Biostrepta

Leaflet attached to the packaging: information for the user

Biostrepta,(15,000 IU + 1,250 IU),
orally disintegrating tablets
Streptokinase + Streptodornase

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

• Please keep this leaflet, so you can read it again if you need to.
• In case of 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 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. Contents of the packaging and other information

1. What is Biostrepta and what is it used for

Biostrepta tablets are used in the following cases:

• Mouth and throat ulcers;
• Purulent and poorly healing wounds in the mouth, with clots;
• Purulent and inflammatory conditions of the gums and jaws after tooth extraction and other surgical procedures in oral surgery.

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, the patient should discuss it with their doctor or pharmacist.
The medicine should be used only in cases where it is necessary to liquefy purulent, bloody, or local clots.
Tablets should be used only on the mucous membrane of the mouth, sublingually. They should not be chewed or swallowed, as they will then be digested and inactivated. The tablets should not be used with other medicines containing calcium salts.

Biostrepta and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Biostrepta should not be used with anticoagulant agents, as local bleeding may occur. The medicine should not be used with other medicines containing calcium salts.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

No adverse effects of the medicine on the ability to drive and use machines have been observed.

Biostrepta contains sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to use Biostrepta

This medicine should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Route of administration: orally, on the mucous membrane of the mouth, sublingually.

Usual doses of the medicine are:

Adults and children
Tablets should be left in the mouth until they are completely dissolved.
The average dose is 4 tablets per day, for 5 consecutive days.
If there are no effects of the medicine, the decision to repeat the treatment cycle is made by the doctor.
Tablets should not be chewed or swallowed, as the active substances are inactivated by gastric juices.

Using a higher dose of Biostrepta than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Biostrepta

The patient should not take a double dose to make up for a missed dose.

Stopping the use of Biostrepta

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Biostrepta 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 reactions, elevated body temperature, and tendency to bleeding.
If any side effects occur, including any side effects not listed in this leaflet, the patient should consult their 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
(current address, phone and fax number of the Department)
e-mail: adr@urpl.gov.pl.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Biostrepta contains

The active substances of the medicine are streptokinase and streptodornase.
The excipients are sucrose, cocoa, magnesium stearate, modified starch, and edible gelatin.

What Biostrepta looks like and what the packaging contains

Glass vials in a cardboard box, containing 20 tablets.

Responsible entity and manufacturer

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

Date of the last update of the leaflet: