Mybracin

Package leaflet: Information for the patient

Mybracin, (3 mg + 1 mg)/ml, eye drops, suspension
Tobramycinum + Dexamethasonum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

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

1. What Mybracin is and what it is used for

Mybracin is used to treat inflammatory eye diseases that may be associated with
infection. Eye inflammation may result from ophthalmic procedures, infections, or other factors penetrating the eye, as well as eye injuries.
Mybracin is a combination preparation containing an antibacterial agent and a
corticosteroid. Corticosteroids (in this case, dexamethasone) are useful in preventing and reducing ocular inflammation. The antibacterial agent contained in the preparation (tobramycin) acts against many species of pathogenic bacteria causing eye infections.
The indication for Mybracin is the prevention and treatment of inflammation and
prevention of infections associated with cataract surgery in adults and children aged 2 years and older.

2. Information before using Mybracin

When not to use Mybracin

• if the patient is allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient suspects that their eye is affected by an infection (viral, tuberculous, fungal, purulent); only a doctor can decide on the appropriate treatment for such an infection;
• if a foreign body has been removed from the cornea and there are no signs of complications.

Warnings and precautions
Before starting to use Mybracin, discuss it with your doctor or pharmacist.
Contact your doctor 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. Suppression of adrenal function may occur following discontinuation
of prolonged or intensive treatment with Mybracin. Contact your doctor before
deciding to stop treatment. This risk is particularly significant in children and in patients
treated with ritonavir or cobicistat.
If the patient experiences blurred vision or other visual disturbances, contact a
doctor.
Special caution is required when using Mybracin if:

• the patient has elevated intraocular pressure (glaucoma); consult a doctor. Intraocular pressure should be monitored regularly during treatment. This is particularly important in children, as the risk of developing corticosteroid-induced ocular hypertension may be higher in children than in adults.
• itching of the eyelids, swelling, or redness of the eye occurs; discontinue use of the medicine and consult a doctor;
• the patient has a condition causing thinning of ocular tissues, such as rheumatoid arthritis, Fuchs' dystrophy, or if the patient has undergone corneal transplantation. Medicines containing corticosteroids may cause further thinning of ocular tissues and perforation.
• the medicine is used long-term (more than 24 days); there is then an increased risk of susceptibility to eye infections and delayed healing of ocular wounds. During treatment, the doctor should frequently monitor intraocular pressure. Follow medical advice carefully.

Important information for contact lens wearers
Benzalkonium chloride, used as a preservative in Mybracin, may
cause eye irritation and discoloration of soft contact lenses. If the patient
wears soft contact lenses, they should be removed before applying Mybracin, and
at least 15 minutes should elapse before reinserting them.
Contact lenses should not be worn when there is an eye infection.
Mybracin and other medicines

Mybracin contains benzalkonium chloride.
Benzalkonium chloride may be absorbed by contact lenses (see above "Important information for patients wearing contact lenses").
3. How to use Mybracin

Use in children and adolescents
The medicine may be used in children aged 2 years and older at the same doses as in adults.
Safety and efficacy in children under 2 years of age have not been established, and no data are available on this subject.

Instructions for use:

1. Wash hands before applying the drops.
2. Shake the bottle and then unscrew the cap.
3. Do not touch the eye or any other surface with the dropper tip, as this may contaminate the medicine.
4. Gently pull down the lower eyelid of the affected eye using the index finger.
5. Bring the dropper tip close to the eye without touching it, and gently squeeze the bottle so that only one or two drops enter the eye.
6. Release the lower eyelid and blink several times to ensure the entire surface of the eye is covered with the liquid.
7. Repeat steps 4 to 6 if instillation into the second eye is required.
8. After using the medicine, tightly replace the cap on the bottle.

If a drop misses the eye, repeat the instillation attempt.

If the patient is using other eye medications simultaneously, a gap of at least 10–15 minutes between the administration of each medication is required.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following eye-related adverse reactions may occur in patients, either some or all of them:
Not common (adverse reactions occurring in 1 to 10 patients per 1,000):
eye irritation, eye pain, eye itching, eye redness, eye tearing/tearing of eyes, feeling of discomfort or sensation of a foreign body in the eye, conjunctival swelling or conjunctivitis, corneal inflammation, allergic reactions affecting the eyes, dry eye sensation, ocular hypertension, increased intraocular pressure, which may cause headaches and vision disturbances.
Frequency unknown (frequency cannot be estimated from available data): blurred vision. In addition, eyelid swelling and eyelid erythema, and glare phenomenon may occur.

Patients may also experience other adverse reactions affecting other parts of the body, including:
Common (adverse reactions occurring in 1 to 10 patients per 100):
postnasal drip.
Not common (adverse reactions occurring in 1 to 10 patients per 1,000):
headache, watery nasal discharge, throat tightness.
Frequency unknown (frequency cannot be estimated from available data): hormonal disturbances: 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 and increased body weight, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

If Mybracin is used for longer than 24 days, it may increase the risk of infection and delay wound healing.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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: 22 49-21-301, fax: 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 provide more information on the safety of the medicine.

5. How to store Mybracin
No special storage precautions are required for this medicinal product.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use the drops for longer than 4 weeks.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Mybracin contains

• The active substances in the medicine are tobramycin and dexamethasone. One ml of eye drops contains 3 mg of tobramycin and 1 mg of dexamethasone.
• Other components are: benzalkonium chloride, hydroxyethylcellulose, disodium edetate, tyloxapol, sodium chloride, anhydrous sodium sulfate (E 514), sulfuric acid and (or) sodium hydroxide for pH adjustment, water for injections.

What Mybracin looks like and contents of the pack
Mybracin is a white, homogeneous suspension.
A 10 ml LDPE bottle with an LDPE dropper and HDPE screw cap, in a cardboard box, containing 5 ml of suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Rafarm S.A. Thesi Pousi-Xatzi Agiou Louka
Paiania, Athens 19002
P.O.Box 37 Greece