Tobrosopt 0,3 %

Leaflet attached to the packaging: patient information

TOBROSOPT 0.3%, 3 mg/ml, eye drops, solution
Tobramycin

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tobrosopt 0.3% and what is it used for
• 2. Important information before using Tobrosopt 0.3%
• 3. How to use Tobrosopt 0.3%
• 4. Possible side effects
• 5. How to store Tobrosopt 0.3%
• 6. Contents of the packaging and other information

1. What is Tobrosopt 0.3% and what is it used for

Tobrosopt 0.3% is a medicine for the eyes, containing tobramycin, which is an aminoglycoside antibiotic.
Tobrosopt 0.3% is used:

• to treat external eye infections and their appendages (eyelid, lacrimal gland) caused by bacteria sensitive to tobramycin.

Tobrosopt 0.3% is intended for use in adults.

2. Important information before using Tobrosopt 0.3%

When not to use Tobrosopt 0.3%

• if you are allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6).
• Due to the boron content of the medicine, it should not be used in children and adolescents under 18 years of age, as well as in pregnant women (see additional information below).

Warnings and precautions

Before starting to use Tobrosopt 0.3%, discuss it with your doctor or pharmacist.
If you experience any allergic reactions after using Tobrosopt 0.3%, stop using the medicine and consult your doctor immediately (see section 4). Symptoms of hypersensitivity may vary in 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 you are using other antibiotic therapy while using Tobrosopt 0.3%, consult your doctor.
If you have or suspect myasthenia or Parkinson's disease, you should consult your doctor. Antibiotics from this group may exacerbate muscle weakness.
If your symptoms worsen or recur, consult your doctor. If you use Tobrosopt 0.3% for a long time, you may be more susceptible to eye infections.

Tobrosopt 0.3% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to use.
If you are using other eye drops or ointments, wait at least 5 minutes between administrations of the next medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Due to the boron content of Tobrosopt 0.3%, it should not be used during pregnancy.
Using Tobrosopt 0.3% is not recommended during breastfeeding. Your doctor will decide whether to continue or stop breastfeeding, or continue or stop treatment, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Tobrosopt 0.3% eye drops have no or negligible influence on the ability to drive and use machines.
For some time after administration of Tobrosopt 0.3%, vision may be blurred.
Do not drive or operate machinery until this symptom has resolved.

Tobrosopt 0.3% contains benzalkonium chloride and boric acid

The medicine contains 0.1 mg of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, consult your doctor.
The medicine contains 13 mg of boric acid (2.27 mg of boron) per 1 ml of solution.
Do not use in children and adolescents under 18 years of age due to the boron content, which may cause fertility disorders.
Pregnant women should consult their doctor before using this medicine, as it may be harmful to the fetus due to the boron content.

3. How to use Tobrosopt 0.3%

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Unless your doctor has told you otherwise, the usual dose is:

• mild to moderate infections: usually 1 or 2 drops into the infected eye (eyes) every 4 hours;
• severe infections: usually 1 or 2 drops into the eye (eyes) every hour until improvement, then the dose should be gradually reduced, as directed by your doctor.

Usually, the medicine is used for 7 to 10 days. Use the medicine for as long as your doctor tells you.
After instillation, gently close your eyelid and press the inner corner of your eye for about 2 minutes. This will help reduce the absorption of the medicine into the body.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

Use in elderly patients

In elderly patients, use the same dose as in adults.

Use in patients with liver or kidney impairment

The safety and efficacy of Tobrosopt 0.3% in patients with liver or kidney impairment have not been established.

Method of administration

The medicine is for external use only - topical application to the conjunctival sac.
Do not touch the tip of the dropper, as this may contaminate the contents of the bottle.

• 1. Before instillation, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Turn the bottle upside down and gently squeeze the bottle until one drop falls into the eye. Do not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, instill another drop.
• 5. After instillation, gently press the inner corner of your eye for about 2 minutes. This will help reduce the absorption of the medicine into the body.
• 6. If your doctor has told you to instill the medicine into both eyes, repeat steps 3, 4, and 5.
• 7. The dropper is designed to deliver a precise dose, so do not enlarge the opening of the dropper.
• 8. After instillation, replace the cap on the bottle. Do not overtighten it.

Regular instillation of the medicine is recommended throughout the entire treatment period prescribed by your doctor, even if the symptoms of the eye infection (infections) have resolved earlier.

Using a higher dose of Tobrosopt 0.3% than recommended

In case of overdose, flush the eye with lukewarm water. Do not expect any side effects. Do not instill additional drops. Administer the next dose at the usual time.

Missing a dose of Tobrosopt 0.3%

If you forget to use Tobrosopt 0.3%, continue treatment by using the next dose according to the dosing schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the recommended dosing schedule. Do not use a double doseto make up for the missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, stop using Tobrosopt 0.3% and contact your doctor or the Emergency Department of your nearest hospital immediately.
The following side effects have been reported during the use of Tobrosopt 0.3% eye drops.
Common side effects (may affect up to 1 in 10 people)
Eye symptoms: feeling of discomfort in the eye, eye redness.
Uncommon side effects (may affect up to 1 in 100 people)
Eye symptoms: inflammation of the eye surface, corneal damage, vision disturbances, blurred vision, eyelid redness, eye and eyelid swelling, eye pain, dry eye, eye discharge, eye itching, increased tear production.
General symptoms: allergy (hypersensitivity), headache, hives, skin inflammation, reduced eyelash growth or eyelash loss, skin depigmentation, itching, and skin dryness.
Frequency not known (cannot be estimated from the available data)
Eye symptoms: eye allergy, eye irritation, eyelid itching.
General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, 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
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 to gather more information on the safety of this medicine.

5. How to store Tobrosopt 0.3%

Store in a temperature below 25°C.
Keep the bottle tightly closed in the outer packaging.
Store the medicine out of the 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.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
After opening the bottle, do not use the medicine for more than 4 weeks.
Medicines should 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 Tobrosopt 0.3% contains

• The active substance is tobramycin. Each 1 ml of solution contains 3 mg of tobramycin.
• The other ingredients are: boric acid, sodium chloride, anhydrous sodium sulfate, benzalkonium chloride solution, purified water.

What Tobrosopt 0.3% looks like and contents of the pack

Tobrosopt 0.3% is a sterile eye drop solution in the form of a colorless, clear liquid.
A colorless LDPE bottle with a capacity of 5 ml with a colorless LDPE dropper and a white HDPE cap in a cardboard box.

Marketing authorization holder

PHARMACEUTICAL WORKS POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

WARSZAWSKIE ZAKŁADY FARMACEUTYCZNE POLFA S.A.
ul. Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: