Sulfacetamidum Vzf 10 % Hec

Package Leaflet: Information for the Patient

SULFACETAMIDUM WZF 10% HEC 100 mg/ml, eye drops, solution
Sulfacetamidum natricum

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, 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 those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Sulfacetamidum WZF 10% HEC and what is it used for
• 2. Important information before using Sulfacetamidum WZF 10% HEC
• 3. How to use Sulfacetamidum WZF 10% HEC
• 4. Possible side effects
• 5. How to store Sulfacetamidum WZF 10% HEC
• 6. Contents of the pack and other information

1. What is Sulfacetamidum WZF 10% HEC and what is it used for

Sulfacetamidum WZF 10% HEC is an eye medicine, containing sulfacetamide, a substance from the sulfonamide group, which acts bacteriostatically.
Hydroxyethylcellulose - an auxiliary substance present in the composition of the medicine, prolongs the time of the medicine's presence in the conjunctival sac of the eye.
Sulfacetamidum WZF 10% HEC is used:

• in bacterial infections of the eyelid margins and conjunctiva, caused by microorganisms sensitive to sulfacetamide.

2. Important information before using Sulfacetamidum WZF 10% HEC

When not to use Sulfacetamidum WZF 10% HEC:

• if the patient is allergic to sulfacetamide or any of the other ingredients of this medicine (listed in section 6),
• in children under 2 months of age.

Warnings and precautions

Before starting to use Sulfacetamidum WZF 10% HEC, discuss it with your doctor, pharmacist, or nurse.

• Caution should be exercised in patients with known hypersensitivity to diuretics, furosemide, antidiabetic drugs (sulfonylurea derivatives) and carbonic anhydrase inhibitors due to the possibility of allergic reactions.
• The medicine should be used with caution in people with the so-called "dry eye" syndrome, due to the possibility of sulfonamide crystallization in the cornea. If the use of sulfacetamide is necessary, "artificial tears" or other eye moisturizing fluids should be used at the same time.
• If the first symptoms of hypersensitivity (e.g. rash, skin swelling, itching) or increased purulent discharge occur, the medicine should be discontinued and immediate consultation with a doctor is necessary.
• The treatment time recommended by the doctor should be followed. The medicine should not be used for a long time, as bacteria resistant to sulfacetamide and fungi may develop.

Children

The medicine can be used in children over 2 months of age.

Sulfacetamidum WZF 10% HEC and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Medicines containing sulfacetamide are incompatible with silver nitrate.
If the doctor recommends using two or more eye drops, wait 10-15 minutes before administering the next medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Due to possible tearing after administration, the medicine should not be used immediately before driving or operating machines.
Sulfacetamidum WZF 10% HEC contains benzalkonium chloride(0.2 mg in 1 ml of solution), which acts as a preservative.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before administration and waited at least 15 minutes before reinsertion.
If you wear contact lenses, you should consult your doctor before using the medicine. Contact lenses should not be used if you have an eye infection.
Benzalkonium chloride may 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 pain in the eye after using the medicine, you should contact your doctor.

3. How to use Sulfacetamidum WZF 10% HEC

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Use in adults and children from 3 months of age

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

• 1 to 2 drops into the conjunctival sac of the eye (eyes) every 3-4 hours. After improvement, the interval between doses can be extended. The average treatment period is 7-10 days. Do not give the medicine to infants under 2 months of age.

Method of administration

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

• 1. Before administering the medicine, wash your hands thoroughly.
• 2. Unscrew the cap on the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eyeball.
• 4. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine falls into the eye. Do not touch the tip of the dropper to the eye or eyelids. If the drop does not get into the eye, administer the next one.
• 5. After administering the medicine Sulfacetamidum WZF 10% HEC, 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 the doctor has prescribed the medicine to be administered to the other eye as well, repeat the actions from points 3, 4, and 5.
• 7. The dropper is designed to accurately measure drops, so do not enlarge the opening in the dropper.
• 8. After administration, screw the bottle cap back on. However, do not screw it too tightly.

It is recommended to regularly administer the medicine throughout the entire treatment period prescribed by the doctor, even if the symptoms of the eye infection (infections) have disappeared earlier.

Missing a dose of Sulfacetamidum WZF 10% HEC

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.
The most common side effects are local symptoms, such as: tearing, burning, stinging, conjunctival hyperemia, conjunctivitis, sometimes blurred vision or pain in the eye area.
Less common side effects may include: eyelid swelling, erythema multiforme, and other hypersensitivity symptoms (e.g. rash, skin swelling, itching).
Rarely, during long-term use of the medicine, fungal or bacterial corneal ulcers resistant to sulfacetamide may occur.
If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Sulfacetamidum WZF 10% HEC

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 after: EXP.
The expiry date refers to the last day of the month.
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 Sulfacetamidum WZF 10% HEC contains

• The active substance is sodium sulfacetamide. 1 ml of solution contains 100 mg of sodium sulfacetamide.
• The other ingredients are: hydroxyethylcellulose; sodium thiosulfate; disodium edetate; benzalkonium chloride solution; polysorbate 80; hydrochloric acid 10% (for pH adjustment); purified water.

What Sulfacetamidum WZF 10% HEC looks like and contents of the pack

Sulfacetamidum WZF 10% HEC is a sterile eye drop in the form of a clear, thick liquid with a color from light yellow to yellow.
The pack consists of 2 polyethylene bottles containing 5 ml of solution, packed in a cardboard box.

Marketing authorization holder

BLAU FARMA Group
Limited liability company - Limited Partnership
ul. Pory 78; 02-757 Warsaw
{logo of the marketing authorization holder}

Manufacturer

Warsaw Pharmaceutical Works Polfa S.A.
ul. Karolkowa 22/24; 01-207 Warsaw

Date of last revision of the leaflet: