Gentamicin Vzf 0,3%

Package Leaflet: Information for the Patient

GENTAMICIN WZF, 0.3% 3 mg/ml, Eye Drops, Solution
Gentamicinum

Read the package 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 or pharmacist.
• This medicine has been prescribed for you. 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Gentamicin WZF 0.3% is a medicine for the eyes, containing gentamicin, which is an aminoglycoside antibiotic.
Gentamicin WZF 0.3% is used:

• for acute and chronic bacterial conjunctivitis, blepharitis, and dacryocystitis;
• for bacterial corneal ulcers and keratitis;
• prophylactically before and after eye surgery.

2. Important information before using Gentamicin WZF 0.3%

When not to use Gentamicin WZF 0.3%

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

Warnings and precautions

Before using Gentamicin WZF 0.3%, discuss it with your doctor or pharmacist.

• Do not use the medicine for a long time, as gentamicin-resistant bacteria or fungi may develop. Before starting and after finishing the treatment (if the treatment result is not satisfactory), your doctor may recommend a culture test.
• In case of severe bacterial eye infections, in addition to using the medicine, your doctor may also recommend taking another antibiotic (e.g., orally).

Children

The medicine can be used in children over 1 year of age.

Gentamicin WZF 0.3% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to use.
Incompatibility occurs when gentamicin is mixed with beta-lactam antibiotics.
When gentamicin is used together with erythromycin or chloramphenicol, antagonism may occur.
Tell your doctor, especially if you are using other aminoglycoside antibiotics, such as tobramycin, at the same time.

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.

Driving and using machines

Do not use the medicine immediately before driving or operating machinery, due to the risk of side effects after administration (see section 4 of the leaflet).

Gentamicin WZF 0.3% contains benzalkonium chloride and phosphates

If you wear contact lenses, tell your doctor before using the medicine. Do not wear contact lenses if you have an eye infection.
The medicine contains 0.1 mg of benzalkonium chloride per ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administration and wait at least 15 minutes before putting them back.
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, contact your doctor.
The medicine contains 6.33 mg of phosphates per ml of solution.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

3. How to use Gentamicin WZF 0.3%

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Use in adults and children over 1 year of age

Unless your doctor has told you otherwise, the usual dose is:

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

Method of administration

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

• 1. Before using the medicine, 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 press the thumb or index finger on the wall of the bottle until one drop of the medicine falls into the eye. Do not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, administer another drop.
• 5. After administering the medicine, gently press the inner corner of the eye for about 2 minutes. This will help prevent the medicine from being absorbed into the body.
• 6. If your doctor has prescribed the medicine for both eyes, repeat the steps from points 3, 4, and 5.
• 7. The dropper is designed to measure the drops accurately, so do not enlarge the opening of the dropper.
• 8. After administration, replace the cap on the bottle. Do not overtighten it.

It is recommended to regularly administer the medicine throughout the entire treatment period prescribed by your doctor, even if the symptoms of the eye infection disappear earlier.

Using more than the recommended dose of Gentamicin WZF 0.3%

Do not use higher doses or use the medicine more often than your doctor has told you.
There are no data on the effects of gentamicin overdose when used topically.

Missing a dose of Gentamicin WZF 0.3%

If you miss a dose, use it as soon as you remember.
If it is almost time for the next dose, skip the missed dose and use the next dose at the scheduled time.
Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (less than 1 in 10,000 people)
In patients with significantly damaged cornea, cloudy spots on the cornea caused by calcium deposition during treatment have been observed.
Frequency not known (frequency cannot be estimated from the available data)
Tearing, eye redness, pain, burning sensation, photophobia. Vision disturbances may persist for a few minutes after administration.
Prolonged use may lead to corneal ulcers (fungal or caused by gentamicin-resistant bacterial strains).
Prolonged use, in case of hypersensitivity, may lead to allergic reactions, thrombocytopenic purpura (manifested by a tendency to bruising and bleeding), hallucinations.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gentamicin WZF 0.3%

Keep the bottle tightly closed in the outer packaging, at a temperature below 25°C.
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 after: EXP.
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 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 in the form of 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 authorization holder

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

Manufacturer

Jadran-Galenski Laboratorij d.d.
Svilno 20, 51000 Rijeka
Croatia

Date of last revision of the leaflet: