Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
olopatadine hydrochloride
Novartis Europharm Limited
S01GX09
olopatadine
Ophthalmologicals
Conjunctivitis, Allergic
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.,
Revision: 23
Authorised
2002-05-16
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INFORMATION FOR THE USER OPATANOL 1 MG/ML EYE DROPS, SOLUTION olopatadine 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 Opatanol is and what it is used for 2. What you need to know before you use Opatanol 3. How to use Opatanol 4. Possible side effects 5. How to store Opatanol 6. Contents of the pack and other information 1. WHAT OPATANOL IS AND WHAT IT IS USED FOR OPATANOL IS USED FOR THE TREATMENT OF SIGNS AND SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS. 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. OPATANOL IS A MEDICINE for treatment of allergic conditions of the eye. It works by reducing the intensity of the allergic reaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPATANOL DO NOT USE OPATANOL • IF YOU ARE ALLERGIC (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6). • You should not use Opatanol if you are breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Opatanol. You should remove contact lenses that are in your eyes before using Opatanol. CHILDREN Do not use Opatanol in children under the age of 3 years. Do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years. OTHER MEDICINES AND OPATANOL Tell your doctor or Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Opatanol 1 mg/mL eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of solution contains 1 mg olopatadine (as hydrochloride). Excipient(s) with known effect Benzalkonium chloride 0.1 mg/ml. Disodium phosphate dodecahydrate (E339) 12.61 mg/ml (equivalent to 3.34 mg/ml of phosphates). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution (eye drops). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary. _Use in elderly _ No dosage adjustment in elderly patients is necessary. _Paediatric patients _ Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of Opatanol in children aged under 3 years has not been established. No data are available. _Use in hepatic and renal impairment _ Olopatadine in the form of eye drops (Opatanol) has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2). 3 Method of administration For ocular use only. After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications. Eye ointments should be administered last. 4.3 CONTRAINDICATIONS Hy Lesen Sie das vollständige Dokument