Active ingredients: Diflucortolone
TEMETEX 1 mg / g hydrophilic cream
Temetex package inserts are available for pack sizes:- TEMETEX 1 mg / g hydrophilic cream
- TEMETEX 1 mg / g hydrophobic cream
- TEMETEX 3 mg / g hydrophobic cream
Indications Why is Temetex used? What is it for?
Temetex contains the active ingredient diflucortolone, which belongs to the class of corticosteroid drugs for topical use. It is indicated for the treatment of some inflammatory and allergic skin diseases such as contact eczema, contact dermatitis (allergic or toxic in nature such as hypersensitivity to detergents or other chemical agents), vulgar eczema (acute and chronic phase), microbial eczema , dermoepidermitis, seborrheic eczema, varicose eczema (however not directly on the ulcer), children's eczema, anal eczema.
Contraindications When Temetex should not be used
Do not use Temetex:
- If you are allergic to the active substance or any of the other ingredients of this medicine
- In the presence, in the area to be treated, of secondary skin lesions such as vaccination, tuberculosis, fungal, bacterial or viral infections (herpes, chicken pox, etc.), acne rosacea and skin ulcers. The preparation is not for ophthalmic use.
- The occlusive dressing (bandage with gauze or other material to keep the medicines locally applied to the skin) is contraindicated in exudative lesions (ie with the presence of fluid deriving from inflammation) and in skin infections.
Precautions for use What you need to know before taking Temetex
In skin diseases accompanied by bacterial infections it is advisable to associate a treatment with chemotherapy for local use; in case of mycosis (fungal infection) local antifungals are needed.
Temetex is not indicated for the treatment of eye diseases. Temetex should not be applied to the eyes. In case of application of the product on the face, avoid that the product comes into contact with the eyes. The application on the skin of corticosteroids in the treatment of dermatoses (skin diseases) extended and / or for long periods of time, can determine secondary phenomena of systemic absorption, thus determining the onset of hormonal disorders (Cushing's syndrome, inhibition of the axis hypothalamus-pituitary). This occurrence is more frequent in children and in the case of occlusive dressing.
In "pediatric use, the skin folds and the diaper can act as an occlusive bandage. Therefore, in the treatment of chronic diseases that require prolonged therapies, if a favorable therapeutic effect has been achieved, it will be advisable to reduce the dosage and frequency of applications to the minimum necessary. to control symptoms and avoid relapses by stopping the use of the preparation as soon as possible.
During the therapy it is necessary to monitor the patient's condition, in order to detect early signs and symptoms of steroid excess (asthenia (fatigue), arterial hypertension, electrolyte disturbances (alteration of the quantity of some minerals present in the blood, etc.). cases it is advisable to limit the use of topical steroids (ie for local application) to short periods of time.
Children
In infants and children under the age of four, treatment for periods longer than three weeks is not recommended, especially in areas covered by diapers. (See "warnings and precautions").
Interactions Which drugs or foods may change the effect of Temetex
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known possible interactions and incompatibilities with other medicines.
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 taking this medicine. Local application of corticosteroids to pregnant laboratory animals may induce the appearance of fetal malformations. The transferability of these data to humans has not been demonstrated. In general, for topical preparations (ie for local use) containing corticosteroids, such as Temetex, it is not recommended to use during the first trimester of pregnancy. In particular, the application of the product on large skin areas or for prolonged periods should be avoided.
In pregnant women Temetex should only be used when clearly needed and under direct medical supervision.
Driving and using machines
Temetex does not affect the ability to drive or use machines.
Important information about excipients
This medicinal product contains methyl p-hydroxybenzoate and propyl phydroxybenzoate which may cause allergic reactions (including delayed).
Dose, Method and Time of Administration How to use Temetex: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Unless otherwise prescribed, start the treatment by spreading the preparation in a thin layer 2-3 times a day. As soon as the clinical picture has improved, only one daily application is sufficient.
Due to its particular composition (low fat "oil in water" emulsion) Temetex is particularly indicated in the treatment of secreting lesions and moist skin areas, such as the anal region and the axillary cavity, where it is advisable to use a base with a high water content. Temetex hydrophilic cream allows the secretion to flow and induces rapid exudation (ie a rapid passage from the smallest circulatory vessels and collection of liquid material produced by tissue inflammation) and drying of the skin.
The preparation leaves no trace of grease on the skin and is therefore also suitable for application to the face and uncovered skin regions.
