Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone sodium phosphate
Special Order
Prednisolone sodium phosphate
5mg/1ml
Drops
No Controlled Drug Status
Valid as a prescribable product
BNF:
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. The name of your medicine is Minims prednisolone sodium phosphate 0.5% w/v eye drops, solution but it will be referred to as Minims throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Minims is and what it is 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 IS AND WHAT IT IS USED FOR Minims 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 exper Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prednisolone Sodium Phosphate 0.5% w/v For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye and ear drops, solution Sterilised clear and colourless aqueous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prednisolone Sodium Phosphate Drops is indicated for short term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections and Non-infected inflammatory conditions of the ear. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children (including the Elderly) _Eyes _ 1 or 2 drops instilled into the eyes every one or two hours until control is achieved, when the frequency may be reduced. _Ears _ 2 or 3 drops instilled into the ear every two or three hours until control is achieved, when the frequency can be reduced. Frequency of dosing depends on clinical response. If there is no clinical response within 7 days treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bacterial, viral, fungal tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to the extension of the ulcer and marked visual deterioration. In the ear, topical corticosteroids are contraindicated in patients with fungal diseases of the auricular structure, and in those with a perforated tympanic membrane. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Topical corticosteroids should never be given for an un Prečítajte si celý dokument