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Lysobact Spray®

PATIENT LEAFLET 

 

LYSOBACT Spray®  with aniseed flavor
LYSOBACT Spray®
  with peppermint flavor
(20 + 1.5) mg/mL
oromucosal spray, solution

lysozyme/cetylpyridine

 

 

Read all this leaflet carefully before use!

This medicine is available without a medical prescription. You need to adhere to this leaflet to get best possible results. Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor or pharmacist.

 

In this leaflet:

This post is also available in: Bosnian

LYSOBACT Spray® is used for:

  • Local treatment of acute oral mucosa and pharynx diseases, such as gingivitis (disease of the gums), stomatitis (oral mucosa inflammation) and aphthae (ulcers in the oral mucosa).
  • Adjuvant therapy of the sore throat and painful swallowing, tonsils, and pharynx inflammation.
  • On doctor’s recommendation, before and after surgeries (of tonsils, larynx), for injuries or abscess, and after a tooth extraction.

Tell your doctor if you are taking other medicines, suffer from a chronic illness, a metabolism disorder, if you are hypersensitive to medications or have ever had allergic reactions to some of them.

Do not use LYSOBACT Spray®:

  • If you are hypersensitive to lysozyme hydrochloride, cetylpyridine chloride or any of the excipients.
  • If you are hypersensitive to egg white.
  • If your child is below 6 years of age.

If any of the above applies to you, talk to your doctor or pharmacist before using this medicine.

Take special care with LYSOBACT Spray® 
Do not use this medicine for more than 5 days.

Diseases of oral mucosa and part of the throat 

Consult your doctor if other symptoms appear (high temperature, purulent sputum, difficulties swallowing), if these symptoms get worse or if you are not feeling better after 5 days.

 

Aphthae
In case the lesions spread, become prolonged or if you have high temperature, consult your doctor straight away.

 

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

If you are taking or have recently taken any other medicines, including medicines available without a prescription, please tell your doctor.

Do not simultaneously take more medicines containing a local antiseptic.

 

LYSOBACT Spray® with food and drinks
Food and drinks should not influence the efficiency of LYSOBACT Spray®.

 

Pregnancy and breast-feeding
Consult your doctor or pharmacist before you take any medicine.

 

Pregnancy
As a precaution, this medicine is not recommended during pregnancy.

 

Breast-feeding
As insufficient data exists about its entering into mother’s milk, this medicine should not be used during the lactation period.

 

Driving and using machines
This medicine does not affect the ability to drive and use machines.

Always use this medicine exactly as your doctor has told you. If you think that it has a too strong or too weak effect, consult your doctor or pharmacist.

 

Method of use:

  • Only one patient should use this medicine.
  • Before the first application, remove the plastic cap from the spray pump.
  • After that, place the spray pump applicator on the spray pump by lightly pressing.
  • Applicator can be moved sideways, and it ensures proper application of spray into the mouth cavity.
  • Applicator should be turned upwards at a right angle from the bottle.
  • Before the first application of the spray, press down the spray pump several times until the spraying is homogenous.
  • Open the mouth wide, point the applicator towards the affected area and press the spray pump as many times as noted in the dosage.
  • Hold your breath during the spraying. Do not swallow.
  • After using the medicine, you should turn the applicator downwards to block the spraying.

Dosage
For a single dose, you need to press the spray pump five times. The procedure can be repeated 3 to 6 times a day, with a minimum of 2-hours intervals between the doses. LYSOBACT Spray® is not intended for children below 6 years of age.

If you use more LYSOBACT Spray® than you should
If you use more LYSOBACT Spray than you should, immediately contact your doctor or pharmacist!

If you use more medicine than you should, contact your doctor for his/her assistance.

If you have forgotten to use LYSOBACT Spray®
If you have forgotten to use this medicine, never take a double dose afterwards, but continue the usage at your usual schedule.

If you forget to use LYSOBACT Spray®, apply it as soon as you remember. After that, continue the usage according to the usual schedule and as recommended.

If you stop using LYSOBACT Spray®

Use this medicine for as long as it was prescribed to you by your doctor. 

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

 

If you have any doubts or questions regarding the use of LYSOBACT Spray®, consult your doctor or pharmacist.

Like all medicines, LYSOBACT Spray® can cause side effects.

Allergic reactions may appear, such as:

Local hypersensitivity reactions.

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

If you notice any side effect which is not listed in this leaflet, inform your doctor or pharmacist.

 

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

If you notice any side effect which is not listed in this leaflet, inform your doctor or pharmacist.

Keep LYSOBACT Spray® out of the reach and sight of children.

Do not store above 25 °C. Do not freeze.

LYSOBACT Spray® must not be used after the expiry date stated on the pack.

Shelf life is 24 months from the manufacturing date given on the pack.

What LYSOBACT Spray®contains
Each 1 mL of LYSOBACT Spray contains 20.00 mg of lysozyme hydrochloride and 1.50 mg of cetylpyridine chloride.

One press down at the spray pump releases 0.20 mL of the solution containing 4 mg of lysozyme and 0.3 mg of cetylpyridine.

LYSOBACT Spray® with aniseed flavor (20 + 1.5) mg/mL oromucosal spray, solution, contains the following excipients: Glycerol 85%, Propylene Glycol, Saccharine Sodium, Methyl Parahydroxybenzoate, Aniseed Flavor, Propyl Parahydroxybenzoate, Sodium Hydroxide, Purified Water.

LYSOBACT Spray® with peppermint flavor (20 + 1.5) mg/mL oromucosal spray, solution, contains the following excipients: Glycerol 85%, Propylene Glycol, Saccharine Sodium, Methyl Parahydroxybenzoate, Peppermint Flavor, Propyl Parahydroxybenzoate, Sodium Hydroxide, Purified Water.

 

What LYSOBACT Spray®looks like and contents of the pack
LYSOBACT Spray® with aniseed flavor (20 + 1.5) mg/mL oromucosal spray, solution, is colorless to pale yellow solution with aniseed odor.

LYSOBACT Spray® with peppermint flavor (20 + 1.5) mg/mL oromucosal spray, solution, is colorless to pale yellow solution with peppermint odor.

Contents of the pack: 30 mL of the solution in amber glass bottle with a spray pump and applicator.

Issuing regime

Available without a medical prescription.

 

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

 

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

 

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

Marketing Authorization number and date

Leaflet revision date

January 2020

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