Dicloabak (Diclofenac Sodium Eye Drops)
Preservative-free ophthalmic NSAID for cataract surgery and ocular inflammation
Quick Facts About Dicloabak
Key Takeaways About Dicloabak
- Preservative-free formulation: Dicloabak uses the ABAK/Novelia multi-dose system, making it gentler on the ocular surface than preserved alternatives
- Surgical eye care: Primarily used before and after cataract surgery to prevent miosis and reduce post-operative inflammation
- Do not use with contact lenses: Contact lens wear is not recommended during the post-operative period when this medication is typically used
- Pregnancy caution: Contraindicated from the sixth month (24 weeks) of pregnancy onwards; use in earlier months only if strictly necessary
- Limited duration: Post-operative treatment typically lasts up to 4 weeks; discard the bottle 8 weeks after opening
What Is Dicloabak and What Is It Used For?
Dicloabak is a preservative-free eye drop containing diclofenac sodium 1 mg/ml, an ophthalmic non-steroidal anti-inflammatory drug (NSAID). It is used to prevent pupil constriction (miosis) during cataract surgery, to reduce inflammation after cataract and anterior segment eye operations, and to relieve eye pain following photorefractive keratectomy (PRK).
Diclofenac sodium belongs to the phenylacetic acid group of NSAIDs and works by inhibiting cyclooxygenase (COX) enzymes in the eye. This blocks the production of prostaglandins — chemical mediators that promote inflammation, pain, and pupil constriction. When applied topically to the eye before and after surgery, Dicloabak helps maintain a dilated pupil during the procedure and controls the inflammatory response in the post-operative period.
Ophthalmic NSAIDs such as diclofenac have been used in ocular surgery since the 1980s and are well-established in clinical practice. Unlike corticosteroid eye drops, NSAIDs do not raise intraocular pressure and do not increase the risk of cataract formation — though they serve a complementary rather than replacement role in many surgical protocols. The European Medicines Agency (EMA) has authorised Dicloabak across multiple European Economic Area (EEA) countries, where it is marketed under various brand names including Dicloabak, Voltabak, Voltarenophtabak, and Voltaren Ophtha Abak.
A key advantage of Dicloabak compared to many other ophthalmic NSAID formulations is its preservative-free design. Traditional multi-dose eye drops contain preservatives such as benzalkonium chloride (BAK), which can cause ocular surface toxicity, particularly with repeated or prolonged use. The ABAK and Novelia bottle systems used for Dicloabak incorporate a filtration membrane that prevents microbial contamination without the need for chemical preservatives, making the product better tolerated by patients with sensitive eyes or pre-existing ocular surface disease.
Approved Indications
Dicloabak is authorised for three main clinical uses, all related to ophthalmic surgery:
- Prevention of intraoperative miosis: Applied before cataract surgery to prevent the pupil from constricting, which would obstruct the surgeon’s view and complicate the procedure
- Post-operative anti-inflammatory treatment: Used after cataract surgery and other anterior segment operations to reduce inflammation, swelling, and discomfort during the healing period
- Pain management after PRK: Applied for up to 24 hours following photorefractive keratectomy (a laser vision correction procedure) to control post-operative eye pain
Diclofenac sodium as found in Dicloabak may also be approved for other conditions not specifically mentioned in the product information. Always follow your prescribing ophthalmologist’s instructions regarding off-label use.
What Should You Know Before Using Dicloabak?
Do not use Dicloabak if you are allergic to diclofenac sodium or any of its ingredients, or if you have a history of asthma, urticaria, or rhinitis triggered by NSAIDs or aspirin. Special caution is needed if you have asthma with chronic rhinitis, sinusitis, or nasal polyps, or if you are in the later stages of pregnancy.
Before starting Dicloabak, it is important to inform your ophthalmologist about your full medical history, current medications, and any known allergies. Like all NSAIDs, diclofenac can rarely cause serious hypersensitivity reactions, including anaphylaxis, even in patients who have not previously been exposed to the drug. Understanding the contraindications and precautions will help ensure safe and effective use of this medication.
