Brazoflamin

Leaflet accompanying the packaging: patient information

Brazoflamin, (3 mg + 1 mg)/ml, eye drops, suspension

Tobramycin + Dexamethasone

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 those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Brazoflamin and what is it used for
• 2. Important information before using Brazoflamin
• 3. How to use Brazoflamin
• 4. Possible side effects
• 5. How to store Brazoflamin
• 6. Contents of the pack and other information

1. What is Brazoflamin and what is it used for

Brazoflamin is used to treat inflammatory eye diseases, which may be accompanied by

infection. Eye inflammation can result from eye surgery, infection, or be caused by the presence of a foreign body or eye injury.

Brazoflamin is a combination drug containing an antibacterial component and

corticosteroid. Corticosteroids (in this case, dexamethasone) are used to prevent and reduce inflammation. The antibacterial drug contained in the medicine (tobramycin) acts on many species of pathogenic bacteria that infect the eye.

The indication for using Brazoflamin is to prevent and treat inflammation and prevent infections related to cataract surgery in adults and children over 2 years of age.

2. Important information before using Brazoflamin

When not to use Brazoflamin

• if the patient is allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6), or if the patient has:
• herpes simplex virus keratitis,
• varicella-zoster virus keratitis, chickenpox, shingles, or other viral diseases of the cornea or conjunctiva, ocular tuberculosis, fungal eye infection, or untreated parasitic eye infections, untreated purulent eye infections, if the patient has had a foreign body removed from the cornea and no complications have occurred.

Warnings and precautions

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

• If the patient experiences allergic reactions after using Brazoflamin, they should stop the treatment and consult a doctor immediately (see section 4). Hypersensitivity symptoms can have varying severity: from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may occur when using other topical or systemic antibiotics from the same group (aminoglycosides).
• If the patient's symptoms worsen or suddenly recur, they should consult a doctor. During the use of this medicine, the patient may be more prone to eye infections.
• If the patient is using other antibiotics, including those taken orally, they should consult a doctor.
• If the patient has or is suspected of having myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group may exacerbate muscle weakness.
• If the patient uses Brazoflamin for a longer period, they may:
• experience increased susceptibility to eye infections,
• experience increased eye pressure (in the eyes),
• develop cataracts,
• develop Cushing's syndrome caused by the absorption of the medicine into the blood. The patient should consult a doctor if they experience swelling and weight gain, especially on the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive use of Brazoflamin. The patient should consult a doctor before deciding to stop the treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• During the use of Brazoflamin, the patient should regularly have their intraocular pressure checked; they should consult a doctor. This is especially important in children, as the risk of developing ocular hypertension caused by corticosteroids may be higher in children and may occur faster than in adults. Especially in the case of children and adolescents, the patient should consult a doctor. The risk of ocular hypertension caused by corticosteroids and cataract formation is also higher in patients with other diseases (e.g., patients with diabetes).
• Corticosteroids administered to the eye can cause delayed wound healing. Topical non-steroidal anti-inflammatory drugs (NSAIDs) can slow down and delay the healing process. Concurrent topical use of non-steroidal anti-inflammatory drugs and corticosteroids may cause a risk of eye healing problems.
• If the patient has a disease that causes thinning of the eye tissues, they should consult a doctor or pharmacist.
• If the patient experiences persistent corneal ulceration while using Brazoflamin, they should consult a doctor as soon as possible, as this may be a sign of fungal eye infection.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Brazoflamin and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should especially tell their doctor if they are using non-steroidal anti-inflammatory drugs (NSAIDs).
Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may cause problems with eye healing.
If the patient is using other eye drops or ointments, they should leave an interval of at least 5 minutes between administering the medicines. Eye ointments should be used last.
The patient should tell their doctor about taking ritonavir or cobicistat, as these medicines may increase the dexamethasone content in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Brazoflamin is not recommended during pregnancy and breastfeeding.

Driving and using machines

Brazoflamin has no or negligible influence on the ability to drive and use machines.
For some time after administering Brazoflamin, vision may be blurred. The patient should not drive or operate machines until this symptom has resolved.

Brazoflamin contains benzalkonium chloride

Brazoflamin contains 0.1 mg of benzalkonium chloride per milliliter (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Brazoflamin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Brazoflamin is intended exclusivelyfor administration to the eyes.
The patient should instill one to two drops of the medicine into the conjunctival sac (sacs) of the infected eye (eyes) every 4-6 hours. The doctor will determine how long the patient should use the medicine.

