NEOSTREPTAZA

Package leaflet: Information for the patient

Neostreptaza, 15 000 IU + 1 250 IU, suppositories
Streptokinasum + Streptodornasum
Please read all of this leaflet carefully before using the medicine, because 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Neostreptaza is and what it is used for

Neostreptaza is a combination medicine containing two active substances, streptokinase and streptodornase. Neostreptaza causes the liquefaction of blood clots, morphotic elements, pus, and dead cells.
Neostreptaza is used in adults in the following conditions:

• Perianal abscesses and fistulas with extensive inflammatory infiltration;
• Hemorrhoids in acute and chronic inflammatory states;
• Infiltrative lesions, postoperative;
• Adjunctive treatment in pelvic inflammatory disease (PID) – a syndrome of inflammatory conditions affecting the ovaries, fallopian tubes, and endometrium;
• Adhesive disease following pelvic surgery.

2. Important information before using Neostreptaza

When not to use Neostreptaza

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in case of fresh wounds, surgical sutures, or after bleeding, for approximately 10 days;
• concomitantly with anticoagulant drugs, as local bleeding may occur;
• in patients with reduced blood coagulation;
• with medicines containing calcium salts;
• in acute inflammation of connective tissue without signs of bleeding.

Warnings and precautions
Before starting treatment with Neostreptaza, consult a doctor, pharmacist, or nurse.
Neostreptaza may cause local irritation.

Children and adolescents
Neostreptaza should not be used in children and adolescents, as there is insufficient data on safety and efficacy in this age group.

Neostreptaza with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Do not use Neostreptaza concomitantly with anticoagulant drugs, as local bleeding may occur (see also section 2 "When not to use Neostreptaza").

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Neostreptaza has no effect on the ability to drive or operate machinery.

3. How to use Neostreptaza

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Adults
The recommended dose is from 4 to 18 suppositories over 2 to 9 days, depending on the patient's condition. The dosage is always determined by the doctor.
In severe and chronic conditions, the following regimen is administered consecutively:
1 suppository three times daily for 3 days;
1 suppository twice daily for 3 days;
1 suppository once daily for 3 days.
Total: 9 days, 18 suppositories.
In conditions of moderate severity, the following regimen is administered consecutively:
1 suppository twice daily for 3 days;
1 suppository once daily for 4 days.
Total: 7 days, 10 suppositories.
In mild conditions, the following dosage is administered:
1 suppository twice daily for 2 days.
Total: 2 days, 4 suppositories.
If there is no therapeutic effect or if symptoms recur, the decision on repeating treatment is always made by the doctor.
Method of administration
Rectal administration. After removal from the blister, the suppository should be inserted deeply into the rectum.
Use of a higher than recommended dose of Neostreptaza
Seek immediate advice from your doctor or pharmacist if more medicine has been used than recommended.
Missed dose of Neostreptaza
Do not use a double dose to make up for a missed dose.
Discontinuation of Neostreptaza
If you have any further doubts regarding 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.
Rare (may affect up to 1 in 1,000 people):

• local pain, swelling and minor bleeding,
• diarrhoea,
• allergic reactions,
• increased body temperature.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, consult a 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Neostreptaza

Keep this medicine out of 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.
Store in a refrigerator (2°C–8°C). Do not freeze. Keep in the original packaging.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Neostreptaza contains

• The active substances are streptokinase and streptodornase. Each suppository (1.4 g) contains 15,000 IU of streptokinase and 1,250 IU of streptodornase.
• Other components: liquid paraffin, solid fat.

What Neostreptaza looks like and contents of the pack
White to beige suppositories.
Packaged in PVC/PE blisters in a cardboard carton.
Pack sizes: 6, 10, 12 or 18 suppositories.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
tel.: +48 12 290 90 00
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Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Farmina sp. z o.o.
Plant in Myślenice
ul. Cegielskiego 2
32-400 Myślenice