Brazoflamin

Patient Information Leaflet

Brazoflamin, (3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet for possible future reference.
If you have any further questions, please consult your doctor or pharmacist.

• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical. If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Brazoflamin is and what it is 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 Brazoflamin is and what it is used for

Brazoflamin is used to treat inflammatory eye conditions that may be associated with
infection. Eye inflammation may result from ophthalmic surgery, infection, or may be caused by the presence of a foreign body or eye injury.
Brazoflamin is a combination medicine containing an antibacterial agent and a
corticosteroid. Corticosteroids (in this case, dexamethasone) are used to prevent and reduce inflammatory reactions. The antibacterial agent contained in the medicine (tobramycin) acts against many species of bacteria causing eye infections.
The indication for Brazoflamin is the prevention and treatment of inflammation and the prevention of infections associated with surgical cataract treatment in adults and children aged 2 years and older.

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:
• viral keratitis caused by herpes virus,
• viral keratitis caused by cowpox virus, varicella/zoster virus or other viral diseases of the cornea or conjunctiva, ocular tuberculosis, fungal eye infection or untreated parasitic eye infections, untreated purulent eye infections, or if a foreign body has been removed from the cornea and there are no signs of complications.

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

• If the patient experiences allergic reactions after using Brazoflamin, treatment should be discontinued and medical advice sought immediately (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may occur when using other topical or systemic antibiotics from the same group (aminoglycosides).
• If symptoms worsen or suddenly recur, consult a doctor. During treatment with this medicine, the patient may be more susceptible to eye infections.
• If the patient is using other antibiotics, including those taken orally, while using Brazoflamin, medical advice should be sought.
• If the patient has or is suspected of having myasthenia gravis or Parkinson's disease, they should consult a doctor. Antibiotics from this group may worsen muscle weakness.
• If the patient uses Brazoflamin for a prolonged period, the following may occur:
  • increased susceptibility to eye infections,
  • increased intraocular pressure,
  • development of cataracts,
  • development of Cushing's syndrome due to systemic absorption of the drug. Seek medical advice if the patient develops swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Brazoflamin. Consult a doctor before deciding to stop treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• During treatment with Brazoflamin, intraocular pressure should be monitored regularly; consult a doctor. This is particularly important in children, as the risk of corticosteroid-induced ocular hypertension may be higher and may develop more rapidly in children than in adults. Consultation with a doctor is especially advised in children and adolescents. The risk of corticosteroid-induced ocular hypertension and cataract formation is also higher in patients with other diseases (e.g., diabetic patients).
• Steroid medicines administered to the eye may delay healing of eye injuries. Topically applied nonsteroidal anti-inflammatory drugs (NSAIDs) may slow down and delay the healing process. Concurrent topical use of NSAIDs and steroid medicines may increase the risk of eye healing problems.
• If the patient has a condition causing thinning of eye tissues, consult a doctor or pharmacist.
• If the patient develops persistent corneal ulceration while using Brazoflamin, they should seek medical advice immediately, as this may be a sign of fungal eye infection.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Brazoflamin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if nonsteroidal anti-inflammatory drugs (NSAIDs) are being used.
Concurrent topical use of a steroid medicine and a nonsteroidal anti-inflammatory drug may lead to problems with healing of eye injuries.
If the patient is using other eye drops or ointments at the same time, wait at least 5 minutes between applications of each medicine. Eye ointments should be applied last.
Inform the doctor if taking ritonavir or cobicistat, as these medicines may increase the blood levels of dexamethasone.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Use of Brazoflamin is not recommended during pregnancy and breastfeeding.

Driving and using machines
Brazoflamin has no or negligible effect on the ability to drive and use machinery.
Vision may be blurred for a short time after instillation of Brazoflamin. Do not drive or operate machinery until this effect has subsided.

Brazoflamin contains benzalkonium chloride
Brazoflamin contains 0.1 mg of benzalkonium chloride per millilitre (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter 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 abnormal sensations, stinging or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Brazoflamin

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Brazoflamin is intended exclusively for ophthalmic use.
Instil one to two drops of the medicine into the conjunctival sac (sacs) of the affected eye(s) every 4–6 hours. The duration of treatment will be determined by the physician.

Use in children and adolescents
Brazoflamin may be used in children aged 2 years and older at the same dosage as in adults. Safety and efficacy in children under 2 years of age have not been established, and there are no data available on use in this age group.

Use in patients with hepatic or renal impairment
The effect of Brazoflamin has not been studied in these patient populations. However, due to the minimal systemic absorption of tobramycin and dexamethasone following topical ophthalmic administration, dosage adjustment is not considered necessary.

Instructions for use:

1. Wash your hands before using the drops.
2. Shake the bottle and unscrew the cap.
3. Hold the bottle in your hand with the bottom facing upwards.
4. Tilt your head backwards and gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball.

5. Bring the dropper tip close to the eye. A mirror may be used to assist.
6. Do not let the dropper tip touch the eye, eyelid, surrounding area, or any other surface. Failure to follow this instruction may result in contamination of the drops.
7. Gently squeeze the bottom of the bottle to release one drop of Brazoflamin into the eye. If the drop does not enter the eye, repeat the instillation attempt.

8. After instilling Brazoflamin, release the lower eyelid. Close the eye gently and press with a finger on the inner corner of the eye near the nose. This helps prevent the medicine from draining into the systemic circulation.
9. If treatment of both eyes is required, repeat the above steps for the second eye.
10. Immediately after use, replace the cap on the bottle.

Overdose of Brazoflamin
If more than the recommended dose is used, excess medicine can be rinsed from the eye with lukewarm water. Do not instil additional drops. The next dose should be administered at the usual time.

Missed dose of Brazoflamin
If the patient forgets to use Brazoflamin, they should continue treatment by instilling the next dose according to the prescribed schedule. If the next dose is due shortly, the missed dose should be skipped and treatment continued as prescribed. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue, and (or)
throat, which may cause difficulty in breathing or swallowing, or other serious adverse effects occur,
treatment with Brazoflamin should be discontinued immediately and the patient should contact a doctor or the nearest hospital Emergency Department.
The following adverse effects have been observed in patients:
Not common (may occur in up to 1 in 100 people): increased intraocular pressure, eye pain, eye itching, sensation of eye discomfort, eye irritation.
Rare (may occur in up to 1 in 1000 people): corneal inflammation, eye allergy, blurred vision, dry eye syndrome, eye redness, taste disturbances.
Frequency unknown (frequency cannot be estimated based on available data): eyelid swelling, eyelid redness, pupil dilation, excessive tearing, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, facial swelling, excessive body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, increased blood pressure, irregular menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and swelling with increased body weight, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects allows the collection of additional information on the safety of using the medicine.

5. How to store Brazoflamin

No special storage instructions are required. Do not freeze.
Store the bottle in an upright position, tightly closed.
Keep the medicine 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 stated month.
To avoid contamination of the medicine, discard the bottle 4 weeks after first opening.
Medicines must 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. Contents of the packaging and other information

What Brazoflamin contains
The active substances in this medicine are tobramycin and dexamethasone. Each ml of eye 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.
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 contents of the pack
Brazoflamin is a white, homogeneous suspension supplied in a 10 ml LDPE bottle with an LDPE dropper, HDPE and LDPE cap, HDPE tamper-evident ring, and in a cardboard box.
Each bottle contains 5 ml of eye drops.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków 65 Street
02-255 Warsaw
Poland

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