Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride
KRKA, d.d., Novo mesto
R02AA; R02AA20
BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride
1.5 mg/ml+5.0 milligram(s)/millilitre
Oromucosal spray, solution
oromucosal use
30 ml
Product not subject to medical prescription
KRKA, d.d.
throat preparations, antiseptics
Antiseptics; various
It is indicated in adults and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis and before and after tooth extractions
Not marketed
2015-07-10
1.3.1 Benzydamine hydrochloride + Cetylpyridinium chloride IE SPC, Labeling and Package Leaflet oromucosal spray 1.5 + 5.0 mg + mg_ml SmPCPIL158970_1 19.10.2020 – Updated: 19.10.2020 Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER SEPTABENE 1.5 MG/ML + 5.0 MG/ML OROMUCOSAL SPRAY, SOLUTION benzydamine hydrochloride/cetylpyridinium chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Septabene is and what it is used for 2. What you need to know before you use Septabene 3. How to use Septabene 4. Possible side effects 5. How to store Septabene 6. Contents of the pack and other information 1. WHAT SEPTABENE IS AND WHAT IT IS USED FOR Septabene oromucosal spray, solution is anti-inflammatory, analgesic and antiseptic medicine for local oral use. Oromucosal spray disinfects the mouth and throat and reduces signs of inflammation of throat such as pain, redness, swelling, heat and impaired function. Septabene is used in the anti-inflammatory, analgesic and antiseptic treatment: - of irritations in the throat, mouth and gums, - in gingivitis and pharyngitis and - before and after tooth extractions. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SEPTABENE DO NOT USE SEPTABENE - if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6). - this medicine should not be used in children aged un Lestu allt skjalið
Health Products Regulatory Authority 15 March 2021 CRN0099HM Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Septabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oromucosal spray, solution contains 1.5 mg benzydamine hydrochloride and 5 mg cetylpyridinium chloride. One actuation contains 0.1 ml of oromucosal spray, solution, containing 0.15 mg benzydamine hydrochloride and 0.5 mg cetylpyridinium chloride. Excipient(s) with known effect: ethanol: 267.60 mg/ml (26.76 mg/one actuation) macrogolglycerol hydroxystearate: 2.5 mg/ml (0.25 mg/one actuation) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution (oromucosal spray) Clear, colourless to yellowish liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Septabene oromucosal spray, solution is indicated in adults, adolescents and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis and pharyngitis and before and after tooth extractions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS: For a single dose, the spray head should be pressed once to twice. This may be repeated every 2 hours, 3-5 times a day. For optimal effect, it is not recommended to use the product immediately before or after cleaning teeth. The stated dose should not be exceeded. Septabene can be used for up to 7 days. Elderly patients The recommended dose is the same as for adults. _Paediatric population_ ADOLESCENTS OVER 12 YEARS OF AGE: For a single dose, the spray head should be pressed once to twice. This may be repeated every 2 hours, 3-5 times a day. CHILDREN FROM 6 TO 12 YEARS OF AGE: For a single dose, the spray head should be pressed once. This may be repeated every 2 hours, 3-5 times a day. Septabene is contraindicated in children under 6 years of age. Health Products Regulatory Authority 15 March 2021 CRN0099HM Page 2 of 6 METHOD OF ADMIN Lestu allt skjalið