Biostrepta

Package Leaflet: Information for the User

Biostrepta,(15,000 IU + 1,250 IU), suppositories
Streptokinase + Streptodornase

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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, tell the doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Biostrepta and what is it used for

Biostrepta suppositories are used in the following cases:

• chronic adnexitis;
• infiltrative changes, postoperative;
• endometritis;
• hemorrhoids (in acute and chronic inflammatory conditions);
• perianal abscesses and fistulas with extensive inflammatory infiltration;
• purulent cysts in the coccygeal region.

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, after bleeding for about 10 days;
• concomitantly with anticoagulants, as they may cause local bleeding, in patients with reduced blood coagulability;
• with other medicines containing calcium salts.

Warnings and precautions

Before starting to use Biostrepta, discuss it with a doctor or pharmacist.
The medicine should be used only in cases where it is necessary to liquefy purulent, bloody, or local clots.
Do not use with other medicines containing calcium salts.
Biostrepta administered rectally may cause local irritation.

Other medicines and Biostrepta and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as medicines the patient plans to take.
Do not use Biostrepta with anticoagulant 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, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

No adverse effect of the medicine on the ability to drive and use machines has been observed.

3. How to use Biostrepta

This medicine should always be used according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Route of administration: rectally, the suppository should be inserted deep into the rectum.

Usual doses of the medicine are:

Adults and children
On average, in a treatment cycle, 4 to 18 suppositories are used over 2 to 9 days, depending on the patient's condition. The dosage is always determined by a doctor.
In severe and chronic conditions, the following quantities of suppositories are administered, in sequence:
3 times a day, 1 suppository for 3 days;
2 times a day, 1 suppository for 3 days;
1 time a day, 1 suppository for 3 days.
In total, 9 days, 18 suppositories.
In moderate to mild conditions, the following quantities of suppositories are administered, in sequence:
2 times a day, 1 suppository for 3 days;
1 time a day, 1 suppository for 4 days.
In total, 7 days, 10 suppositories.
In the mildest conditions, the following quantities of suppositories are administered:
2 times a day, 1 suppository for 2 days.
In total, 2 days, 4 suppositories.
In the event of no effect of the medicine or recurrence of the disease, the doctor decides on the repetition of the treatment cycle.

Using more than the recommended dose of Biostrepta

In case of taking a larger dose than recommended, consult a doctor or pharmacist immediately.

Missing a dose of Biostrepta

Do not use a double dose to make up for a missed dose.

Stopping the use of Biostrepta

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely(occurring in 1 to 10 people out of 10,000):
General disorders and administration site conditions: local pain and swelling, allergic symptoms, elevated body temperature, and tendency to bleeding.
If any side effects occur, including any possible side effects not listed in the leaflet, consult a doctor or pharmacist.
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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Reporting side effects can help gather more information on the safety of the medicine.

How to store Biostrepta

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
The medicine should be stored 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Biostrepta contains

The active substances of 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 what the package contains

Blister packs of pharmaceutical foil in a cardboard box containing 6 suppositories (1 blister of 6), 12 suppositories (2 blisters of 6), or 18 suppositories (3 blisters of 6).

Responsible entity and manufacturer

BIOMED Serum and Vaccine Plant Ltd.
Chełmska 30/34 Street, 00-725 Warsaw
phone: 22 841 40 71

Date of the last update of the leaflet:

December 2021