Yellox 0.9 mg/ml Eye Drops, Bromfenac Solution
What Yellox Is, And What Is Yellox Eye Drops Used For
Yellox eye drops contain bromfenac and belong to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ). It works by blocking certain substances that cause inflammation.
Yellox is used to reduce eye inflammation after cataract surgery in adults.
What You Need To Know Before Using Yellox
Do Not Use
- If you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6).
- If you have developed asthma, skin allergy, or severe nose inflammation when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid , ibuprofen , ketoprofen , diclofenac .
Warnings And Precautions
Talk to your doctor or pharmacist before using this medicine
- If you use local steroids (eg cortisone ), this can cause unwanted side effects.
- If you have bleeding problems (e.g. haemophilia) or have had them in the past, or if you are taking other medicines that can prolong bleeding time (e.g. warfarin, clopidogrel, aspirin ).
- If you have eye problems (eg dry eyes, corneal problems).
- If you have diabetes.
- If you have chronic rheumatoid arthritis.
- If you have had repeated eye operations in a short period.
Other Medicines And Yellox
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Children And Young People
Yellox eye drops should not be used in children and adolescents.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Yellox.
These eye drops should not be used during the last three months of pregnancy. Doctors may prescribe this medicine during pregnancy if the expected benefit to the mother exceeds the possible risk to the baby. Eye drops can be prescribed to nursing mothers and have no significant effect on fertility.
Driving Ability And Use Of Machinery
After using this eye drop, you may experience blurred vision for a short time. If you get blurred vision while instilling Yellox, do not drive or operate machinery until you see clearly.
Yellox Contains Benzalkonium Chloride
- This medicine contains 0.00185 mg per drop, corresponding to 0.05 mg/ml.
- Benzalkonium chloride can be absorbed by soft contact lenses and can discolour the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in.
- Benzalkonium chloride can irritate the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How To Use Yellox
- Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is one drop of Yellox in the affected eye(s) twice daily (morning and evening). Do not use more than one drop in the affected eye(s) twice daily.
- Start using the drops the day after cataract surgery.
Yellox should be used in the eyes.
- Wash your hands before using the eye drops.
- Sit in a comfortable and stable position.
- Unscrew the bottle cap.
- Hold the bottle upside down between your thumb and fingers.
- Tilt your head back.
- Pull down your lower eyelid with a clean finger.
- Place the tip of the bottle close to the eye.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper.
- Gently press the bottle to release a drop of Yellox.
- Close the bottle cap tightly immediately after use.
- Keep the bottle tightly closed when not in use.
If you use other eye drops, wait at least five minutes after using Yellox before using the other drops.
Continue with the drops for the first two weeks after surgery. Do not use Yellox for longer than 2 weeks.
If You Have Used Too Much Yellox
Rinse out the eye with warm water. Do not instil more drops until it is time for the next regular dose. If you accidentally swallow Yellox, drink a glass of water or other liquid to dilute the medicine.
If You Forget To Use Yellox
Take a single dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Continue with the next regularly scheduled dose. Do not take a double dose to make up for a missed dose.
If You Stop Using Yellox
Do not stop using Yellox without talking to your doctor.
In rare cases, when you stop taking Yellox, you may have a flare-up of an inflammatory reaction, e.g. in the form of swelling of the retina due to the cataract surgery.
Possible Yellox Eye Drops Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Contact your doctor immediately if you experience reduced or blurred vision the week after treatment has stopped.
Contact your doctor immediately if you notice the following side effects while using the drops.
Uncommon side effects (may affect up to 1 in 100 users)
- A sensation of having a foreign object in the eye
- Redness and inflammation of the eye
- Damage and inflammation of the surface of the eye
- Watery eyes
- Itching, irritation or pain in the eye
- Swelling or bleeding in the eyelid, reduced vision due to inflammation, dots or spots moving in front of the eyes or reduced vision, which may indicate bleeding or damage to the back of the eye (retina)
- Discomfort in the eye
- Sensitivity to light
- Reduced or blurred vision
- Swelling of the face
- Nosebleed or runny nose
Rare side effects (may occur in 1 in 1000 users)
- Damage to the eye surface
- Eye redness
How Yellox Should Be Stored
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the bottle or carton after “EXP”. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
- Discard the bottle 4 weeks after opening to prevent infection, even if there is a solution left. Write the date of opening on the carton label in the space provided.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
- The active substance is bromfenac. One ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms of bromfenac.
- The other ingredients are boric acid, borax, anhydrous sodium sulfite (E221), benzalkonium chloride (see section 2), tyloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity).
Appearance And Package Sizes Of The Medicine
Yellox is a clear Yellox liquid (solution) supplied in a package containing a 5 ml plastic bottle with a screw cap.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173