Active ingredients: Fluocinolone (Fluocinolone acetonide), Neomycin (Neomycin sulfate)
LOCALYN 0.025% + 325.000 I.U./100 g cream
Localyn package inserts are available for pack sizes:- LOCALYN 0.025% + 325.000 I.U./100 g cream
- LOCALYN 0.025% + 325.000 I.U./100 ml ear drops, solution
Indications Why is Localyn used? What is it for?
Localyn contains two active ingredients: fluocinolone acetonide and neomycin sulfate. Fluocinolone acetonide belongs to a group of medicines called "corticosteroids" and works against inflammation (anti-inflammatory), allergies (anti-allergic) and itching (antipruritic); it is specific for local use. Neomycin sulphate belongs to a group of medicines called 'antibiotics' and fights infections due to various microbes called bacteria (broad spectrum antibacterial).
Localyn is used for the local treatment of the following conditions, when there is a risk or a local infectious complication is ongoing:
- skin diseases of an inflammatory or allergic nature, such as dermatitis: - atopic (characterized by itching, redness, peeling and lumps of the skin) - eczematous (characterized by blisters, blisters, scabs and itching) - seborrheic (characterized by yellowish and greasy scales, redness, small scabs and sometimes itching) - exfoliative (characterized by itchy, red skin with erythema and peeling) - by contact (characterized by redness, flaking, small blisters, blisters, small superficial wounds and scabs that occur when touching with certain substances) - from drugs (characterized by rashes on the skin that occur after taking medicines) - from stasis (characterized by darker areas, with red, thin, sometimes thickened spots, with the presence of itching and pain) - of actinic origin (involves areas of the skin affected by UV radiation from the sun or artificial lamps)
- skin conditions characterized by itching or peeling (neurodermatitis and lichen simplex)
- itching near the anus and consequences of surgery near the anus (perianal surgery)
- a skin disease caused by the constant rubbing between two neighboring body surfaces (intertrigo)
- a disease characterized by the appearance on the skin of wheals, red or pale patches of various sizes, usually very itchy (hives)
- burns
- insect bites
- small blisters on the hands and feet (dyshidrosis)
- skin lesions sometimes with blisters (polymorphic erythema)
- an inflammatory disease affecting the lips (cheilitis)
- a disease characterized by spots on the skin (pityriasis rosea)
- a skin disease characterized by plaque, thickening, silvery white flaking and sometimes itching (chronic stabilized psoriasis, etc.)
- a disease characterized by lesions and inflammation of the skin (lupus erythematosus).
Contraindications When Localyn should not be used
Do not use Localyn
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines of the same class as fluocinolone acetonide and neomycin sulphate
- if you have a skin disease characterized by reddish-brown lesions and plaques (cutaneous tuberculosis), infections caused by the Herpes simplex virus and other diseases caused by viruses localized on the skin (smallpox, chicken pox, etc.).
Precautions for use What you need to know before taking Localyn
Talk to your doctor or pharmacist before using Localyn. The use of Localyn for long periods can cause allergic reactions and irritation. In these cases, contact your doctor who will stop the treatment and will prescribe a suitable therapy.
The use of Localyn can determine an absorption in the whole organism (systemic) which increases with the treatment time, with the extension of the skin surfaces to be treated and with the use of the occlusive dressing (plastic bandage applied to keep the medicine on the wound). The medicinal product should not be applied with an occlusive dressing. In infants, the diaper can act as an occlusive dressing. Even with local corticosteroids such as Localyn, especially in children and adolescents, the undesirable effects described for systemic corticosteroids may occur, including reduced and / or insufficient adrenal function (hypoadrenalism).
Talk to your doctor if:
- develops "excessive dryness or" increased skin irritation. In this case your doctor may advise you to stop using Localyn
- you have an infection caused by microbes or fungi (mycotic). In this case your doctor may associate a specific treatment with Localyn. If you do not get a result quickly, your doctor may advise you to stop using Localyn until when it does not recover from the infection
- you develop a "whole organism (systemic) infection" or an infection caused by non-sensitive microbes, in which case your doctor will recommend appropriate therapy.
Localyn should not be used for the eyes (ophthalmic use). Avoid contact with the eyes and the internal walls of the body (mucous membranes).
Children and adolescents
In very early childhood, Localyn should only be used in cases of real need and under the direct supervision of the doctor. Children and adolescents may be more sensitive than adults to the effects of corticosteroids. Corticosteroids for local use can reduce the activity of some glands in the body (hypothalamus, pituitary, adrenal glands), interfere with growth and development, increase internal pressure in the skull (intracranial hypertension) or cause a disease characterized by a " excessive production of a hormone called cortisol (Cushing's syndrome), so your doctor will carefully check for any effects of the medicine.
Interactions Which drugs or foods can modify the effect of Localyn
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. There are no known interactions of other medicines with Localyn.
