Distreptaza

Package leaflet: information for the patient

DISTREPTAZA
Streptokinase + Streptodornase
15,000 I.U. + 1,250 I.U.
Suppositories
Please read all of this 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Distreptaza is and what it is used for

Distreptaza is a medicine in the form of rectal suppositories, containing the active substances streptokinase and streptodornase.
Distreptaza liquefies blood clots and morphotic components of pus, thereby enabling antibiotics, chemotherapeutic agents, and antibodies to reach the sources of infection more easily.

Indications:

• Adjunctive treatment in pelvic inflammatory disease (PID) – a syndrome of inflammatory conditions affecting the ovaries, fallopian tubes, and endometrium;
• Post-surgical adhesion disease in the pelvic region;
• Acute (AHD, acute haemorrhoidal disease) and chronic haemorrhoidal disease;
• Adjunctive treatment in perianal abscesses and fistulas with extensive inflammatory infiltration.

2. Important information before using the medicine Distreptaza

When not to use the medicine Distreptaza:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has wounds covered with a fresh scab or surgical sutures in the area of application;
• after hemorrhages for approximately 10 days, as it may cause re-bleeding;
• with other medicines containing calcium salts;
• in acute inflammation of connective tissue without signs of suppuration;
• in patients with reduced blood coagulation;
• with anticoagulants (blood-thinning medicines) due to the risk of local bleeding.

Warnings and precautions
Before starting to use the medicine Distreptaza, consult a doctor or pharmacist.
The medicine should not come into contact with a wound freshly covered with a scab or with recently placed surgical sutures,
as this may lead to loosening of the sutures and secondary bleeding from the wound. The medicine may
cause local irritation.
Distreptaza and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use simultaneously with anticoagulant medicines (blood-thinners), as this may lead to local bleeding. Do not use with other medicines containing calcium salts.
Pregnancy and breastfeeding
The medicine should not be used during pregnancy and while breastfeeding.
Driving and operating machinery
The medicine has no influence on the ability to drive or operate machinery.

3. How to use the medicine Distreptaza

This medicine should always be used according to the doctor's instructions.
If in doubt, consult your doctor.
After removing the suppository from the blister pack, insert it deeply into the rectum.
Recommended dose
Adults
The dosage depends on the type and severity of the inflammatory condition.
For severe conditions, the following regimen is recommended:
3 x 1 suppository for the first 3 days
2 x 1 suppository for the next 3 days
1 x 1 suppository for the following 3 days
For milder conditions:
2 x 1 suppository for 3 days
1 x 1 suppository for the next 4 days
or
2 x 1 suppository for 2 days
The average number of suppositories used during treatment is 8–18.
Average duration of treatment is 7–10 days.
Children and adolescents
The safety of use in children and adolescents has not been adequately documented.
Elderly patients
There is no need to adjust the dosage in patients over 65 years of age.
Liver function impairment
Distreptaza is administered in the form of rectal suppositories. It is not metabolized in the liver; therefore, there is no need to adjust the dosage in patients with liver impairment.
Kidney function impairment
There is no need to adjust the dosage in patients with renal impairment.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will experience them.
Generally, it is well tolerated.
Occasionally, allergic reactions, increased body temperature, tendency to bleeding, local pain and swelling may occur.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz2.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Distreptaza

Store in a refrigerator (2ºC - 8ºC). Do not freeze.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must 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.
Batch number (Lot)
Expiry date (EXP)

6. Contents of the package and other information

What Distreptaza contains

• The active substances are: streptokinase and streptodornase.
• The other ingredients are: liquid paraffin, solid fat.

What Distreptaza looks like and contents of the pack
What Distreptaza looks like
The medicine is a white-cream coloured suppository in the shape of a cone or cylinder with a pointed end.
Pack
1 blister pack containing 6 suppositories
2 blister packs containing 5 suppositories each
PVC/PE blister in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Synthaverse S.A.
Uniwersytecka 10, 20-029 Lublin
tel 81 533 82 21
fax 81 533 80 60
e-mail [email protected]
09/2023