Consumer medicine information

Voltaren Ophtha 1 mg/ml

Diclofenac sodium


Brand name

Voltaren Ophtha

Active ingredient

Diclofenac sodium




Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Voltaren Ophtha 1 mg/ml.

What is in this leaflet

Please read this leaflet carefully before you use Voltaren Ophtha Eye Drops.

This leaflet answers some common questions about Voltaren Ophtha. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

You can also download the most up to date leaflet from

The updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Voltaren Ophtha against the risks this medicine could have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Voltaren Ophtha is used for

This medicine is used to treat inflammation of the eye e.g. inflammation which occurs as a result of surgery.

It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs relieve pain and reduce inflammation (i.e. swelling, redness and throbbing).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor's prescription.

Use in Children

There is not enough information to recommend the use of this medicine for children.

Before you use Voltaren Ophtha

When you must not use it

Do not use Voltaren Ophtha if you have ever had an allergic reaction or attack of asthma after taking or using:

  • any medicine containing diclofenac sodium, including Voltaren tablets or suppositories
  • any similar medicine such as Voltaren Rapid tablets (diclofenac potassium), Voltaren Emulgel (diclofenac diethylammonium), aspirin or any other NSAID, or any other medicine to relieve pain or reduce swelling
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not use this medicine if the expiry date has passed, the packaging is torn or the safety seal around the closure and neck area is broken. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using Voltaren Ophtha talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • stomach ulcer, severe attacks of indigestion or other stomach or bowel trouble
  • known bleeding tendency
  • asthma
  • an eye infection that is not being treated.

Tell your doctor if:

  • You are pregnant or intend to become pregnant
    Your doctor will discuss the possible risks and benefits of using Voltaren Ophtha during pregnancy.
    Voltaren Ophtha eye drops should not be used in early pregnancy or during the third trimester of pregnancy.
  • You are breast-feeding or intend to breast-feed
    Your doctor will discuss the possible risks and benefits of using Voltaren Ophtha when you are breast-feeding.

If you have not told your doctor about any of the above, tell him/her before you start using Voltaren Ophtha.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Voltaren Ophtha may interfere with each other. These include:

  • medicines used to thin the blood or prevent blood clots such as warfarin
  • steroid eye drops or eye ointment used to treat inflammation
  • voriconazole, a medication used to treat fungal infections.

These medicines may be affected by Voltaren Ophtha or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Voltaren Ophtha

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to use

The usual dose of Voltaren Ophtha is:

Before surgery
Use up to 5 drops during the 3 hours before surgery.

After surgery
Use one (1) drop 3 times on the day of surgery followed by one (1) drop 3 to 5 times daily.

How to use it

If you wear soft contact lenses, remove your contact lenses before using this medicine. Wait for 15 minutes after using it before reinserting your contact lenses into your eyes. Wearing your lenses is discouraged during treatment of inflammation.

One of the ingredients in Voltaren Ophtha is benzalkonium chloride which can affect contact lenses.

Follow these steps to use the eye drops:

  1. Wash your hands before using the drops.
  2. Open the bottle.
  3. Make sure the tip of the dropper does not touch anything as this may contaminate the solution.
  4. Hold the bottle in one hand between the thumb and middle finger.
  5. With your head tilted back, use the forefinger of your other hand to pull down the lower lid of the eye to be treated.
  6. Place the dropper close to your eye, but without touching your eye or eyelid, and gently squeeze so that one drop falls into the pouch between your lower eyelid and your eye, and then release your lower eyelid.
  7. Close your eye and gently press the inner corner of your eye with your forefinger for one minute.
  8. Treat your other eye in the same way if your doctor has told you to do this.
  9. Replace the lid on the bottle.
  10. Discard the bottle and remaining solution four weeks after opening.

If you are using any other eye drops at the same time as Voltaren Ophtha, leave an interval of at least 5 minutes between each eye drop to stop the drops being washed out of the eye.

How long to use it

Continue using your medicine for as long as your doctor tells you.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor, the Poisons Information Centre on 13 11 26 or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have accidentally swallowed the contents of the bottle. Do this even if there are no signs of discomfort or poisoning.

While you are using Voltaren Ophtha

Things you must do

Tell your doctor if you have any crusty discharge from your eyes while using Voltaren Ophtha. This may mean your eyes are infected and you may need additional treatment.

Tell your doctor if your symptoms persist, worsen or recur.

If you become pregnant while using this medicine, tell your doctor immediately.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Voltaren Ophtha.

Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

Things you must not do

Do not use Voltaren Ophtha to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not stop using your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Voltaren Ophtha affects you. This medicine may cause blurred vision in some people. If you get blurred vision when you use it, do not drive, operate machinery or do anything else that could be dangerous until this effect has worn off.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Voltaren Ophtha.

This medicine helps most people with inflammation of the eye, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • pain, itching, redness, discomfort or irritation of your eye
  • blurred vision immediately after using the drops
  • gritty foreign body sensation in your eye
  • unusual sensitivity of your eyes to light.

The above list includes the more common side effects of your medicine. They also occur with many other eye drops and are usually mild and short-lived.

Additional side effects that are noticed less often include:

  • allergic conditions such as swollen, runny eyes, itching or rash elsewhere on your body, cough, sneezing, runny or blocked nose, facial pressure or pain.
  • discharge from the eye
  • crusty or irritated eyelids
  • eye and eyelid swelling
  • eyelid redness or itchiness
  • watery eyes
  • damage, scarring, thinning or cloudiness of eye surface
  • increase in eye pressure
  • impaired wound healing.

Tell your doctor as soon as possible if you notice any of the following:

  • changes in your vision other than temporary blurring
  • wheezing or difficulty breathing.

The above list includes more serious side effects which may require medical attention. Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor checks your eyes from time to time to check your progress.

After using Voltaren Ophtha


Keep your eye drops in a cool dry place where the temperature stays below 25°C.

Protect your eye drops from light and do not freeze them.

Discard any remaining contents four weeks after opening.

Do not store Voltaren Ophtha or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep your eye drops in a safe place away from the sight and reach of children. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.


If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

Voltaren Ophtha is a slightly yellowish sterile eye drop solution which is supplied in a 5 ml bottle.


Voltaren Ophtha contains 1 mg/mL of diclofenac sodium as the active ingredient.

Voltaren Ophtha multidose bottle also contains:

  • benzalkonium chloride (as a preservative)
  • disodium edetate
  • hydroxypropylbetadex
  • hydrochloric acid
  • propylene glycol
  • trometamol
  • tyloxapol
  • water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.


These products are supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1-800-671-203
Web site:

Australian registration numbers

Multidose Bottle: AUST R 96654

Date of preparation

This leaflet was prepared in November 2020.

™ a trademark of Novartis

© Novartis Pharmaceuticals Australia Pty Limited 2020

Internal document code:

(vlo181120c) based on PI (vlo181120i)

Published by MIMS January 2021


Brand name

Voltaren Ophtha

Active ingredient

Diclofenac sodium




1 Name of Medicine

Diclofenac sodium.

2 Qualitative and Quantitative Composition

Voltaren* Ophtha is sterile aqueous solution containing diclofenac sodium 1.0 mg/mL (0.1% w/v).
For the full list of excipients, see Section 6.1 List of Excipients.
* A trademark of Novartis.

3 Pharmaceutical Form

Eye drops, solution.
Clear, colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Reduction of postoperative inflammation in cataract surgery and other surgical interventions.
The single dose units can also be used to inhibit operative miosis during cataract surgery.

4.2 Dose and Method of Administration



Up to 5 drops during 3 hours before surgery.


1 drop 3 times on the day of surgery, followed by 1 drop 3 to 5 times daily.
Although systemic absorption of diclofenac sodium has been found to be minimal following ocular application, as a general precaution to reduce systemic absorption, pressure should be applied to the tear duct immediately after application.
In clinical studies, effectiveness was demonstrated in patients treated throughout the first two weeks of the post-operative period. In some patients with persisting signs of inflammation, treatment continued for up to four weeks post-operatively.
To prevent the active substances from being washed out when additional ophthalmic medication is used, an interval of at least 5 minutes between each application should be adhered to.
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 as this may contaminate the solution.

4.3 Contraindications

Patients with known hypersensitivity to diclofenac or other components of the medication.
Like other nonsteroidal anti-inflammatory agents, Voltaren Ophtha eye drops is also contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or by other medicines with prostaglandin synthetase inhibiting activity. There is the potential for cross sensitivity to aspirin, phenylacetic acid derivatives and other nonsteroidal anti-inflammatory agents.

4.4 Special Warnings and Precautions for Use

As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. However, in considering potential systemic toxicity, it should be noted that the effective daily dose of Voltaren Ophtha eye drops after ophthalmic administration corresponds to less than 1% of the daily dose recommended for Voltaren in rheumatic indications. In addition, application of 2 drops of 0.1% diclofenac sodium solution to each eye of healthy humans resulted in blood levels below the detection limit (10 nanogram/mL).
The anti-inflammatory activity of ophthalmic nonsteroidal anti-inflammatory agents (NSAIDs) including diclofenac may mask the onset and/or progression of ocular infections. In the presence of infection, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be given concurrently with Voltaren Ophtha eye drops.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of Voltaren Ophtha eye drops and should be monitored closely for corneal health.
Administer with caution in the presence of active gastrointestinal lesions or a history of recurrent gastrointestinal lesions.
There is a potential for increased bleeding time due to interference with thrombocyte aggregation with nonsteroidal anti-inflammatory drugs. There have been reports (with other NSAIDs) of increased bleeding of ocular tissues in conjunction with ocular surgery. Caution should be used in surgical patients with known bleeding tendencies or who are receiving other medications that may prolong bleeding time.
There is a possibility that patients receiving other medications which may prolong bleeding time, or with known haemostatic defects may experience exacerbation with Voltaren Ophtha eye drops.
Topical NSAIDs are known to slow or delay healing. Topical ophthalmic corticosteroids may slow corneal wound healing. Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Eye drops are not for injection. They should never be injected subconjunctivally, nor should they be directly introduced into the anterior chamber of the eye.
Voltaren Ophtha should not be used while wearing soft contact lenses. The lenses must be removed before application of the drops and not reinserted earlier than 15 minutes after use.
Voltaren Ophtha contains benzalkonium chloride as a preservative; benzalkonium chloride may cause irritation and is known to discolour soft contact lenses. Voltaren Ophtha should not be used while wearing soft contact lenses. The lenses must be removed before application of the drops and not reinserted earlier than 15 minutes after use. The wearing of contact lenses is discouraged during treatment of an ocular inflammation.

Use in the elderly.

No data available.

Paediatric use.

Voltaren Ophtha is not indicated for use in children as safety and effectiveness have not been demonstrated in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of topical NSAIDs such as diclofenac and topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications including slow or delay corneal healing, therefore caution should be used.
A previous formulation of this product, which also contained 0.1% diclofenac sodium, has been used safely in clinical studies in combination with antibiotics and beta-blocking agents for ocular use.
Concomitant administration of voriconazole with diclofenac may increase plasma diclofenac levels.
Concomitant use of Voltaren Ophtha eye drops with medications that prolong bleeding time may increase the risk of haemorrhage.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed to evaluate the effect of topical ocular administration of Voltaren Ophtha on human fertility. Animal studies suggest that prostaglandins are necessary for implantation. Therefore, long-term use of NSAIDs by prescription for chronic nonreproductive disorders and continuing use of over the counter NSAIDs preparations, while trying to conceive, could potentially adversely affect the peri-implantation process and outcome.
(Category C)
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation and delay labour and birth. Voltaren Ophtha eye drops should not be used during the third trimester of pregnancy due to possible risk of premature closure of the ductus arteriosus and possible inhibition of contractions. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided.
In addition, data from epidemiological studies suggest an increased risk of miscarriage after the use of prostaglandin synthesis inhibitor in early pregnancy.
Safety of diclofenac sodium in human pregnancy has not been established. Therefore Voltaren Ophtha should not be used in pregnant women or in those likely to become pregnant unless the expected benefits are likely to outweigh any possible risk.
No measurable amounts of active substance are to be expected in the breast milk of nursing mothers. However, since no experience has been acquired with Voltaren Ophtha during lactation, it is not recommended for use in this circumstance.

4.7 Effects on Ability to Drive and Use Machines

Patients experiencing blurred vision or other visual disturbances should refrain from driving a vehicle or operating machines until vision clears (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at
In clinical studies with Voltaren Ophtha eye drops, the following adverse events have been reported, see Table 1.
Corneal disorders have also been reported usually after frequent application. In patients with risk factors of corneal disorders such as during the use of corticosteroids or with concomitant diseases such as infections or rheumatoid arthritis, diclofenac has been associated, in rare cases, with ulcerative keratitis, corneal thinning, punctate keratitis, corneal epithelial defect or corneal oedema, which may become sight threatening. Most patients were treated for a prolonged period of time.
In rare cases dyspnoea and exacerbation of asthma have been reported.
Allergic conditions such as conjunctival hyperaemia, allergic conjunctivitis, eyelid erythema, eye allergy, eyelid oedema, eyelid pruritus, urticaria, rash, eczema, erythema, pruritus, hypersensitivity, cough and rhinitis have been reported. Another less frequently observed reaction is eye pain.

