Brofestill

Package Leaflet: Information for the User

Brofestill, 0.9 mg/mL, eye drops, solution in a single-dose container
Bromfenac

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Brofestill and what is it used for
• 2. Important information before using Brofestill
• 3. How to use Brofestill
• 4. Possible side effects
• 5. How to store Brofestill
• 6. Package contents and other information

1. What is Brofestill and what is it 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 inflammation of the eye 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 had asthma, skin allergy, or intense inflammation of the nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Warnings and precautions

Before starting to use Brofestill, discuss it with your doctor or pharmacist.

• if you are using steroid medicines (e.g., cortisone) locally, as this may cause side effects,
• if you have blood clotting disorders (e.g., hemophilia) or if you have had them in the past or if you are taking other medicines that may prolong bleeding time (e.g., warfarin, clopidogrel, acetylsalicylic acid),
• if you have eye disease (e.g., dry eye syndrome, corneal disease),
• if you have diabetes,
• if you have rheumatoid arthritis,
• if you have had recent eye surgery.

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

Children and adolescents

Brofestill should not be used in children and adolescents.

Brofestill and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 potential risk to the child.
Brofestill can be prescribed to a breastfeeding woman and has no significant effect on fertility.

Driving and using machines

For a short time after using the medicine, blurred vision may occur. Patients experiencing decreased visual acuity after using the medicine should not drive or operate machines until these symptoms have resolved.

3. How to use Brofestill

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dose
The recommended dose is one drop of Brofestill into the affected eye (eyes) twice a day (morning and evening). Do not use more than one drop into the affected eye (eyes) twice a day.
Start using Brofestill the day after cataract surgery.
Method of administration
Brofestill should be administered into the eye.

• Wash your hands before using the eye drops.
• Take a comfortable and stable position.
• Open the sachet
• Remove one single-dose container from the strip
• Open the single-dose container by bending or twisting the tip - use the medicine immediately after opening.
• Tilt your head back.
• Use a clean finger to pull the lower eyelid down.
• Bring the tip of the container close to the eye.
• Do not touch the tip of the container to the eye, eyelid, or surrounding area.
• Gently squeeze one drop into the conjunctival sac.
• If your doctor has told you to use one drop in both eyes, repeat the process for the other eye
• After use, throw away the single-dose container. Do not store it for later use.
• To protect from light, store any unused single-dose containers in the sachet for no more than 7 days after first opening the sachet.

If you are using other eye drops, wait 5 minutes between using Brofestill and the other eye drops.
Duration of treatment
Use the drops for 2 weeks after surgery. Do not use Brofestill for more than 2 weeks.

Using more than the recommended dose of Brofestill

Rinse your eye with warm water. Do not use any more drops until the next scheduled dose. If you accidentally swallow Brofestill, drink a glass of water or other liquid to rinse out the medicine.

Missing a dose of Brofestill

Use a single dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Continue using the medicine as you did before. Do not use a double dose to make up for the missed dose.

Stopping use of Brofestill

Do not stop using Brofestill without talking to your doctor.
In rare cases, after stopping the use of Brofestill, an increase in inflammatory reactions has been observed after cataract surgery, e.g., in the form of macular edema.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your vision gets worse or your visual acuity decreases after one week of finishing 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)

Feeling of a foreign body in the eye, redness and inflammation of the eye, damage and inflammation of the eye surface, discharge from the eye, itching, irritation, or pain in the eye, swelling or bleeding of the eyelid, impaired vision due to inflammation, floaters or moving dots before the eyes, or decreased vision, which may indicate bleeding or damage to the back of the eye (retina), eye discomfort, sensitivity to light, blurred or decreased vision, facial swelling, cough, nosebleed, or runny nose.

Rare side effects (may affect up to 1 in 1,000 people)

Damage to the eye surface, redness of the eye, asthma.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on 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 month.
Do not store above 25°C. Do not freeze.
Single-dose containers should be stored in the sachet to protect from light. After 7 days from the first opening of the sachet, unused single-dose containers should be discarded.
Each single-dose container of Brofestill is sterile and does not contain preservatives. Therefore, after opening, it should be used immediately, and any remaining contents should be discarded.
Write the date of opening on the carton in the space provided.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Brofestill contains

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

What Brofestill looks like and contents of the pack

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

Marketing authorization holder

Pharm Supply Sp. z.o.o
ul. Marconich 2/9,
02-954 Warsaw
tel: +48 (22) 642 33 31
e-mail: kontakt@pharmsupply.com.pl

Manufacturer

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

Date of last revision of the package leaflet:

BRO(unit) ver 22 07 2024