FLUTICREM 0.5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Fluticrem 0.5 mg/g Cream

Fluticasone Propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Fluticrem and what is it used for
2. What you need to know before you use Fluticrem
3. How to use Fluticrem
4. Possible side effects
5. Storage of Fluticrem
6. Contents of the pack and other information

1. What is FLUTICREM and what is it 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 diseases. It is used to relieve inflamed skin, redness, and itching in various skin problems that are not caused by germs and that respond to corticosteroids.

2. What you need to know before you use FLUTICREM

Do not use Fluticrem

• if you are allergic to fluticasone or 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 eruption around the mouth).
• if you have perianal or genital itching (itching around the anal and genital area).
• if you have skin ulcers, atrophy (thinning of the skin), or fragile skin blood vessels.
• if you have ichthyosis (skin diseases characterized by dryness and scaly skin like that of a fish).
• if you have juvenile dermatosis (any skin disease characterized by inflammation) or dermatosis in babies 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 breast-feeding (see section "Pregnancy and breast-feeding").
• if you use this medicine on large areas of the body for prolonged periods, especially in 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 produce 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. 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 frequently at regular time intervals 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 of age.

If the symptoms do not improve during the first or second week of 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 skin, redness, and itching caused by atopic dermatitis, under the supervision of a specialist doctor. You should consult a dermatologist before using Fluticrem for any other type of dermatosis in children.

Other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breast-feeding

It is not known whether fluticasone is excreted in breast milk. Fluticrem should only be used during breast-feeding if the expected benefit for the mother outweighs the possible risk for the child.

Driving and using machines

It is not known whether fluticasone has a negative effect on driving and using machines.

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 to release small amounts of a chemical called formaldehyde. Formaldehyde may cause an allergic reaction such as a rash or itching when applied to the skin.

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

3. How to use FLUTICREM

Your doctor will prescribe the appropriate dose for you.

Follow exactly the administration instructions of this medicine indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

For children over 1 year of age, apply a thin layer of Fluticrem once or twice a day to the affected skin areas, unless your doctor advises 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 exactly the instructions indicated by your doctor.

If, after recovery, the symptoms reappear, 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 about 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 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 Toxicology Information Service, phone 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 forgotten doses.

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

If you stop using 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.

4. Possible side effects

Like all medicines, Fluticrem can cause side effects, although not everybody gets them.

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

• Itching (pruritus).

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

• Local burning sensation.

Rare side 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 appear, use of Fluticrem should be discontinued.
• Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids, or treatment of extensive skin areas. This side effect is more likely to occur in babies and children when occlusive dressings are used.
• Dilation of superficial blood vessels, due to intense and prolonged treatment with potent corticosteroid preparations.
• Contact allergic dermatitis (allergic skin reactions).
• Worsening of dermatosis signs and symptoms (skin reaction involving inflammation of the skin).
• Pustular psoriasis caused by treatment or its interruption.
• Local atrophic changes of the skin such as thinning, striae, hirsutism (excessive hair growth in a particular area), and hypopigmentation (skin discoloration) caused by prolonged and intense treatment with potent corticosteroid preparations.

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

• Vasculitic 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
• Blurred vision.

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

Reporting of side effects:

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

5. Storage of FLUTICREM

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

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Do not store above 30°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate, liquid paraffin, purified water, propylene glycol, citric acid monohydrate, anhydrous disodium phosphate, imidazolidinyl urea.

Appearance of the product and pack contents

Fluticrem is a viscous white cream that comes in a 30 or 60 g aluminum tube with a screw cap. Not all 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 medicine is authorized in the following EEA Member States with the following names:

Spain Fluticrem 0.5 mg/g cream

Netherlands Fluticrem 0.5 mg/g crème

Italy Fluticrem 0.05% crema

Portugal Fluticrem 0.5 mg/g creme

This leaflet was approved in March 2021

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.gob.es/