SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT: PEITEL® ointment • PEITEL® cream • PEITEL® unguent • PEITEL® solution • PEITEL® solution with applicator.

QUALITATIVE AND QUANTITATIVE COMPOSITION: Pharmacologically active ingredients: 1 gram of PEITEL® ointment, cream, unguent, solution and solution with applicator contains 2.5 mg of prednicarbate (INN).

PHARMACEUTICAL DOSAGE FORM: Ointment, cream, unguent, solution, solution with applicator.

CLINICAL PARTICULARS: Therapeutic indications. PEITEL® ointment, cream and unguent are indicated in all inflammatory skin affections in which treatment with topical corticoids is indicated, such as dermatitis, eczema and psoriasis. PEITEL® ointment, cream and unguent is suitable for the treatment of particularly sensitive skin regions, large surfaces and those in which a repeat long-term treatment is necessary (maximum 4 weeks). PEITEL® ointment, cream and unguent may be used in children and the elderly. PEITEL® solution is indicated in dermatosis of the pilose areas of the body (e.g. scalp, beard, axilla and pubis) that respond to treatment with topical corticoids, such as psoriasis, atopic eczema and seborrhoeic eczema. PEITEL® solution may also be given for the treatment of these diseases in regions such as the palm of the hand and the sole of the feet. PEITEL® solution with applicator facilitates its application in large skin areas. Dosage and method of administration. The indications given by the doctor on the duration and frequency of treatment should be followed exactly. PEITEL® ointment, cream and unguent: unless prescribed otherwise by a doctor, apply a fine layer of PEITEL® once or twice daily on the affected skin area, rubbing lightly, if possible. 2 or 3 weeks of treatment will normally suffice. As occurs with other corticoids, uninterrupted administration for more than 4 weeks is not advisable. PEITEL® solution and PEITEL® solution with applicator: unless prescribed otherwise by a doctor, apply a few well-distributed drops of PEITEL® solution or a fine layer of PEITEL® solution with applicator once or twice daily on the affected skin area, rubbing lightly, if possible. The treatment may be reduced to one application a day when an evident improvement has been observed. The dosage forms have been developed specifically according to the skin area to be treated, thus: PEITEL® ointment is a development formulation that is suitable for acute and chronic skin affections, and may be applied to normal, moist or dry skin. PEITEL® cream is a development formulation that is suitable for acute dry or exudative skin affections. PEITEL® unguent is a development formulation that is suitable for chronic and dry skin affections. PEITEL® solution is a hydroalcoholic solution particularly suitable for the treatment of inflammatory skin affections of the pilose areas. The peculiar viscosity of PEITEL® solution makes it easy to apply on the skin without sticking to the hair, and being a hydroalcoholic solution it has a pleasant refreshing effect. PEITEL® solution with applicator facilitates use on large skin areas, since it is easy to apply a fine layer of foam-like product. Contraindications. Hypersensitivity to prednicarbate or any of the excipients. Do not use on the eyes; even the application of PEITEL® -if prolonged- in the immediate proximity of the eyes must be preceded by a careful assessment of risks and benefits and should only be performed under medical supervision since, if small doses of topical corticosteroid come repeatedly into contact with the conjunctiva, an increase in intraocular pressure may occur over time. Skin phenomena derived from vaccinations, tuberculosis, syphilis or viral infections (e.g. varicella). Acne rosacea and perioral dermatitis. PEITEL® cream, ointment and unguent contain a paraffin that may cause leaks or ruptures in latex preservatives, whereby contact between the latter and PEITEL® should be avoided. The use of PEITEL® solution in infants and young children is not recommended, since there is not sufficient clinical experience in this age group with this formulation. Special warnings and precautions for use. Avoid contact with the eyes. In case of local bacterial or mycotic superinfections give additional antibacterial or antimycotic treatment. The administration of all forms of PEITEL® in children should be performed with caution and limited to the lowest dose compatible with an efficacious treatment. The short-term application of over-high doses (use of excessive amounts of PEITEL®, application on an excessively large area or over-frequent applications) or forgetting the treatment once is not expected to cause harmful effects. Patients are advised to inform their doctor of any such deviation from the scheduled treatment. Interaction with other medicinal products and other forms of interaction. Not described. Pregnancy and lactation. Its harmlessness in pregnancy has not been demonstrated, whereby prolonged uninterrupted treatment (more than four weeks) should be avoided in the first quarter of pregnancy. During the first quarter of pregnancy do not use the extensive application (more than 30% of the body surface) of PEITEL®. There is not sufficient clinical experience with the use of PEITEL®, in any of its pharmaceutical forms, during lactation, whereby its use during this period is not recommended. Effects on the ability to drive and use machines. Not described. Undesiderable effects. Experience indicates that if the product is used properly no side effects such as cutaneous atrophy, telangiectasias or striae distensa are to be expected (maximum uninterrupted duration of treatment: 4 weeks). PEITEL® ointment, cream and unguent: rarely pruritus, local skin irritations (stinging, rubefaction, exudation) as a sign of an allergic skin reaction; folliculitis. Occasionally, a burning sensation may appear with the application of ointment or cream. PEITEL® solution and PEITEL® solution with applicator: due to the solution’s alcohol content, occasionally local skin irritation, such as a mild and transient burning sensation, erythema and dry skin may occur. The doctor should be informed if these or any other clinical symptoms appear. Overdose. If the recommended doses are significantly surpassed, the adverse effects specific to the corticoids cannot be ruled out. No acute intoxications following the accidental intake of PEITEL® solution have been reported, and if it did occur it would probably be asymptomatic, it only being necessary to keep the patient under observation for hydrosaline retention and hypopotassaemia. With the PEITEL® cream, ointment and unguent presentations, the possibility of intoxications following application is unlikely.

