Mibracin

Package Leaflet: Information for the Patient

Mybracin, (3 mg + 1 mg)/ml, Eye Drops, Suspension

Tobramycin + Dexamethasone

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 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 pack and other information

1. What Mybracin is and what it is used for

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

infection.Eye inflammation can result from eye surgery, infection, and other factors penetrating the eye or eye injuries.

Mybracin is a combination preparation containing an antibacterial component and

corticosteroid.Corticosteroids (in this case, dexamethasone) are useful in preventing and reducing eye inflammation. The antibacterial agent contained in the preparation (tobramycin) acts on many species of pathogenic bacteria infecting the eye.

The indication for using Mybracin 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 Mybracin

When not to use Mybracin

• if you are allergicto tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you suspect that your eye is infected(viral, tuberculous, fungal, purulent); only a doctor can then decide on the choice of treatment for the infection;
• if a foreign body has been removed from the cornea and no complications are present.

Warnings and precautions

Before starting to use Mybracin, discuss it with your doctor or pharmacist.
You should consult a doctor if you experience swelling and weight gain, particularly on the trunk and face, as these are usually the first symptoms of a disease called Cushing's syndrome. Adrenal gland suppression may occur as a result of prolonged or intensive use of Mybracin. You should consult a doctor before deciding to stop treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
If you experience blurred vision or other vision disturbances, you should contact your doctor.

Special caution should be exercised when using Mybracin if:

• you have high intraocular pressure (glaucoma);you should consult a doctor. During treatment, intraocular pressure should be regularly monitored. This is particularly important in children, as the risk of developing ocular hypertension under the influence of Mybracin may be higher in them than in adults.
• you experience eyelid itching, swelling, or redness;you should stop using the medicine and consult a doctor;
• you have a condition that causes thinning of the eye tissues, such as rheumatoid arthritis, Fuchs' dystrophy, or if you have undergone a corneal transplant. Corticosteroid-containing medications may cause additional thinning of the eye tissues and perforation.
• the medicine is used for a long time(more than 24 days); there is then a risk of increased susceptibility of the eye to infections and delayed healing of eye injuries. During the use of the preparation, the doctor should frequently monitor the intraocular pressure in the patient. You should follow the doctor's instructions.

Important information for patients wearing contact lenses

Benzalkonium chloride, used as a preservative in Mybracin, may cause
irritation of the eyes and discoloration of soft contact lenses. If you wear soft contact lenses, you should remove them before using Mybracin and then wait at least 15 minutesbefore putting them back on.
You should not wear contact lenses when you have 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 can be used in children over 2 years of age in 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.

Method of administration:

• 1. Before using the drops, wash your hands.
• 2. Shake the bottle and then unscrew the cap.
• 3. Do not touch the dropper tip to the eye or other surfaces, as this may contaminate the medicine.
• 4. Gently pull down the lower eyelid of the affected eye with your index finger.
• 5. Bring the dropper close to the eye without touching it, and gently squeeze the bottle so that only one or two drops get into the eye.
• 6. Release the lower eyelid and blink several times to ensure that the entire surface of the eye is covered with the liquid.
• 7. Repeat steps 4-6 if it is necessary to administer drops to the other eye.
• 8. After using the medicine, tighten the bottle cap properly.

If a drop does not get into the eye,you should repeat the attempt to administer the drop.
If you are using other eye medicines at the same time, you should maintain an interval of at least 10-15 minutes between administering the individual medicines.

4. Possible side effects

Like all medicines, Mybracin can cause side effects, although not everybody gets them.

You may experience some or all of the following side effects related to the eye(s):

Uncommon (side effects that occur in 1 to 10 patients per 1,000):
eye irritation, eye pain, eye itching, eye redness, tearing, feeling of discomfort or feeling of a foreign body in the eye, swelling of the conjunctiva or conjunctivitis, keratitis, allergic reactions related to the eyes, feeling of dryness in the eye, ocular hypertension, increased intraocular pressure, which may cause headaches and vision disturbances.
Frequency not known (frequency cannot be estimated from the available data): blurred vision
In addition, the following may occur: eyelid swelling and eyelid redness, glare phenomenon.

You may also experience other side effects in other parts of the body, including:

Common (side effects that occur in 1 to 10 patients per 100): runny nose.
Uncommon (side effects that occur in 1 to 10 patients per 1,000): headache, rhinorrhea, throat tightness.
Frequency not known (frequency cannot be estimated from the available data): hormonal disorders: 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, and swelling and weight gain, particularly on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").
If Mybracin is used for more than 24 days,it may increase the risk of infection and prolong the healing time of eye injuries.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Mybracin

There are no special precautions for storing the medicinal product.
The medicine should be stored 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 month.
After opening the bottle, do not use the drops for more than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Mybracin contains

• The active substances of the medicine are tobramycin and dexamethasone. One ml of the drops contains 3 mg of tobramycin and 1 mg of dexamethasone.
• The other ingredients 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 a dropper made of LDPE, with an HDPE cap, in a cardboard box, containing 5 ml of suspension.

Marketing authorization holder and manufacturer

Marketing authorization 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
Date of last revision of the leaflet:02.2023