Package leaflet: Information for the user

Brofestill, 0.9 mg/mL, eye drops, solution
Bromfenacum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Brofestill is and what it is used for
Important information before using Brofestill
How to use Brofestill
Possible side effects
How to store Brofestill
Contents of the pack and other information

1. What Brofestill is and what it is used for
Brofestill contains bromfenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain substances that cause inflammation.
Brofestill is used to reduce ocular inflammation after cataract surgery in adults.

2. Important information before using Brofestill

When not to use Brofestill

if you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6),
if you have experienced asthma, skin allergy, or severe nasal inflammation while taking other NSAIDs. Examples of NSAIDs include: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Warnings and precautions
Before starting Brofestill, discuss this with your doctor or pharmacist if:

you are using topical steroids (e.g. cortisone), as this may lead to adverse effects,
you have blood clotting disorders (e.g. haemophilia) or have had them in the past, or if you are taking other medicines that may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid),
you have eye disorders (e.g. dry eye syndrome, corneal disease),
you have diabetes,
you have rheumatoid arthritis,
you have undergone repeated eye surgery within a short period.

Wearing contact lenses after cataract surgery is not recommended. Therefore, do not wear contact lenses during treatment with Brofestill.
Children and adolescents
Brofestill must not be used in children and adolescents.
Brofestill with other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Brofestill must not be used during the last three months of pregnancy.
Your doctor may prescribe this medicine during pregnancy if the expected benefit to the mother outweighs the possible risk to the fetus.
Brofestill may be prescribed to a breastfeeding woman and has no significant effect on fertility.
Driving and using machines
Blurred vision may occur for a short time after using the medicine. Patients experiencing reduced visual acuity after instillation should not drive or operate machinery until these symptoms resolve.
Brofestill contains benzalkonium chloride
The medicine contains 0.00185 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Remove contact lenses before instilling the drops and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal eye sensations, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Brofestill

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dose
The recommended dose is one drop of Brofestill into the treated eye(s) twice daily (morning and
evening). Do not use more than one drop into the treated eye(s) twice daily.
Treatment with Brofestill should begin the day after cataract surgery.
Method of administration
Brofestill should be administered into the eye.

Wash your hands before using the eye drops.
Assume a comfortable and stable position.
Unscrew the bottle cap.
Hold the bottle with the dropper pointing downwards between your thumb and other fingers.
Tilt your head backwards.
Gently pull down the lower eyelid with a clean finger.
Bring the tip of the bottle close to the eye.
Do not touch the eye, eyelid, surrounding area, or any other surface with the dropper tip.
Gently squeeze the bottle to release one drop of Brofestill.
Immediately after use, close the bottle cap tightly.
Keep the bottle securely closed except when administering the medicine.

If using other eye drops, wait at least 5 minutes between applying Brofestill and the other drops.
Duration of treatment
Use the drops for 2 weeks after surgery. Do not use Brofestill for longer than 2 weeks.
Use of more than the recommended dose of Brofestill
Rinse the eye with warm water. Do not use any additional drops until the next scheduled dose.
In case of accidental ingestion of Brofestill, drink a glass of water or another fluid to rinse out the
medicine.
Missed dose of Brofestill
Apply a single dose as soon as you remember. If it is nearly time for the next dose, skip the missed
dose. Continue with your regular dosing schedule. Do not use a double dose to make up for a
missed dose.
Stopping treatment with Brofestill
Do not stop using Brofestill without consulting your doctor.
In rare cases, after discontinuation of Brofestill, an increase in postoperative inflammatory
reaction following cataract surgery has been observed, for example, in the form of macular
edema.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If there is a worsening of vision or reduced visual acuity one week after completion of treatment,
you should contact your doctor immediately.
If any of the following adverse reactions occur during use of the drops, you should contact your doctor immediately:
Uncommon adverse reactions (may affect up to 1 in 100 patients)
Foreign body sensation in the eye, redness and inflammation of the eye, damage and inflammation
of the eye surface, eye discharge, itching, irritation or eye pain, swelling or bleeding
of the eyelid, impaired vision caused by inflammation, floaters or moving spots
in front of the eyes, or worsening of vision which may indicate bleeding or
damage to the back of the eye (retina), eye discomfort, light sensitivity, blurred or
reduced vision, facial swelling, cough, nosebleed or nasal congestion.
Rare adverse reactions (may affect up to 1 in 1000 patients)
Damage to the eye surface, eye redness, asthma.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products,
Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Brofestill

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after "EXP". The expiry date refers to the last day of the specified month.
Do not store above 25°C. Do not freeze.
Dispose of the bottle 4 weeks after first opening to prevent infection, even if some solution remains.
The date of opening should be recorded on the box label in the space provided for this purpose.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Brofestill contains

The active substance is bromfenac. One mL of solution contains 0.9 mg of bromfenac (as sodium bromfenac sesquihydrate). One drop contains approximately 33 micrograms of bromfenac.
The other ingredients are: boric acid, borax, sodium sulfite (E 221), benzalkonium chloride, tyloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to adjust pH to the correct level).

What Brofestill looks like and contents of the pack
A 5 mL bottle of solution made of LDPE with a dropper made of LDPE, with a PP cap
and a tamper-evident seal, in a cardboard box
Marketing Authorisation Holder
Pharm Supply Sp. z o.o.
ul. Marconich 2/9,
02-954 Warsaw
tel: +48 (22) 642 33 31
e-mail: [email protected]
Manufacturer
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA)
Italy
BRO multi ver 22 07 2024