Sulfacetamidum Polpharma

Leaflet attached to the packaging: patient information

Sulfacetamidum Polpharma

100 mg/ml, eye drops, solution

Sulfacetamidum sodium

Read the 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sulfacetamidum Polpharma and what is it used for

The active substance of Sulfacetamidum Polpharma is sulfacetamide sodium. Sulfacetamidum Polpharma is a bacteriostatic agent, it inhibits the growth of bacteria. Its mechanism of action involves inhibiting the synthesis of folic acid, necessary for bacterial growth. The medicine is used locally in the treatment of acute, subacute, and chronic inflammatory conditions of the eye tissues: conjunctiva, eyelid margins, cornea, anterior segment of the vascular membrane of the eyeball, and tear ducts caused by bacteria sensitive to sulfacetamide. Prophylactically after injuries and burns in the eyeball area. The medicine is intended for adults and children (over 2 months of age).

2. Important information before using Sulfacetamidum Polpharma

When not to use Sulfacetamidum Polpharma

Warnings and precautions

• With long-term, local use, the medicine may cause excessive growth of microorganisms insensitive to sulfonamides, as well as fungi. Strains resistant to sulfonamides may also develop.
• In the presence of purulent discharge, the effectiveness of the medicine is reduced.
• When reusing sulfonamide, allergic reactions may occur, regardless of the route of administration, and cross-sensitivity between different sulfonamides. If symptoms of hypersensitivity occur, such as purulent discharge, exacerbation of inflammation, or increased pain, treatment should be discontinued and a doctor consulted.
• In very rare cases, after using sulfonamides, severe allergic reactions have been reported, which in exceptional cases were fatal, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant liver necrosis, agranulocytosis, aplastic anemia, and other blood disorders. Allergic reactions have also been reported in patients who had not previously shown hypersensitivity to sulfonamides.
• If symptoms of allergy occur, such as skin rash or other serious reactions, the use of the medicine should be discontinued.

Sulfacetamidum Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially about the use of:

• Tetracaine: tetracaine and other local anesthetics from the PABA derivative group weaken the bacteriostatic effect of sulfacetamide.
• Gentamicin: sulfacetamide sodium used in high concentrations reduces the effectiveness of gentamicin.
• Pilocarpine: sulfacetamide sodium may cause pilocarpine to precipitate - a minimum of 15-20 minutes should be allowed between instilling both medicines into the same eye.
• Silver compounds: sulfacetamide sodium solution is incompatible with silver nitrate - they should not be used together.
• Photodynamic therapy: the use of sulfacetamide sodium in combination with photosensitizing agents administered during photodynamic therapy (e.g., sodium porfimer) increases the risk of severe hypersensitivity reactions - the eyes and skin should be protected from UV radiation for 30 days after the end of photodynamic therapy.
• Other ophthalmic medicines: when using Sulfacetamidum Polpharma eye drops with other, unlisted medicines administered into the conjunctival sac, a minimum of 15 minutes should be allowed before instilling the other medicine.

Sulfacetamidum Polpharma with food and drink

The medicine can be taken regardless of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Pregnancy The safety of using sulfacetamide during pregnancy has not been established. Sulfacetamide may be used during pregnancy only if the doctor believes that the potential benefits to the mother outweigh the risk of fetal harm. Breastfeeding Breastfeeding is not recommended during the use of sulfacetamide.

Driving and using machines

There are no data on contraindications for driving vehicles and operating machines.

3. How to use Sulfacetamidum Polpharma

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Dosage: Adults and children over 1 year of age: usually 1-2 drops of the solution are instilled into the eye, every 1-3 hours during the day. At night, the medicine is administered less frequently. Infants (over 2 months to 1 year of age): usually 1 drop of the solution is instilled into the eye, every 1-3 hours during the day. At night, the medicine is administered less frequently. Newborns The safety and dosage of sulfacetamide in newborns and infants under 2 months of age have not been established. Eye flushing For eye flushing, the entire contents of the minim are used. Before use, twist the tip of the container without touching the tip of the dropper. Pull the eyelids apart. Flush the eye with the liquid directly from the container. Administration method After removing the medicine from the refrigerator, warm the container in your hands for a moment before instilling the drops. If there is purulent discharge in the eye, it should be removed before instilling the medicine, as its presence reduces the antibacterial effectiveness of sulfacetamide. Instructions for using the drops Follow the instructions below to ensure proper use of Sulfacetamidum Polpharma:

