Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
nepafenac
Novartis Europharm Limited
S01BC10
nepafenac
Ophthalmologicals
Pain, Postoperative; Ophthalmologic Surgical Procedures
Nevanac is indicated for: , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
Revision: 17
Authorised
2007-12-11
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER NEVANAC 1 MG/ML EYE DROPS, SUSPENSION nepafenac 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NEVANAC is and what it is used for 2. What you need to know before you use NEVANAC 3. How to use NEVANAC 4. Possible side effects 5. How to store NEVANAC 6. Contents of the pack and other information 1. WHAT NEVANAC IS AND WHAT IT IS USED FOR NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NEVANAC is to be used by adults: - to prevent and relieve eye pain and inflammation following cataract surgery on the eye - to reduce the risk of macular oedema (swelling in the back of the eye) following cataract surgery on the eye in diabetic patients. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEVANAC DO NOT USE NEVANAC - if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6), - if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) - if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using NEVANAC: - if you bruise easily or have bleeding problems or have had them in the past. - if you have any other eye disorder (e.g. an eye infection) or if you are using other m Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NEVANAC 1 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains 1 mg nepafenac. Excipient with known effect Each ml of suspension contains 0.05 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension Light yellow to light orange uniform suspension, pH 7.4 (approximately). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEVANAC 1 mg/ml is indicated in adults for: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, including the elderly _ For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery. For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery. _Special populations_ _Patients with renal or hepatic impairment _ NEVANAC has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular a Citiți documentul complet