as an eruption or itching when applied to the skin.

This medication contains 100 mg of propilenglicol in each gram of cream. Propilenglicol can cause skin irritation. This medication contains propilenglicol, do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

Your doctor will prescribe the appropriate dose for you.

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

For children 1 year of age and older, apply a thin layer of Fluticrem one or two times a day to the affected skin areas, 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 your doctor indicates.

If after recovery, symptoms reappear, your doctor will indicate the appropriate dose for you. The normal dose is a daily application, two days a week.

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

Usage instructions:

1. Wash your hands.
2. Apply a thin layer of cream and extend 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 Fluticrem than you should

If you use more Fluticrem 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 Fluticrem

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

If you forget to apply the cream, apply the correct dose when you remember or wait until the next application if it is almost time for it.

If you interrupt treatment with Fluticrem

Do not stop treatment even if you feel well, unless your doctor advises you to. If you have any doubts about the use of this product, ask your doctor or pharmacist.

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

Frequent side effects(may affect up to 1 in 10 people):

• Itching (pruritus).

Less frequent side effects(may affect up to 1 in 100 people):

• Local burning sensation.

Very rare side effects(may affect up to 1 in 10,000 people):

• Infections, especially when using occlusive dressings or when skin folds are involved.
• Hypersensitivity. If signs of hypersensitivity appear, discontinue use of Fluticrem.
• Hypercortisolism (elevated levels of corticosteroids) due to prolonged use of large quantities of corticosteroids, or treatment of extensive areas of skin. This side effect is more likely to occur in infants and children when using occlusive dressings.
• Superficial blood vessel dilation, due to intense and prolonged treatment with potent corticosteroid preparations.
• Contact dermatitis (allergic skin reactions).
• Worsening of signs and symptoms of dermatosis (skin reaction involving inflammation of the skin).
• Pustular psoriasis caused by treatment or its interruption.
• Local skin atrophy changes, such as thinning, striae, hirsutism (excessive hair growth in a specific area), and hypopigmentation (skin discoloration) caused by prolonged and intense treatment with potent corticosteroid preparations.

Unknown(frequency cannot be estimated from available data):

• 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 face).
• Crusts.
• Leg ulcers.
• Blurred vision.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the PUNTO SIGRE of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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

Composition of Fluticrem

The active ingredient is fluticasone propionate. Each gram of cream contains 0.5 mg of fluticasone propionate.

The other components are:macrogol cetoestearil éter, cetoestearic alcohol, isopropyl myristate, liquid paraffin, purified water, propylene glycol, citric acid monohydrate, anhydrous disodium phosphate, imidazolinyl urea.

Appearance of the product and contents of the packaging

Fluticrem is a white viscous cream that is presented in an aluminum tube of 30 or 60 g with a screw cap.Only some packaging sizes may be marketed.

Holder of the marketing authorization and Responsible for the manufacture

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

This medicinal product is authorized in the following Member States of the EEA with the following names:

SpainFluticrem 0.5 mg/g cream

NetherlandsFluticrem 0.5 mg/g crème

ItalyFluticrem 0.05% cream

PortugalFluticrem 0.5 mg/g creme

This leaflet was approved in March 2021

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