BIOSTREPTA

Package leaflet: Information for the user

Biostrepta, (15,000 IU + 1,250 IU), suppositories
Streptokinase + Streptodornase
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Biostrepta is and what it is used for

Biostrepta suppositories are used in the following conditions:

• chronic adnexitis;
• infiltrative postoperative changes;
• endometritis;
• hemorrhoids in acute and chronic inflammatory states;
• perianal abscesses and fistulas with extensive inflammatory infiltration;
• suppurating cysts in the region of the coccyx.

2. Important information before using Biostrepta

When not to use Biostrepta

• if the patient is allergic to streptokinase and (or) streptodornase, or any of the other ingredients of this medicine (listed in section 6);
• in cases of fresh wounds, surgical sutures, and after recent tooth extraction, for approximately 10 days following bleeding;
• concomitantly with anticoagulants, as they may cause local bleeding, in patients with reduced blood coagulation;
• with other medicines containing calcium salts.

Warnings and precautions
Before starting to use Biostrepta, discuss this with your doctor or pharmacist.
Use the medicine only when necessary to liquefy purulent, bloody exudates or local clots.
Do not use with other medicines containing calcium salts.
Biostrepta administered rectally may cause local irritation.

Other medicines and Biostrepta
Tell your doctor or pharmacist 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 Biostrepta together with antithrombotic agents, as local bleeding may occur. Do not use the medicine with other medicines containing calcium salts.

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

Driving and operating machinery
No adverse effect of the medicine on the ability to drive or operate machinery has been observed.

3. How to use Biostrepta

This medicine should always be used as directed by a physician. In case of doubt, consult a doctor or pharmacist.
Route of administration: rectally; the suppository should be inserted deeply into the rectum.
Typically used doses of the medicine are:
Adults and children
On average, treatment cycles consist of 4 to 18 suppositories administered over 2 to 9 days, depending on the patient's condition. The physician always determines the dosage.
In severe and chronic conditions, the following dosages are administered consecutively:
1 suppository 3 times daily for 3 days;
1 suppository 2 times daily for 3 days;
1 suppository once daily for 3 days.
Total: 9 days, 18 suppositories.
In moderate and milder conditions, the following dosages are administered consecutively:
1 suppository 2 times daily for 3 days;
1 suppository once daily for 4 days.
Total: 7 days, 10 suppositories.
In the mildest conditions, the following dosage is administered:
1 suppository 2 times daily for 2 days.
Total: 2 days, 4 suppositories.
If there is no therapeutic effect or if symptoms recur, the decision on repeating the treatment cycle is made by the physician.
Use of a higher than recommended dose of Biostrepta
Seek immediate advice from a doctor or pharmacist if an overdose of this medicine has been taken.
Missed dose of Biostrepta
Do not use a double dose to make up for a missed dose.
Discontinuation of Biostrepta
If you have any further questions 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 everybody will experience them.
Rare (occur in 1 to 10 people per 10,000):
General disorders and administration site conditions: local pain and swelling, allergic symptoms,
elevated body temperature, and tendency to bleeding.
If any adverse reactions occur, including any possible 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Biostrepta
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect from light.
Keep 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Biostrepta contains
The active substances in the medicine are streptokinase and streptodornase.
The excipients are liquid paraffin and solid fat.
The weight of one suppository is 2.0 g.

What Biostrepta looks like and contents of the pack
Pharmaceutical foil blisters in a cardboard box containing 6 suppositories (1 blister with 6 pieces),
12 suppositories (2 blisters with 6 pieces each) or 18 suppositories (3 blisters with 6 pieces each).

Marketing Authorisation Holder and Manufacturer
BIOMED Ltd. Vaccine and Serum Works
ul. Chełmska 30/34, 00-725 Warsaw, Poland
tel. +48 22 841 40 71
December 2021