Post-marketing experience.

The following adverse reactions have been reported during Alcon clinical studies with Voltaren Ophtha and are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Eye disorders.

Common (≥ 1% to < 10%): punctate keratitis, eye pain, eye irritation, eye pruritus, conjunctival hyperaemia.
Uncommon (≥ 0.1% to < 1%): keratitis, intraocular pressure increased, corneal oedema, conjunctival oedema, corneal deposits, conjunctival follicles, ocular discomfort, eye discharge, eyelid margin crusting, lacrimation increased, eyelid irritation, ocular hyperaemia.

Immune system disorders.

Uncommon (≥ 0.1% to < 1%): hypersensitivity.

General disorders and administration site conditions.

Uncommon (≥ 0.1% to < 1%): impaired healing.
The following adverse reactions have been identified from post-marketing surveillance following administration of Voltaren Ophtha. Frequency cannot be estimated from the available data. Within each system organ class adverse reactions are presented in order of decreasing seriousness.

Eye disorders.

Not known: corneal perforation, ulcerative keratitis, corneal epithelium defect, corneal opacity, corneal thinning, allergic conjunctivitis, eye allergy, eyelid erythema, eyelid oedema, eyelid pruritus, vision blurred.

Infections and infestations.

Not known: rhinitis.

Respiratory, thoracic and mediastinal disorders.

Not known: asthma exacerbations, dyspnoea, cough.

Skin and subcutaneous tissue disorders.

Not known: urticaria, rash, eczema, erythema, pruritus.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
There is no experience of overdose with Voltaren Ophtha eye drops. However, accidental oral ingestion carries a minimal risk of adverse effects, since the eye drop solution in a 5 mL bottle contains only 5 mg diclofenac sodium corresponding to about 3% of the maximum recommended daily adult dose of Voltaren Ophtha for oral administration.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: anti-inflammatory agents; ATC code: S01BC03.
Voltaren Ophtha eye drops contain diclofenac sodium, a non-steroidal compound with anti-inflammatory and analgesic properties.
Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation and pain.
In clinical trials Voltaren Ophtha has been found to inhibit miosis during cataract surgery and to reduce inflammation following surgical interventions.
The effective daily dose after ocular application of Voltaren Ophtha eye drops (approx. 0.25-0.5 mg diclofenac sodium) corresponds to less than 1% of the daily dose recommended for Voltaren in rheumatic indications.
The benzalkonium chloride containing formulation of Voltaren Ophtha eye drops contains a cyclodextrin, hydroxypropyl betadex. Cyclodextrins (CDs) increase the aqueous solubility of some lipophilic water soluble drugs. It is believed that CDs act as true carriers by keeping hydrophobic drug molecules in solution and delivering them to the surface of biological membranes.

5.2 Pharmacokinetic Properties

In rabbits, peak concentrations of 14C-labelled diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. The highest amounts are found in these two tissues and in the choroid and retina.
Penetration of diclofenac into the anterior chamber has been confirmed in humans. No measurable plasma levels of diclofenac (limit of detection 10 nanogram/mL) could be found in 22 human subjects after ocular application of a multidose formulation of 0.1% diclofenac sodium eye drops preserved with sorbic acid.
The pharmacokinetics of the reformulated multidose product were not studied in humans and were not compared with the pharmacokinetics of the original multidose formulation.

5.3 Preclinical Safety Data

Carcinogenicity and mutagenicity.

Dietary administration of diclofenac to mice and rats at doses up to 0.5 mg/kg/day revealed no carcinogenic activity. However, the plasma concentration of diclofenac at this dose level was 20 to 100 times lower than that in humans after oral administration. Administration of higher doses to rats and mice resulted in increased mortality due to gastrointestinal ulceration. Diclofenac showed no mutagenic effects in the studies conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride (50 microgram/mL as preservative), disodium edetate, hydroxypropyl betadex, hydrochloric acid, propylene glycol, trometamol, tyloxapol and water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light. Do not freeze. Discard 4 weeks after opening.

6.5 Nature and Contents of Container

Voltaren Ophtha is available in LDPE bottles containing 3 mL and 5 mL solution.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Diclofenac sodium is a yellowish-white, odourless, crystalline powder sparingly soluble in water.

Chemical structure.

Chemical name: sodium [2-(2,6-dichloroanilino)phenyl] acetate, a phenylacetic acid derivative.
Molecular formula: C14H10Cl2NNaO2.
Molecular weight: 318.1.

CAS number.


7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription medicine.

Summary Table of Changes