Contraindications
You must not use Dicloabak in the following situations:
- Allergy to diclofenac sodium or any other ingredient in Dicloabak (including macrogolglycerol ricinoleate, trometamol, or boric acid)
- History of NSAID or aspirin sensitivity: If you have previously developed allergic reactions, urticaria (hives), acute rhinitis (nasal congestion and runny nose), angioedema (swelling of the face, lips, or throat), or asthma attacks triggered by diclofenac, other NSAIDs, or acetylsalicylic acid (aspirin)
Warnings and Precautions
Talk to your ophthalmologist, pharmacist, or nurse before using Dicloabak if any of the following apply to you:
- Asthma with chronic rhinitis, sinusitis, or nasal polyps: These conditions increase the risk of NSAID-triggered bronchospasm, a potentially serious breathing complication
- Bleeding tendency or anticoagulant therapy: If you have a disorder that affects blood clotting, or if you are taking blood-thinning medications (e.g. warfarin, heparin, direct oral anticoagulants), diclofenac eye drops may increase bleeding risk at the surgical site
- Pre-existing ocular surface disease: Patients with chronically dry eyes, rheumatoid arthritis, or other conditions affecting the corneal surface may be at increased risk of corneal adverse effects, including keratitis and corneal thinning
- Repeated eye surgeries in a short period: Multiple ocular procedures performed close together increase the risk of corneal complications when ophthalmic NSAIDs are used
- Diabetes mellitus: Diabetic patients may be more susceptible to corneal healing problems
Stop using Dicloabak immediately and contact your doctor or go to the emergency department if you experience signs of a severe allergic reaction, such as difficulty breathing, swelling of the face or throat, severe skin rash, or dizziness. Although rare, anaphylactic reactions can occur even without prior exposure to the drug.
Be aware that ophthalmic NSAIDs can mask the signs and symptoms of an ocular infection. If you develop redness, pain, or discharge that worsens during treatment, contact your ophthalmologist promptly, as you may need additional antimicrobial treatment. NSAIDs have no antibacterial properties and should not be used as a substitute for antibiotic eye drops when infection is suspected.
Concurrent use of topical corticosteroid eye drops (such as dexamethasone) with Dicloabak may increase the risk of delayed corneal healing. If both types of drops are prescribed together, your ophthalmologist will monitor your recovery carefully. Prolonged or high-dose use of topical NSAIDs can also contribute to corneal complications, including corneal thinning or ulceration, particularly in vulnerable patients.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Dicloabak.
- From the 6th month of pregnancy onwards (24 weeks): Dicloabak must not be used. Oral NSAIDs taken during the third trimester can adversely affect the unborn baby, including premature closure of the ductus arteriosus and impaired renal function. Although it is uncertain whether topical ophthalmic use carries the same risk, the contraindication applies as a precautionary measure.
- During the first 5 months of pregnancy: Dicloabak should only be used if strictly necessary, at the lowest possible dose for the shortest possible duration, and only on the advice of your doctor.
- Breastfeeding: Dicloabak can be used during breastfeeding. The systemic absorption from ophthalmic use is minimal, and the amount expected to reach breast milk is negligible.
- Fertility: Like all NSAIDs, diclofenac may impair female fertility and make it more difficult to become pregnant. This effect is reversible upon discontinuation. Inform your doctor if you are planning a pregnancy or having difficulty conceiving.
Driving and Operating Machinery
You may experience temporary visual disturbances (blurred vision) immediately after applying Dicloabak eye drops. Do not drive or operate machinery until your vision has returned to normal. This effect is typically short-lived, lasting only a few minutes after each application.
Excipient Information
Dicloabak contains macrogolglycerol ricinoleate, which may cause skin reactions (contact dermatitis) in some individuals. If you develop a rash or irritation around the eyes during treatment, inform your ophthalmologist.
How Does Dicloabak Interact with Other Drugs?
