Infladrop

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Infladrop and what is it used for

Infladrop 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.
Infladrop is used to reduce inflammation of the eye after cataract surgery in adults.

2. Important information before using the medicine

When not to use Infladrop

• if the patient is allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had asthma, skin allergy, or intense nasal inflammation while using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Warnings and precautions

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

• if the patient is using topical steroid medicines (e.g. cortisone), as this may cause side effects,
• if the patient has bleeding disorders (e.g. hemophilia) or if they have occurred in the past or if the patient is taking other medicines that may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid),
• if the patient has eye disease (e.g. dry eye syndrome, corneal disease),
• if the patient has diabetes,
• if the patient has rheumatoid arthritis,
• if the patient has had repeated eye surgery recently.

It is not recommended to wear contact lenses after cataract surgery. For this reason, do not wear contact lenses while using Infladrop.

Children and adolescents

Infladrop should not be used in children and adolescents.

Infladrop and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Infladrop should not be used during the last three months of pregnancy.
The doctor may prescribe this medicine during pregnancy if the expected benefit to the mother outweighs the potential risk to the child.
Infladrop may 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 Infladrop

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Dose
The recommended dose is one drop of Infladrop into the affected eye(s) twice a day (morning and evening). Do not use more than one drop into the affected eye(s) twice a day.
Infladrop treatment should be started the day after cataract surgery.
Method of administration
Infladrop should be administered into the eye.

• 1) Before using the eye drops, wash your hands.
• 2) Take a comfortable and stable position.
• 3) Open the aluminum sachet containing the single-dose containers.
• 4) Tear off one single-dose container from the strip.

• 5) Put the strip with the remaining single-dose containers back into the sachet and fold the edge to close the sachet.
• 6) To open the single-dose container, twist the top part of the container.

• 7) Hold the container between your thumb and index finger.
• 8) Tilt your head back or lie down. Look up and with a clean finger of the other hand, pull down the lower eyelid. Do not let any part of the container touch the eye or its surroundings. Release one drop into the space between the eyelid and the eyeball by gently squeezing the container.

• 9) Close your eye and press the inner corner of your eye with your finger for about two minutes. This prevents the medicine from entering the entire body.

• 10) Wipe off any excess solution from the skin around the eye.

If the doctor recommends using the medicine in both eyes, steps 7 to 9 should be repeated for the second eye. After use, discard the single-dose container with any remaining medicine.
If other eye drops are used, wait 5 minutes between using Infladrop and other eye drops.
Duration of treatment
The medicine should be used for 2 weeks after surgery. Do not use Infladrop for more than 2 weeks.

Using more Infladrop than recommended

Rinse your eye with warm water. Do not use any additional drops until the next scheduled dose. If Infladrop is accidentally ingested, drink a glass of water or other fluid to dilute the medicine.

Missing a dose of Infladrop

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 scheduled. Do not use a double dose to make up for a missed dose.

Stopping Infladrop treatment

Do not stop using Infladrop without consulting your doctor.
In rare cases, after stopping the use of eye drops with bromfenac, an increase in inflammatory reactions has been observed, e.g. retinal edema after cataract surgery.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Infladrop can cause side effects, although not everybody gets them.
If your vision worsens 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 points 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)

Damaged eye surface, redness of the eye, asthma.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Infladrop

Keep the medicine out of the 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 month stated.
Store in a temperature below 25°C.
Single-dose containers should be stored in the aluminum sachet.
After opening the aluminum sachet, the shelf life of the single-dose containers is 7 days; after this time, discard any unused containers remaining in the sachet.
The medicine does not contain preservatives: after opening the single-dose container, use the medicine immediately.
After instilling the medicinal product into the eye(s), discard the single-dose container, even if there are remaining solution.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Infladrop contains

• The active substance of the medicine 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 maintain the correct acidity).

What Infladrop looks like and what the pack contains

Infladrop is a clear, greenish-yellow liquid (solution) available in single-dose containers of LDPE with a capacity of 0.25 mL. The packaging contains 4 sachets with PET/Aluminum/PE containing 5 connected single-dose containers each – a total of 20 single-dose containers

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A,
05–152 Czosnów
phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Genetic S.p.A.
Nucleo Industriale
Contrada Canfora
84084 Fisciano (SA)
Italy

Date of last revision of the leaflet: