País: Israel
Idioma: anglès
Font: Ministry of Health
CHLORHEXIDINE DIHYDROCHLORIDE; DEXPANTHENOL
BAYER ISRAEL LTD
D08AC52
CREAM
DEXPANTHENOL 5 %; CHLORHEXIDINE DIHYDROCHLORIDE 0.5 %
TOPICAL
Not required
GP GRENZACH PRODUKTIONS GMBH, GERMANY
CHLORHEXIDINE, COMBINATIONS
CHLORHEXIDINE, COMBINATIONS
Antiseptic healing treatment of wounds of any kind with an infection risk : such as slight skin irritations, wounds, cuts, burns and skin inflammation.
2015-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription. BEPANTHEN ® PLUS Cream ACTIVE INGREDIENTS: Each gram contains: Dexpanthenol 50 mg Chlorhexidine dihydrochloride 5 mg FOR A LIST OF THE INACTIVE INGREDIENTS AND ALLERGENS, SEE SECTION 6 ‘ADDITIONAL INFORMATION’ AND SECTION 2 ‘IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Use this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Consult a doctor if your symptoms of illness get worse or do not improve within 10-14 days. 1. WHAT IS THIS MEDICINE INTENDED FOR? Antiseptic healing treatment of wounds with an infection risk such as slight skin irritations, wounds, cuts, mild burns and skin inflammation. THERAPEUTIC GROUP: Dexpanthenol - provitamin B5 Chlorhexidine dihydrochloride - antiseptic Bepanthen ® Plus contains chlorhexidine which fights the bacteria on the skin or which get into the wound with dirt, and by doing so prevents or moderates bacterial infection in wounds. The medicine also contains dexpanthenol, which is converted in the skin into the vitamin pantothenic acid which supports the accelerated regeneration of skin cells from within, causing the wound to heal more quickly. Furthermore, the newly formed skin is more elastic. The cream is easy to apply and wash off and is not greasy or sticky. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to dexpanthenol, chlorhexidine dihydrochloride or to any of the other ingredients in this medicine. • Do not apply this preparation to a perforated eardrum. • Do not use Bepanthen ® Plus on deep, serious or infected wounds. Such wounds will be treated by a do Llegiu el document complet
1 NAME OF THE MEDICINAL PRODUCT Bepanthen Plus. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: 1 g cream contains 50 mg dexpanthenol and 5 mg chlorhexidine dihydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic healing treatment of wounds of any kind with an infection risk, such as slight skin irritations, wounds, cuts, burns and skin inflammation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a thin layer of cream on the affected area(s) up to 4 times daily. The wound may either be left uncovered or bandaged. Application to larger areas of skin should be avoided. In the case of inflamed nipples during lactation: any cream adhering to the nipples should always be carefully and completely off before the baby is fed. 4.3 CONTRAINDICATIONS Bepanthen Plus must not be used in patients with known hypersensitivity to the active substances or to any of the excipients listed in section 6.1. In addition, chlorhexidine must not be used on a perforated eardrum. Bepanthen Plus is not to be used for wounds that are deep, serious or infected. Such wounds are to be treated by a doctor. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid letting Bepanthen Plus come into contact with the eyes, ears or mucous membranes. Bepanthen Plus should not be used for the treatment of irritated skin that is not specifically susceptible to infection (e.g. sunburn). Use of a medication without a disinfectant is recommended for this purpose. If symptoms do not improve after 10 – 14 days or get worse, patients should be told to contact a doctor. Prescribing doctors should inform their patients about early and mild/moderate symptoms of an allergic reaction with the corresponding clinical manifestations, including mild to moderate reactions of the skin (e.g. pruritus, urticaria), the face (e.g. angioedema), the respiratory tract (e.g. asthma, wheezing or other breathing problems), the gastrointestinal tract and the cardiovascular Llegiu el document complet