Patient Information Leaflet

Brofestill, 0.9 mg/mL, eye drops, solution in single-dose container
Bromfenac
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, 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 following 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
Talk to your doctor or pharmacist before using Brofestill:

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

Wearing contact lenses after cataract surgery is not recommended. Therefore, you should not wear contact lenses during treatment with Brofestill.
Children and adolescents
Brofestill should not be used in children and adolescents.
Brofestill with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor before using this medicine.
Brofestill should 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 unborn child.
Brofestill may be prescribed to breastfeeding women and has no significant effect on fertility.
Driving and using machines
Blurred vision may occur briefly after using this medicine. Patients who experience reduced visual acuity after using the medicine should not drive or operate machinery until these symptoms have resolved.

3. How to use Brofestill

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Dosage
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 per treated eye (eyes) 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.
Open the sachet.
Detach one single-dose container from the strip.
Open the single-dose container by bending or twisting the tip – the medicine should be used immediately after opening.
Tilt your head backward.
Gently pull down the lower eyelid with a clean finger.
Bring the container tip close to the eye.
Do not touch the tip of the container to the eye, eyelid, surrounding area, or any other surface.
Gently squeeze out one drop into the conjunctival sac.
If your doctor has instructed you to do so, also administer one drop into the other eye.
After use, discard the single-dose container. Do not store it for later use.
To protect from light, store the remaining single-dose containers in the sachet and use within 7 days of first opening the sachet.

If you are using other eye drops, wait at least 5 minutes between applying Brofestill and the other eye 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 eye drops until the next scheduled dose. In case of accidental ingestion of Brofestill, drink a glass of water or another liquid to rinse the medicine out.
Missed dose of Brofestill
Apply a single dose as soon as you remember. If it is almost time for your 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 Brofestill
Do not stop using Brofestill without consulting your doctor.
In rare cases, after discontinuation of Brofestill, an exacerbation of inflammatory reaction following cataract surgery has been observed, for example, in the form of macular edema.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
If there is a deterioration in vision or reduced visual acuity one week after completion of treatment,
immediate contact with a physician is required.
If any of the following adverse reactions occur during use of the drops, contact a physician immediately:

Uncommon adverse reactions (may occur in up to 1 in 100 patients)
Foreign body sensation in the eye, eye redness and inflammation, damage and inflammation of
the eye surface, eye discharge, itching, irritation or eye pain, swelling or bleeding of the eyelid,
impaired vision due to inflammatory conditions, floaters or moving spots before the eyes, or
worsening of vision which may indicate bleeding or damage to the back of the eye (retina), eye
discomfort, photophobia (light sensitivity), blurred or diminished vision, facial swelling, cough,
nosebleeds or nasal congestion.

Rare adverse reactions (may occur in up to 1 in 1000 patients)
Damage to the eye surface, eye redness, asthma.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of 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 marketing authorization holder.
Reporting adverse reactions helps to increase knowledge about the safety of this medicine.

5. How to store Brofestill

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after: "EXP".
The expiry date refers to the last day of the specified month.
Do not store above 25°C. Do not freeze.
Single-dose containers should be stored in the pouch to protect from light.
Unused containers must be discarded 7 days after first opening the pouch.
Each single-dose container of Brofestill is sterile and contains no preservatives.
Therefore, it should be used immediately after opening, and any remaining contents after use must be discarded.
The date of opening should be recorded on the label of the carton in the space provided for this purpose.
Medicines must 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 packaging and other information

What Brofestill contains

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

What Brofestill looks like and contents of the pack

Single-dose LDPE containers containing 0.250 mL of solution.
Packaging: 5, 10, 20 or 30 single-dose containers, packed in sets of 5 in a PET/Al/PE pouch within a cardboard box.

Marketing Authorisation Holder
Pharm Supply Sp. z o.o.
ul. Marconich 2/9,
02-954 Warsaw,
Poland
Tel: +48 (22) 642 33 31
Email: [email protected]

Manufacturer
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA),
Italy

BRO(unit) ver 22 07 2024