Distreptaza

Leaflet attached to the packaging: patient information

DISTREPTAZA

Streptokinase + Streptodornase

15,000 IU + 1,250 IU

Rectal suppositories

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Distreptaza and what is it used for
• 2. Important information before using Distreptaza
• 3. How to use Distreptaza
• 4. Possible side effects
• 5. How to store Distreptaza
• 6. Package contents and other information

1. What is Distreptaza and what is it used for

Distreptaza is a medicine in the form of rectal suppositories, containing the active substances streptokinase and streptodornase.
Distreptaza causes the liquefaction of blood clots and morphological components of pus, allowing antibiotics, chemotherapeutics, and antibodies to easily reach the sources of infection.

Indications for use:

• Supportive treatment for pelvic inflammatory disease (PID, from English pelvicinflammatory disease) - a complex of inflammatory diseases of the ovaries, fallopian tubes, and uterine mucosa;
• Adhesive disease after surgeries in the pelvic area;
• Acute (AHD, from English acute haemorrhoidal disease) and chronic hemorrhoidal disease;
• Supportive treatment for perianal abscesses and fistulas with extensive inflammatory infiltration.

2. Important information before using Distreptaza

When not to use Distreptaza:

• after bleeding for about 10 days, as this may cause re-bleeding;
• with other medicines containing calcium salts;
• in acute inflammation of connective tissue without signs of purulence;
• in patients with reduced blood coagulability;
• with anticoagulants (antithrombotic drugs) due to the risk of local bleeding.

Warnings and precautions

Before starting to use Distreptaza, you should discuss it with your doctor or pharmacist.
The medicine should not come into contact with a freshly scabbed wound or freshly applied sutures,
as this may lead to suture loosening and secondary bleeding from the wound. The medicine may
cause local irritation.

Distreptaza and other medicines

You should tell your doctor about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take.
You should not use Distreptaza at the same time as antithrombotic drugs, as local bleeding may occur. You should not use it with other medicines containing calcium salts.

Pregnancy and breastfeeding

The medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive vehicles and operate machinery.

3. How to use Distreptaza

This medicine should always be used in accordance with the doctor's recommendations.
In case of doubts, you should consult a doctor.
The suppository should be inserted deeply into the rectum after removal from the blister pack.
Recommended dose
Adults
The dosage depends on the type and severity of the inflammatory condition.
In severe cases, the following dosages are used:
3 times 1 suppository for the first 3 days
2 times 1 suppository for the next 3 days
1 time 1 suppository for the next 3 days
In milder cases:
2 times 1 suppository for 3 days
1 time 1 suppository for the next 4 days
or
2 times 1 suppository for 2 days
The average number of suppositories used in the treatment is 8-18.
The average treatment duration is 7-10 days.
Children and adolescents
The safety of using Distreptaza in children and adolescents has not been sufficiently documented.
Elderly patients
There is no need to change the dosage in patients over 65 years old.
Liver function disorders
Distreptaza is administered in the form of rectal suppositories. It is not metabolized in the liver,
so there is no need to change the dosage in patients with liver failure.
Kidney function disorders
There is no need to change the dosage in patients with kidney failure.

4. Possible side effects

Like any medicine, Distreptaza can cause side effects, although they do not occur in everyone.
It is generally well-tolerated.
Sometimes, allergic reactions, elevated body temperature, bleeding tendency, local pain, and swelling may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz2.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Distreptaza

Store in a refrigerator (2°C - 8°C). Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Batch number (Lot)
Expiration date (EXP)

6. Package contents and other information

What Distreptaza contains

• The active substances of the medicine are: streptokinase and streptodornase.
• The excipients are: liquid paraffin, solid fat

What Distreptaza looks like and what the package contains

What Distreptaza looks like

The medicine is a white-cream-colored suppository in the shape of a cone or cylinder with a pointed end.

Package

1 blister pack of 6 suppositories
2 blister packs of 5 suppositories
Blister pack with PVC/PE in a cardboard box.

Marketing authorization holder and manufacturer

Synthaverse S.A.
ul. Uniwersytecka 10, 20-029 Lublin
tel 81 533 82 21
fax 81 533 80 60
e-mail [email protected]

Date of last update of the leaflet:

09/2023