Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
DOCUSATE SODIUM
Meda Health Sales Ireland Limited
A06AA02
DOCUSATE SODIUM
0.5 %w/v
Ear Drops Solution
Product not subject to medical prescription
docusate sodium
Marketed
2011-05-03
PACKAGE LEAFLET: INFORMATION FOR THE USER 0.5% W/V EAR DROPS SOLUTION Docusate Sodium READ ALL OF THIS LEAFLET CARE- FULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFOR - MATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further ques - tions, ask your doctor or pharmacist. • This medicine has been pre - scribed for you. 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 phar - macist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. What WAXSOL is and what it is used for 2. What you need to know before you use Waxsol 3. How to use WAXSOL 4. Possible side effects 5. How to store WAXSOL 6. Contents of the pack and other information 1. WHAT WAXSOL IS AND WHAT IT IS USED FOR WAXSOL is used to help remove ear wax in adults, the elderly and children. The drops help to clear your ear canal if it is blocked with wax by soften - ing it and breaking it up. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE WAXSOL DO NOT USE WAXSOL: • If you are allergic (hypersen - sitive) to docusate sodium or any of the other ingredients of WAXSOL. • if you have a perforated (burst) ear drum • if your ear is sore inside WARNINGS AND PRECAUTIONS Talk to your doctor or pharma - cist before using WAXSOL. • If pain or inflammation is ex - perienced treatment should be discontinued • As WAXSOL contains par - ahydroxybenzoates, allergic reactions (possibly delayed) may be experienced. OTHER MEDICINES AND WAXSOL Please tell your doctor or phar - macist if you are taking or have recently taken any other medi - cines, including medicines ob- tained without a prescription. PREGNANCY AND BREAST-FEED- ING Ask your doctor or pharmacist for advice before taking this medicine • WAXSOL can be used if you are pregnant or thinking of becoming pregnant • Waxsol can be used if you are breastfeeding DRIVING AND USING MACHINES WAXSOL should not a Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT WAXSOL 0.5% w/v Ear Drops Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION WAXSOL Ear Drops contain the following active ingredient: Docusate Sodium 0.5% w/v. Excipients: Contains parahydroxybenzoates max 0.6% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, solution (Ear Drops) A clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS WAXSOL Ear Drops are indicated as an aid in the removal of ear wax. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended dose and dosage schedules: _ADULTS (INCLUDING THE ELDERLY):_ The application of ear drops sufficient to fill the affected ear on not more than two consecutive nights, prior to attending syringing if this is necessary. If the problem persists patients should consult their doctor. _CHILDREN:_ (6 – 12 years): As for adult dose. 4.3 CONTRAINDICATIONS Perforation of the ear drum or inflammation of the ear. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If pain or inflammation is experienced, treatment should be discontinued. As WAXSOL contains parahydroxybenzoates, allergic reactions (possibly delayed) may be experienced. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _2_ _8_ _8_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 FERTILITY, P Läs hela dokumentet