Fluticrem 0.5 mg/g cream

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluticrem 0.5 mg/g cream

Fluticasone propionate

Read the entire 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 should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet Contents

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. How to store Fluticrem
6. Contents of the pack and other information

1. What FLUTICREM is and what it is used for

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 variety of inflammatory skin conditions. It is used to relieve inflamed skin, redness, and itching in various skin disorders not caused by germs and that respond to corticosteroids.

2. What you need to know before using FLUTICREM

Do not use Fluticrem

• if you are allergic to fluticasone or to any of the other ingredients of this medicine listed in section 6.
• if you have rosacea (redness and inflammation of the facial skin), acne vulgaris, or perioral dermatitis (inflammatory rash around the mouth).
• if you have perianal or genital itching (itching around the anal and genital areas).
• if you have skin ulcers, atrophy (thinning of the skin), or fragile blood vessels in the skin.
• if you have ichthyosis (skin disorders characterized by dry, scaly skin resembling fish scales).
• if you have juvenile dermatoses (any inflammatory skin disease) or skin conditions in infants under 1 year of age, including dermatitis (skin inflammation) and diaper rash.
• if you have ulcerated skin 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 might be pregnant, or if you are breastfeeding (see section “Pregnancy and breastfeeding”).
• if you are using this medicine over large areas of the body for prolonged periods, especially when treating children, as this may increase absorption and the risk of toxicity.
• if you use it on the face, as it may cause atrophic changes such as skin thinning. It is important not to allow the cream to come into contact with the eyes.
• if you use it on covered parts of the body. Do not use this product under occlusive dressings; the affected area must be exposed to air and not covered by bandages, tight clothing, or similar materials. In infants, diapers may act as occlusive dressings. The skin should be washed before changing the dressing.
• if your doctor has prescribed the cream for psoriasis. You should visit your doctor regularly at periodic intervals to monitor your progress.
• if you are using other products (including cosmetics) on the affected skin areas, as they may negatively affect 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 of age.

If symptoms do not improve within the first or second week of treatment, inform your doctor. Once the skin condition has improved (usually within the first to second week), the cream should be applied less frequently. Daily use of the cream is not recommended for more than 4 weeks.

Fluticrem should only be used in children to relieve inflamed, red, and itchy skin due to atopic dermatitis, and only under the supervision of a specialist doctor. Consult a dermatologist before using Fluticrem for any other type of dermatosis in children.

Other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

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

Breastfeeding

It is unknown whether fluticasone is excreted in breast milk. Fluticrem should only be used during breastfeeding if the expected benefit to the mother outweighs the potential risk to the infant.

Driving and operating machinery

It is unknown whether fluticasone has a negative effect on driving and operating machinery.

Fluticrem contains cetostearyl alcohol, imidurea, and propylene glycol

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

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

This medicine contains 100 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation. This medicine contains propylene glycol; do not use on open wounds or large damaged skin areas (such as burns) without consulting your doctor or pharmacist first.

3. How to use FLUTICREM

Your doctor will prescribe the appropriate dose for you.

Always follow exactly the instructions for use of this medicine as given by your doctor. In case of doubt, please consult your doctor or pharmacist again.

For children aged 1 year and older, apply a thin layer of Fluticrem once or twice daily to the affected areas of skin, unless your doctor instructs otherwise. Consult your doctor regarding the duration of treatment.

In certain conditions (such as psoriasis, atopic dermatitis, etc.), treatment should not be stopped abruptly; the number of applications must be gradually reduced. Always follow your doctor's specific instructions.

If symptoms reappear after recovery, your doctor will advise you on the appropriate dose for you. The usual dose is one application daily, two days per week.

Discontinuing treatment is not recommended in certain skin conditions such as psoriasis or atopic dermatitis. You should consult your doctor on the most appropriate way to discontinue treatment.

Instructions for use:

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

If your skin condition does 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 recommended, especially in children, carefully wash the affected areas of skin to remove all the cream and consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Fluticrem

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

If you forget to apply the cream, apply the correct dose as soon as you remember, or wait until the next scheduled application if it is almost due.

If you stop treatment with Fluticrem

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

4. Possible adverse effects

Like all medicines, Fluticrem may cause adverse effects, although not everyone experiences them.

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

• Itching (pruritus).

Uncommon adverse effects (may affect up to 1 in 100 people):

• Local burning sensation.

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

• Secondary infections, especially when occlusive dressings are used or when skin folds are involved.
• Hypersensitivity. If signs of hypersensitivity occur, Fluticrem should be discontinued.
• Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids, or treatment over extensive areas of skin. This adverse effect is more likely to occur in infants and children when occlusive dressings are used.
• Dilation of superficial blood vessels due to intense and prolonged treatment with potent corticosteroid preparations.
• Allergic contact dermatitis (allergic skin reactions).
• Worsening of signs and symptoms of dermatoses (skin reaction involving skin inflammation).
• Pustular psoriasis triggered by treatment or its discontinuation.
• Local skin atrophic 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.

Not known (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 (flushing and inflammation of the facial skin).
• Crusting.
• Leg ulcers.
• Blurred vision.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of FLUTICREM

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE POINT at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

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

6. Contents of the pack and other information

Composition of Fluticrem

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

The other components are: macrogol cetyl stearyl ether, cetyl stearyl 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 container

Fluticrem is a white, viscous cream supplied in 30 g or 60 g aluminium tubes with a screw cap. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

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

Spain Fluticrem 0.5 mg/g cream
Netherlands Fluticrem 0.5 mg/g crème
Italy Fluticrem 0.05% cream
Portugal Fluticrem 0.5 mg/g cream

This leaflet was approved in March 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/