Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Docusate sodium
HOE PHARMACEUTICALS SDN. BHD.
Docusate sodium
10ml mL; 100ml mL
HOE PHARMACEUTICALS SDN. BHD.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SOLUWAX EAR DROPS Docusate Sodium (0.5% w/v) 1 WHAT IS IN THIS LEAFLET? 1. What SOLUWAX EAR DROPS is used for? 2. How SOLUWAX EAR DROPS works? 3. Before you use SOLUWAX EAR DROPS 4. How to use SOLUWAX EAR DROPS 5. While you are using SOLUWAX EAR DROPS 6. Side effects 7. Storage and Disposal of SOLUWAX EAR DROPS 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision This leaflet answers some common questions about _ _ SOLUWAX EAR DROPS. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking SOLUWAX EAR DROPS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SOLUWAX EAR DROPS IS USED FOR? SOLUWAX EAR DROPS is used to easily disperse and remove excessive amounts of hardened ear wax. HOW SOLUWAX EAR DROPS WORKS? SOLUWAX EAR DROPS contains the active ingredient Docusate Sodium 0.5% w/v. Docusate Sodium is an anionic surface acting agent and thus penetrates into thick wax to soften and facilitates easy removal of ear wax. Ask your pharmacist or doctor if you have any questions about this medicine. BEFORE YOU USE SOLUWAX EAR DROPS _ _ _When you must not use it _ Do not use SOLUWAX EAR DROPS if: • You are allergic (hypersensitive) to Docusate Sodium or to any of the other ingredients in this medicine. • Your ear drum has been perforated or experienced pain. _Before you start to use it _ Tell your pharmacist or doctor if: • If you are allergic (hypersensitive) to Docusate Sodium or to any of the other ingredients in this medicine. • If your ear drum has been perforated or experienced pain. Pregnancy and breast feeding: • Docusate Sodium is absorbed from the gastro-intestinal tract after oral administrati Прочитајте комплетан документ
SOLUWAX EAR DROPS DOCUSATE SODIUM 0.5% W/V EAR DROPS Est. 1979 DESCRIPTION : A clear solution with characteristic odour. PHARMACODYNAMICS : Docusate sodium is an anionic surface acting agent and thus penetrates into thick wax to soften and facilitate easy removal of ear wax. PHARMACOKINETICS : Docusate sodium is absorbed from the gastro-intestinal tract after oral administration and there is significant biliary excretion. It is also excreted in breast milk. INDICATION : For softening wax in the ear. CONTRAINDICATION : Do not use this preparation in patients with known hypersensitivity to Docusate sodium. Docusate sodium must not be used if the ear drum has been perforated. Discontinue use if any pain is experienced. SIDE EFFECT/ADVERSE REACTION : Cramping pains have been reported occasionally and liquid preparation sometimes causes nausea. Docusate sodium increases the intestinal absorption of other concomitantly administered drugs. PRECAUTION/WARNING : Do not use this preparation if the ear drum is perforated. Discontinue use if irritation of ear develops or persists. RECOMMENDED DOSAGE : With the head tilted, fill the affected ear with sufficient SOLUWAX Ear Drops (approx. 10 drops) for two consecutive nights. Remain in this position for 4 to 5 minutes. The ear wax should then be easily removed by normal cleansing. If the ear wax is unusually hard or if symptoms persist, consult your doctor or pharmacist. ROUTE OF ADMINISTRATION : Auricular (otic). SYMPTOMS AND TREATMENT FOR OVERDOSE : Treatment after accidental consumption is purely symptomatic. Pain relieve in cramping pain and antinauseant for treatment of nausea. PACKING : Amber glass bottles of 10ml (with dropper) and 100ml. STORAGE : For external use only. Keep container well closed. Protect from light. Store below 30°C. Keep out of reach of children. Recommended shelf-life : 18 months. MANUFACTURED BY : HOE Pharmaceuticals Sdn. Bhd. Lot 10, Jalan Sultan Mohamed 6, Bandar Sultan Suleiman, 42000 Port Klang, Selangor, MALAYSIA. Revision date : August 2022 Прочитајте комплетан документ