Use in children
In infants and children under the age of 4, treatment for periods longer than three weeks is not recommended, especially in areas covered by diapers.
If you forget to use Temetex
Do not take a double dose to make up for a forgotten dose.
If you stop taking Temetex
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you have any further questions on the use of Temetex, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Temetex
In case of accidental ingestion / intake of an overdose of Temetex, notify your doctor immediately or go to the nearest hospital. There are no known cases of overdose.
Side Effects What are the side effects of Temetex
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects that may occur with the use of this medicine include:
Locally redness, edema (swelling), peeling (loss of the upper layer of the skin), itching as signs of hypersensitivity to the medicine. Other effects include hypertrichosis (increased growth of body hair), acneiform eruptions (similar to acne), skin atrophy (reduction in skin volume), hypopigmentation (decreased skin color), telangiectasias (dilation of small blood vessels that become visible under the skin), striae, vascular fragility, purpura (reddish discoloration of the skin due to small blood extravasations from capillaries).
After prolonged treatments (especially on the face) rebound pustular dermatitis (cutaneous manifestations of the skin that resemble vesicles and which appear when the drug is discontinued) which, being sensitive to steroids, such as Temetex, become evident only upon discontinuation of therapy.
During the treatment of large skin areas (about 10% and more of the body surface) and / or of prolonged use (over 4 weeks), especially under occlusive dressing, it is not possible to exclude, as for all other topical cortisone following concomitant reactions: skin atrophy (loss of the upper layer of the skin), telangiectasias (dilation of small blood vessels that become visible under the skin), striae, acneiform manifestations (similar to "acne), perioral dermatitis (inflammation of the skin around the mouth ), increased growth of body hair (hypertrichosis).
Systemic symptoms (i.e. which can manifest throughout the body, for example as hormonal disturbances) from skin absorption of corticosteroids. In occlusive treatments it should be borne in mind that the films used for the bandage can themselves cause sensitization phenomena. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an adequate therapy.
Hypersensitivity reactions may occur in predisposed subjects.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.it/it/responsabili. 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.
Temetex does not require any special storage precautions. Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month. The expiry date refers to the unopened, correctly stored product.
Do not use this medicine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What Temetex contains
100 g of cream contain:
Active ingredient: diflucortolone valerate 0.1 g.
Other components: polyethylene glycol monostearate, stearyl alcohol, liquid paraffin, white petroleum jelly, disodium edetate, carbomer, sodium hydroxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.
Description of what Temetex looks like and contents of the pack
Temetex 1 mg / g hydrophilic cream comes in white or slightly yellowish cream for local use packaged in 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
TEMETEX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Temetex 0.1% hydrophilic cream. 100 g contain: diflucortolone valerate 0.1 g.
Temetex 0.1% hydrophobic cream. 100 g contain: diflucortolone valerate 0.1 g.
Temetex 0.1% ointment. 100 g contain: diflucortolone valerate 0.1 g.
Temetex 0.1% cutaneous solution. 100 g contain: diflucortolone valerate 0.1 g.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Temetex 0.1% is available in hydrophilic cream, hydrophobic cream, ointment and solution for cutaneous use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Temetex 0.1% hydrophilic cream:
Contact eczema, contact dermatitis (with allergic or toxic etiology such as hypersensitivity to detergents or other chemical agents), vulgar eczema (acute and chronic phase), microbial eczema, dermoepidermitis, seborrheic eczema, varicose eczema (however not directly on the ulcer) , children's eczema, anal eczema, rosacea.
Temetex 0.1% hydrophobic cream:
Dermatitis and contact eczema, professional eczema, vulgar eczema, nummular (microbial) eczema, varicose eczema (however not directly on the ulcer), infantile eczema, anal eczema, neurodermatitis, first degree burns, solar erythema, insect bites, erythematode cutaneous, psoriasis, lichen ruber planus and warty.
Temetex 0.1% ointment:
Neurodermatitis, eczema vulgaris (chronic phase), microbial eczema (dry), lichenified eczema, psoriasis, lichen ruber planus and warty
Temetex 0.1% cutaneous solution:
Local treatment of corticosteroid-sensitive dermatoses, particularly of the scalp (pityriasis simplex, commonly known as dandruff, seborrheic parakeratosis, psoriasis, neurodermatitis, lichen ruber planus, chronic discoid erythematoid) and of the external ear (eczema, psoriasis of the ear canal) .
