Nevanac

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

nepafenac

Available from:

Novartis Europharm Limited

ATC code:

S01BC10

INN (International Name):

nepafenac

Therapeutic group:

Ophthalmologicals

Therapeutic area:

Pain, Postoperative; Ophthalmologic Surgical Procedures

Therapeutic indications:

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.

Product summary:

Revision: 17

Authorization status:

Authorised

Authorization date:

2007-12-11

Patient Information leaflet

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

Summary of Product characteristics

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