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Lysobact®

PATIENT LEAFLET

 

LYSOBACT®
20 mg/10 mg, compressed lozenges
lysozyme/pyridoxine

                                                     

Please carefully read this leaflet as it contains information that is important to you!

This medicine is available without medical prescription. It is necessary that you observe this leaflet to get the best results from using this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, please contact your doctor or pharmacist.

 

In this leaflet:

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The medicine is used for treatment of mild sore throat which is not accompanied by elevated body temperature, aphthae and small wounds in the mouth in adults and children over 6 years of age.

Warn your doctor if you take other medicines, have some chronic illness, some metabolism disorder, if you are hypersensitive to medicines or had allergic reactions to some of them.

 

Do not take LYSOBACT®compressed lozenges:

  • Do not take LYSOBACT®compressed lozenges.
  • If you are hypersensitive to lysozyme chloride or pyridoxine chloride or any other ingredients of the medicine.

 

Take special care with LYSOBACT®compressed lozenges

 

When using high pyridoxine doses (B6 vitamin) for a longer time (several months, or even years), pins and needles, balance disorder, hand and foot tremor, as well as difficult coordination of movements may appear, and they usually withdraw after discontinuation of the medicine.

You must not take this medicine for longer than 5 days, as it can lead to imbalance in the normal oral cavity microflora with the risk of bacterial or fungal infection spreading.

 

Diseases of the mucosa of the mouth and part of the pharynx
If other symptoms appear (elevated temperature, purulent sputum, difficult swallowing), worsening of these symptoms or if there is no improvement after 5 days, consult your doctor.

 

Aphthae
In case the lesions spread, their duration prolongs or in case of high temperature, immediately consult your doctor.

Taking LYSOBACT® compressed lozenges with other medicines

Please keep in mind that this information may refer to the medicines you are no longer using, as well as to those that you plan to use in the future. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a medical prescription.

 

Do not simultaneously use several antiseptics.

 

This medicine contains lysozyme chloride and pyridoxine chloride. Other medicines contain it too. Do not use them simultaneously with LYSOBACT® in order not to exceed the maximum recommended doses(see dosage and method of administration).

 

Taking food and drink with LYSOBACT® compressed lozenges

Taking of food and drinks should not affect the efficiency of LYSOBACT® compressed lozenges.

 

Pregnancy and lactation

Before you start taking any medicine, consult your doctor or pharmacist.

Pregnancy

As a precaution, it is not recommended to use this medicine during pregnancy.

Lactation

Considering that there is not enough data on lysozyme excretion in the breast milk and a large share of pyridoxine, the medicine should be avoided during lactation.

 

Driving and using machines

LYSOBACT®compressed lozenges do not affect the ability to drive and/or use machines.

 

Other warnings

LYSOBACT® compressed lozenges contain lactose. In case of intolerance to certain sugars, consult your doctor before taking this medicine.

Take this medicine according to the enclosed leaflet. If you think that the action of the medicine is too strong or too weak, consult your doctor or pharmacist.

 

Dosage

This medicine is intended for adults and children over 6 years of age. The usual dosage is 6 to 8 compressed lozenges during the day.

Method of administration

The medicine is taken orally (by mouth). Compressed lozenges should be left to slowly dissolve under the tongue.

Frequency of administration

The interval between doses should be minimum 1hour.

Treatment duration

Treatment duration is limited to 5 days. If your symptoms do not improve after 5 days of treatment, consult your doctor.

 

If you take more LYSOBACT®compressed lozenges than you should

If you take more medicine than you should, immediately talk to your doctor or pharmacist!

 

When using high doses of the medicine for a longer time (several months, or even years) peripheral neuropathy may appear (pins and needles, hand and feet tremor, muscular weakness) that usually withdraws upon medicine discontinuation.

In case of overdose immediately contact your doctor for assistance.

 

If you forget to take LYSOBACT® compressed lozenges

If you forget to take the medicine, do not take a double dose afterwards, but continue taking the medicine according to the usual schedule.  If you forget to take LYSOBACT®compressed lozenges, take it as soon as you remember. After that, continue taking LYSOBACT® compressed lozenges according to the usual schedule and as recommended.

 

If you stop taking LYSOBACT®compressed lozenges

Take this medicine for as long as it was prescribed to you by your doctor. If you suddenly stop taking this medicine, no harmful effects on your organism are expected.

Like other medicines LYSOBACT® compressed lozenges can cause side effects.

The following allergic reactions may appear:

Skin rash, severe skin itching, increased sensitivity of the skin to the sunlight (photosensitivity).

Severe allergic reaction (anaphylactic shock), a sudden swelling of the face and neck (Quincke’s oedema).

If any of the side effects becomes serious, or if you notice a side effect that is not listed in this leaflet, please inform your doctor thereof.

Keep LYSOBACT® compressed lozenges out of the reach and sight of children.

Store at temperature up to 30 °C.

Shelf life: 5 years.

What LYSOBACT® compressed lozenges contains

Each LYSOBACT® compressed lozenge contains lysozyme chloride 20 mg and pyridoxine chloride (vitamin B6) 10 mg.

LYSOBACT® compressed lozenges contain the following excipients: Lactose, Tragacanth, Saccharin Sodium, Magnesium Stearate, Vanillin.

What LYSOBACT® compressed lozenges looks like and contents of the pack

LYSOBACT® compressed lozenges are of 8 mm of diameter, round, white to off white, with smooth undamaged edges and embossed break-mark on one side and flat smooth surface on the other side.

LYSOBACT® compressed lozenges are packed in boxes containing 10 compressed lozenges (1 blister with 10 lozenges) and in boxes containing 30 compressed lozenges (3 blisters with 10 lozenges respectively).

Marketing Authorisation Holder

Bosnalijek, Pharmaceutical and Chemical Industry, Joint Stock Company, Sarajevo, Jukićeva 53, Bosnia and Herzegovina

Manufacturer

Bosnalijek, Pharmaceutical and Chemical Industry, Joint Stock Company, Sarajevo, Jukićeva 53, Bosnia and Herzegovina

Issuing regime

Available without medical prescription.

Marketing Authorisation number and date

Leaflet revision date

July 2017

Read the package leaflet carefully before use. Ask your doctor or pharmacist for information on indications, precautions and side effects.