04.2 Posology and method of administration
Unless otherwise prescribed, start the treatment by spreading the preparation in a thin layer 2-3 times a day. Temetex 0.1% cutaneous solution should initially be applied twice a day on the area to be treated, massaging lightly. As soon as the clinical picture has improved, only one daily application is sufficient.
Temetex 0.1% is presented in four different pharmaceutical forms, to be chosen according to the appearance and location of the skin lesion. Temetex 0.1% cutaneous solution is particularly indicated in dermatosis of the scalp and external ear. Temetex 0.1% hydrophilic cream, due to its particular low fat excipient ("oil in water" emulsion) is particularly indicated in the treatment of secreting lesions and moist skin areas, such as the anal region and the axillary cavity, where it is appropriate to use a base with a high aqueous content. Temetex 0.1% hydrophilic cream allows the secretion to flow and induces rapid exudation and drying of the skin. The preparation leaves no trace of grease on the skin and is therefore also suitable for application to the face and uncovered skin regions. Temetex 0.1% hydrophobic cream, due to its particular excipient (fat base containing a modest percentage of water) , has very wide possibilities of use ranging from skin diseases that are not excessively secreting to those that are not particularly dry. The preparation ensures an appropriate lipid supply to the skin, without blocking perspiration and heat exchanges. Temetex 0.1% ointment, for its completely greasy base is particularly indicated in the dry forms and in the chronic stages in which the use of anhydrous preparations is required. Temetex 0.1% ointment maintains the moisture of the skin and for this reason softens the thickened stratum corneum thus facilitating the penetration of the active ingredient. The base of the ointment exerts an occlusive effect and therefore does not generally require the occlusive dressing. In particular cases resistant to therapy, the doctor may prescribe a treatment under an occlusive bandage. The diseased skin area, treated with the preparation, will be covered with a film of impermeable material which must be fixed to the surrounding healthy skin. The duration of the application of the occlusive bandage will be established by the doctor, but should not exceed two days, in order to avoid possible disturbances of homeostasis. The occlusive dressing can be repeated several times if necessary. If infectious processes occur during the course of treatment, it will be necessary not to apply occlusive bandages for some time. In case of extensive lesions it is however advisable to subsequently treat partial areas one at a time.
If, after treatment with Temetex 0.1% cutaneous solution, there is a significant drying of the skin, it is advisable to switch to the "use of" another pharmaceutical form (Temetex 0.1% hydrophilic cream, hydrophobic cream or ointment).
04.3 Contraindications
Known hypersensitivity to the components. Tuberculous and viral infections of the skin to be treated (herpes, chicken pox, etc.). Rosacea acne. Skin ulcers. The preparation is not for ophthalmic use.
Occlusive dressing is contraindicated in exudative lesions and skin infections.
04.4 Special warnings and appropriate precautions for use
In skin diseases accompanied by bacterial infections it is advisable to associate a treatment with topical chemotherapy; in case of mycosis local antifungals are necessary.
Temetex 0.1% is not indicated for the treatment of eye diseases.
The percutaneous application of corticosteroids in the treatment of extended dermatoses and / or for long periods of time, can determine secondary phenomena of systemic absorption (Cushing's syndrome, inhibition of the hypothalamic-pituitary axis). This occurrence is more frequent in children and in the case of occlusal dressing. In "pediatric use, the skin folds and the diaper can act as an occlusive bandage. Therefore, in the treatment of chronic diseases that require prolonged therapies, if a favorable therapeutic effect has been achieved, it will be advisable to reduce the dosage and frequency of applications to the minimum necessary. to control symptoms and avoid relapses, stopping the use of the preparation as soon as possible.
During the therapy it is necessary to monitor the patient's condition, in order to detect early signs and symptoms of steroid excess (asthenia, hypertension, electrolyte disturbances, etc.). In all cases it is advisable to limit the use of topical steroids to short periods of time.
Infants and children under the age of four should not be treated for longer than three weeks, especially in areas covered with nappies.
Medicines should not be kept within reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known possible drug interactions and incompatibilities.
04.6 Pregnancy and breastfeeding
Local application of corticosteroids to pregnant laboratory animals may induce the appearance of fetal malformations. The transferability of this finding to humans has not been demonstrated. However, high quantities or topical corticosteroid preparations should not be used in the first three months of pregnancy. for a long time and generally in pregnant women and in very early childhood, the preparation should be used only in case of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Temetex 0.1% does not affect the ability to drive or the use of particular machines.
