VOLTAREN OPHTHA EYE DROPS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC SODIUM

Available from:

NOVARTIS ISRAEL LTD

ATC code:

S01BC03

Pharmaceutical form:

EYE DROPS

Composition:

DICLOFENAC SODIUM 1 MG/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA AG.,SWITZERLAND

Therapeutic group:

DICLOFENAC

Therapeutic area:

DICLOFENAC

Therapeutic indications:

Post-operative inflammation following cataract extraction. Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK or accidental trauma.

Authorization date:

2013-10-31

Patient Information leaflet

THE FORMAT OF THIS LEAFLET WAS DETERMINED
BY THE MINISTRY OF HEALTH AND ITS CONTENT
WAS CHECKED AND APPROVED BY IT
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with
a doctor’s prescription only.
VOLTAREN OPHTHA EYE DROPS
COMPOSITION: Diclofenac sodium 1 mg/ml
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THIS MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them
even if it seems to you that their medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
THERAPEUTIC
GROUP:
Non-steroidal
anti-
inflammatories.
THERAPEUTIC ACTIVITY: For treatment of post-
operative eye inflammation after cataract surgery.
For relief of ocular pain and discomfort associated
with corneal epithelial defects after laser surgery
or accidental trauma to the eye.
2. BEFORE USING THE MEDICINE:
X DO NOT USE THIS MEDICINE:
∙ if you have a known sensitivity to the
active ingredient or to any ingredient in the
preparation (see section 6).
∙ in patients in whom asthma attacks, urticaria,
or acute rhinitis are caused by use of
acetylsalicylic acid or by other medicines which
inhibit prostaglandin synthesis.
∙ if you are sensitive to acetylsalicylic acid,
to phenylacetic acid derivatives or to other
non-steroidal anti-inflammatories, there is a
chance of sensitivity to this preparation, and
vice versa.
∙ if you are in the third trimester of pregnancy.
BEFORE TREATMENT WITH VOLTAREN OPHTHA, TELL
THE DOCTOR IF:
• you are pregnant or breastfeeding.
• you are suffering from impaired blood clotting.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE:
• The anti-inflammatory activity of VOLTAREN
OPHTHA may mask the onset and/or progression
of ophthalmic infections. In case of infection or
risk of infection, appropriate therapy should be
given concurrently with VOLTAREN OPHTHA.

Summary of Product characteristics

Alcon MAT
VOL API MAY13 CL V1 COR MAT CL
1
ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
י"ע עבקנ הז ןולע טמרופ
יאמב
2013
PRESCRIBING INFORMATION
VOLTAREN
®
OPHTHA EYE DROPS
1 NAME OF THE MEDICINAL PRODUCT
Voltaren Ophtha Eye Drops.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of Voltaren
®
Ophtha Eye Drops contains 1 mg of diclofenac sodium.
For a full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Eye drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Post-operative inflammation following cataract extraction.
•
Control of ocular pain and discomfort associated with corneal
epithelial defects after
laser excimer PRK surgery or accidental trauma.
4.2 POSOLOGY, DOSAGE AND METHOD OF ADMINISTRATION
ADULTS
A) OCULAR SURGERY AND ITS COMPLICATIONS
Preoperatively, up to 1 drop 5 times during the 3 hours before
surgery.
Postoperatively, 1 drop 3 times on the day of surgery, followed by 1
drop 3 to 5 times
daily for as long as required.
B) TREATMENT OF PAIN AND DISCOMFORT
One drop 4 to 6 hourly.
When pain is due to a surgical procedure (e.g. refractive surgery(.
instill 1 drop, 30-60
minutes prior to surgery, into the eye to be operated on. During the
first 10 minutes following
surgery, instill 1-2 doses of 1 drop each, followed by 1 drop 4 times
daily for 2 days.
ELDERLY:
There is no indication that dosage needs to be modified for the
elderly.
Alcon MAT
VOL API MAY13 CL V1 COR MAT CL
2
PAEDIATRIC USE:
Voltaren Ophtha is not indicated for use in children. Paediatric
experience is limited
to a few published clinical studies in strabismus surgery.
The dispenser remains sterile until the original closure is broken.
Patients must be
instructed to avoid allowing the tip of the dispensing container to to
contact the eye or
surrounding structures as this may contaminate the solution.
If more than one medication needs to be instilled in the eye, an
interval of at least 5
minutes between application of the different medicinal pr