Biodacyna ophthalmicum 0,3%

Package leaflet: Information for the patient

Biodacyna Ophthalmicum 0.3%, 3 mg/ml, eye drops, solution
Amikacinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What is Biodacyna Ophthalmicum 0.3% and what is it used for

This medicine is intended for instillation into the eye as directed by a physician.
Biodacyna Ophthalmicum 0.3% eye drops contain the aminoglycoside antibiotic amikacin. Amikacin is a semi-synthetic aminoglycoside antibiotic with a broad spectrum of activity. It exerts strong bactericidal activity against most strains resistant to other aminoglycoside antibiotics (gentamicin, tobramycin, and kanamycin). It is active against Gram-negative bacteria and some Gram-positive bacteria.
The antibiotic is effective in the treatment of ocular infections caused by the following bacteria: Staphylococcus aureus, Proteus spp., Escherichia coli, Serratia spp., Enterobacter spp., Klebsiella spp., and Pseudomonas spp., including Pseudomonas aeruginosa.
Biodacyna Ophthalmicum 0.3% is indicated for the treatment of bacterial eye infections: conjunctivitis, keratitis, blepharitis, and dacryocystitis, as well as in the treatment of hordeolum (stye).
The medicine is also administered prophylactically to patients undergoing preparation for ocular surgery.

2. Important information before using Biodacyna Ophthalmicum 0.3%

When not to use Biodacyna Ophthalmicum 0.3%:

• if the patient is allergic to amikacin or other aminoglycoside antibiotics, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Biodacyna Ophthalmicum 0.3%, discuss this with your doctor or pharmacist.

• If use of the medicine causes disturbing symptoms of eye irritation (itching, burning, or eyelid swelling), contact your doctor immediately.
• If there is no improvement after several days of treatment, contact your doctor.
• Do not use the medicine for longer than recommended by your doctor; prolonged use of antibiotics may lead to the development of resistant strains and secondary bacterial or fungal superinfection.
• Do not let the dropper tip touch the surface of the eye.
• Wearing contact lenses is not recommended in case of eye infection.
• If the patient or members of their family have a disease associated with mitochondrial mutation (a genetic disorder) or hearing loss caused by antibiotic medications, it is advisable to inform the doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss after using this medicine. Before administering Biodacyna Ophthalmicum 0.3%, the doctor may recommend genetic testing. Aminoglycoside antibiotics may cause irreversible, partial or complete deafness when administered systemically or when applied topically to open wounds or damaged skin. This effect is dose-dependent and increases in case of renal or hepatic impairment.

Biodacyna Ophthalmicum 0.3% 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 severe infections caused by Pseudomonas aeruginosa bacteria, the doctor may prescribe amikacin in the form of an injection solution and other medicines for ocular administration.
When using Biodacyna Ophthalmicum 0.3% eye drops together with another eye preparation, wait at least 15 minutes between applications, so that the drop can spread over the cornea without being diluted by another medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
The symptoms of the disease and the occurrence of adverse effects of the medicine may impair the ability to drive and operate machinery.

Biodacyna Ophthalmicum 0.3% contains phosphate buffers
The medicine contains 6.34 mg of phosphates in each millilitre of solution. In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, very rarely, cause corneal opacities during treatment due to calcium accumulation.

Biodacyna Ophthalmicum 0.3% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride in each millilitre of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Soft contact lenses should be removed before instilling the drops, and at least 15 minutes should be waited before reinserting them.
Wearing contact lenses is not recommended in case of eye infection.
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 in the eye, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Biodacyna Ophthalmicum 0.3%

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
Instill 1–2 drops into the conjunctival sac (by slightly pulling down the lower eyelid) 3 or 4 times daily, usually for a period of 7 to 10 days, as directed by the physician.
Instructions for use:

1. Wash your hands and assume a comfortable sitting or standing position.
2. Unscrew the cap.
3. Do not touch any surface with the dropper tip, as this may contaminate the drops. Using contaminated drops may lead to dangerous complications, including loss of vision.
4. Gently pull down the lower eyelid of the affected eye with the fingertip.

5. Hold the upper part of the dropper close to the eye without touching the eye. Squeeze the bottle gently so that one drop enters the eye. Be sure not to squeeze the bottle too hard, to ensure that no more than one drop enters the eye.
6. Then release the lower eyelid.
7. After administering the medicine, keep the eyes closed for as long as possible (3–5 minutes) and press with a finger on the inner corner of the affected eye near the nose. This prevents the medicine from spreading to other parts of the body. If the drop did not enter the eye, instill a second drop.

8. Close the bottle.

Use of a higher than recommended dose of Biodacyna Ophthalmicum 0.3%
Overdose may occur if the drops are used more than 4 times a day.
This may intensify adverse effects.
Discontinuation of Biodacyna Ophthalmicum 0.3%
Do not discontinue use without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Adverse reactions occur very rarely (less frequently than in 1 out of 10,000 people). Usually,
this does not require discontinuation of treatment.
Non-specific conjunctivitis, burning sensation, itching, irritation, and hypersensitivity reactions
manifesting as redness, itching, and eyelid swelling may occur.
If hypersensitivity reactions occur in a patient after administration of Biodacyna Ophthalmicum 0.3%,
the use of the medicine should be discontinued and immediate medical advice should be sought.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may,
in very rare cases, lead to corneal opacities during treatment due to calcium accumulation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
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
Phone: +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 enables further collection of information on the safety of the medicine.

5. How to store Biodacyna Ophthalmicum 0.3%

Keep this medicine out of sight and reach of children.
Store below 25°C. Protect from light.
The medicine is suitable for use within 28 days after first opening the bottle.
After completion of treatment, the medicine should be discarded.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Biodacyna Ophthalmicum 0.3% contains

• The active substance is amikacin (as sulfate). Each ml of solution contains 3 mg of amikacin.
• The excipients are: disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, benzalkonium chloride, purified water.

What Biodacyna Ophthalmicum 0.3% looks like and contents of the pack
LDPE bottle with LDPE dropper and HDPE screw cap in a cardboard box.
The pack contains 5 ml of solution.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
Poland
Tel. +48 22 364 61 01
Manufacturer
Jadran-Galenski Laboratorij d.d.
Svilno 20, 51000 Rijeka
Croatia