Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - yellox

Document Subject

Generated Narrative: MedicinalProductDefinition mp802da6d86549eecc6e51c1bae9cf0471

identifier: http://ema.europa.eu/identifier/EU/1/11/692/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Yellox 0.9 mg/ml eye drops solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-802da6d86549eecc6e51c1bae9cf0471

identifier: http://ema.europa.eu/identifier/EU/1/11/692/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - yellox

Attesters

What is in this leaflet:

1. What Yellox is and what it is used for
2. What you need to know before you use Yellox
3. How to use Yellox
4. Possible side effects
5. How to store Yellox
6. Contents of the pack and other information

Yellox contains bromfenac and belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). It works by blocking certain substances involved in causing inflammation.
Yellox is used to reduce eye inflammation following cataract surgery in adults.

Do not use Yellox

• if you are allergic to bromfenac or to any of the other ingredients of this medicine (listed in section 6).
• if you have experienced asthma, skin allergy or intense inflammation in your nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Warning and precautions
Talk to your doctor or pharmacist before using this medicine

• if you are using topical steroids (e.g. cortisone), as this may cause unwanted side effects.
• if you have bleeding problems (e.g. haemophilia) or have had them in the past, or you are taking other medicines which 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 had repeated eye surgery within a short period of time.

Wearing contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses whilst using Yellox.

Children and adolescents Yellox should not be used in children and adolescents.

Other medicines and Yellox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 for advice before you use Yellox. Yellox should not be used during the last three months of pregnancy. The doctor may prescribe this medicine during pregnancy if expected benefit to mother outweigh possible risk to baby.
Yellox may be prescribed to breast-feeding woman and have no important influence on fertility.

Driving and using machines Your vision may be blurred for a short time after using this eye drops. If you experience blurred vision upon instillation, do not drive or use machines until your vision is clear.

Yellox contains benzalkonium chloride This medicine contains 0.00185 mg benzalkonium chloride in each drop which is equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

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) 2 times daily. Start using the drops the next day after your cataract surgery.

Method of administration

Yellox is for ocular use.

• Wash your hands before using the eye drops.
• Put yourself in a comfortable and stable position.
• Twist off the bottle cap.
• Hold the bottle, pointing down, between your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a clean finger.
• Bring the bottle tip close to the eye.
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
• Gently squeeze 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 any other eye drops, wait at least five minutes between using Yellox and the other drops.

Duration of treatment Continue the drops through the first 2 weeks after your surgery. Do not use Yellox longer than 2weeks.

If you use more Yellox than you should Rinse out your eye with warm water. Do not put in any more drops until it is time for your next regular dose. If Yellox is accidentally swallowed, a glass of water or other fluid should be taken to water down the medicine.

If you forget to use Yellox
Use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed dose. Continue with the next regularly scheduled dose. Do not use a double dose to make up for a forgotten dose.

If you stop using Yellox
Do not stop using Yellox without speaking to your doctor.

In rare cases upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of retina swelling, due to the cataract operation has been observed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience decreased or blurred vision the week after the end of treatment, contact your doctor immediately. If you notice any of the following side effects while using the drops, contact your doctor immediately:

Uncommon side effects (may affect up to 1 in 100 people) Foreign body sensation in the eye, redness and inflammation of the eye, damage and inflammation of the surface of the eye, eye discharge, itching, irritation or pain of the eye, swelling or bleeding of the eyelid, impaired vision due to inflammation, floaters or moving spots before the eyes or diminishing vision that can indicate bleeding or damage of the back of the eye (retina), ocular discomfort, sensitivity to light, reduced or blurred vision, swelling of the face, cough, nosebleeding or runny nose.

Rare side effects (may affect up to 1 in 1,000 people)
Damage of the eye surface, redness of the eye, asthma.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the bottle and outer carton after EXP . The expiry date refers to the last day of that month.

Do not store above 25 C.

Discard the bottle 4 weeks after first opening to prevent infection even if there is solution remaining. Write the date of opening on the carton label in the space provided.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.

What Yellox contains

• The active substance is bromfenac. One ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms bromfenac.
• The other ingredients are: boric acid, borax, sodium sulphite anhydrous (E221), benzalkonium chloride (see section 2), tyloxapol, povidone (K30), disodium edetate, water for injection, sodium hydroxide (to keep acidity levels normal).

What Yellox looks like and contents of the pack Yellox is a clear yellow liquid (solution) supplied in a pack containing one 5 ml plastic bottle with a screw cap.

Marketing Authorisation Holder
BAUSCH + LOMB IRELAND LIMITED 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH Brunsb tteler Damm 165/13581 Berlin Germany

This leaflet was last revised in

Detailed information on this medicine is available on the website of the European Medicines Agency