Flunutrac 0,5 mg/g crema
Jak stosować Flunutrac 0,5 mg/g crema
Introduction
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
1. What is Flunutrac and what is it used for
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.
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 skin of the face), acne vulgar or perioral dermatitis (inflammatory eruption around the mouth).
- If you have skin infections caused by viruses such as herpes simplex or varicella
- If you have pruritus perianal or genital (itching around the anal or genital area).
- If you have skin ulcers, atrophy (thinning of the skin) or fragility of cutaneous blood vessels.
- If you have ichthyosis (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 skin lesions infected by bacterial or fungal infection
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 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 important 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 infants, the diaper can act as an occlusive dressing. You should clean your skin before changing the dressing.
- 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 efficacy of the product. Consult your doctor if you have doubts.
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.
3. How to use Flunutrac
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.
4. Possible Adverse Effects
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
5. Flunutrac Storage
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.
6. Contents of the packaging and additional information
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/
Ile kosztuje Flunutrac 0,5 mg/g crema w Hiszpania ( 2025)?
Średnia cena Flunutrac 0,5 mg/g crema w wrzesień 2025 to około 4.68 €. Ceny mogą się różnić w zależności od regionu, apteki oraz wymogu recepty. Zawsze sprawdź aktualne informacje w lokalnej aptece.
- Kraj rejestracji
- Średnia cena w aptece4.68 EUR
- Substancja czynna
- Wymaga receptyTak
- Producent
- SkładPropilenglicol (10,00 g mg), Cetoestearilico, alcohol (5,25 g mg), Fosfato disodico (0,06 g mg)
- Te informacje mają charakter wyłącznie poglądowy i nie stanowią porady medycznej. Przed zastosowaniem jakiegokolwiek leku zawsze skonsultuj się z lekarzem. Oladoctor nie ponosi odpowiedzialności za decyzje medyczne podjęte na podstawie tych treści.
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