Dicloabak may interact with corticosteroid eye drops (increasing the risk of delayed corneal healing), anticoagulants (potentially increasing bleeding risk), and other NSAID eye drops. If you are using other eye medications, wait at least 15 minutes between applications.
As a topically applied ophthalmic medication, Dicloabak has limited systemic absorption, which reduces the risk of systemic drug interactions compared to oral NSAIDs. However, local ocular interactions and some systemic considerations remain important. Always inform your ophthalmologist and pharmacist about all medications you are using, including over-the-counter medicines, herbal supplements, and other eye drops.
The table below summarises the key drug interactions to be aware of when using Dicloabak. Because ophthalmic NSAIDs achieve low systemic concentrations, the most clinically significant interactions occur with other topically applied eye medications.
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Corticosteroid eye drops (e.g. dexamethasone, prednisolone) | Increased risk of delayed corneal healing and corneal complications | Use combination only under close ophthalmologist supervision; monitor corneal integrity |
| Anticoagulants (e.g. warfarin, heparin, DOACs) | Potential increase in bleeding tendency at the surgical site | Inform your ophthalmologist; additional monitoring may be required during surgery |
| Other NSAID eye drops (e.g. ketorolac, nepafenac) | Additive risk of corneal adverse effects and delayed healing | Avoid concurrent use of multiple ophthalmic NSAIDs |
| Acetylsalicylic acid (aspirin) | Cross-sensitivity in patients with NSAID/aspirin-triggered asthma or urticaria | Use with caution in aspirin-sensitive patients; monitor for hypersensitivity |
| Other eye drops (any type) | Potential dilution or washout of one medication by the other | Wait at least 15 minutes between applications of different eye drops |
In clinical practice, many patients undergoing cataract surgery are prescribed both a corticosteroid eye drop and an NSAID eye drop for the post-operative period. When these medications are used together, careful monitoring of the corneal surface is essential. Studies have shown that the combination may provide superior inflammation control compared to either agent alone, but the increased risk of corneal healing problems must be weighed against the benefit.
If you are using multiple eye medications, always wait at least 15 minutes between applying different drops. This allows each medication to be properly absorbed and prevents one drop from washing away the other. Apply the drops in the order recommended by your ophthalmologist.
What Is the Correct Dosage of Dicloabak?
The recommended dose varies by indication: for cataract surgery, apply 1 drop up to 5 times during the 3 hours before surgery, then 1 drop 3–5 times daily for up to 4 weeks after surgery. For PRK pain relief, apply 2 drops within 1 hour before and after surgery, followed by 4 drops within the first 24 hours post-operatively.
Always use Dicloabak exactly as your ophthalmologist has prescribed. The dosing regimen depends on the type of surgical procedure and whether you are in the pre-operative or post-operative phase. The following guidelines apply to adults and elderly patients. No studies have been conducted in children, and Dicloabak is not currently recommended for paediatric use.
Adults and Elderly
Prevention of Miosis During Cataract Surgery
Pre-operative: Apply 1 drop up to 5 times during the 3 hours before surgery. This helps maintain a wide, dilated pupil throughout the procedure.
Post-operative Inflammation (Cataract & Anterior Segment Surgery)
Pre-operative: Apply 1 drop up to 5 times during the 3 hours before surgery.
Post-operative: Apply 1 drop 3 times immediately after surgery, then 1 drop 3–5 times daily for a maximum of 4 weeks.
Pain After Photorefractive Keratectomy (PRK)
Pre-operative: Apply 2 drops within 1 hour before surgery.
Post-operative: Apply 2 drops within 1 hour after surgery, then 4 drops within the first 24 hours after surgery.
| Indication | Pre-operative | Post-operative | Duration |
|---|---|---|---|
| Miosis prevention (cataract) | 1 drop × 5 over 3 hours | — | Pre-op day only |
| Post-op inflammation (cataract / anterior segment) | 1 drop × 5 over 3 hours | 1 drop 3–5 × daily | Up to 4 weeks |
| PRK pain (laser vision correction) | 2 drops within 1 hour | 2 drops within 1 hour + 4 drops over 24 hours | 24 hours only |
Children
No clinical studies have been performed in children. Dicloabak is not currently recommended for use in paediatric patients. If your child requires an ophthalmic NSAID, your ophthalmologist will determine the most appropriate treatment and dosage.