Use in children and adolescents

Brazoflamin can be used in children over 2 years of age in the same doses as in adults. The safety and efficacy in children under 2 years of age have not been established, and there are no data available for this age group.

Use in patients with liver or kidney impairment

The action of Brazoflamin has not been studied in these patient populations. However, due to the low systemic absorption of tobramycin and dexamethasone after their topical administration, it is considered that there is no need to modify the dosage.

Method of administration:

• 1. Before using the drops, the patient should wash their hands.
• 2. Shake the bottle and unscrew the cap.
• 3. Hold the bottle in the hand and point it upwards with the bottom.
• 4. Tilt the head back and pull the lower eyelid down with a clean finger, creating a "pocket" between the eyelid and the eyeball.

• 5. Bring the dropper tip close to the eye. For convenience, the patient can use a mirror.
• 6.

Do not touch the dropper tip to the eye, eyelid, or surrounding areas.

Failing to follow this instruction may cause contamination of the drops.

• 7. Gently squeeze the bottom of the bottle to release one drop of Brazoflamin. If the drop does not get into the eye, the patient should repeat the attempt.

• 8. After administering the medicine, the patient should release the lower eyelid. They should gently close their eye and press the corner of their eye near the nose with their finger. This will prevent the medicine from entering the entire body.
• 9. If it is necessary to administer the medicine to both eyes, the patient should repeat the above steps for the second eye.
• 10. Immediately after using the medicine, the patient should tighten the bottle cap.

Using a higher dose of Brazoflamin than recommended

If a higher dose than recommended is used, the excess medicine can be rinsed out of the eye with warm water. The patient should not re-administer the eye drops. The next dose should be administered at the usual time.

Missing a dose of Brazoflamin

If the patient forgets to use Brazoflamin, they should continue the treatment by administering the next dose according to the dosage schedule. If there is not much time left before the next dose, the patient should skip the missed dose and continue the treatment according to the recommended dosage schedule. The patient should not use a double doseto make up for the missed dose.

In case of any further doubts about using this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Brazoflamin can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, face, lip, tongue, and (or)
throat swelling, which may cause difficulty breathing or swallowing, or other severe
side effects, they should stop using Brazoflamin and immediately contact their doctor or the Emergency Department of the nearest hospital.
Patients have reported the following side effects:
Uncommon (may affect up to 1 in 100 people):high intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.
Rare (may affect up to 1 in 1,000 people):keratitis, eye allergy, blurred vision, dry eye syndrome, eye redness, taste disturbances.
Frequency not known (frequency cannot be estimated from the available data):eyelid swelling, eyelid redness, pupil dilation, increased tearing, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, face swelling, increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, as well as swelling and weight gain, especially on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Brazoflamin

There are no special precautions for storing the medicine. Do not freeze.
Store the bottle in an upright position, tightly closed.
The medicine should be stored out of sight and reach of children.
Do not use Brazoflamin after the expiry date stated on the carton and bottle after: EXP. The expiry date refers to the last day of the specified month.
To avoid contamination of the medicine, the bottle should be discarded 4 weeks after first opening.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Brazoflamin contains

The active substances of the medicine are tobramycin and dexamethasone. Each milliliter of the drops contains 3 mg of tobramycin and 1 mg of dexamethasone. One drop contains 0.1 mg of tobramycin and 0.04 mg of dexamethasone.
The other ingredients are: hydroxyethylcellulose, benzalkonium chloride, disodium edetate, tyloxapol, sodium chloride, anhydrous sodium sulfate, sodium hydroxide, and (or) sulfuric acid (for pH adjustment), water for injections.

What Brazoflamin looks like and what the pack contains

Brazoflamin is a white, homogeneous suspension supplied in a 10 ml LDPE bottle with a dropper made of LDPE, a cap made of HDPE and LDPE, a guarantee ring made of HDPE, in a cardboard box.
Each bottle contains 5 ml of eye drops.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Rafarm S.A.
Thesi Pousi-Xatzi Agiou Louka
19002, Paiania Attiki
P.O. Box 37
Greece

Date of last revision of the leaflet: