Active ingredients: Fluticasone (Fluticasone propionate)
Flixoderm 0.05% cream
Flixoderm 0.005% ointment
Why is Flixoderm used? What is it for?
Flixoderm contains fluticasone propionate which belongs to a group of medicines called corticosteroids. Corticosteroids help reduce swelling and irritation.
Flixodem cream and Flixodem ointment are used to help reduce the redness and itching caused by certain skin problems in adults and children aged one year and over such as:
- eczema;
- prurigo nodularis (itchy lumps in the arms and legs);
- psoriasis (thickened patches of inflamed red skin, often covered with silvery scales);
- neurodermatosis, including chronic lichen simplex (patches of itchy thickened skin caused by scratching);
- lichen planus (a skin disease that causes itchy, reddish-purple redness of the skin, on the wrists, arms, legs);
- seborrheic dermatitis (itching that develops on the face, scalp, chest and back with red scaly formations);
- contact allergic reactions;
- discoid lupus erythematosus (a skin disease that most often affects the face, ears and scalp causing scarring and increased sensitivity of the skin to sunlight);
- Generalized erythroderma in association with systemic steroid therapy, a "skin disease characterized by a diffuse and uniform redness which is accompanied by desquamation of lamellae of the stratum corneum of the" epidermis
- insect bites;
- miliaria rubra (acute inflammatory state of the skin characterized by the appearance of an itchy rash caused by the obstruction of the sweat glands and the consequent retention of sweat in the subcutaneous layers).
Contraindications When Flixoderm should not be used
Do not use Flixoderm
- if you are allergic to the active substance or any of the other ingredients of this medicine
- if your child is less than one year old
- to treat any of the following skin problems, which may otherwise get worse:
- acne
- severe redness of the skin and redness around the nose (rosacea)
- blotchy rash around the mouth (perioral dermatitis)
- in case of viral skin infections (herpes simplex, chicken pox)
- itching in the anal area and genitals (penis and vagina)
- infected skin (unless anti-infective treatment for the infection is already in progress)
- itchy skin without inflammation
- in case of infection caused by fungi or bacteria
Do not use Flixoderm if any of the above conditions apply to you or your baby. If you are unsure of proper use, consult your doctor or pharmacist.
Precautions for use What you need to know before taking Flixoderm
Talk to your doctor or pharmacist before using Flixoderm if:
- if you or your child have had a previous allergic reaction using steroids.
- if you are applying a cream with an occlusive dressing (in children the diaper can act as an occlusive dressing). The bandage can facilitate the passage of the active ingredient through the skin, in this way you can accidentally use too much of the drug
- if you are elderly and / or suffer from reduced kidney / liver function. In this case it is advisable to use the smallest amount of drug for the shortest time required to obtain the desired clinical benefit.
- if you have psoriasis, your doctor will want to see you more often.
If you are not sure if any of the above applies to you or your child, talk to your doctor or pharmacist before using this drug.
Interactions Which drugs or foods can change the effect of Flixoderm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines
Be especially careful if you are taking ritonavir and itraconazole as they increase the effect of the drug.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use the least amount of medication for the shortest time possible
Feeding time
If you use fluticasone propionate while breastfeeding, avoid applying it to the breast to prevent the baby from swallowing it.
Flixoderm cream contains imidurea, cetostearyl alcohol and propylene glycol
Flixoderm cream contains an excipient called imidurea. The body transforms the imidurea into a degradation product called formaldehyde. Formaldehyde can cause a skin reaction, including redness and itching.
Flixoderm cream contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).
Flixoderm cream contains propylene glycol. It can cause skin irritation.
Flixoderm ointment contains propylene glycol. It can cause skin irritation.
Dose, Method and Time of Administration How to use Flixoderm: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Cream - The application of the cream is indicated in lesions at any location and is preferable in the treatment of delicate and moist skin surfaces.
Ointment - Dry skin irritations are most beneficial with the application of the ointment.
How to use this medicine
- Apply a thin layer of cream or ointment sufficient to cover the entire affected area up to a maximum of twice a day. The frequency may be reduced or you may switch to a less potent cortisone if you notice improvement in your skin.
- Use this cream only on the skin.
- Do not use this product on a large body surface for a long time (every day for weeks or months) - unless prescribed by your doctor.
- Always clean your skin before each new application because the germs that cause infections prefer warm and humid areas.
- If you are applying the cream to another person, be sure to wash your hands after use or wear disposable plastic gloves.
- If the problem you are treating does not improve, contact your doctor.
