Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Oxymetazoline Hydrochloride
BAYER CO. (MALAYSIA) SDN. BHD.
Oxymetazoline Hydrochloride
20 ml; 15 ml
Delpharm Montreal Inc.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CLARICLEAR _® _ Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%w/v 1 WHAT IS IN THIS LEAFLET 1. What _CLARICLEAR _ is used for 2. How _CLARICLEAR _ works 3. Before you use _CLARICLEAR_ 4. How to use _CLARICLEAR_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _CLARICLEAR_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _CLARICLEAR _IS USED FOR _CLARICLEAR _ is indicated for the symptomatic relief of nasal and nasopharyngeal congestion due to the common cold, sinusitis, hay fever or other upper respiratory allergies. HOW _CLARICLEAR _WORKS _CLARICLEAR _ contains the active substance oxymetazoline hydrochloride. It constricts the arteriolar network within the nasal mucosa producing a prolonged decongestant effect. BEFORE YOU USE _CLARICLEAR _ - _When you must not use it_ • If you are allergic to any of the ingredients • If you have heart or blood vessel disease • If you have an overactive thyroid • If you are a man with prostate problems - _Before you start to use it_ Talk to your doctor or pharmacist before taking _CLARICLEAR_ Do not exceed the recommended dosage and it may cause rebound congestion if used for longer than three days. - _Taking other medicines_ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you are taking: • Medicines for depression (e.g. tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors) HOW TO USE _CLARICLEAR _ Check the seal is not broken before first use. If it is, do not use the medicine. - _How much to use_ For adults and children six years of age and older: two or three sprays into each nostril. - _When to use it_ Twice daily, morning and evening - _How long to use it_ Do not use it more than 3 days unless your doctor tells you to. - _If you forget to use it_ Use it as soon as you remember, unless is very near to the next dose. Baca dokumen lengkapnya
44 mm 180 mm 17,5 mm 238 mm 52,5 mm Inside margins 5 mm 16/08/19 NPI017289 31000425 86984636 A TR1659161 Philip Ives G=1; O=0; R=0; - PI - 16/08/19 13:36:04 N/A N/A 1011101(220) N/A N/A Famar Montreal (ex Bayer Pointe Claire) [CA] CCL Montréal White Paper 1 DIG Process Black Colours DESCRIPTION: Each ml of AFRIN Nasal Spray contains 0.5mg (0.05%) oxymetazoline hydrochloride. Benzalkonium chloride is used as preservative. Other inactive ingredients include sodium hydroxide, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol, hydrochloric acid and purified water. Appearance: Clear, colourless solution with a slight odour, free from foreign matter. ACTIONS: The sympathomimetic action of oxymetazoline hydrochloride constricts the arteriolar network within the nasal mucosa producing a prolonged decongestant effect. PHARMACODYNAMIC PROPERTIES: Oxymetazoline hydrochloride is a sympathomimetic agent with exerts a local vasoconstriction action in the nasal mucosa, reducing nasal congestion. Clinical studies have shown that oxymetazoline acts within a few minutes and its effect can last up to 12 hours following treatment. INDICATION AND USAGE: AFRIN Nasal Spray 0.05% is indicated for the symptomatic relief of nasal and nasopharyngeal congestion due to the common cold, sinusitis, hay fever or other upper respiratory allergies. It is also recommended for office use on a nasal tampon to facilitate intranasal examination or before nasal surgery. DOSAGE AND ADMINISTRATION: FOR ADULTS AND CHILDREN SIX YEARS OF AGE AND OLDER: AFRIN Nasal Spray 0.05% - Two or three sprays into each nostril twice daily, morning and evening. With the head upright, place the spray nozzle into the nostril without completely occluding the nostril. During each administration, the patient should bend his head slightly forward and squeeze bottle quickly and firmly to spray the recommended number of sprays in each nostril. DRUG INTERACTIONS: If significant systemic absorption of oxymetazoline occurs, concomitant use of tricyclic ant Baca dokumen lengkapnya