Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ephedrine hydrochloride
The Boots Company Plc
R01AA03
Ephedrine hydrochloride
10mg/1ml
Nasal drops
Nasal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12020200
FRONT FACE TOP REVERSE FACE TOP _Data Matrix:_ 22562009 VERIFIED PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 557112 11911 Addition of reporting of side effects statement PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 557112 11911 Addition of reporting of side effects statement MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 10ml 22562009 210 x 148mm flat (27 x 148mm folded) 2 05.02.2015 Process Black Keyline (Does not print) Ephedrine Nasal Drops 1% w/v Helvetica EPHEDRINE NASAL DROPS 1% W/V (ephedrine hydrochloride) IMPORTANT INFORMATION ABOUT EPHEDRINE NASAL DROPS • This medicine relieves nasal congestion in adults and children over 12 years old. DO NOT USE…. • For anyone under 12 years old. • For longer than 7 days. TALK TO YOUR DOCTOR…. • If your congestion has not cleared up after 7 days. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. WHAT THE MEDICINE IS FOR Ephedrine Nasal Drops belong to a group of medicines known as nasal decongestants. They act to relieve congestion by constricting blood vessels in the nose. 2. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU HAVE…. • Taken MAOIS (MONOAMINE OXIDASE INHIBITORS) for depression in the last two weeks. • Taken BETA-BLOCKERS for your HEART OR BLOOD PRESSURE. • AN ALLERGY to any of the ingredients listed in section 6. • A HEART CONDITION, HIGH BLOOD PRESSURE or POOR CIRCULATION. • An OVERACTIVE THYROID GLA Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ephedrine Nasal Drops 1.0% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ephedrine Hydrochloride BP 1.0% W/V 3. PHARMACEUTICAL FORM Nasal Drops. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of nasal congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nasal, by application to the mucous membranes. RECOMMENDED DOSE Instil one or two drops into each nostril. DOSAGE SCHEDULE As required, but not more than 4 times a day. The above dose and schedule are recommended for adults, the elderly and children over 12 years. 4.3. CONTRA-INDICATIONS Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors, or within two weeks of stopping such treatment (see section 4.5). Ephedrine should not be taken with beta-blockers (see section 4.5) It should be used with caution in patients receiving halogenated anaesthetics. Ephedrine nasal drops should not be used concomitantly with other sympathomimetic decongestants. It should also be avoided in patients with cardiovascular disease, cardiac arrhythmias, cardiomyopathy and peripheral vascular disease,_ _hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed-angle glaucoma and urinary retention. Ephedrine nasal drops should not be used after nasal or sinus surgery. Excessive and/or frequent use of a nasal decongestant should be avoided. Children under 12 years of age. Hypersensitivity to ephedrine or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Store below 25°C. Do not allow to freeze. Keep all medicines away from children. Warning: asthmatics should consult their doctor before using this product. Ephedrine should be used with care in the elderly and in patients with prostatic hypertrophy, diabetes mellitus or renal impairment. The product should not be used for longer than 7 days. Avoid contamination during use. Keep away from eyes. 10ml pack label states: do not share the drops with anyone. 10ml pack states: di Przeczytaj cały dokument