Topical corticosteroid therapy should be gradually discontinued as the disease is under control and treatment should be continued with an emollient cream as maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, particularly with potent ones, a relapse of pre-existing dermatoses may occur.
Application on the face.
Only apply Flixoderm on your face if advised by your doctor. The applications on the face cannot be continued for a long time because the skin on the face thins easily. Do not apply the cream on the eyes.
Overdose What to do if you have taken too much Flixoderm
If you use more Flixoderm than necessary
If, by mistake, you sometimes use more Flixoderm than you should, don't worry. If you accidentally swallow the drug, you may feel unwell. Talk to your doctor or go to a hospital as soon as possible.
If you forget to use Flixoderm
- If you forget to use Flixoderm apply it as soon as you remember, then continue as before
- Do not apply an extra dose to make up for the forgotten one
If you stop taking Flixoderm
If you use Flixoderm regularly make sure you talk to your doctor before you stop using it. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Flixoderm
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Flixoderm and tell your doctor as soon as possible if:
- the skin problem does not improve or gets worse or if you notice swelling during treatment. Flixoderm can cause allergy, you may have an infection or need other treatments.
- Stop using Flixoderm and call your doctor as soon as possible
Other side effects that may be noticed when using Flixoderm include:
Common (may affect up to 1 in 10 people)
- irritation or itching.
Uncommon (may affect up to 1 in 100 people)
- burning sensation during application.
Very rare (may affect up to 1 in 10,000 people)
Using Flixoderm over a long period of time, or when using an occlusive dressing, can cause the following symptoms:
- weight gain
- moon shaped face / face rounding
- obesity
- skin discoloration, which can cause streaked marks
- thinning of the skin which can highlight the veins under the skin
- skin lightening
- hirsutism, increased body hair
Other very rare reactions that can occur are:
- allergic reactions at the application site
- worsening of conditions
- redness
- rash or hives
- the treatment of psoriasis with corticosteroids or, its suspension, can provoke the appearance of the pustular form of the disease.
- skin infection.
Additional side effects in children
In children, the following symptoms may occur:
- slowdown in growth
- delay in weight gain
Very rarely, abnormal parameters can be found following blood tests:
- decrease in endogenous cortisol levels
- hyperglycemia / glycosuria
- hypertension
- osteoporosis
- cataract
- glaucoma
If these situations occur, it is advisable to talk to your doctor for further investigation.
If you experience an undesirable effect
Tell your doctor or pharmacist if any of the side effects listed become serious or troubling, or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V *. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Store below 30 ° C.
Do not freeze
What Flixoderm contains
Flixoderm cream
- The active substance is fluticasone propionate. Each gram contains 0.5 mg of fluticasone propionate (0.05% w / w).
The other ingredients are: liquid paraffin; isopropyl myristate; cetostearyl alcohol; polyoxyethylene methylstearyl ether (Cetomacrogol 1000); propylene glycol; imidurea; sodium phosphate; citric acid monohydrate; purified water.
Flixoderm ointment
- The active substance is fluticasone propionate. Each gram contains 0.05 mg of fluticasone propionate (0.005% w / w).
The other ingredients are: propylene glycol; sorbitan sesquioleate; microcrystalline wax; liquid paraffin.
What Flixoderm looks like and contents of the pack
Flixoderm 0.05% cream: 30 g tube
Flixoderm 0.005% ointment: 30 g tube
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLIXODERM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active ingredient: fluticasone propionate (micronized) 0.05 g.
Excipients with known effects: cetostearyl alcohol; propylene glycol; imidurea
FLIXODERM0.005% Ointment
100 g of ointment contains:
Active ingredient: fluticasone propionate (micronized) 0.005 g.
Excipients with known effects: propylene glycol
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
Ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Fluticasone propionate is indicated for the treatment of inflammatory manifestations and pruritus in cortisensitive dermatoses in adults and children aged one year and over, such as:
- eczema, including atopic, infantile and discoid eczema;
- prurigo nodularis;
- psoriasis (excluding diffuse plaque psoriasis);
- neurodermatosis, including lichen simplex;
- lichen planus;
- seborrheic dermatitis;
- allergic contact reactions;
- discoid lupus erythematosus;
- generalized erythroderma in association with systemic steroid therapy;
- insect bites;
- miliaria rubra.
04.2 Posology and method of administration
Ointment - Dry scaly dermatoses with lichenoid and hyperkeratotic imprint are most affected by the application of the ointment.
Cream - The application of the cream is indicated in all lesions at any location. The hydrodispersible vehicle makes the cream preferable in the treatment of delicate and moist skin surfaces.
Adults, the elderly and children aged one year and over.
