Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Neomycin sulfate; BETAMETHASONE SODIUM PHOSPHATE
RPH Pharmaceuticals AB
S03CA; S03CA06
Neomycin sulfate; BETAMETHASONE SODIUM PHOSPHATE
0.1% w/v 3500 international unit(s)/millilitre
Ear/eye/nasal drops, solution
Product subject to prescription which may not be renewed (A)
Corticosteroids and antiinfectives in combination; betamethasone and antiinfectives
Marketed
1993-08-13
PATIENT INFORMATION LEAFLET: BETNESOL-N 0.1% W/V, 3500 IU/ML EYE, EAR AND NASAL DROPS, SOLUTION. BETAMETHASONE SODIUM PHOSPHATE AND NEOMYCIN SULPHATE. BETNESOL-N 0.1% W/V, 3500 IU/ML EYE, EAR AND NASAL DROPS, SOLUTION. BETAMETHASONE SODIUM PHOSPHATE AND NEOMYCIN SULPHATE. 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. • In this leaflet, Betnesol-N Eye, Ear & Nose Drops will be called Betnesol-N Drops. WHAT IS IN THIS LEAFLET: 1. What Betnesol-N Drops is and what it is used for 2. What you need to know before you use Betnesol-N Drops 3. How to use Betnesol-N Drops 4. Possible side effects 5. How to store Betnesol-N Drops 6. Contents of the pack and other information. 1. WHAT BETNESOL-N DROPS IS AND WHAT IT IS USED FOR Betnesol-N Drops belongs to a group of medicines called topical corticosteroids (‘steroids’ for short). Betnesol-N Drops work by reducing inflammation (redness, itching and soreness). Topical means that they are used on the outside of the body and not taken by mouth or injection. Betnesol-N Drops also contain neomycin sulphate, an aminoglycoside antibiotic, which prevents bacterial infection developing. Betnesol-N Drops is used to treat inflammation of the eye, ear or nose when there may also be a risk of bacterial infection. It is important to use this medicine to prevent any damage to the delicate tissues of your eyes, ear or nose and to prevent any infection developing. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETNESOL-N DROPS IMPORTANT: NEVER USE THIS MEDICINE IN YOUR EYE WITHOUT FIRST CHECKING WITH YOUR DOCTOR. IF IT IS USED FOR THE WRONG CONDITION, IT COULD LEAD TO BLINDNESS. DO NOT USE BETNESOL-N DROPS IF: • You are allergic to betamethason Прочетете целия документ
Health Products Regulatory Authority 27 January 2021 CRN00C33W Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 0.1% w/v betamethasone sodium phosphate and 3500 IU/ml Neomycin sulphate. Excipients with known effect Benzalkonium chloride – 0.01% w/v Disodium Phosphate Anhydrous – 0.2% w/v Sodium Dihydrogen Phosphate Dihydrate – 0.03% w/v For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye, ear and nasal drops, solution (ear, eye and nasal drops) A colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eye Short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease. Ear Otitis externa or other steroid responsive conditions where prophylactic antibiotic treatment is also required. Nose Steroid responsive inflammatory conditions where prophylactic antibiotic treatment is also required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. Normally, Betnesol-N Drops should not be given for more than 7 days, unless under expert supervision. After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse. Eyes 1 or 2 drops applied to each affected eye up to six times daily depending on clinical response. Ears 2 or 3 drops instilled into the ear three or four times daily. Nose 2 or 3 drops instilled into each nostril two or three times daily. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 27 January 2021 CRN00C33W Page 2 of 5 Viral, fungal, tuberculous or purulent conditions of the eye. Fungal infections of the nose Прочетете целия документ