Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
emedastine difumarate
Immedica Pharma AB
S01GX06
emedastine
Ophthalmologicals
Conjunctivitis, Allergic
Symptomatic treatment of seasonal allergic conjunctivitis.
Revision: 26
Authorised
1999-01-27
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EMADINE 0.5 MG/ML EYE DROPS, SOLUTION emedastine 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 your 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 of the 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 EMADINE is and what it is used for 2. What you need to know before you use EMADINE 3. How to use EMADINE 4. Possible side effects 5. How to Store EMADINE 6. Contents of the pack and other information 1. WHAT EMADINE IS AND WHAT IT IS USED FOR EMADINE IS A MEDICINE for the treatment of seasonal allergic conjunctivitis of the eye (allergic conditions of the eye). It works by reducing the intensity of the allergic reaction. ALLERGIC CONJUNCTIVITIS. Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMADINE DO NOT USE EMADINE • IF YOU ARE ALLERGIC to emedastine or any of the other ingredients of this medicine listed in section 6. Ask your doctor for advice. WARNING AND PRECAUTIONS • DO NOT USE EMADINE IN CHILDREN UNDER THE AGE OF 3 YEARS. • IF YOU WEAR CONTACT LENSES please see section ‘EMADINE contains benzalkonium chloride below’. • EMADINE IS NOT RECOMMENDED for use in patients over 65 years of age, as it has not been studied in clinical trials in this age group. • EMADINE IS NOT RECOMMENDED for use in patients with kidney or liver problems. Talk to your doctor or pharmacist bef Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EMADINE 0.5 mg/ml, eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains emedastine 0.5 mg (as difumarate) Excipient with known effect Benzalkonium chloride 0.1 mg/ml For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of seasonal allergic conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION EMADINE has not been studied in clinical trials beyond six weeks. Posology The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily. When used with other ophthalmic medicines, an interval of ten minutes should be allowed between applications of each medicinal product. Eye ointments should be administered last. _Elderly population _ EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population. _Paediatric population _ EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in adults. _Hepatic and Renal impairment Use _ EMADINE has not been studied in these patients and therefore, its use is not recommended in this population. Method of administration For ocular use. 3 To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. After cap is removed, if tamper evident snap collar is loose, remove before using product. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ocular corneal infiltrates Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management should be implemented. Excipients Benzalkonium chloride Lestu allt skjalið