Apply and gently massage a thin layer of product sufficient to cover the entire affected area, once or twice a day until a significant improvement is obtained, then reduce the frequency of applications or switch to a less powerful cortisone. Allow some time to pass. sufficient for absorption after each application before applying the emollient cream.
If conditions worsen or do not clear up in 2-4 weeks, treatment and diagnosis should be reassessed.
In atopic eczema, topical corticosteroid therapy should be gradually discontinued as the disease is under control and treatment should be continued with an emollient cream as maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, particularly with potent ones, a relapse of pre-existing dermatoses may occur.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
The following conditions should not be treated with fluticasone propionate: - Untreated skin infections
- Acne rosacea and vulgaris
- Perioral dermatitis
- Primary viral skin infections (herpes simplex, chicken pox)
- Anogenital itching
- Itching without inflammation
The use of dermatological preparations of fluticasone propionate is not indicated in the treatment of skin lesions with primary infections caused by fungi or bacteria.
Dermatosis of children under 1 year of age, including dermatitis and diaper rash.
Application of the product to the breast should be avoided during breastfeeding.
04.4 Special warnings and appropriate precautions for use
Fluticasone propionate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients of the drug. Local hypersensitivity reactions (see section 4.8 Undesirable Effects) may resemble symptoms of the disease being treated.
In some individuals, manifestations of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal axis (HPA), leading to glucocorticoid insufficiency, may occur due to increased systemic absorption of topical steroids. observed one of the above effects, the application of the drug should be gradually reduced by decreasing the frequency of applications or by replacing it with a less potent corticosteroid. Abrupt discontinuation of treatment may lead to glucocorticosteroid insufficiency (see section 4.8 Undesirable Effects).
The risk factors for increased systemic effects are:
- Topical steroid potency and formulation
- Duration of exposure
- Application on a large surface area
- Use on occluded areas of skin for example on intertriginous areas or under occlusive dressing (in children the diaper can act as an occlusive dressing)
- Increased hydration of the stratum corneum
- Use on thin skin areas such as the face
- Use on skin that is not intact or in other conditions where the skin barrier may be damaged
Compared to adults, children can absorb proportionally more topical corticosteroids and thus be more susceptible to systemic side effects.This is due to the fact that children have an immature skin barrier and a higher surface area to body weight ratio than adults.
Children
Fluticasone propionate is contraindicated in children less than 1 year of age.
Prolonged application of high doses over a large body surface, especially in infants and young children, could lead to adrenal suppression.
Children are much more likely to develop local and systemic side effects typical of topical corticosteroids, and children generally require shorter and less potent corticosteroid treatments than adults.
Fluticasone propionate should be used with caution to ensure application of the minimum amount that gives therapeutic benefit.
In infants and children under the age of 12, continuous, long-term therapy with topical corticosteroids should be avoided where possible, as suppression of adrenal activity is more likely to occur.
Senior citizens
Clinical studies have revealed no differences in response between elderly and younger patients. Decreased hepatic or renal function, which is very common in the elderly, may lead to a delay in elimination of the drug, in case of systemic absorption. Therefore, the minimum quantity should be used for the shortest time required to obtain the desired clinical benefit.
Population with renal / hepatic insufficiency
In case of systemic absorption (when the application is extended to a large body surface for a prolonged period) the metabolism and elimination of the drug may be delayed, thus increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest time required to obtain the desired clinical benefit.
Psoriasis
Topical corticosteroids should be used with caution in psoriasis: in fact they can be dangerous in psoriasis for various reasons, such as rebound relapses, the development of tolerance, the risk of generalized pustular psoriasis and the development of local or systemic toxicity due to altered barrier function of the skin. Therefore, if topical steroids are used in psoriasis it is important to monitor the patient closely.
Application on the face
Prolonged application of potent topical corticosteroids to the face is not recommended as this area of the body is more susceptible to atrophic changes than other skin areas. This should be borne in mind when treating conditions such as psoriasis, discoid lupus erythematosus and severe eczema.
Application on the eyelids
If the drug is applied to the eyelids, extreme caution should be used to ensure that the drug does not get into the eye, as prolonged exposure can cause cataracts and glaucoma.
Superinfections
In the case of superinfection of inflammatory lesions, appropriate antimicrobial therapy is required. If infection spreads, topical corticosteroid therapy should be discontinued and appropriate antibacterial therapy administered.
Risk of infection in case of occlusion
Hot humid conditions in skin folds or those caused by occlusive dressing promote bacterial infections. If an occlusive dressing is used, the skin surface must be thoroughly cleansed before each renewal of the dressing.
