Nevanac 3 mg/ml eye drops, suspension

Land: Europeiska unionen

Språk: engelska

Källa: myHealthbox

Aktiva substanser:

Nepafenac

Tillgänglig från:

Alcon Laboratories (UK) Ltd.

ATC-kod:

S01BC10

INN (International namn):

Nepafenac

Dos:

3mg/1 ml

Läkemedelsform:

Eye drops, suspension

Administreringssätt:

Ocular use

Enheter i paketet:

3 ml plastic bottle (round or oval)

Receptbelagda typ:

Subject to medical prescription

Tillverkad av:

S.A. Alcon–Couvreur N.V

Terapeutisk grupp:

Ophthalmologicals, anti-inflammatory agents, non-steroids

Terapiområde:

Ophthalmologic Surgical Procedures, Postoperative Pain

Terapeutiska indikationer:

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery

Bemyndigande status:

Authorized

Tillstånd datum:

2013-05-03

Bipacksedel

 
37 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

NEVANAC 3 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 non-
steroidal anti-inflammatory drugs (NSAIDs). 

NEVANAC 3 mg/ml eye drops, suspension is to be used
by adults to prevent and relieve eye pain and 
inflammation following cataract surgery on the eye. 

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�

Produktens egenskaper

 
10 
1. 
NAME OF THE MEDICINAL PRODUCT 

NEVANAC 3 mg/ml eye drops, suspension  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 ml of suspension contains 3 mg nepafenac. 

Excipient(s) with known effect:  
Each ml of suspension contains 0.05 mg benzalkonium chloride  

For the full list of excipients, see section 6.1.  

3. 
PHARMACEUTICAL FORM 

Eye drops, suspension (eye drops). 

Light yellow to dark orange uniform suspension,
pH 6.8 (approximately). 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

NEVANAC 3 mg/ml eye drops, suspension is indicated in
adults for: 

- Prevention and treatment of postoperative pain and inflammation
associated with cataract surgery 
(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) once a
day beginning 1 day prior to cataract surgery, continued 
on the day of surgery and up to 21 days of the postoperative
period, as directed by the clinician.  An 
additional drop should be administered 30
to 120 minutes prior to surgery. 

In clinical trials, patients were treated for up to 21
days with NEVANAC 3 mg/ml eye drops, 
suspension (see section 5.1). 

Once-daily dosing with NEVANAC 3 mg/ml eye drops, suspension
provides the same total daily dose 
of nepafenac as three-times-daily dosing with
NEVANAC 1 mg/ml eye drops, suspension. 

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 administration.  No dose adjustment is warranted