Voltarol Ophtha Multidose 0.1% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Thea Pharmaceuticals Ltd

ATC code:

S01BC03

INN (International Name):

Diclofenac sodium

Dosage:

1mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11080200; GTIN: 4891572090034

Patient Information leaflet

00000000
VOLTAROL
® OPHTHA
MULTIDOSE
0.1% EYE DROPS
(DICLOFENAC SODIUM)
PATIENT INFORMATION LEAFLET
Your doctor has decided that you need
these eye drops to help treat your
condition.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE THE EYE
DROPS. IT CONTAINS IMPORTANT
INFORMATION. Keep the leaflet in a safe
place because you may want to read it
again.
If you have any other questions,
or if there is something you don’t
understand, please ask your doctor or
pharmacist.
This medicine has been prescribed for
you. Never give it to someone else. It
may not be the right medicine for them
even if their symptoms seem to be the
same as yours.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
The eye drops will be referred to as
Voltarol Ophtha in this leaflet.
IN THIS LEAFLET:
1. What Voltarol Ophtha are and what
they are used for
2. Things to consider before you start
to use Voltarol Ophtha
3. How to use Voltarol Ophtha
4. Possible side effects
5. How to store Voltarol Ophtha
6. Further information
1. WHAT VOLTAROL OPHTHA ARE
AND WHAT THEY ARE USED FOR
Voltarol Ophtha contain 0.1% of the
active ingredient diclofenac sodium.
Diclofenac sodium is one of a group of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.
Voltarol Ophtha are used
• before eye surgery, to help keep the
pupil open during surgery,
or
• after eye surgery or injury, to control
pain and/or inflammation,
• to reduce the symptoms, such as
red, runny or itchy eyes associated
with seasonal allergic conjunctivitis
(hayfever).
2. THINGS TO CONSIDER BEFORE
YOU START TO USE VOLTAROL
OPHTHA
SOME PEOPLE MUST NOT HAVE
VOLTAROL OPHTHA. TALK TO YOUR
DOCTOR IF:
• you think you may be allergic to
diclofenac sodium, aspirin or any
other NSAIDs, or to any of the other
ingredients of the eye drops. (These
are listed at the end of the leaflet.)
• You are more than 6 months
pregnant.
YOU SHOULD ALSO ASK YOURS

Summary of Product characteristics

OBJECT 1
VOLTAROL OPHTHA MULTIDOSE
Summary of Product Characteristics Updated 26-Feb-2015 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Voltarol Ophtha Multidose 0.1% Eye Drops
2. Qualitative and quantitative composition
Contains diclofenac sodium 1mg/ml
3. Pharmaceutical form
Eye drops solution
4. Clinical particulars
4.1 Therapeutic indications
i. Inhibition of peroperative miosis during cataract surgery (Voltarol
Ophtha Multidose has no intrinsic
mydriatic properties and does not replace standard mydriatic agents).
ii. Treatment of post-operative inflammation in cataract surgery.
iii. Control of ocular pain and discomfort associated with corneal
epithelial defects after excimer PRK
surgery or accidental non-penetrating trauma.
iv. Control of inflammation after Argon Laser Trabeculoplasty (ALT).
v. The relief of the ocular signs and symptoms of Seasonal Allergic
Conjunctivitis (SAC).
vi. Treatment of inflammation and discomfort after strabismus surgery
vii. Treatment of ocular pain and discomfort after radial keratotomy
4.2 Posology and method of administration
Voltarol Ophtha eye drop solution is for instillation into the
conjunctival sac only. It should never be
injected subconjunctivally, nor should it be directly introduced into
the anterior chamber of the eye.
ADULTS:
Prophylaxis of preoperative miosis
Apply 1 drop four times during the 2 hours before
surgery.
Control of post-operative inflammation
Apply 1 drop 4 times daily for up to 28 days.
Control of Post-PRK pain and discomfort
Apply 1 drop 2 times in the hour prior to surgery, 1
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.
Control of ocular pain associated with corneal
epithelial defects after accidental non-penetrating
trauma.
Apply 1 drop 4 times daily for up to 2 days.
Control of post-ALT inflammation.
Apply one drop 4 times during the 2 hours before
ALT, and then one drop 4 times daily for up to 7
days.
The relief of the ocular signs an