Chronic leg ulcers
In some cases, topical corticosteroids are used to treat dermatitis near chronic leg ulcers. However, this use may be associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.
The application of corticosteroids in the treatment of large areas of skin or for long periods of time at high doses can lead to adrenocortical suppression. This occurrence is more common in young children.
However, overt suppression of the hypothalamic-pituitary-adrenal axis (plasma cortisol concentrations in the morning
Children have a higher surface area to body weight ratio than adults. Therefore, compared to adults, children can absorb proportionately greater amounts of topical corticosteroids and consequently may be more sensitive to systemic toxicity.
Care should be taken when using FLIXODERM to ensure that the amount applied is the minimum that allows for therapeutic benefit.
Important information about some of the ingredients
FLIXODERM cream contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).
FLIXODERM cream contains propylene glycol. It can cause skin irritation.
FLIXODERM cream contains imidurea which releases traces of formaldehyde as a degradation product. Formaldehyde can cause allergic sensitization or irritation in contact with the skin.
FLIXODERM ointment contains propylene glycol. It can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction
Co-administration of drugs that can inhibit CYP3A4 (eg ritonavir and itraconazole) has been shown to inhibit the metabolism of corticosteroids resulting in increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
04.6 Pregnancy and lactation
Fertility
There are no human data to evaluate the effect of topical corticosteroids on fertility (see section 5.3 Preclinical safety data).
Pregnancy
There are limited data from the use of fluticasone propionate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities in fetal development. (See section 5.3 Preclinical safety data).
The relevance of this experimental finding has not been established in humans: however administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother outweighs any possible risk to the fetus. The minimum amount should be used. for the shortest possible time.
Feeding time
It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities of the active substance in breast milk.
When measurable plasma levels were obtained in lactating laboratory mice following subcutaneous administration, fluticasone propionate was found in milk. However, plasma levels in patients after cutaneous application of fluticasone propionate at recommended doses are likely to be low.
Topical administration of fluticasone propionate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the baby.
If used during breastfeeding, fluticasone propionate should not be applied to the breast to avoid accidental ingestion by the baby.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed. No adverse effect on these activities is expected given the side effect profile of topical fluticasone propionate.
04.8 Undesirable effects
Side effects are listed below by organ, organ / system, and MedDRA frequency. Frequencies are defined as: very common (≥1 / 10), common (≥ 1/100 and
Data after marketing
Infections and infestations
Very rare: opportunistic infections
Furthermore, opportunistic infections have been reported with the use of corticosteroids, particularly when the occlusive bandage is used or where skin folds are involved.
Disorders of the immune system
Very rare: hypersensitivity
Should signs of hypersensitivity occur, the application must be discontinued immediately.
Endocrine pathologies
Very rare: features of hypercortisolism suppression of the hypothalamus-pituitary-adrenal axis:
• weight gain / obesity
• delay in gaining weight / growth retardation of children
• Cushingoid characteristics (for example face to moon, obesity of the central part of the body)
• decrease in endogenous cortisol levels
• hyperglycemia / glycosuria hypertension osteoporosis
• cataracts, glaucoma
Prolonged application of corticosteroids in large quantities or treatment of large surfaces can cause systemic absorption such as to produce suppression of the hypothalamus-pituitary-adrenal axis. This effect is more likely to occur in children and when occlusive dressing is used. In children, the diaper can act as an occlusive dressing (see section 4.4 Special warnings and precautions for use).
Vascular pathologies
Very rare: superficial vasodilation
Prolonged and intensive treatment with potent corticosteroid preparations can cause superficial vasodilation.
Skin and subcutaneous tissue disorders
Common: itching
Uncommon: local skin burning
Very rare: skin thinning, skin atrophy, striae, telangiectasia, pigmentation changes (hypopigmentation), hypertrichosis, allergic contact dermatitis, exacerbation of latent symptoms, pustular psoriasis, erythema, rash, urticaria.
Local skin burning and itching have been reported, however in clinical trials the incidence of these side effects was generally comparable to the placebo and comparator groups.
Prolonged and intensive treatment with potent corticosteroid preparations can cause atrophic skin lesions such as thinning, striae, hypertrichosis and changes in pigmentation (hypopigmentation).
Exacerbation of latent signs and symptoms and allergic contact dermatitis have been reported with the use of corticosteroids.
Treatment of psoriasis with corticosteroids or, its withdrawal, can provoke the appearance of the pustular form of the disease.
04.9 Overdose
Symptoms and signs
Topically applied fluticasone propionate can be absorbed in sufficient quantities to give systemic effects.
