Nerisone

Diflucortolone valerate.

1 g fatty ointment (anhydrous) contains 1 mg (0.1%) diflucortolone valerate.
Excipients/Inactive Ingredients: The other excipients are: Liquid paraffin, White soft paraffin, Microcrystalline wax, Hydrogenated castor oil.

Nerisone is an anti-inflammatory medicine (containing the active substance diflucortolone valerate, a glucocorticoid) to be used on the skin. Nerisone suppresses inflammatory and allergic skin reactions and thus relaxes symptoms deriving from skin problems such as itching, burning and pain.
Nerisone fatty ointment is especially suitable for very dry conditions and chronic stages. The occlusive effect of the fatty ointment base promotes the healing process.

Nerisone is used for the treatment of all skin ailments which respond to topical glucocorticoid therapy, e.g.: psoriasis, lichen ruber planus and lichen verrucosus, lupus erythematosus chronicus discoides, insect bites.

Always use this medicine exactly as the doctor or pharmacist has told to. Check with them if unsure.
For topical application.
If not prescribed otherwise by the doctor, the dosage is as follows: At the beginning of treatment, Nerisone fatty ointment is applied thinly twice or, perhaps, three times per day. Once the clinical picture has improved, one application per day usually suffices.
Adults should not be treated for more than 3 weeks.
Application over a large area (more than 10% of the body surface) should not last more than one week.
Children and adolescents: In children, Nerisone fatty ointment should not be used for more than 2 weeks and only on small areas (<10% of the body surface).
The use under occlusive dressing (see as follows) should be avoided in children.
Safety and efficacy of Nerisone fatty ointment in infants up to 23 months is not proven. There are no adequate data.
Glucocorticoid therapy should only be applied as long as necessary to obtain and maintain the desired therapeutic effect with the lowest effective dose.
Occlusive dressing (impermeable dressing): Nerisone fatty ointment should not be used under occlusive conditions (patches etc.). An occlusive dressing may be called for in unusually refractory cases after advise of the doctor. In this case, it should be managed as follows: After application of the fatty ointment, the area under treatment should be covered with a plastic film which should then be fixed firmly all around the healthy skin by means of adhesive plaster. Plastic gloves can be used to occlude the hands.
The dressing should be kept in place for as long as can be expected or as the doctor decides, but generally not for longer than 24 hours. If the occlusive treatment is expected to be prolonged, it is advisable to change the dressing every 12 hours.
If an infection develops under the dressing, occlusive treatment must be terminated.
In many cases, the so-called tandem therapy is useful, i.e. the application of Nerisone fatty ointment once a day and the application of a suitable external free of active ingredients.

No risk of acute intoxication is to be expected following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.
Talk to the doctor or pharmacist, if more information is required.

Do not use Nerisone fatty ointment: if allergic to diflucortolone valerate or any of the other ingredients of this medicinal product listed in Description; if suffering from specific skin diseases (tuberculosis, syphilis) in the area to be treated; if suffering from virus infections (for example: herpes simplex, chicken pox, herpes zoster); if suffering from rosacea (chronic disease in the face), perioral dermatitis (inflammation of the skin in the face except for a line around the lips), ulcers, acne vulgaris, skin atrophies (thinning of the skin), and post-vaccination skin reactions in the area to be treated.
Nerisone fatty ointment must not be used on the face.
For pregnancy and lactation, see Use in Pregnancy & Lactation.

Please talk to the doctor before using Nerisone fatty ointment.
Additional specific therapy is required in bacterially infected skin diseases and/or in fungus infections.
On application in the face, care should be taken to avoid contact with the eyes. Avoid application on the skin in the area around the eyes.
The excipients in Nerisone fatty ointment may reduce the effectiveness of latex condoms upon concomitant use when applied to the genital or anal region, due to the excipients paraffin. The tear resistance and effectiveness of the condoms may be reduced.
During prolonged use (over 4 weeks) and/or treatment of large skin areas (about 10% or more of the body surface), the possibility of absorption of the glucocorticoid cannot be excluded, especially under occlusive dressings. Extensive application of topical glucocorticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects.
Tell the doctor if there is history of glaucoma. As known from systemic glucocorticoids, glaucoma may also develop from using local glucocorticoids (e.g. after large doses or extensive application over a prolonged period, occlusive dressing techniques, or application to the skin around the eyes).
The use of Nerisone fatty ointment may lead to positive results in doping tests.
Driving and using machines: No effects on the ability to drive and use machines have been observed.
Use in Pregnancy & Lactation: If pregnant or lactating, please inform the doctor.
Use in Children: In general, increased caution has to be applied in the use in children, as an increased uptake of the glucocorticoid through the infantile skin may occur.

If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine. The doctor will decide about an application during pregnancy and lactation.
Pregnancy: Prolonged use or treatment of large skin areas or application under dressings must be avoided during pregnancy.
In general, the use of topical preparations containing glucocorticoids should be avoided during the first trimester of pregnancy.
Lactation: Nursing mothers must not be treated on the breasts. Inform the doctor if lactating. Prolonged use or treatment of large skin areas or application under dressings must be avoided during lactation.
Fertility: There are no data on the influence of Nerisone fatty ointment on fertility.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following undesirable effects were observed in clinical studies with Nerisone fatty ointment.
The following categories regarding frequency were used: Common (1 to 10 of 100 patients treated); Uncommon (1 to 10 of 1000 patients treated); Rare (1 to 10 of 10000 patients treated); Very rare (less than 1 of 10000 patients treated); Not known (frequency cannot be estimated from the available data).
Uncommon: Burning and irritation in administration site.
Local symptoms such as itching, burning, erythema or vesiculation may occur in isolated cases under treatment with Nerisone fatty ointment.
The following reactions may occur especially when preparations containing glucocorticoids are applied to large areas of the body (about 10% and more) or for prolonged periods of time (more than 4 weeks): symptoms such as reduction of the skin (atrophy), expansion of vessels in the skin (telangiectasia), stretch marks of the skin (striae), acneiform changes of the skin, and systemic effects of the glucocorticoid due to absorption.
As with other glucocorticoids for topical application, the following side effects may occur in rare cases: hair follicle inflammation (folliculitis), excessive hair growth (hypertrichosis), inflammation of the skin in the face except for a line around the lips (perioral dermatitis), skin discoloration, allergic skin reactions to any of the ingredients of the formulation.
Side effects cannot be excluded in neonates whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while lactating (for example, reduced adrenocortical function, when applied during the last weeks of pregnancy).
Diapers can have the same effect as occlusive dressings.
Report of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not previously listed.
By reporting side effects, more information about the safety of this medicinal product can be given.

Tell the doctor or pharmacist if taking, have recently taken, or might take any other medicines.
During prolonged use or treatment of large skin areas, the interactions can be the same as after systemic use (application concerning the whole body as with tablets) due to the possibility of absorption.
So far, no interactions are known.

Do not dispose of medicinal products with wastewater or household waste. Ask the doctor or pharmacist how to dispose of the medicinal product if it is not being used anymore. Help protect the environment.

Store in the original container to protect from light.

Topical Corticosteroids

D07AC06 - diflucortolone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

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