Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Prednisolone sodium phosphate
Bausch + Lomb Ireland Limited
S01BA; S01BA04
Prednisolone sodium phosphate
Eye drops, solution
Corticosteroids, plain; prednisolone
Marketed
1982-02-18
BAUSCH & LOMB MINIMS® PREDNISOLONE SODIUM PHOSPHATE 0.5%W/V EYE DROPS, SOLUTION PREDNISOLONE SODIUM PHOSPHATE 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. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Minims® Prednisolone Sodium Phosphate eye drops are and what they are used for 2. What you need to know before you use your eye drops 3. How to use your eye drops 4. Possible side effects 5. How to store your eye drops 6. Contents of the pack and other information 1. WHAT MINIMS® PREDNISOLONE SODIUM PHOSPHATE EYE DROPS ARE AND WHAT ARE THEY USED FOR Minims® Prednisolone Sodium Phosphate contains a corticosteroid. It is used to treat inflamed eyes (red and painful) for which the inflammation is not caused by an infection. The part of the eye affected will vary depending on the cause of the inflammation. Your doctor may sometimes prescribe other drugs at the same time to make sure that the inflammation is treated effectively. This medicine is indicated for children, adults and the elderly. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS IF: • you are allergic to the active substance (prednisolone) or any of the other ingredients of this medicine (listed in section 6). • you have high pressure inside the eye or you are at risk of developing glaucoma. Your doctor will have checked for this. • you have an eye infection. • it is intended for long term continuous therapy in children (at the discretion of the physician). WARNING AND PRECAUTIONS Contact your doctor if you experience blurred vision or Baca dokumen lengkap
Health Products Regulatory Authority 03 June 2022 CRN00CTY6 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prednisolone sodium phosphate 0.5 % w/v. Excipients with known effect Sodium dihydrogen phosphate dihydrate (0.07 mg phosphates in each drop equivalent to 1.83mg/ml) For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless, aqueous, single-use eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-infected inflammatory conditions of the eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and the elderly_ One or two drops applied topically to the eye as required. _Paediatric population_ At the discretion of the physician. 4.3 CONTRAINDICATIONS Use of this medicine is contraindicated in patients with a known hypersensitivity to the active ingredient. Use is also contraindicated in viral, fungal, tuberculosis and other bacterial infections. Prolonged application to the eye of preparations containing corticosteroids has caused increased intra-ocular pressure and, therefore, the drops should not be used in patients with glaucoma. In children, long-term, continuous topical corticosteroid therapy should be avoided due to possible adrenal suppression. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken to ensure that the eye is not infected before Minims Prednisolone is used. Topical corticosteroids should not be used for longer than one week, except under ophthalmic supervision with regular checks of intra-ocular pressure. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children). Health Products Regulatory Authority 03 June 2022 CRN00 Baca dokumen lengkap