Pharmacotherapeutic group: group 2.2. Central nervous system. Local anaesthetics.

Pharmaceutical form: cutaneous spray, solution for the use in mucosae membranes. The medicine is presented as a solution in glass bottles of 50 g and 80 g with an actuator and crimping pump (measuring device).

Lidonostrum Bomba – Spray 10% is a medicine used for:

• nasal procedures;
• oral and dental procedures;
• oropharyngeal procedures;
• respiratory tract procedures;
• procedures in the larynx, trachea and bronchi;
• procedures in obstetrics and gynaecology.

Do not use Lidonostrum Bomba – Spray 10%:

• if you have hypersensitivity to lidocaine or any other local anaesthetic of the amide type or to any other ingredient of this cutaneous spray solution.

Avoid contact of Lidonostrum Bomba – Spray 10% with the eyes.

Take special care with Lidonostrum Bomba – Spray 10%

Talk to your doctor about any health problems you may have, have already had and also about your allergies.

An excessive dose or short intervals between doses may cause serious adverse effects. The absorption from mucosae membranes is variable and it is particularly high at the level of bronchi which explains the increased risk of toxic symptoms such as seizures. Lidocaine in cutaneous spray solution must be used with caution in patients with wounds or traumatism in the mucosae in the site for applying the product since an injured mucosa will allow a higher systemic absorption. In case of serious adverse reactions, the equipment and drugs for resuscitation, including oxygen, may be needed. (See section 3. How to use Lidonostrum Bomba-Spray 10%).

The use of topical anaesthetics at an oral level may interfere with swallowing, increasing the risk of aspiration. The anaesthesia of tongue and oral mucosa may increase the risk of injury through biting oneself.

In cases where the administered dose may cause high levels in the blood, some patients require special care in order to prevent the appearance of side effects:

• Patients with cardiovascular disease or cardiac deficiency.
• Patients with partial or total heart block.
• Elderly patients or in poor general health conditions.
• Patients with decreased protein binding capacity or nephrotic syndrome.
• Patients with advanced hepatic disease.

Other medicines and Lidonostrum Bomba – Spray 10%

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without medical prescription.

You must also tell any other doctor prescribing you new medication that you are using Lidonostrum Bomba – Spray 10%.

Lidocaine must be used with precaution in patients receiving other local anaesthetics or agents structurally related to local anaesthetics of the amide type since toxic effects are additive.

Lidonostrum Bomba – Spray 10% with food and drink

Not applicable.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking this or any medicine.

It is reasonable to assume that lidocaine has been used in a large number of pregnant or potentially pregnant women. Until today, no problems related to the reproductive process, such as, for instance, an increase in the incidence of foetus malformations, have been reported.

As with other local anaesthetics lidocaine is present in the mother’s milk but in such small amounts that usually there is no risk for the breastfed baby.

Driving and using machines

Depending on the dose, local anaesthetics may have a very mild effect in brain functions and may temporarily affect locomotion and coordination.

If after using Lidonostrum Bomba – Spray 10% you feel drowsy you must not drive or use any vehicles or machines.

Always use Lidonostrum Bomba-Spray 10% exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Lidonostrum Bomba-Spray 10% is intended for use in the mucousae membranes for superficial anaesthesia that lasts between 10 to 15 minutes. The anaesthetic effect onset usually begins within 1 to 3 minutes depending on the site of application.

As with any other local anaesthetic, the safety and efficacy of lidocaine depend on the use of correct doses and techniques, adequate precautions and readiness for solving emergencies.

The dose recommendations that follow must be considered as guidance, the experience of the doctor and the knowledge of the general condition of the patient being essential for the determination of the dose.

Each spraying applies 10 mg of base lidocaine. It is not necessary to dry the site prior to the application.

Area	Recommended dose(mg)	Maximum dose for short procedures 1)(mg)	Maximum dose for prolonged procedures 2) (mg)
Nasal procedures, e.g. maxillary sinus puncture	20-60	500	600
Oral and dental procedures, e.g. prior to the injection.	20-200	500	600
Oropharynx procedures, e.g. gastrointestinal endoscopy.	20-200	500	600
Respiratory tract procedures, e.g. insertion of instruments and tubes.	50-400	400	600
Larynx, trachea and bronchi procedures.	50-200	200 3)	400
Obstetric procedures, e.g. vaginal delivery, suture of the mucosae and cervical biopsies.	50-200	400

1) For short procedures the drug is administered for less than one minute.
2) For prolonged procedures the duration of application is higher than 5 minutes.
3) During mechanical ventilation the dose must be reduced.

Since absorption is variable and particularly high in the trachea and bronchi (See section 4. Possible side effects) the maximum recommended doses vary depending on the site of application.