Elderly
No dose adjustment is required for elderly patients. The standard adult dosing regimen applies. However, elderly patients may be at greater risk of corneal adverse effects, particularly if they have pre-existing dry eye disease or have undergone multiple previous eye surgeries.
Administration Instructions
Dicloabak is a preservative-free eye drop solution supplied in a multi-dose bottle with the ABAK or Novelia delivery system. Follow these steps for correct administration:
- Wash your hands thoroughly before handling the bottle or touching your eyes
- Unscrew the cap to open the multi-dose container. Avoid touching the tip of the bottle to your eye, eyelid, or any other surface
- Tilt your head back slightly and hold the bottle upright above your eye with one hand
- Gently pull down the lower eyelid with the index finger of your other hand to create a small pocket (the lower conjunctival sac)
- Squeeze the bottle to release one drop into the lower conjunctival sac of the affected eye(s)
- If the drop misses your eye, try again
- Wipe away excess that runs down your cheek
- Close your eye and press gently on the inner corner of your eye (near the nose) with your finger for about 2 minutes. This technique, called punctal occlusion, helps prevent the medication from draining into your body through the tear duct
- Repeat in the other eye if instructed to treat both eyes
- For the Novelia bottle system: after use and before closing, shake the bottle once (without touching the tip) to remove residual liquid from the tip
- Close the bottle securely after use
Missed Dose
If you forget to use Dicloabak at the scheduled time, apply the drop as soon as you remember and then continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.
Overdose
If you accidentally use too many drops in your eye, rinse your eye with clean water. If a child accidentally swallows the medication, or if you are concerned about possible overdose, contact your doctor, local hospital, or poison control centre for advice.
What Are the Side Effects of Dicloabak?
The most common side effects of Dicloabak are a burning sensation and temporary visual disturbances when applying the drops. Rare but serious side effects include corneal ulceration, hypersensitivity reactions, and worsening of asthma. Contact your ophthalmologist if you experience worsening symptoms or any unexpected reactions.
Like all medicines, Dicloabak can cause side effects, although not everyone experiences them. Most side effects are local (affecting the eye) and mild in nature. Systemic side effects are uncommon because very little diclofenac enters the bloodstream when applied as eye drops. The side effects are grouped below by how frequently they occur, based on clinical trial data and post-marketing surveillance reports.
Uncommon
May affect up to 1 in 100 users
- Burning sensation when applying the eye drops
- Temporary visual disturbances (blurred vision) immediately after application
Rare
May affect up to 1 in 1,000 users
- Hypersensitivity reactions with itching and redness
- Photosensitivity (allergic reaction to sunlight exposure)
- Punctate keratitis (a specific type of corneal inflammation with small dot-like lesions)
- Corneal ulceration (erosion of the corneal surface)
- Corneal thinning
- Breathing difficulties
- Worsening of asthma
Not Known
Frequency cannot be estimated from available data
- Runny nose (rhinitis)
- Red eyes (conjunctival hyperaemia)
- Allergic conjunctivitis
- Swollen eyelids
- Cough
- Urticaria (hives) and skin rash
- Contact dermatitis (due to macrogolglycerol ricinoleate excipient)
The risk of corneal adverse effects is higher in certain patient groups, including those who have had multiple eye surgeries within a short period, patients with diabetes, individuals with pre-existing ocular surface disease (such as chronic dry eyes), and those with rheumatoid arthritis. If you fall into any of these categories, your ophthalmologist will monitor your corneal health closely during treatment.
Prolonged or high-dose use of ophthalmic NSAIDs may increase the risk of corneal problems. Clinical studies have demonstrated that when topical NSAIDs are used at recommended doses and durations, the incidence of serious corneal events is low. However, exceeding the prescribed treatment duration or using doses beyond the recommendations may increase risk.
