Product Information for the User

Yellox 0.9 mg/mL Eye Drops Solution

Bromfenaco

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What you need to know before starting to use Yellox
2. How to use Yellox
3. Possible adverse effects
4. Storage of Yellox
5. Contents of the container and additional information

Yellox contains bromfenaco and belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain substances involved in inflammation.

Yellox is used to reduce eye inflammation after cataract surgery in adults.

Do not use Yellox

• If you are allergic to bromfenac or any of the other components of this medication (listed in section 6).
• If you have experienced asthma, skin allergy, or intense nasal inflammation when using other NSAIDs. Examples of NSAIDs include acetylsalicylic acid, ibuprofen, ketoprofen, and diclofenac.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Yellox.

• If you are using topical steroids (e.g., cortisone), as this may cause unwanted side effects.
• If you have bleeding disorders (e.g., hemophilia) or have had them in the past, or are taking other medications that may prolong bleeding time (e.g., warfarin, clopidogrel, acetylsalicylic acid).

• If you have eye problems (e.g., dry eye syndrome, corneal problems).

• If you have diabetes.

• If you have rheumatoid arthritis.

• If you have undergone multiple eye surgeries in a short period of time.

It is not recommended to wear contact lenses after cataract surgery. Therefore, do not use contact lenses while using Yellox.

Children and adolescents

Yellox should not be used in children or adolescents.

Use of Yellox with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using Yellox.

Yellox should not be used during the last three months of pregnancy. Your doctor may prescribe this medication during pregnancy if the expected benefit for the mother outweighs the possible risk to the baby.

Yellox may be prescribed during breastfeeding and does not have a significant impact on fertility.

Driving and operating machinery

It may occur that vision becomes blurry temporarily when using this eye drop. If you experience blurry vision after instillation, do not drive or operate machinery until vision clears.

Yellox contains benzalkonium chloride

This medication contains 0.00185 mg of benzalkonium chloride in each drop, equivalent to 0.05 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

Dose

The recommended dose is one drop of Yellox in the affected eye/eyes twice a day (morning and evening). Do not use more than one drop in the affected eye/eyes 2 times a day. Start using this eye drop the day after your cataract surgery.

Administration method

Yellox is administered via the ophthalmic route.

• Wash your hands before using the eye drop.

• Position yourself comfortably and stably.
• Remove the cap from the bottle.
• Hold the bottle, pointing downwards, between your fingers.
• Tilt your head back.
• Pull the lower eyelid downwards with your finger.
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, or surrounding areas, or other surfaces with the dropper.
• Gently press the bottle to release one drop of Yellox.
• Close the bottle cap firmly immediately after use.
• Keep the bottle tightly closed when not in use.

If you use other eye drops, wait at least five minutes between using Yellox and the other eye drops.

Duration of treatment

Continue with the drops for the first two weeks after surgery. Do not use Yellox for more than two weeks.

If you use more Yellox than you should

Flush the eye with warm water. Do not put more drops until it is time for your next scheduled dose.

If Yellox is accidentally ingested, drink a glass of water or other liquids to dilute the medication.

If you forget to use Yellox

Instill one drop as soon as you remember. If it is almost time for your next dose, skip the missed dose. Continue with the next scheduled dose. Do not take a double dose to make up for the missed one.

If you interrupt treatment with Yellox

Do not stop treatment with Yellox without talking to your doctor.

Rarely, after stopping Yellox, a worsening of the inflammatory response has been observed, for example in the form of swelling of the retina due to cataract surgery

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience loss of vision or blurred vision a week after completing treatment, contact your doctor immediately.

If you notice any of the following adverse effects while using the eye drops, consult your doctor immediately:

Adverse effects that are infrequent (may affect up to 1 in 100 people)

Foreign body sensation in the eye, eye redness and inflammation, eye surface damage and inflammation, eye discharge, itching, eye irritation or pain, eyelid swelling or bleeding, vision deterioration due to inflammation, "floaters" or moving spots in front of the eyes, or vision deterioration that may indicate hemorrhage or retinal injury, eye discomfort, light sensitivity, reduced or blurred vision, facial inflammation, cough, nasal bleeding or rhinorrhea.

Adverse effects that are rare (may affect 1 in 1,000 people)

Eye surface damage, eye redness, asthma.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendixVBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “EXP”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Dispose of the bottle 4 weeks after its first opening to prevent infections, even if there is solution remaining.

Write the date of opening on the exterior packaging label in the space provided.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Yellox

• The active principle is bromfenaco. 1 ml of solution contains 0.9 mg of bromfenaco (in the form of sesquihydrate sodium). One drop contains approximately 33 micrograms of bromfenaco.
• The other components are: boric acid, boric acid, sodium anhydrous sulfite (E221), benzalkonium chloride (see section 2), tiloxapol, povidone (K30), disodium edetate, water for injectable preparations, sodium hydroxide to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the packaging

Yellox is a yellow transparent liquid (solution) supplied in a box containing a 5 ml plastic vial with a screw cap.

Marketing Authorization Holder

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Dr. Gerhard Mann

Chem.-pharm. Fabrik GmbH

Brunsbütteler Damm 165/173

13581 Berlin

Germany

This leaflet has been revised in

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.