Neostreptaza

Package Leaflet: Information for the Patient

Neostreptaza, 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Neostreptaza and what is it 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 is Neostreptaza and what is it used for

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

• perianal abscesses and fistulas with extensive inflammatory infiltration;
• haemorrhoids (haemorrhoids) in acute and chronic inflammatory conditions;
• infiltrative changes, postoperative;
• supportive treatment in pelvic inflammatory disease (PID, English pelvic inflammatory disease) - a complex of inflammatory diseases of the ovaries, fallopian tubes, and mucous membrane of the uterus;
• adhesive disease after operations in the minor pelvis.

2. Important information before using Neostreptaza

When not to use Neostreptaza

• with anticoagulant medicines, as local bleeding may occur;
• in patients with reduced blood coagulability;
• with medicines containing calcium salts;

Warnings and precautions

Before starting to use Neostreptaza, discuss it with your doctor or pharmacist, or nurse.
Neostreptaza may cause local irritation.

Children and adolescents

Neostreptaza should not be used in children and adolescents, as there is not enough data on the safety and efficacy of its use in this age group.

Neostreptaza and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Do not use Neostreptaza at the same time as anticoagulant medicines, as local bleeding may occur (see also section 2 "When not to use Neostreptaza").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Neostreptaza has no effect on the ability to drive and use machines.

3. How to use Neostreptaza

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Adults
The recommended dose is from 4 to 18 suppositories for 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 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.
Total 9 days, 18 suppositories.
In conditions of moderate severity, 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.
Total 7 days, 10 suppositories.
In conditions of the mildest severity, the following quantities of suppositories are administered:
2 times a day, 1 suppository for 2 days.
Total 2 days, 4 suppositories.
In the absence of treatment effects or recurrence of the disease, the doctor always decides on the repetition of treatment.
Method of administration
Rectal administration. After removing from the blister, the suppository should be inserted deep into the rectum.

Using more than the recommended dose of Neostreptaza

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

Missing a dose of Neostreptaza

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

Stopping the use of Neostreptaza

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Neostreptaza can cause side effects, although not everybody gets them.
Rarely(may affect up to 1 in 1000 people):

• local pain, swelling, and minor bleeding,
• diarrhea,
• allergic symptoms,
• increased body temperature.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neostreptaza

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

6. Contents of the pack and other information

What Neostreptaza contains

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

What Neostreptaza looks like and contents of the pack

Suppositories are white to beige in color.
The packaging consists of PVC/PE blisters in a cardboard box.
Pack sizes: 6, 10, 12, or 18 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Farmina sp. z o.o.
ul. Lipska 44
30-721 Krakow
tel.: +48 12 290 90 00
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Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Krakow
Farmina sp. z o.o.
Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice

Date of last revision of the leaflet: