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Acoin-Lidocaine Hydrochloride

 

40 mg/ml Solution with attached pump system

 

The active substance is lidocaine hydrochloride 1 H2O.


1 ml solution contains 40 mg lidocaine hydrochloride (in form of lidocaine hydrochloride 1 H2O).


Further ingredients are: poloxamer 188, saccharin-sodium, sodium hydroxide for PH adjustment, ethanol 96 %.

What exactly is Acoin-Lidocaine Hydrochloride 40 mg/ml Solution and what is it used for?


Acoin-Lidocaine Hydrochloride 40 mg/ml Solution is a drug for local anesthetic. 


Acoin-Lidocaine Hydrochloride 40 mg/ml Solution is used for surface anesthesia 

Before surgery and diagnostic interventions in throats and noses

When tissue samples are taken (biopsy) from the oral cavity and nasopharyngeal cavity

Before endoscopy of the trachea or lung (bronchoscopy)

Before X-ray examination of the upper respiratory tract, after injection of contrast agents (bronchography).


Type of application


For application in the mouth and throat region. This product is not suitable for injection purposes.


Acoin-Lidocaine Hydrochloride 40 mg/ml Solution must not be applied in the following cases:

  • If you are allergic (hypersensitive) to lidocaine hydrochloride, or certain other drugs that are applied to stop the pain (local anesthetic of amide and ester type), Para-amino benzoic acid (PAB, degradation product of local anesthetics of the ester type) or to one of the other components of Acoin-Lidocaine Hydrochloride 40 mg/ml Solution,
  • with significant malfunctions of the cardiac conduction system,
  • with cardiac insufficiency that cannot be compensated by an increased activity of the heart muscle (decompensated heart failure),
  • in case of a shock due to a reduced heart activity, when the circulating blood volume is to low (cardiogenic and hypovolaemic shock),

with a previously damaged mucosa (if you are not sure please contact your doctor).


Possible side effects

  • When applying a local anesthetic, some risks cannot generally be excluded. Rarely allergic reactions may occur, in the worst case, the application of a local anesthetic of the amide type may lead to an acute hypersensitivity reaction, even an anaphylactic shock.
  • When applying Acoin-Lidocaine Hydrochloride 40 mg/ml Solution in the mouth or throat, occasionally swelling of the mucosa (oedemas) in the throat or larynx may occur. Rarely this can provoke hoarseness.
  • Local irritations in the application area have been reported.
  • The active substance is especially quickly absorbed on wound surfaces and the upper parts of the airways (bronchial tree). Regardless the high tolerance of lidocaine proofed in clinical trials, after exceeding a critical blood level, toxic side effects cannot be excluded. These side effects lead mainly to central nervous and cardiovascular symptoms (refer to Section 3.3 “In case that you have administered a higher quantity of Acoin-Lidocaine Hydrochloride 40 mg/ml Solution as you should”). The safest way of prevention is the exact observance of the recommended dose, and the impact of this must be strictly monitored by doctors (with visual and verbal direct contact to the patient).
  • As being a potential source for side effects, may be considered malfunctions of degradation (liver) or excretion (reins) of lidocaine.


Reporting side effects

If you notice any side-effects you should tell your doctor or pharmacist. This applies also for those side-effects that are not described in this leaflet. You can report side-effects directly to the Bundesinstitut für Arzneimittel und Medizinprodukte, (the Federal Institute for Drugs and Medical Devices), Abt. Pharmakovigilanz,
Kurt-Georg-Kiesinger-Allee 3, D53175 Bonn, Germany. Website: www.bform.de.

By reporting the side-effects, you can contribute to gathering more information on the safety of this medical product.


Storage conditions for Acoin-Lidocaine Hydrochloride 40 mg/ml Solution 


            Always store pharmaceuticals out of reach of children.


Do not use the product after the expiry date which is stated on the label/carton.


Shelf-life after opening: 3 months

Patient Information Leaflet

Combustin also offers more local anesthetics in form of prescription drugs.

Only specialist circles such as hospitals, physicians, doctors and pharmacists are entitled to get here information. Please write us an e-mail to info@combustin.de if you are interested in getting more detailed information.