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
During pregnancy, your doctor will prescribe Localyn only in cases of real need and under his direct control.
Feeding time
If you are breastfeeding, your doctor will decide whether to stop breastfeeding or treatment with Localyn. During breastfeeding, your doctor will prescribe Localyn only when clearly needed and under your direct control.
Driving and using machines
Localyn does not affect the ability to drive and use machines.
Localyn contains
- para-hydroxybenzoates which can cause allergic reactions (including delayed)
- propylene glycol which can cause skin irritation
- stearyl alcohol and cetyl alcohol which can cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Localyn: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is a sufficient amount of cream to cover the affected area, to be applied 2 or 3 times a day, massaging lightly.
Overdose What to do if you have taken too much Localyn
If you use more Localyn than you should
The excessive or prolonged use of corticosteroids for local use, medicines belonging to the same family as Localyn, can cause a reduced activity of some glands of the body (pituitary and adrenal glands, causing secondary hypoadrenalism) and manifestations of hypercorticism (increased production of hormones adrenal cortex) including:
- a disease characterized by "excessive production of a hormone called cortisol (Cushing's syndrome)
- decreased muscle strength (asthenia)
- weakness (adynamia)
- high blood pressure (arterial hypertension)
- changes in heart rhythm (heart rhythm disturbances)
- decreased potassium in the blood (hypokalaemia)
- increase of acids in the blood (metabolic acidosis).
In case of accidental overdose of Localyn, notify your doctor immediately or go to the nearest hospital.
If you forget to use Localyn
Do not use a double dose to make up for a forgotten dose.
If you stop using Localyn
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 Localyn
Like all medicines, this medicine can cause side effects, although not everybody gets them.
They can occur especially in cases of intense and prolonged treatments:
- burning sensation
- itch
- irritation and dryness of the skin
- reduction in skin thickness (skin atrophy)
- acne
- reduced skin discoloration (hypopigmentation)
- reduction in thickness (atrophy) and the appearance of localized striae in the treated areas for a long period of time.
Undesirable effects that may affect the whole body (systemic) are very rare, as the active ingredients are contained in the medicine in very low doses. However, for neomycin, one of the two active ingredients in Localyn, there is a potential risk of toxicity. to the ears and kidneys (oto- and nephrotoxicity).
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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
Do not store above 25 ° C.
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 "Expiry". 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.
Composition and pharmaceutical form
What Localyn
- The active ingredients are fluocinolone acetonide and neomycin sulfate. 100 g of cream contain 0.025 g of fluocinolone acetonide and 325,000 I.U. of neomycin sulfate.
- The other ingredients are citric acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, stearyl alcohol, cetyl alcohol, petroleum jelly, sorbitan monostearate, polysorbate 60, purified water.
What Localyn looks like and contents of the pack
Localyn comes in the form of a cream. The contents of the package is a 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
LOCALYN 0.025% + 325.000 I.U./100 G CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain 0.025 g of fluocinolone acetonide and 325,000 I.U. of neomycin sulfate.
Excipients with known effects:
100 g of cream contains 0.15 g of methyl para-hydroxybenzoate, 0.05 g of propyl para-hydroxybenzoate, 15 g of propylene glycol, 4 g of stearyl alcohol, 4 g of cetyl alcohol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Acute, subacute and chronic dermatoses of an inflammatory or allergic nature such as: atopic, eczematous, seborrheic, exfoliative, contact, drug, stasis and actinic origin dermatitis; neurodermatitis and lichen simplex; anal itching and sequelae of perianal surgery; intertrigo; urticaria, burns, insect bites; dyshidrosis; polymorphic erythema; cheilitis; pityriasis rosea; chronic stabilized psoriasis etc., as well as cutaneous manifestations of lupus erythematosus, when a local infectious complication threatens or is in progress.
04.2 Posology and method of administration
Apply the dose necessary to cover the area to be treated, 2 or 3 times a day, massaging lightly.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to other closely related substances from a chemical point of view.
Infections from cutaneous tuberculosis and Herpes Simplex, as well as from viral diseases with skin localization (smallpox, chicken pox, etc.).
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for local use, can give rise to sensitization phenomena or irritation. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
The cutaneous application of cortisone can determine a systemic absorption which increases with the treatment time, with the extension of the skin surfaces to be treated and with the use of the occlusive dressing. appropriate precautions, particularly in pediatric patients.
Given the chemical-physical characteristics of the preparation, application with an occlusive bandage is not recommended. In newborns, the diaper can act as an occlusive bandage.
If you develop "excessive dryness or" increased skin irritation, discontinue use of Localyn cream.
In dermatoses, where a microbial or fungal component is present, a specific treatment should be associated with Localyn cream.
If a response is not obtained quickly, discontinue corticosteroid treatment until the infection is adequately controlled.
In case of development of systemic infection, appropriate coverage therapy should be instituted; likewise in the case of the development of non-sensitive microorganisms.
Any of the undesirable effects described for systemic corticosteroids, including hypoadrenalism, can also occur with locally used corticosteroids, especially in pediatric patients.
Localyn cream should not be used for ophthalmic use.
Avoid contact with eyes and mucous membranes.
Localyn cream contains para-hydroxybenzoates which can cause allergic reactions (even delayed); propylene glycol which can cause skin irritation; stearyl alcohol and cetyl alcohol which can cause local skin reactions (e.g. contact dermatitis).
USE IN PEDIATRICS
In very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
Pediatric patients may prove to be more sensitive than adults to the effects of exogenous corticosteroids and, in particular, to the depression of the hypothalamic-pituitary-adrenal axis induced by locally used cortisones, given the greater absorption due to the high ratio of skin surface to weight. bodily.
Depression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation and weight loss and intracranial hypertension have been described in children treated with local corticosteroids.
In children, manifestations of secondary hypoadrenalism include low cortisol levels and unresponsiveness to ACTH stimulation. Manifestations of intracranial hypertension include fontanel tension, headache, and bilateral papilledema.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
During pregnancy and breastfeeding, the medicine should be administered in cases of real need, under the direct supervision of the doctor.
Pregnancy
The safety of corticosteroids for local use has not been established in pregnant women and, therefore, during pregnancy, the use of drugs belonging to this class should be limited to cases where the expected benefit justifies the potential risk to the fetus. .
In any case, in pregnant women these drugs should not be used intensively at high doses and for long periods of time.
Feeding time
As it is not known whether local administration of corticosteroids can result in sufficient systemic absorption to produce measurable concentrations in breast milk, a decision must be made whether to discontinue breastfeeding or to discontinue therapy given the importance of the drug to the mother.
04.7 Effects on ability to drive and use machines
The medicine does not affect the ability to drive and use machines.
04.8 Undesirable effects
During epicutaneous cortisone therapy, especially for intense and prolonged treatments, some of the following side effects may occur: burning sensation, itching, irritation, dry skin, skin atrophy, acne rash, hypopigmentation; atrophy and striae localized to the treated areas for a long period of time. Systemic effects are extremely rare in consideration of the low doses used of the active ingredients. However, there is a potential risk of oto- and nephrotoxicity for neomycin.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Symptoms
The excessive or prolonged use of corticosteroids for local use can depress the adrenal pituitary function, causing secondary hypoadrenalism and manifestations of hypercorticism including Cushing's syndrome, in particular asthenia, adynamia, arterial hypertension, heart rhythm disturbances, hypokalemia, metabolic acidosis.
Treatment
Appropriate symptomatic treatment is indicated. Symptoms of acute hypercorticism are usually reversible. If necessary, treat the electrolyte imbalance. In the case of chronic toxicity, slow elimination of the corticosteroid is recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Active corticosteroids associated with antibiotics, ATC code: D07CC02.
The medicine combines the broad-spectrum antibacterial effect of neomycin with the anti-inflammatory, anti-allergic and anti-itching action of fluocinolone acetonide.
Fluocinolone acetonide is a fluorinated steroid with a remarkable anti-inflammatory, anti-allergic and anti-reactive action. In the experimental inflammation tests, fluocinolone acetonide showed a significantly higher activity than that of hydrocortisone and most of the steroids for local use. Fluocinolone acetonide is also very active in the vasoconstriction test. The optimal active concentrations are between 0 .01 and 0.025%.
05.2 "Pharmacokinetic properties
After skin application, the action of fluocinolone acetonide occurs locally: a transcutaneous absorption of steroid doses capable of depressing the pituitary-adrenal axis can occur only for quantities considerably higher than the therapeutic ones. The local activity / systemic activity ratio for fluocinolone acetonide is 10 to 20 times higher than that of hydrocortisone and other locally used steroids.
05.3 Preclinical safety data
Fluocinolone acetonide has very poor toxicity: oral LD50 in mice 3 g / kg. Oral doses of 0.05-0.125 mg / kg / day in dogs and 0.125-0.500 mg / kg / day in monkeys for 3 months produced no hormonal effects (adrenal hypotrophy) other than those expected. Good local tolerability (0.5 ml of 0.01% solution in the conjunctival sac of rabbit).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Citric acid
Methyl para-hydroxybenzoate
Propyl para-hydroxybenzoate
Propylene glycol
Stearyl alcohol
Cetyl alcohol
Vaseline oil
Sorbitan monostearate
Polysorbate 60
Purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube internally coated with protective paint.
30 g tube.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
RECORDATI Chemical and Pharmaceutical Industries S.p.A. - Via M. Civitali, 1 - 20148 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
Localyn 0.025% + 325.000 I.U./100 g cream - 30 g tube A.I.C. n. 020163085
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: January 16, 1965
Date of most recent renewal: May 31, 2010
10.0 DATE OF REVISION OF THE TEXT
13/10/2015