Contact your ophthalmologist or go to the emergency department immediately if you experience: sudden severe eye pain, significant vision loss, severe swelling of the face or throat, difficulty breathing, or widespread hives. These could indicate a serious allergic reaction or corneal complication requiring urgent treatment.
Reporting of suspected side effects is important and helps regulatory agencies continuously monitor the benefit-risk balance of medicines. If you experience any side effect, whether listed here or not, report it to your doctor, pharmacist, or directly to your national medicines agency. In the European Union, you can report side effects through your national pharmacovigilance system.
How Should You Store Dicloabak?
Store Dicloabak at or below 25°C, out of the reach and sight of children. The eye drops must not be used for longer than 8 weeks after first opening the bottle. Always check the expiry date before use.
Proper storage of Dicloabak is essential to maintain its sterility and effectiveness. Because Dicloabak is a preservative-free formulation, the sterility of the solution depends entirely on the integrity of the ABAK or Novelia delivery system. Following these storage guidelines will help ensure the medicine remains safe and effective throughout its use:
- Temperature: Store at or below 25°C (77°F). Do not freeze. Do not expose to direct sunlight or excessive heat.
- After opening: Use within 8 weeks of first opening the bottle. Write the date of opening on the carton to help you remember.
- Expiry date: Do not use Dicloabak after the expiry date printed on the carton and bottle (after “EXP”). The expiry date refers to the last day of the stated month.
- Keep out of reach of children: Store in a safe location inaccessible to young children.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.
What Does Dicloabak Contain?
The active substance in Dicloabak is diclofenac sodium at a concentration of 1 mg/ml. The inactive ingredients include macrogolglycerol ricinoleate, trometamol (tromethamine), boric acid, and water for injections. The solution is preservative-free.
Understanding the composition of your medication can be helpful, particularly if you have known allergies to specific excipients. Below is a complete breakdown of what Dicloabak contains:
Active Substance
- Diclofenac sodium – 1 mg per ml of solution (0.1% w/v). This is the anti-inflammatory and analgesic component that provides the therapeutic effect.
Inactive Ingredients (Excipients)
- Macrogolglycerol ricinoleate – A solubilising agent derived from castor oil. This excipient may occasionally cause skin reactions (contact dermatitis) in sensitive individuals.
- Trometamol (tromethamine) – A buffering agent that maintains the pH of the solution at a level comfortable for the eye.
- Boric acid – Used as a tonicity-adjusting agent to make the solution isotonic with tears.
- Water for injections – The purified water base of the solution.
Appearance and Packaging
Dicloabak is a yellowish liquid supplied in a multi-dose bottle containing 10 ml of eye drop solution. The bottle uses either the ABAK (PE bottle) or Novelia (LDPE bottle) preservative-free delivery system. Both systems incorporate a filtration mechanism that maintains sterility without chemical preservatives.
Frequently Asked Questions About Dicloabak
Dicloabak is a preservative-free eye drop containing diclofenac sodium 1 mg/ml. It is used in ophthalmology for three main purposes: (1) to prevent pupil constriction (miosis) during cataract surgery, (2) to reduce inflammation after cataract surgery and anterior segment eye operations for up to 4 weeks, and (3) to manage eye pain following photorefractive keratectomy (PRK) for up to 24 hours after surgery. It works by blocking the production of prostaglandins, which are chemicals that cause inflammation and pain in the eye.
Yes, Dicloabak is a preservative-free formulation. Unlike many other multi-dose eye drops that contain preservatives such as benzalkonium chloride (BAK), Dicloabak uses the innovative ABAK or Novelia multi-dose bottle system. These systems incorporate a filtration membrane that prevents bacterial contamination without the need for chemical preservatives. This makes Dicloabak better tolerated and less likely to cause irritation or damage to the ocular surface, which is particularly important for patients who need to use eye drops frequently after surgery.
