Voltarol Ophtha Multidose 1mg/ml Eye Drops Solution

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Diclofenac sodium

Beschikbaar vanaf:

Laboratoires Thea

ATC-code:

S01BC; S01BC03

INN (Algemene Internationale Benaming):

Diclofenac sodium

Dosering:

1 milligram(s)/millilitre

farmaceutische vorm:

Eye drops, solution

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Antiinflammatory agents, non-steroids; diclofenac

Autorisatie-status:

Marketed

Autorisatie datum:

2002-05-03

Bijsluiter

LEAFLET
VOLTAROL®
OPHTHA MULTIDOSE
1MG/ML EYE DROPS SOLUTION
DICLOFENAC SODIUM
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 Voltarol Ophtha Multidose Eye Drops is and
what it is used for
2.
What you need to know before you use Voltarol Ophtha Multidose Eye
Drops
3.
How to use Voltarol Ophtha Multidose Eye Drops
4.
Possible side effects
5.
How to store Voltarol Ophtha Multidose Eye Drops
6.
Contents of the pack and other information
1.
WHAT VOLTAROL OPHTHA MULTIDOSE EYE DROPS
IS AND WHAT IT IS USED FOR
Voltarol Ophtha Multidose Eye Drops contains the
active substance diclofenac sodium. This is one of a group
of medicines called non-steroidal anti-inflammatory drugs. These drops
are used to help keep the pupil open
during eye surgery; to treat inflammation of the eye associated with
cataract surgery or after laser surgery for
glaucoma; to treat pain and discomfort associated with excimer laser
surgery or accidental non-penetrating
injury to the eye; to provide relief from the ocular signs
and symptoms of Seasonal Allergic Conjunctivitis
(hayfever). Doctors sometimes prescribe these eye drops for other
purposes. Consult your doctor if this
applies to
you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL OPHTHA MULTIDOSE EYE
DROPS
Do not use Voltarol Ophtha Multidose Eye Drops:
•
If you are allergic to diclofenac sodium or any of the other
ingredients of this medicine (listed in section 6).
•
If you have had an allergic reaction, skin rash, blocked nose or
wheezing after taking

Productkenmerken

Health Products Regulatory Authority
30 September 2020
CRN009TW5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol Ophtha Multidose 1mg/ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac Sodium 1 mg/ml.
Excipient with known effect: benzalkonium chloride (0.05 mg/ml)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution. (Eye drops)
A clear, colourless, odourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For pre and post operative prevention of post-surgery aphakic cystoid
macular oedema associated with cataract lens extraction
and intraocular lens implantation. In inhibition of intraoperative
miosis. In post-operative inflammation in cataract surgery and
other surgical interventions. In non-infected inflammatory conditions
of the anterior segment of the eye. In inflammation
following trauma and non-penetrating injuries (in combination with
local anti-infective treatment). Control of ocular pain and
discomfort associated with corneal epithelial defects after excimer
PRK surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Pre-operatively: 1 drop four times during the 2 hours before surgery.
Post-operatively: 1 drop four times daily for up to 12 weeks.
Post PRK pain: 1 drop 2 times in the hour prior to surgery, one drop 2
times five minutes apart immediately after PRK surgery
and then post-operatively 1 drop every 2-5 hours while awake for up to
24 hours.
Other indications: 1 drop 4 to 5 times daily depending upon the
severity of the disease.
CHILDREN
Paediatric Use: Voltarol Ophtha is not indicated for use in children.
Paediatric experience is limited to a few published clinical
studies in strabismus surgery.
ELDERLY
There is no indication that dosage needs to be modified for the
elderly.
The dispenser remains sterile until the original closure is broken.
Patients must be instructed to avoid allowing the tip of the
dispensing container to contact the eye or surrounding structures as
this may co