Sulfacetamide wzf 10 % hec

Package leaflet: Information for the patient

SULFACETAMIDUM WZF 10% HEC, 100 mg/ml, eye drops, solution
Sulfacetamidum natricum
Please read the entire leaflet carefully 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, pharmacist, or nurse.
• 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

Sulfacetamidum WZF 10% HEC is an ophthalmic medicine containing sulfacetamide,
an active substance belonging to the sulfonamide group, which has a bacteriostatic effect.
Hydroxyethylcellulose – an excipient contained in the formulation – prolongs the retention time
of the medicine in the conjunctival sac of the eye.
Sulfacetamidum WZF 10% HEC is used:

• in bacterial inflammations 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 treatment with Sulfacetamidum WZF 10% HEC, discuss it with your doctor,
pharmacist, or nurse.

• Exercise caution in patients with known hypersensitivity to diuretics, furosemide, antidiabetic drugs (sulfonylurea derivatives), or carbonic anhydrase inhibitors due to the possibility of allergic reactions.
• This medicine should be used with caution in patients with dry eye syndrome due to the risk of sulfonamide crystallization in the cornea. If sulfacetamide use is necessary, artificial tears or other eye lubricants should be used simultaneously.
• If first signs of hypersensitivity occur (e.g. rash, skin swelling, itching) or increased purulent discharge, discontinue the medicine immediately and consult a doctor without delay.
• Follow the treatment duration recommended by the doctor. Do not use the medicine for prolonged periods, as resistant bacteria and fungi may develop.

Children
This medicine may be used in children over 2 months of age.
Sulfacetamidum WZF 10% HEC and other medicines
Inform 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 use.
Sulfacetamide-containing medicines are incompatible with silver nitrate.
If your doctor prescribes two or more eye drop medicines, wait 10–15 minutes before administering the next medicine.
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
Due to possible tearing after instillation, this medicine should not be used immediately before driving or operating machinery.
Sulfacetamidum WZF 10% HEC contains benzalkonium chloride (0.2 mg per 1 ml of solution), which acts as a preservative.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instillation, and at least 15 minutes should be waited before reinserting them.
If the patient wears contact lenses, they should consult their doctor before using this medicine. Contact lenses should not be worn when the patient has an eye infection.
Benzalkonium chloride may cause eye irritation, especially in patients 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.

3. How to use Sulfacetamidum WZF 10% HEC

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Use in adults and children from the age of 3 months
Unless otherwise directed by a physician, the usual way of using this medicine is as follows:

• 1 to 2 drops into the conjunctival sac of the eye (eyes) every 3–4 hours. After improvement has been achieved, the interval between doses may be extended. The average duration of treatment is 7–10 days. Do not administer to infants under 2 months of age.

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.

1. Wash your hands thoroughly before instilling the medicine.
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 squeeze with the thumb or index finger on the side of the bottle until one drop of the medicine is instilled into the eye. Do not touch the eye or eyelids with the dropper tip. If the drop missed the eye, instill another drop.
5. After instillation of Sulfacetamidum WZF 10% HEC, gently press the inner corner of the eye for about 2 minutes. This helps prevent absorption of the medicine into the body.
6. If your doctor has instructed you to instill the medicine into the other eye as well, repeat steps 3, 4, and 5.
7. The dropper is designed to deliver drops accurately; therefore, do not enlarge the opening of the dropper.
8. After instillation, replace the cap on the bottle. Do not overtighten.

Regular administration of Sulfacetamidum WZF 10% HEC is recommended throughout the entire treatment period prescribed by the doctor, even if symptoms of eye infection (infection of the eye[s]) improve earlier.
Missed dose of Sulfacetamidum WZF 10% HEC
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 not everybody will experience them.
The most commonly occurring adverse reactions are local symptoms such as lacrimation,
burning, stinging, conjunctival hyperemia, conjunctivitis, occasionally blurred vision or pain
around the eye.
Sometimes eyelid swelling, erythema multiforme and other hypersensitivity symptoms (e.g.
rash, skin swelling, itching) may occur.
Rarely, during prolonged use of the medicine, fungal or bacteria-resistant to sulfacetamide corneal ulceration may occur.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of using the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Sulfacetamidum WZF 10% HEC

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 after: EXP.
The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use the medicine for longer than 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package 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 solution in the form of a clear, viscous liquid, ranging in colour from light yellow to yellow.
The packaging consists of 2 polyethylene bottles, each containing 5 ml of solution, packed in a cardboard box.
Marketing Authorisation Holder
BLAU FARMA Group
Spółka z ograniczoną odpowiedzialnością - S.K.A
ul. Pory 78; 02-757 Warszawa
{logo of the marketing authorisation holder}
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24; 01-207 Warszawa