Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
DEXAMETHASONE
Novartis Pharmaceuticals UK Ltd
S01BA01
DEXAMETHASONE
0.1 %w/w
Eye Ointment
Product subject to prescription which may be renewed (B)
Corticosteroids, plain
Authorised
2017-05-05
1 PACKAGE LEAFLET - INFORMATION FOR THE USER MAXIDEX ® 0.1 % W / W EYE OINTMENT DEXAMETHASONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE KEEP THIS LEAFLET. You may need to read it again. IF YOU HAVE ANY FURTHER QUESTIONS, ask your doctor or your pharmacist. This medicine has been prescribed for you. DO NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. IF ANY OF THE SIDE EFFECTS GET SERIOUS, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. WHAT MAXIDEX IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE MAXIDEX 3. HOW TO USE MAXIDEX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MAXIDEX 6. FURTHER INFORMATION 1. WHAT MAXIDEX IS AND WHAT IT IS USED FOR MAXIDEX belongs to a group of medicines called corticosteroids. IT IS USED TO TREAT allergy and inflammation of the eye. It helps to relieve the symptoms of allergy and inflammation such as redness, soreness and swelling. 2. BEFORE YOU USE MAXIDEX DO NOT USE MAXIDEX... If you think that you have any type of infection, including viral, fungal, untreated parasitic eye infections and tuberculosis of the eye. If you are ALLERGIC to dexamethasone or any of the other ingredients listed in section 6. If any of these apply, ask your doctor for advice. TAKE SPECIAL CARE... Only use MAXIDEX in your eye (s). MAXIDEX is not recommended for use IN CHILDREN UNDER 2 YEARS . MAXIDEX should not be used for MORE THAN ONE WEEK , unless advised by your doctor. Use of MAXIDEX FOR LONG PERIODS OF TIME , may cause: o INCREASED PRESSURE in your eye(s). If you already have high pressure in your eye(s) or an eye disease such as GLAUCOMA . You should have your eye pressure checked regularly while using MAXIDEX. Ask your doctor for advice. This is especially important in paediatric patients, as the risk of corticosteroid-induced increased pressure in the eye may be greater in children and may occur earlier than in adults. The ris Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxidex 0.1% w/w Eye Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1g of ointment contains 1mg dexamethasone Excipients: Also contains Methyl parahydroxybenzoate (E218) 0.05% w/w Propyl parahydroxybenzoate (E216) 0.01% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye ointment A colourless to pale straw coloured slightly transparent ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for the treatment of allergic and inflammatory conditions of the eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, adolescents and children (2 years of age and above) Apply a small amount into the conjunctival sac 3-4 times daily for 3-4 days or until a satisfactory response occurs. Method of Administration For ocular use only. Do not let the tip of the tube touch the eye. Paediatric patients The safety of this product has not been established in children below 2 years of age Elderly population No overall differences in safety or effectiveness have been observed between elderly and younger patients. Hepatic and renal impairment The safety and efficacy of MAXIDEX in patients with hepatic or renal impairment have not been established. 4.3 CONTRAINDICATIONS Ocular viral infections such as vaccinia, varicella Herpes simplex keratitis. Fungal disease of ocular structures or untreated parasitic eye infections and mycobacterial ocular infections. Acute, untreated bacterial infections. Hypersensitivity to dexamethasone or to any of the excipients listed in section 6.1. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Przeczytaj cały dokument