• 1. Wash your hands, then sit or stand comfortably.
• 2. Detach the container from the blister pack. Twist the elongated end of the container at the point marked with a dashed line.
• 3. Gently squeeze the container and discard the first two drops.
• 4. With your finger, gently pull down the lower eyelid of the affected eye.
• 5. Bring the tip of the dropper as close to the eye as possible without touching it.
• 6. Gently squeeze the container so that one drop (or two if indicated) gets into the eye, then release the lower eyelid.
• 7. Close your eye and press the corner of your eye near your nose with your finger for a minute, keeping your eye closed. This pressure should be applied for a minute, with the eye still closed.
• 8. If necessary, repeat the same procedure to instill drops into the other eye.

Sometimes, after applying the drops, a bitter taste may occur in the mouth. The duration of treatment is from 7 to 10 days. The packaging is not sufficient for the entire treatment.

Caution!

The medicine is intended for local use in the eyes only. The medicine should be stored in its original packaging to protect the immediate packaging from external contamination. The single-use packaging eliminates the risk of contamination of the medicine during use. The residue after single use is not suitable for reuse.

Using more than the recommended dose of Sulfacetamidum Polpharma

If a larger dose of the medicine is used than recommended, consult a doctor or pharmacist.

Missing a dose of Sulfacetamidum Polpharma

If a dose of the medicine is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose. If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If severe side effects occur, the use of the medicine should be discontinued and a doctor consulted immediately. Take the packaging with you to show the doctor which medicine you used. After administering sulfonamide, severe hypersensitivity reactions have been observed, including:

• fulminant liver necrosis,
• agranulocytosis (complete or almost complete disappearance of a certain type of white blood cell, manifested by: high fever, chills, throat pain, difficulty swallowing, inflammation of the mucous membranes of the mouth, nose, throat, genital organs, and anus),
• aplastic anemia and other blood disorders, ending in an unfavorable outcome.

Immune system disorders

Very rare (less than 1 in 10,000 people):

• hypersensitivity reactions, including skin rash (sometimes blistering), itching of the skin.

Nervous system disorders

• occasionally, headache, fever.

Eye disorders

• conjunctival irritation, stinging, burning (usually short-term),
• a single case of corneal clouding in a patient with advanced dry eye syndrome,
• bacterial and fungal corneal ulcers, non-specific conjunctivitis.

Rare (less than 1 in 1,000 people):

• itching, eyelid swelling, reactive hyperemia, blurred vision, pain in the brow area, transient epithelial keratitis.

Skin and subcutaneous tissue disorders

• a single case of systemic lupus erythematosus, which ended in the patient's death.

Very rare (less than 1 in 10,000 people):

• hypersensitivity reactions:
• single cases of widespread multiform erythema in the form of Stevens-Johnson syndrome (blisters turning into erosions on the mucous membranes of the mouth, conjunctiva, genital organs),
• photosensitivity, exfoliative dermatitis,
• toxic epidermal necrolysis (erythematous-bullous changes in the skin and mucous membranes leading to peeling of large areas of the epidermis and exposure of large areas of skin).

General disorders and administration site conditions

• bacterial and fungal superinfections,
• bitter taste in the mouth combined with irritation of the nasal mucosa.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should 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 Tel.: +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 Sulfacetamidum Polpharma

Keep the medicine out of the sight and reach of children. Store in a temperature between 2°C and 8°C, in a dark place. Do not use the medicine after the expiry date stated on the packaging. The expiry date stated on the packaging is the last day of the stated month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sulfacetamidum Polpharma contains

• The active substance of the medicine is sulfacetamide sodium. Each container with a capacity of 0.5 ml contains 50 mg of sulfacetamide sodium.
• The other ingredients are: sulfacetamide, disodium edetate, water for injections.

What Sulfacetamidum Polpharma looks like and what the packaging contains

Sulfacetamidum Polpharma is packaged in single-use polyethylene containers with a capacity of 0.5 ml (minims) and is provided with a leaflet in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Date of last revision of the leaflet: