Sulfacetamide polpharma

Package leaflet: Information for the patient

Sulfacetamidum Polpharma
100 mg/ml, eye drops, solution
Sulfacetamidum natricum
Please read carefully all the information in this leaflet 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 or pharmacist.
• 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 you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sulfacetamidum Polpharma is and what it is 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 pack and other information

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

The active substance in Sulfacetamidum Polpharma is sodium sulfacetamide.
Sulfacetamidum Polpharma is a bacteriostatic agent that inhibits bacterial growth. Its mechanism of action involves inhibition of folic acid synthesis, which is essential for bacterial growth.
The medicine is used topically in the treatment of acute, subacute, and chronic inflammatory conditions of ocular tissues: conjunctiva, eyelid margins, cornea, anterior segment of the uvea, and lacrimal passages caused by bacteria sensitive to sulfacetamide.
Prophylactically after injuries and burns affecting the eyeball.
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

• if the patient is allergic to sulfonamides or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• With prolonged topical use, the medicine may lead to overgrowth of microorganisms resistant to sulfonamides, as well as fungi. Resistant strains may also develop.
• The efficacy of the medicine is reduced in the presence of purulent discharge.
• Upon re-administration of sulfonamides, allergic reactions may occur regardless of the route of administration, and cross-sensitivity between different sulfonamides may occur. If symptoms of hypersensitivity occur, such as purulent discharge, worsening of inflammation, or increased pain, treatment should be discontinued and the patient should contact a physician.
• Very rarely, severe allergic reactions have been reported after administration of sulfonamides, which in exceptional cases have been fatal, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood abnormalities. Allergic reactions have also been observed in patients who previously showed no hypersensitivity to sulfonamides.
• If allergic symptoms such as skin rash or other serious reactions occur, the use of the medicine should be discontinued.

Sulfacetamidum Polpharma with other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, or those planned to be used, especially when using:

• Tetracaine: tetracaine and other local anesthetics derived from PABA reduce the bacteriostatic effect of sulfacetamide.
• Gentamicin: sodium sulfacetamide used in high concentrations reduces the efficacy of gentamicin.
• Pilocarpine: sodium sulfacetamide may cause precipitation of pilocarpine – at least a 15-20 minute interval should be maintained between instillation of both medicines into the same eye.
• Silver compounds: sodium sulfacetamide solution is incompatible with silver nitrate – do not use concurrently.
• Photodynamic therapy: using sodium sulfacetamide in combination with photosensitizing agents administered during photodynamic therapy (e.g., porfimer sodium) increases the risk of severe hypersensitivity reactions – protect eyes and skin from UV light exposure for 30 days after completion of photodynamic therapy.
• Other ophthalmic medicines: when using Sulfacetamidum Polpharma eye drops together with other medicines not listed above administered into the conjunctival sac, at least a 15-minute interval should be maintained before instilling the other medicine.

Sulfacetamidum Polpharma with food and drink
This medicine may be used regardless of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a 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, in the opinion of the physician, the potential benefits to the mother outweigh the risk to the fetus.
Breastfeeding
Breastfeeding is not recommended during treatment with sulfacetamide.
Driving and operating machinery
There are no data regarding contraindications to driving or operating machinery.

3. How to use Sulfacetamidum Polpharma

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage:

Adults and children over 1 year of age:
Typically, 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 up to 1 year of age):
Typically, 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 this medicine in newborns and infants under 2 months of age have not been established.

Eye irrigation:
The entire contents of a minims unit should be used for eye irrigation.

Before use, twist off the container tip without touching the dropper tip.

Separate the eyelids and irrigate the eye directly from the container.

Administration method:
After removing the medicine from the refrigerator, warm the container in your hands for a moment before instillation.

If purulent discharge is present in the eye, it should be removed before instilling the medicine, as its presence reduces the antibacterial efficacy of sulfacetamide.

Instructions for using the eye drops:

1. Wash your hands and then sit or stand comfortably.
2. Detach the container from the leaflet. Twist off the extended end of the container at the point marked by a dotted line on the illustration.
3. Gently squeeze the container and discard the first two drops.
4. Gently pull down the lower eyelid of the affected eye with your finger.
5. Bring the dropper tip as close as possible to the eye without touching it.
6. Gently squeeze the container so that one drop (or two, if indicated) enters the eye, then release the lower eyelid.
7. Close the eye and press gently with your finger on the inner corner of the eye near the nose. Maintain this pressure for one minute while keeping the eye closed.
8. If necessary, instill drops into the other eye in the same manner.

A bitter taste in the mouth may occasionally occur after instillation.

The treatment duration is 7 to 10 days. The package does not contain enough medicine for the full course of treatment.

Warning!
This medicine is intended for topical ocular use only.

The medicine should be stored in its original packaging to protect the primary container from external contamination.

Single-use packaging eliminates the risk of medicine contamination during use.

Any remaining solution after single instillation must not be reused.

Use of more than the recommended dose of Sulfacetamidum Polpharma:
If more medicine is used than recommended, contact your doctor or pharmacist immediately.

Missed dose of Sulfacetamidum Polpharma:
If a dose is missed, administer it as soon as possible. However, if it is nearly time for the next dose, do not take the missed dose. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If severe adverse reactions occur, treatment with the medicine should be discontinued immediately
and medical advice should be sought immediately from a doctor or the nearest hospital Emergency Department.
The medicine packaging should be taken along to show the doctor which medicine the patient has used.
Severe hypersensitivity reactions have been observed following administration of sulfonamides, including:

• fulminant hepatic necrosis,
• agranulocytosis (complete or almost complete absence of a type of white blood cells, manifested by: high fever, chills, sore throat, difficulty swallowing, inflammatory conditions of the mucous membranes of the oral cavity, nose, throat, genital organs and rectum),
• aplastic anaemia and other blood abnormalities, which may have a fatal outcome.

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

• hypersensitivity reactions including skin rash (sometimes bullous), skin itching.

Nervous system disorders

• sporadic headache, fever.

Eye disorders

• conjunctival irritation, stinging, burning (usually transient),
• single case of corneal opacity 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 hyperaemia, blurred vision, brow ache, transient epithelial keratitis.

Skin and subcutaneous tissue disorders

• a single case of systemic lupus erythematosus, resulting in patient death, has been reported.

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

• hypersensitivity reactions:
• isolated cases of extensive erythema multiforme including Stevens-Johnson syndrome (blisters progressing to erosions affecting mucous membranes of the oral cavity, conjunctivae, and genital organs),
• photosensitivity, exfoliative dermatitis,
• toxic epidermal necrolysis (erythematous-bullous lesions of the skin and mucous membranes leading to detachment of large areas of the epidermis and exposure of extensive skin surfaces).

General disorders and administration site conditions

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should be reported to a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 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 allows further information on the safety of the medicine to be collected.

5. How to store Sulfacetamidum Polpharma

Keep the medicine out of sight and reach of children.
Store 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 refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Sulfacetamidum Polpharma contains

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

What Sulfacetamidum Polpharma looks like and contents of the pack
Sulfacetamidum Polpharma is supplied in single-use polyethylene containers
with a capacity of 0.5 ml (minims), placed together with the leaflet in a cardboard box.
Marketing authorisation holder and manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01