Nazione: Malta
Lingua: inglese
Fonte: Malta Medicines Authority
XYLOMETAZOLINE HYDROCHLORIDE, IPRATROPIUM BROMIDE
Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece
R01AB06
IPRATROPIUM BROMIDE 0.6 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml
NASAL SPRAY, SOLUTION
IPRATROPIUM BROMIDE 0.6 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml
POM
NASAL PREPARATIONS
Authorised
2013-02-13
PACKAGE LEAFLET: INFORMATION FOR THE USER Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml nasal spray, solution Xylometazoline hydrochloride/Ipratropium bromide _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET 1. What Otrivine Extra Dual Relief is and what it is used for 2. What you need to know before you use Otrivine Extra Dual Relief 3. How to use Otrivine Extra Dual Relief 4. Possible side effects 5 How to store Otrivine Extra Dual Relief 6. Contents of the pack and other information 1. WHAT OTRIVINE EXTRA DUAL RELIEF IS AND WHAT IT IS USED FOR Otrivine Extra Dual Relief is a combination medicinal product consisting of two different substances. One of the active ingredients helps against runny nose, the other has a decongesting effect. Otrivine Extra Dual Relief is used for the treatment of nasal congestion with runny nose (rhinorrhea) in connection with common colds. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE EXTRA DUAL RELIEF DO NOT USE OTRIVINE EXTRA DUAL RELIEF - In children below 18 years of age, as adequate information on safety and efficacy is not available - If you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6) - If you are allergic to atropine or atropine like substances such as hyoscyamine and scopolamine - If you had your pituitary gland removed by surgery carried out through the nose - If you have had brain surgery where the operation was carried out through the nose or mouth - If you suf Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratropium bromide. 1 puff ( approx. 140 microliters ) contains 70 micrograms xylometazoline hydrochloride and 84 micrograms ipratropium bromide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of nasal congestion and rhinorrhea in connection with common colds. 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. Do not exceed 3 applications daily into each nostril. 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_ Otrivine Extra Dual Relief 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 nozzl Leggi il documento completo