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Lysobact Complete Spray®

PATIENT LEAFLET

 

LYSOBACT COMPLETE SPRAY®
(20 + 1.5 + 0.5) mg/mL
oromucosal spray, solution

lysozyme/cetylpyridine/lidocaine

 

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:

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LYSOBACT COMPLETE SPRAY® is used for: Local treatment of acute inflammatory diseases of mouth and throat mucosa, such as gingivitis (gum disease), stomatitis (oral cavity mucosa inflammation) and aphthae (small ulcers in the mouth). 

  • Adjuvant local treatment of painful, irritable, and inflamed throat and pharynx.
  • On doctor’s recommendation, before and after surgeries (tonsils, larynx), and in case of injuries or abscess, as well as 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 COMPLETE SPRAY®:

  • If you are hypersensitive to lysozyme hydrochloride, cetylpyridine chloride, lidocaine hydrochloride as well as other amide-type anesthetics or any other drug ingredient.
  • If you are hypersensitive to egg white.
  • If your child is below 6 years of age.

 If any of the above-mentioned refers to you, consult your doctor or pharmacist before using this medicine.

 

Take special care with LYSOBACT COMPLETE SPRAY®
Use LYSOBACT COMPLETE SPRAY® only when it is necessary, to eliminate pain and irritability.

LYSOBACT COMPLETE SPRAY® is not intended for long-lasting, repeated, and continuous usage.

Do not use this medicine for more than 5 days.

In case no improvement occurs within 5 days and/or if other symptoms appear (severe sore throat, headache, nausea, vomiting) or the associated high temperatures, consult your doctor.

If you have ever had allergic reactions, avoid usage of LYSOBACT COMPLETE SPRAY®.

If you or some of your relatives had porphyria (rare blood pigment disorder), use LYSOBACT COMPLETE SPRAY® only in case of vital and urgent conditions, exercising special precaution.

If you have difficulties with swallowing, you must not use this medicine and you need to consult your doctor.

When using this medicine, ensure that this solution does not enter your eyes. If that accidentally happens, rinse your eyes with clean water or with the eyewash, and keep the eyelids open for at least 15 minutes.

Other medicines and LYSOBACT COMPLETE 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.

Consult your doctor or pharmacist if you take any of the following:

  • Beta-blockers or other medicines for heart problems (e.g., propranolol, mexiletine);
  • Medicine for treating stomach ulcer (e.g., cimetidine);
  • Diuretics, which help in eliminating the excess fluids from your organism through urinating;
  • Medicine for epilepsy (e.g., phenytoin or another barbiturate).

While using LYSOBACT COMPLETE SPRAY® you must not simultaneously take other local antiseptics, for the purpose of disinfecting mouth and/or throat.

Using LYSOBACT COMPLETE SPRAY® with food and drink
Do not take any food or drinks one hour after using LYSOBACT COMPLETE SPRAY®, because difficulty swallowing may appear as well as danger from aspiration (entering of food into the lungs) due to presence of anesthetic in this medicine. Additionally, it is advised to avoid teeth brushing and chewing gum whiles the mouth and/or throat is being anaesthetized.

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

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

Breast-feeding
It is not recommended to use this medicine in the period of breast-feeding.

Driving and using machines
No significant effects on these abilities of a patient are known.

 

Other warnings
LYSOBACT COMPLETE SPRAY® contains glycerol (85%), which may cause headache, stomach difficulties and diarrhea.

LYSOBACT COMPLETE SPRAY® contains propylene glycol, which may induce symptoms like alcohol.

Always use this medicine according to this leaflet. If you think that this medicine has a too strong or too weak action, 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 down 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, press down the spray pump five times. This procedure can be repeated 3-6 times a day, with a minimum of 2-hrs intervals between the doses.

Pressing down the spray pump once releases 0.20 ml of the solution containing 4 mg of lysozyme and 0.3 mg of cetylpyridine and 0.1 mg of lidocaine hydrochloride.

Usage of LYSOBACT COMPLETE SPRAY® is not recommended in children below 6 years of age.

LYSOBACT COMPLETE SPRAY® does not contain sugar and it is convenient for use by people with diabetes.

 

If you use more LYSOBACT COMPLETE SPRAY® than you should
If you use more medicine than you should, contact your doctor or pharmacist straight away!

If you apply more LYSOBACT COMPLETE SPRAY® than you should or accidentally swallow certain amount of the liquid directly from the bottle, contact your doctor immediately. Bring the drug pack with you, so that the healthcare personnel could identify which medicine you have swallowed.

 

If you have forgotten to use LYSOBACT COMPLETE SPRAY®

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

If you have forgotten to use LYSOBACT COMPLETE SPRAY®, do it as soon as you remember. After that, continue the usage at your usual schedule and in the recommended way.

If you stop using LYSOBACT COMPLETE SPRAY®
Use this medicine for as long as your doctor has told you.

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

If you have any doubts or questions regarding the usage of LYSOBACT COMPLETE SPRAY®, consult your doctor or pharmacist.

Like all medicines, LYSOBACT COMPLETE SPRAY® can cause side effects.

  • Frequency unknown (Frequency cannot be estimated from the available data)
    Allergic reactions such as anaphylactic shock, a sudden swelling of the face and neck (Quincke’s oedema) as well as local hypersensitivity reactions rarely appear. In extremely rare cases, hypersensitivity reactions to lidocaine hydrochloride, following local injection, appear in the form of a localized oedema with mild breathing difficulties, or as a generalized rash.
  • Gastrointestinal system disorders appear rarely, and they are mainly associated with usage of doses which are higher than recommended.
  • Keep LYSOBACT COMPLETE SPRAY® out of the reach and sight of children.
  • Do not store above 25 °C. Do not freeze.
  • Shelf life: 24 months.
  • LYSOBACT COMPLETE SPRAY® must not be used after the expiry date stated on the pack.

What LYSOBACT COMPLETE SPRAY®contains

Each 1 mL of LYSOBACT COMPLETE SPRAY®  contains 20.00 mg of lysozyme hydrochloride (corresponding to minimum 720 000 FIP units), 1.50 mg of cetylpyridine chloride and 0.50 mg of lidocaine hydrochloride.

One press down at the spray pump releases 0.20 mL of the solution containing 4 mg of lysozyme, 0.3 mg of cetylpyridine and 0.1 mg of lidocaine.

LYSOBACT COMPLETE SPRAY® contains the following excipients: Glycerol 85%, Propylene Glycol, Methyl Parahydroxybenzoate, Propyl Parahydroxybenzoate, Peppermint Flavor, Sodium Hydroxide, Purified Water.

How LYSOBACT COMPLETE SPRAY® looks like and contents of the pack
LYSOBACT COMPLETE SPRAY® is colorless to light yellow solution with peppermint odor.

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

Issuing regime
Available without a medical prescription.

Manufacturer (administrative seat)
Bosnalijek, Pharmaceutical and Chemical Industry, Joint Stock Company, Sarajevo, Jukićeva 53, Bosnia and Herzegovina

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

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
October, 2019

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