البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
IPRATROPIUM BROMIDE; XYLOMETAZOLINE HYDROCHLORIDE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
R01AX03
NASAL SPRAY, SOLUTION
IPRATROPIUM BROMIDE 0.6 MG/ML; XYLOMETAZOLINE HYDROCHLORIDE 0.5 MG/ML
NASAL
Not required
NOVARTIS CONSUMER HEALTH SA, SWITZERLAND
IPRATROPIUM BROMIDE
Symptomatic treatment of nasal congestion and rhinorrhea in connection with common cold in adults.
2017-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor’s prescription OTRIVIN COMPLETE 0.05% W/V + 0.06% W/V METERED DOSE NASAL SPRAY Ipratropium Bromide 0.06% w/v Xylometazoline Hydrochloride 0.05% w/v Inactive ingredients and allergens in the medicine – see section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. Use the medicine according to the instructions in the section “How should you use the medicine?” in this leaflet. Consult the pharmacist if you need more information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Treatment of symptoms of nasal congestion and rhinitis associated with the common cold in adults. THERAPEUTIC CLASS: Ipratropium bromide, an anticholinergic agent, which helps in case of rhinitis. Xylometazoline hydrochloride, a sympathomimetic agent, which has a decongesting effect. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are a child or are treating a child under the age of 18, as no information is available regarding its safety and efficacy. You are sensitive (allergic) to the active ingredients (ipratropium bromide, xylometazoline hydrochloride) or to any of the other components the medicine contains (see section 6). There is a known sensitivity to atropine or to similar agents, such as hyoscyamine and scopolamine. You have undergone surgery in which the hard external membrane in the central nervous system (dura mater) was penetrated, e.g., surgery to remove your pituitary gland (hypophysis) through the nose, or other surgery carried out through the nose. You have glaucoma (increased pressure in the eye). You have a very dry nose (inflammatory nasal dryness, rhinitis sicca or atrophic rhinitis). SPECIAL WARNINGS REGARDING THE USE اقرأ الوثيقة كاملة
OTRIVIN COMPLETE 1. NAME OF THE MEDICINAL PRODUCT Otrivin Complete 0.05 % w/v + 0. 0 6% w/v nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IPRATROPIUM BROMIDE 0.06% w/v XYLOMETAZOLINE HYDROCHLORIDE 0.05% w/v 1 puff approx. 140 microliters contains 70 micrograms xylometazoline hydrochloride and 84 micrograms ipratropium bromide. For the full list of excipients see 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution The product is a clear, colorless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of nasal congestion and rhinorrhea in connection with common cold in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ 1 puff in each nostril up to 3 times daily. At least 6 hours should elapse between two doses. The treatment duration should not exceed 7 days (see section 4.4) Do not exceed the stated dose. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. It is recommended to stop treatment, when the symptoms have diminished, even before the maximum duration of treatment of 7 days, in order to minimize the risk of adverse reactions (see section 4.8). _Paediatric population: _ Otrivin Complete is not recommended for use in children and adolescents below 18 years of age due to lack of sufficient documentation. _ _ _Geriatrics_ There is only limited experience of use in patients above 70 years of age. Method of administration Two fingers vertically actuated pump: Before the first application, prime the pump by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. 1. Clear the nose. 2. Hold the bottle upright with thumb under base and nozzle between two fingers. 3. Lean forward slightly and insert the nozzle into a nostril. 4. Spray and breathe in gently through the nose at the same time. 5. Repeat this procedure in the other nostril. 6. Clean and dry the nozzle before replacing back the cap right after use. Should the spray not be ejected during اقرأ الوثيقة كاملة