Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
CLOTRIMAZOLE; DEXAMETHASONE ACETATE; NEOMYCIN SULFATE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC20
CREAM
CLOTRIMAZOLE 1 %; NEOMYCIN SULFATE 0.645 %; DEXAMETHASONE ACETATE 0.044 %
TOPICAL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
COMBINATIONS
COMBINATIONS
Treatment of dermatitis involving also a bacterial and/or fungal infection.
2020-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only POLYCUTAN ® Cream Active ingredients and quantities per dosage unit: Each tube contains: Clotrimazole 1% Neomycin sulfate 0.645% Dexamethasone acetate 0.044% Inactive and allergenic ingredients in the preparation – see section 6 of the leaflet. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of dermatitis also involving a bacterial and/or fungal infection. Therapeutic group Clotrimazole – a topical imidazole antifungal Neomycin sulfate – an aminoglycoside antibiotic Dexamethasone acetate – a corticosteroid 2. BEFORE USING THE MEDICINE Do not use the medicine: • If you are sensitive )allergic( to the active ingredients or to any of the additional ingredients contained in the medicine, including cetostearyl alcohol. • If you have a known sensitivity to any other medicines from the aminoglycoside group. • If you are suffering from herpes simplex or chickenpox. • As with any other medicines for external use containing neomycin, do not use this medicine for external ear inflammation if you have a perforated ear drum. • Do not use on the scalp. Special warnings regarding use of the medicine • Before treatment with Polycutan, tell the doctor if: - You are pregnant or breastfeeding - You are suffering or have suffered in the past from an impaired immune system function - You are suffering or have suffered in the past from diabetes - You are suffering or have suffered in the past from kidney problems - You are suffering or have suffered in the past from dizziness - You are suffering or have Izlasiet visu dokumentu
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Polycutan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% Neomycin sulfate 0.645% Dexamethasone acetate 0.044% Excipients with known effect: Polycutan contains Cetostearyl alcohol and Benzyl alcohol. For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Dermal white cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of dermatitis involving also a bacterial and/or fungal infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Polycutan is for external topical use only. Apply a thin layer of the cream twice daily (morning and evening) on the affected area and massage into the skin. If there is no improvement within a few days or if there is worsening, the condition should be assessed. ELDERLY (OVER 65 YEARS): For Corticosteroids Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. PEDIATRICS For Corticosteroids Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients, because of a larger skin surface area to body weight ratio. Therefore, application of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Topical corticosteroids are contraindicated in tuberculosis of the skin, varicella and herpes simplex. - The cream should not be applied in the external auditory canal of patients with perforated eardrum. - Do not use the cream to treat scalp infections 4.4 Izlasiet visu dokumentu