Do not take LYSOBACT

• If you are hypersensitive to lysozyme chloride or pyridoxine chloride or any other ingredients (listed in section 6. Further information).
• If you are allergic to eggs (because lysozyme is extracted from chicken egg albumen).
• If your child is below 6 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking LYSOBACT.

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

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

Sore throat

If other symptoms appear (high temperature, purulent sputum, difficult swallowing), aggravation of these symptoms or if there is no improvement after 5 days, consult your doctor.

Mouth aphthae and sores

If the lesions are spread, their duration prolonged or if high temperature occurs, contact your doctor immediately.

Other medicines and LYSOBACT

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not concomitantly use several medicines containing an antiseptic agent.

This medicine contains lysozyme hydrochloride and pyridoxine hydrochloride.

Other medicines contain it too. Do not use them concomitantly in order not to exceed the maximum recommended doses (see dosage and method of administration).

LYSOBACT with food and drink

Presence of food and drinks should not affect the effectiveness of LYSOBACT.

Pregnancy and lactation

Pregnancy

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

Lactation

As there is insufficient data on excreting lysozyme in the breast milk, as well as a large portion of pyridoxine, this medicine should be avoided in the breast-feeding period.

Driving and using machines

LYSOBACT does not affect the patient’s ability to drive and use machines.

Other warnings

LYSOBACT contains lactose. Therefore, please consult your doctor first before taking LYSOBACT if you know that you have intolerance to certain sugars.

Take this medicine according to the given leaflet.

If you think this medicines has too weak or too strong action onto your organism, please consult your doctor or pharmacist.

Dosage

Only to be taken by adults and children over 6 years of age.

Take 6 to 8 compressed lozenges at regular intervals throughout the day.

Method of administration

Orally.

The compressed lozenges should be dissolved slowly under the tongue.

Frequency of administration

The interval between doses should be at least 1 hour.

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 than you should

If you take more LYSOBACT than you should, contact your doctor or pharmacist straight away!

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

In case of overdose, contact your doctor immediately, so that he/she can administer medical aid.

If you forget to take LYSOBACT

If you forgot to take the medicine, do not take double dose of the medicine afterwards, but continue drug administration according to the usual schedule.

If you forget to take LYSOBACT, take it as soon as you remember. After that, continue taking LYSOBACT at your regular schedule and in the recommended manner.

If you stop taking LYSOBACT

If you suddenly stop using this medicine, no harmful effects on your organism are expected.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like other medicines, this medicine can cause side effects, although not everybody gets them.

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).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet as well as all listed side effects.

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Shelf life: 5 years.

Do not use this medicine after the expiry date which is stated on the label.

What LYSOBACT contains

Each LYSOBACT compressed lozenges contains: Lysozyme Hydrochloride 20.00 mg and Pyridoxine Hydrochloride (vitamin B6) 10.00 mg.

Excipients: Lactose Monohydrate, Tragacanth, Saccharin Sodium, Magnesium Stearate, Vanillin.

What LYSOBACT looks like and contents of the pack 

Round white or off white, compressed lozenges  with smooth surfaces edges of which are undamaged with a break-mark on one side, the another side with smooth surface and diameter of 8 mm.

LYSOBACT compressed lozenges are packed in a box containing 30 compressed lozenges (3 blisters with 10 lozenges).

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 a medical prescription in pharmacies.

Date of revision of the text

February 2019