04.8 Undesirable effects
Locally redness, edema, desquamation, itching as signs of hypersensitivity to the product. Other effects include hypertrichosis, acneiform eruptions, skin atrophy, hypopigmentation, telangiectasias, striae, vascular fragility, purpura and after prolonged treatments (especially on the face) rebound pustular dermatitis which, being sensitive to steroids, become evident only upon discontinuation of the therapy. Prolonged and / or high dose use can induce an excess syndrome with arterial hypertension, asthenia, adynamia, heart rhythm disturbances, hypokalaemia and metabolic alkalosis.
In occlusive treatments it should be borne in mind that the films used for the bandage can themselves cause sensitization phenomena.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an adequate therapy.
Hypersensitivity reactions may occur in predisposed subjects.
04.9 Overdose
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Diflucortolone valerianate (DFV) is a corticosteroid for topical application, with anti-inflammatory, antipruritic and vasoconstrictive action. Corticosteroids reduce inflammation with different mechanisms, especially by promoting the synthesis of a factor (lipocortin) which keeps the enzyme (phospholipase A2) under control, which activates the arachidonic acid cascade, leading to the formation of phlogogenic factors, such as prostaglandins and lipoperoxides .
DFV exhibits 3 to 30 times higher anti-inflammatory activity than other comparator topical corticosteroids and 10 times higher antiproliferative activity than flucortolone.
05.2 Pharmacokinetic properties
Applied to the skin, corticosteroids are largely retained by the stratum corneum and only a small part reach the dermis where they can be absorbed. Numerous factors can favor a more evident absorption: the area and the extension of the skin to be treated, the type of lesion, the duration of the treatment, any occlusive bandage. In this regard, it should be borne in mind that certain areas of the skin (face, eyelids, hair, scrotum) absorb them more easily than others (skin of the knees, elbows, palm of the hand and soles of the feet).
DFV rapidly penetrates the human epidermis, reaching its maximum concentration within 4 hours of application. This concentration is prevalent in the more superficial skin layers. Systemic absorption, after 7 hours of application, is less than 1% of the initial dose. The small amount absorbed into the circulation is rapidly metabolized (plasma half-life of about 4 hours) to at least three degrading substances which are rapidly and completely eliminated by the kidney in conjugated form. 7 metabolites of DFV have been identified in urine.
The intracutaneous metabolism of DFV, after application on human skin, consists in a slow hydrolysis of the substance to diflucortolone and valeric acid (5-15% of the dose applied for 7 hours).
05.3 Preclinical safety data
Toxicology:
The acute toxicity of DFV is negligible (LD50 per os in mice> 4 g / kg). Tests carried out with topical applications in concentrations equal to 0.5% have confirmed the absence of a determinable acute toxicity. Only after prolonged applications in dogs for 14 weeks of preparations at 0.1% at a dose of 100 mg / kg / day yes systemic effects are manifested.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Temetex 0.1% hydrophilic cream:
polyethylene glycol monostearate, stearyl alcohol, liquid paraffin, white petroleum jelly, sodium edetate, carbomer, sodium hydroxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.
Temetex 0.1% hydrophobic cream:
white wax, liquid paraffin, white petroleum jelly, dehymuls E, purified water.
Temetex 0.1% ointment:
liquid paraffin, white petroleum jelly, lunacera M, hydrogenated castor oil.
Temetex 0.1% cutaneous solution:
alcohol, glycerol, polyvinylpyrrolidone, purified water.
06.2 Incompatibility
No specific incompatibilities are known to date.
06.3 Period of validity
Expiry of the unopened package correctly stored:
Hydrophilic cream, hydrophobic cream, ointment: 5 years.
Skin solution: 3 years.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Temetex 0.1% hydrophilic cream, Temetex 0.1% hydrophobic cream, Temetex 0.1% ointment:
Flexible aluminum tube internally protected by lacquer and closed with plastic screw cap.
Temetex 0.1% cutaneous solution:
Glass bottle, closed with a polythene screw cap; cap-dispenser, contained in a polythene bag, to be applied to the bottle at the time of first use.
The various containers are enclosed in the respective cardboard box together with the illustrative leaflet.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER
"0.1% hydrophilic cream" tube 30 g AIC n ° 023682089
"0.1% hydrophobic cream" tube 30 g AIC n ° 023682026
"0.1% ointment" tube 30 g AIC n ° 023682053
"0.1% cutaneous solution" bottle 30 ml AIC n ° 023682103
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2005
10.0 DATE OF REVISION OF THE TEXT
01/03/2005