Contact lens use is not recommended immediately after cataract surgery, which is the primary context in which Dicloabak is prescribed. Your ophthalmologist will advise you on when it is safe to resume wearing contact lenses after your procedure. Although Dicloabak is preservative-free (and therefore less likely to interact with contact lens materials than preserved drops), the post-surgical healing process requires that the eye be free from foreign bodies, including contact lenses.
Dicloabak should not be used for longer than 8 weeks after first opening the bottle. Despite being preservative-free, the ABAK and Novelia delivery systems are designed to maintain sterility for up to 8 weeks after the bottle is first opened. After this period, discard the remaining solution and use a new bottle if treatment is still required. It is helpful to write the opening date on the carton as a reminder. Store the bottle at or below 25°C (77°F).
Dicloabak must not be used from the beginning of the sixth month of pregnancy (24 weeks gestation) until delivery. This is because oral NSAIDs used in the third trimester can cause harmful effects to the unborn baby, including premature closure of the ductus arteriosus and kidney problems. Although it is not established whether topical ophthalmic use carries the same risks, the same precautionary contraindication applies. During the first five months of pregnancy, Dicloabak should only be used if strictly necessary and prescribed by your doctor, at the lowest effective dose for the shortest possible time.
The most commonly reported side effects of Dicloabak (occurring in up to 1 in 100 users) are a burning sensation when applying the drops and temporary blurred vision immediately after application. These effects are usually mild and short-lived. Rare side effects (up to 1 in 1,000 users) include hypersensitivity reactions, photosensitivity, punctate keratitis, corneal ulceration, breathing difficulties, and worsening asthma. If you experience severe or persistent symptoms, stop using the drops and contact your ophthalmologist.
References and Medical Sources
This article is based on the following evidence-based medical sources and international guidelines. All claims are supported by peer-reviewed research and authoritative pharmacological references.
- European Medicines Agency (EMA). Diclofenac sodium ophthalmic solution – Summary of Product Characteristics. EMA. Available from: www.ema.europa.eu.
- Kessel L, Tendal B, Jørgensen KJ, et al. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014;121(10):1915-1924. doi:10.1016/j.ophtha.2014.04.035
- Kim SJ, Schoenberger SD, Thorne JE, et al. Topical nonsteroidal anti-inflammatory drugs and cataract surgery: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(11):2159-2168. doi:10.1016/j.ophtha.2015.05.014
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023. Available from: www.who.int.
- British National Formulary (BNF). Diclofenac sodium (ophthalmic). National Institute for Health and Care Excellence (NICE). Available from: bnf.nice.org.uk.
- Flach AJ. Topical nonsteroidal antiinflammatory drugs in ophthalmology. International Ophthalmology Clinics. 2002;42(1):1-11. doi:10.1097/00004397-200201000-00003
- Colin J, Paquette B. Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery. Clinical Therapeutics. 2006;28(4):527-536. doi:10.1016/j.clinthera.2006.04.006
- Laboratoires Théa. Dicloabak (diclofenac sodium 1 mg/ml eye drops) – Patient Information Leaflet. Clermont-Ferrand, France: Laboratoires Théa.
- Baudouin C, Labbé A, Liang H, et al. Preservatives in eyedrops: the good, the bad and the ugly. Progress in Retinal and Eye Research. 2010;29(4):312-334. doi:10.1016/j.preteyeres.2010.03.001
About the Medical Editorial Team
This article was written, reviewed, and fact-checked by the iMedic Medical Editorial Team, comprising licensed specialist physicians in ophthalmology and clinical pharmacology. Our editorial process follows international standards for medical content, including the GRADE evidence framework and E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness) principles.
Specialist physicians with expertise in ophthalmology and pharmacology. All content is based on peer-reviewed research and international clinical guidelines.
Independent review by the iMedic Medical Review Board. Content is evaluated for accuracy, completeness, and adherence to evidence-based medicine principles.
Evidence Level 1A – based on systematic reviews and meta-analyses of randomized controlled trials. Following GRADE framework for quality of evidence.
No commercial funding. No pharmaceutical company sponsorship. All content is independently produced and free from conflicts of interest.