PHARMACOLOGICAL PROPERTIES: Pharmacodynamic properties. Prednicarbate, the active ingredient of PEITEL®, is a non-halogenated topical corticosteroid esterified in the positions 17 and 21 by the ethyl carbonate and propionate groups, respectively, characterised by its marked antiphlogistic, antiallergic, antiexudative and antipruriginous properties. If the product is used properly, none of the local side effects specific to the corticosteroids, such as cutaneous atrophy and telangiectasias, are to be expected (maximum uninterrupted duration of treatment: 4 weeks).The extremely reduced influence of prednicarbate in the synthesis of collagen and in the growth of human skin fibroblasts reflects the scant atrophogenic potency of the active ingredient. Following the extensive application of prednicarbate on a diseased skin (psoriasis, neurodermatitis) no suppression of the natural synthesis of cortisol was observed. Pharmacokinetic properties. The healthy skin only absorbs PEITEL® at a proportion of 0.1%. Comparative studies with prednisolone show that the metabolism of prednicarbate is substantially analogous to that of prednisolone. Preclinical safety data. The 24 hour epicutaneous test carried out with the preparations of PEITEL® on intact and damaged skin of guinea pigs and rabbits led them to be rated as “non-irritant for the skin” according to the FDA guidelines. The application of prednicarbate ointment on the intact and damaged skin of rabbits, rats and dogs did not cause identifiable lesions. The phototoxicity and photosensitisation tests by contact of prednicarbate showed no sign of the possible appearance of this skin reaction. Prednicarbate showed no mutagenic effect in the Ames Test or the micronuclei test.

PHARMACEUTICAL PARTICULARS: List of excipients. PEITEL® ointment: Glycerol monodioleate, 2-octyl-1-dodecanol, edetic acid, vaseline, benzyl alcohol and magnesium sulphate. PEITEL® cream: 2-octyl-dodecanol, perliquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, sorbitan monostearate, polysorbate 60, benzyl alcohol and edetate disodium. PEITEL® unguent: Glycerine monodioleate, 2-octyl-dodecanol and white vaseline. PEITEL® solution and PEITEL® solution with applicator: Polyol fatty acid ester, 1,2 propylene glycol, ethanol (24.36% v/v), citric acid, edetic acid and purified water. Incompatibilities. Not described. Shelf-life. Cream: 3 years. Ointment: 2 years. Unguent: 3 years. Solution and solution with applicator: 2 years. The preparations may be used until the sell-by date indicated on the container. Once the bottle of PEITEL® solution has been opened it is usable for three months. Special precautions for storage. PEITEL® cream, ointment, unguent: Store at a temperature not higher than +25ºC. PEITEL® solution and PEITEL® solution with applicator: Store in the fridge between 2ºC and 8ºC. Once the container has been opened it should be kept in the same conditions indicated. Nature and contents of container. PEITEL® ointment, cream, unguent: Aluminium tubes containing 30 g and 60 g; PEITEL® solution and solution with applicator: bottle with 60 ml of solution and applicator. Instructions for use/handling. To use PEITEL® solution with applicator, if applying to large skin areas, the patient should remove the threaded stopper and replace it with the applicator supplied in the box which acts as a closure. The patient should unlock the safety closure by turning the head of the applicator and pressing the sides of the bottle -not the applicator – to obtain a foam-like solution; once used, close the applicator head again.

Not all dosage forms are available.