Acute overdose is very unlikely, however signs of hyperadrenalism may occur in the event of chronic overdose or abuse (see section 4.8 Undesirable Effects).
Treatment
In the event of an overdose, the application of fluticasone propionate, as with other corticosteroids, should be discontinued gradually, reducing the frequency of applications or replacing the drug with a less potent corticosteroid, to avoid the risk of adrenal insufficiency.
Further medical evaluation should be undertaken as clinically indicated or as recommended by the National Poisons Center, if information is available.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: active corticosteroids (Group III).
ATC code: D07AC17.
Mechanism of action
Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
They act as anti-inflammatory agents through a multiple mechanism aimed at inhibiting delayed phase allergic reactions including decreased mast cell density, decreased chemotaxis and activation of eosinophils, decreased cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibition of metabolism of arachidonic acid.
Fluticasone propionate is a glucocorticoid with high topical anti-inflammatory potency, but, after cutaneous application, with reduced suppression activity of the hypothalamic-pituitary-adrenal axis. It therefore has a therapeutic index higher than that of most of the available steroids.
Probably due to the metabolic inactivation, it proves to have a high systemic glucocorticoid activity after subcutaneous administration, while this activity is very weak after oral administration. Studies in vitro they show a strong affinity and a high agonist activity towards human glucocorticoid receptors.
Pharmacodynamic effects
Fluticasone propionate has no unexpected hormonal effects, nor evident relevant effects on the central and peripheral nervous system, on the gastrointestinal, cardiovascular or respiratory systems.
05.2 Pharmacokinetic properties
Absorption
Bioavailability after topical or oral administration is very low, both due to limited absorption through the skin and gastrointestinal tract, and to the high first pass metabolism. Therefore, systemic exposure due to occasional ingestion of the product is limited.
Distribution
Distribution studies have shown that only small traces of the compound, administered orally, reach the systemic circulation, and that any radiolabelled, systemically traceable compound is rapidly eliminated in the bile and excreted in the faeces.
Fluticasone propionate does not accumulate in any tissue, and does not bind to melanin.
Metabolism
Pharmacokinetic data in rats and dogs indicate rapid elimination and extensive metabolic clearance. Extensive metabolic clearance is also present in humans, and elimination is consequently rapid, so that the product entering the systemic circulation through the skin is rapidly inactivated.
The main metabolic pathway is hydrolysis into a carboxylic acid, with very weak glucocorticoid and anti-inflammatory activity.
Elimination
In all tests conducted in various animal species, the route of excretion was always independent of the route of administration of fluticasone propionate. Excretion is predominantly faecal and is practically complete within 48 hours.
05.3 Preclinical safety data
Long-term studies using fluticasone propionate in topical and oral formulations on animals in order to evaluate their carcinogenic potential have shown no evidence of carcinogenicity.
Genotoxicity
Fluticasone propionate was not shown to be mutagenic in a series of in vitro bacterial and mammalian cell assays.
Fertility
In a fertility and general reproductive capacity study in rats, fluticasone propionate administered subcutaneously to females up to 50 mcg / kg per day and to males up to 100 mcg / kg per day (subsequently reduced to 50 mcg / kg / per day) had no effect on mating or fertility.
Pregnancy
Subcutaneous administration of fluticasone propionate in mice (150 micrograms / kg / day), rats (100 micrograms / kg / day) or rabbits (300 micrograms / kg / day) during pregnancy resulted in fetal abnormalities including cleft palate.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
FLIXODERM 0.05% Cream
Liquid paraffin; isopropyl myristate; cetostearyl alcohol; polyoxyethylene methylstearyl ether (Cetomacrogol 1000); propylene glycol; imidurea; sodium phosphate; citric acid monohydrate; purified water.
FLIXODERM 0.005% Ointment
Propylene glycol; sorbitan sesquioleate; microcrystalline wax; liquid paraffin.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store below 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Carton containing an aluminum tube with perforable membrane, internal epoxy resin coating and polypropylene capsules, containing 30 g or 100 g of cream.
Carton containing an aluminum tube with pierceable membrane and polypropylene cap, containing 30 g or 100 g of ointment.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
GlaxoSmithKline S.p.A. - ViaA. Fleming, 2 - Verona.
08.0 MARKETING AUTHORIZATION NUMBER
FLIXODERM 0.05% Cream - 30 g tube A.I.C .: 029014014
FLIXODERM 0.005% Ointment - 30 g tube A.I.C .: 029014038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
March 19, 1998 / April 29, 2003
10.0 DATE OF REVISION OF THE TEXT
November 13, 2012
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