Gentamicin wzf 0,3%

Package leaflet: Information for the patient

GENTAMICIN WZF, 0,3% 3 mg/ml, eye drops, solution
Gentamicinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Gentamicin WZF 0.3% is and what it is used for

Gentamicin WZF 0.3% is an ophthalmic medicine containing gentamicin, which is an aminoglycoside antibiotic.
Gentamicin WZF 0.3% is used:

• in acute and chronic bacterial conjunctivitis, blepharitis, and dacryocystitis;
• in bacterial infections and corneal ulcers caused by bacteria sensitive to gentamicin;
• prophylactically before and after surgical procedures on the eyeball.

2. Important information before using Gentamicin WZF 0.3%

When not to use Gentamicin WZF 0.3%

• if the patient is allergic to gentamicin sulfate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to aminoglycoside antibiotics.

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

• Do not use the medicine for prolonged periods, as bacteria resistant to gentamicin or fungi may develop. Your doctor may recommend performing a culture before starting treatment and after discontinuation (if treatment results are unsatisfactory).
• In cases of severe bacterial eye infections, your doctor may additionally recommend taking another antibiotic (e.g., administered orally) alongside the use of this medicine.

Children
This medicine may be used in children over 1 year of age.
Gentamicin WZF 0.3% and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently used, as well as any medicines the patient plans to use.
Incompatibility occurs when gentamicin is mixed with β-lactam antibiotics.
When gentamicin is used concomitantly with erythromycin or chloramphenicol, antagonism may occur.
Inform your doctor, especially if the patient is simultaneously using other aminoglycoside antibiotics, such as tobramycin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Do not use the medicine immediately before driving or operating machinery due to the risk of adverse effects after instillation (see section 4 of the leaflet).
Gentamicin WZF 0.3% contains benzalkonium chloride and phosphates
If the patient wears contact lenses, they should inform their doctor before using the medicine. Contact lenses should not be worn when an eye infection is present.
The 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 color. Contact lenses should be removed before instillation, and at least 15 minutes should elapse before reinserting them.
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, stinging, or eye pain occur after using the medicine, contact your doctor.
The medicine contains 6.33 mg of phosphates in each ml of solution.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use Gentamicin WZF 0.3%

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
Use in adults and children over 1 year of age
Unless otherwise directed by your doctor, the usual dosage is:

• 1 to 2 drops into the conjunctival sac every 4 hours.

Instructions for administration
This medicine is for external use only – apply locally into the conjunctival sac.
Do not touch the dropper tip, as this may contaminate the contents of the bottle.

1. Wash your hands thoroughly before instilling the drops.
2. Unscrew the cap from the bottle.
3. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eyeball.
4. Invert the bottle and gently press with your thumb or index finger on the side of the bottle until one drop of medicine is instilled into the eye. Do not touch the eye or eyelids with the dropper tip. If the drop misses the eye, instill another drop.
5. After instilling Gentamicin WZF 0.3%, gently press on the inner corner of the eye for about 2 minutes. This helps prevent the medicine from being absorbed into the body.
6. If your doctor has instructed you to instill the drops into the other eye as well, repeat steps 3, 4, and 5.
7. The dropper is designed to deliver accurately measured drops; therefore, do not enlarge the opening of the dropper.
8. After instilling the drops, replace the cap on the bottle. Do not overtighten.

It is recommended to use the medicine regularly throughout the entire treatment period prescribed by your doctor, even if symptoms of eye infection (eyes) improve earlier.
Use of a higher than recommended dose of Gentamicin WZF 0.3%
Do not use larger doses or more frequently than prescribed by your doctor.
There are no data available on overdose with topically applied gentamicin.
Missed dose of Gentamicin WZF 0.3%
If you miss a dose, take it as soon as possible.
However, if it is almost time for your next dose, skip the missed dose and instill the next dose according to your doctor's prescribed schedule.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very rare (less than 1 in 10,000 people)
In patients with significantly damaged cornea (the clear front layer of the eye), calcium deposits causing corneal opacities have been observed during treatment.
Frequency unknown (frequency cannot be estimated from available data)
Tearing, eye redness, pain, burning sensation, photophobia. Visual disturbances may persist for several minutes after instillation.
With prolonged use of the medicine, corneal ulceration (fungal or caused by gentamicin-resistant bacterial strains) may occur.
Prolonged use, in case of hypersensitivity, may lead to allergic reactions, thrombocytopenic purpura (manifesting as tendency to bruising and bleeding), hallucinations.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions 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 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 helps to provide more information on the safety of the medicine.

5. How to store Gentamicin WZF 0.3% medicine

Keep the bottle tightly closed in the outer packaging, at a temperature below 25°C.
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 after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
After first opening the bottle, the medicine should not be used for longer than 4 weeks.
Medicines must 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 pack and other information

What Gentamicin WZF 0.3% contains

• The active substance is gentamicin. Each ml of solution contains 3 mg of gentamicin as gentamicin sulfate.
• The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, benzalkonium chloride solution, sodium chloride, purified water.

What Gentamicin WZF 0.3% looks like and contents of the pack
Gentamicin WZF 0.3% is a sterile eye drop solution, a colorless or slightly yellowish, clear liquid.
The medicine is available in polyethylene bottles containing 5 ml of solution, packed in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Jadran-Galenski Laboratorij d.d.
Svilno 20, 51000 Rijeka
Croatia