Tobrosopt 0.3 %
Poland
Table of Contents
Patient Information Leaflet
TOBROSOPT 0.3%, 3 mg/ml, eye drops, solution
Tobramycinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Tobrosopt 0.3% is and what it is used for
- Important information before using Tobrosopt 0.3%
- How to use Tobrosopt 0.3%
- Possible side effects
- How to store Tobrosopt 0.3%
- Contents of the pack and other information
1. What Tobrosopt 0.3% is and what it is used for
Tobrosopt 0.3% is an ophthalmic medicine containing tobramycin, which is an aminoglycoside antibiotic.
Tobrosopt 0.3% is used:
- for the treatment of external infections of the eye and its adnexa (eyelids, lacrimal apparatus), 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 the patient is allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6).
- Due to the boron content, do not use in children and adolescents under 18 years of age or in pregnant women (see additional information below).
Warnings and precautions
Before starting treatment with Tobrosopt 0.3%, consult a doctor or pharmacist.
If the patient experiences allergic reactions after using Tobrosopt 0.3%, discontinue use immediately and consult a doctor without delay (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 antibiotics from the same group (aminoglycosides), whether applied locally or systemically.
If the patient is undergoing other antibiotic therapy while using Tobrosopt 0.3%, consult a doctor.
If the patient has or is suspected of having myasthenia gravis or Parkinson's disease, medical advice should be sought. Antibiotics from this group may worsen muscle weakness.
If symptoms of the disease worsen or recur, consult a doctor. Prolonged use of Tobrosopt 0.3% may increase susceptibility to eye infections.
If persistent corneal ulceration occurs during treatment with Tobrosopt 0.3%, the patient should seek immediate medical advice, as this may be a sign of fungal eye infection.
Tobrosopt 0.3% and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
If the patient is using other eye drops or ointments simultaneously, wait at least 5 minutes between administering each product. Eye ointments should be applied last.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Due to the boron content, Tobrosopt 0.3% must not be used during pregnancy.
Use of Tobrosopt 0.3% is not recommended during breastfeeding. The doctor will decide whether to continue or discontinue breastfeeding or to continue or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and operating machinery
Tobrosopt 0.3% eye drops have no or negligible effect on the ability to drive and operate machinery.
For a short period after instillation of Tobrosopt 0.3% eye drops, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.
Tobrosopt 0.3% contains benzalkonium chloride and boric acid
This medicine contains 0.1 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion. Benzalkonium chloride may also cause eye irritation, particularly 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.
This medicine contains 13 mg of boric acid (2.27 mg of boron) in each 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 a doctor before using this medicine, as the medicine may be harmful to the unborn child due to its boron content.
3. How to use Tobrosopt 0.3%
This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual way of using this medicine is as follows:
- Mild to moderate infections: usually 1 or 2 drops into the affected eye(s) every 4 hours;
- Severe infections: usually 1 or 2 drops into the eye(s) every hour until improvement occurs, after which the dose should be gradually reduced before discontinuation, as directed by the physician.
This medicine is usually used for 7 to 10 days. Continue using the medicine for as long as directed by your doctor.
After instilling the drops, it is recommended to gently close the eyelid and press the corner of the eye near the nose.
This helps reduce systemic absorption of ophthalmic drops and their potential systemic effects.
Use in children and adolescents
Do not use in children and adolescents under 18 years of age.
Use in elderly patients
The same dose as in adults should be used in elderly patients.
Use in patients with hepatic or renal impairment
The safety and efficacy of Tobrosopt 0.3% in patients with hepatic or renal impairment have not been established.
Method of administration
This medicine is intended for external use only – locally into the conjunctival sac.
Do not touch the dropper tip, as this may contaminate the contents of the bottle.
- Wash your hands thoroughly before instilling the drops.
- Unscrew the cap from the bottle.
- Tilt your head backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eyeball.
- Turn the bottle upside down and gently squeeze the thumb or index finger against the bottle wall until one drop of medicine is dispensed into the eye. Do not let the dropper tip touch the eye or eyelids. If the drop misses the eye, instill another drop.
- After instilling Tobrosopt 0.3%, gently press the inner corner of the eye for about 2 minutes. This helps prevent systemic absorption of the medicine.
- If your doctor has instructed you to instill the drops into the other eye as well, repeat steps 3, 4, and 5.
- The dropper is designed to deliver drops accurately; therefore, do not enlarge the dropper orifice.
- After instillation, replace the cap on the bottle. Do not overtighten.
Regular instillation of the medicine throughout the entire treatment period prescribed by your doctor is recommended, even if symptoms of eye infection (eye[s]) improve earlier.
Use of a higher than recommended dose of Tobrosopt 0.3%
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No adverse effects are expected. Do not instill additional drops. Apply the next dose at the usual time.
Missed dose of Tobrosopt 0.3%
If the patient forgets to instill Tobrosopt 0.3%, 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 according to the prescribed schedule. Do not use a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, 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 breathing or swallowing, or if other serious adverse reactions occur,
discontinue use of Tobrosopt 0.3% immediately and contact a doctor or the nearest hospital Emergency Department
without delay.
The following adverse reactions have been observed during the use of Tobrosopt 0.3% eye drops.
Common adverse reactions (may occur in 1 to 10 patients out of 100)
Ocular symptoms: eye discomfort, eye redness.
Uncommon adverse reactions (may occur in 1 to 10 patients out of 1,000)
Ocular symptoms: ocular surface inflammation, corneal damage, visual 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, urticaria, skin inflammation, decreased growth or loss of eyelashes, skin depigmentation, skin itching, and dry skin.
Frequency unknown (frequency cannot be estimated from available data)
Ocular symptoms: eye allergy, eye irritation, eyelid itching.
General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 Tobrosopt 0.3% medicine
Store below 25°C.
Keep the bottle tightly closed in the outer packaging.
Keep 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 stated month.
The marking on the packaging, following the abbreviation EXP, indicates the expiry date, and following the abbreviation Lot, indicates the batch number.
After first opening the bottle, the medicine should not be used for longer than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
6. Contents of the pack and other information
What Tobrosopt 0.3% contains
- The active substance is tobramycin. Each 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 colourless, clear liquid.
A colourless LDPE bottle with a capacity of 5 ml, fitted with a colourless LDPE dropper and a white HDPE screw cap, packaged in a cardboard box.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Warsaw Pharmaceutical Works Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw