Biostrepta
PolandTable of Contents
Package leaflet: Information for the user
Biostrepta, (15,000 IU + 1,250 IU),
orally disintegrating tablets
Streptokinase + Streptodornase
Please read all of this leaflet carefully before taking this 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 questions, 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 someone else, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What Biostrepta is and what it is used for
- Important information before taking Biostrepta
- How to take Biostrepta
- Possible side effects
- How to store Biostrepta
- Contents of the pack and other information
1. What Biostrepta is and what it is used for
Biostrepta tablets are used in the following conditions:
- Ulceration of the oral cavity and throat;
- Suppurating and poorly healing oral wounds with clots;
- Purulent and inflammatory conditions of the dental alveoli and jaws following tooth extraction and other 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 to 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 about 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 treatment with Biostrepta, consult a doctor or pharmacist.
This medicine should be used only when necessary to liquefy purulent, bloody exudates or local clots.
Tablets should be applied only to the oral mucosa, sublingually. Do not chew or swallow the tablets, as they will then be digested and inactivated. Do not use the tablets with other medicines containing calcium salts.
Biostrepta and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Do not use Biostrepta together with anticoagulant drugs, as this may lead to local bleeding. 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 have a child, 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.
Biostrepta contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Biostrepta
This medicine should always be used as directed by the physician. In case of doubts, consult a
doctor or pharmacist.
Route of administration: Orally on the oral mucosa, sublingually.
Typically used doses of the medicine are:
Adults and children
Leave the tablets in the oral cavity until they dissolve completely.
The usual dose is 4 tablets per day, for 5 consecutive days.
If no therapeutic effect is observed, the decision on repeating the treatment cycle is made by the physician.
Do not chew or swallow the tablets, as the active substances are inactivated by gastric juices.
Use of a higher than recommended dose of Biostrepta
Seek immediate advice from a doctor or pharmacist if a higher than recommended dose of the medicine has been taken.
Missed dose of Biostrepta
Do not take a double dose to make up for a missed dose.
Discontinuation of Biostrepta
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax numbers of the above-mentioned Department}
e-mail: [email protected].
Reporting adverse reactions allows gathering further information on the safety of using 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 the 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.
Medicines must 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 sucrose, cocoa, magnesium stearate, modified starch, and food-grade gelatin.
What Biostrepta looks like and contents of the packaging
Glass vials in a cardboard box containing 20 tablets.
Marketing Authorisation Holder and Manufacturer
BIOMED S.A. Institute of Serums and Vaccines
ul. Chełmska 30/34, 00-725 Warsaw, Poland
tel. 22 841 40 71