In children, doses must not exceed 3 mg/kg for laryngotracheal use and 4-5 mg/kg for nasal, oral and oropharyngeal use.

In newborns children and babies, less concentrated solutions of lidocaine are recommended.

If you use more Lidonostrum Bomba-Spray 10% than you should

If you have used an excessive dose of Lidonostrum Bomba – Spray 10%, please tell your doctor or pharmacist.

Toxic reactions are mainly originated in the central nervous system or in the cardiovascular system.

• Toxicity at Central Nervous System level Response with symptoms and signs of growing seriousness. The first symptoms are perioral paraesthesia, tongue numbness, mild dizziness, hyperacusis and tinnitus. Visual disturbances and muscle tremor are more serious complications and precede the beginning of generalized seizures. Loss of consciousness and seizures of the grand-mal type that can last from a few seconds to several minutes may follow. Hypoxia and hypercapnia rapidly occur after seizures. In the most severe cases apnoea may occur.

Recovery is due to the redistribution and metabolism of the local anaesthetic from the central nervous system. Recovery may be quick unless large amounts of the drug have been administered.

• Toxicity at Cardiovascular system level: Cardiovascular effects only occur in cases where high systemic concentrations are reached which may lead to severe hypotension, bradycardia, arrhythmia and cardiovascular collapse.

Usually, signs of toxicity from Central Nervous System precede cardiovascular toxic effects except if the patient is under general anaesthesia or heavily sedated, for instance with benzodiazepines or barbiturates.

Treatment: Should seizures occur, urgent treatment is necessary. The goals of the treatment are to keep the oxygenation, stop seizures and provide circulatory support. Oxygen must be administered and, if necessary, assisted ventilation.

If seizures do not stop spontaneously within 15-30 seconds an anticonvulsant must be administrated, such as 100-150 mg of intravenous thiopental. Alternatively, 5-10 mg of intravenous diazepam can be administered although this drug acts slower. Suxamethonium also stops seizures quickly but it requires tracheal intubation and mechanical ventilation and thus it must only be handled by personnel with experience in these techniques.

If hypotension or bradycardia occur, 5-10 mg of intravenous ephedrine must be administered and repeated, if necessary after 2-3 minutes.

If circulatory arrest occurs, proceed to cardiopulmonary resuscitation immediately as well as treatment of acidosis. Adrenaline (intravenous or intracardiac 0,1-0,2 mg) must be administered as soon as possible and repeated if necessary.

In children, the administered doses must be adapted to their weight and age.

If you forget to use Lidonostrum Bomba-Spray 10%

Always use Lidonostrum Bomba – Spray 10% exactly as your doctor has told you. Do not apply a double dose to make up for a forgotten dose.

If you stop using Lidonostrum Bomba-Spray 10%

Not applicable.

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

Like all medicines, Lidonostrum Bomba-Spray 10% can cause side effects, although not everybody gets them.

• Reactions on the application site
  Cases of irritation on the site of application are described. In the case of application in the larynx mucosa prior to endotracheal intubation, reversible symptoms such as “inflamed throat”, “hoarseness”, “loss of voice” are described. Lidonostrum Bomba-Spray 10% is used for superficial anaesthesia during endotracheal procedures but it does not prevent irritation after intubation.
• Allergic reactions
  Allergic reactions to local anaesthetics of the amide type are rare.
• Acute systemic toxicity
  Lidocaine can cause acute toxic effects when present in the blood at high levels due to fast absorption, for instance due to application in areas located below vocal chords or due to overdose.

If any of the side effects gets worse or if you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Store below 25º C.

During storage below 8º C formation of precipitates may occur. These dissolve when the solution is re-heated at room temperature.

Keep out of the sight and reach of children.

Do not use Lidonostrum Bomba – Spray 10% after the expiry date which is stated on the carton after VAL.:. The expiry date refers to the last day of that month.

Keep the medicine in the original package.

Do not use Lidonostrum Bomba – Spray 10% if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Lidonostrum Bomba – Spray 10% contains

• The active substance is lidocaine.
• The other ingredients are: ethanol, polyethylene glycol, banana essence, menthol, saccharin and purified water.

What Lidonostrum Bomba – Spray 10% looks like and contents of the pack

Lidonostrum Bomba – Spray 10% is presented as a cutaneous spray solution, in bottles of 50 and 80 g.

Marketing Authorisation Holder and Manufacturer:

Sidefarma – Sociedade Industrial de Expansão Farmacêutica, S.A.
Rua da Guiné, n.º 26
2689-514 Prior Velho
Portugal

Should you need any other information on this medicine, please contact the Marketing Authorization Holder local representative or the Marketing Authorization Holder.

Medicinal product subject to medical prescription.

Your doctor has more complete information on Lidonostrum Bomba – Spray 10% and can assure you will use the medicine adequately.