The name of your medicine is Lidonostrum Bomba-Spray 10%.

Lidonostrum Bomba-Spray 10% contains a medicine called lidocaine and belongs to a group of medicines called “local anaesthetics”.

Lidonostrum Bomba-Spray 10% is a non-sterile solution used to numb (anaesthetise) parts of the body to reduce pain.

It can be used:

– during medical examination of the nose, throat or lungs (larynx, trachea and bronchi) requiring the insertion of specific medical instruments

– during treatment at the dentist (oral and dental procedures)

– in minor procedures involving the nose and throat (oropharynx)

– after childbirth (obstetrics and gynaecology)

Do not use Lidonostrum Bomba-Spray 10%:

– if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6).

– if you are allergic to any other local anaesthetics of the same class (such as prilocaine or bupivacaine).

You must not use Lidonostrum Bomba-Spray 10% if any of the above applies to you.

If you are not sure, talk to your doctor, pharmacist or nurse before using Lidonostrum Bomba-Spray 10%.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidonostrum Bomba-Spray 10%:

– if you have any cuts, sores or ulcers in your throat, mouth or nose, or in the area where Lidonostrum Bomba-Spray is going to be applied.

– if you have heart problems such as a slow heartbeat or cardiac disease or deficiency.

– if you have liver or kidney problems.

– if you are an elderly or have poor general health conditions.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using 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 mucous 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, have recently taken or might take any other medicines including medicines that you buy without a prescription. This is important because Lidonostrum Bomba-Spray 10% can affect the way some medicines work and some medicines can have an effect on Lidonostrum Bomba-Spray 10%.

In particular, tell your doctor, pharmacist or nurse if you are using other local anaesthetics or similar medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Lidonostrum Bomba-Spray 10% may affect you being able to drive or use tools or machines. This depends on the where in the body Lidonostrum Bomba-Spray 10% is used and how much is used. If you feel drowsy you must not drive or use any tools or machines.

Your doctor will tell you when it is safe for you to do these activities.

Lidonostrum Bomba-Spray 10% contains ethanol and propylene glycol

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per spray.

This medicine contains 24.1 mg of ethanol by dose, which is equivalent to 241 mg/ml. 1 ml of this medicine is equivalent to 6 ml of beer or 2.41 ml of wine.

The banana flavouring in Lidonostrum Bomba-Spray 10% contains propylene glycol. Propylene glycol may cause skin irritation.

Lidonostrum Bomba-Spray 10% will usually be given to you by a doctor or nurse. The dose that your doctor or nurse gives you will depend on the type of pain relief that you need. It will also depend on your age and physical condition.

If you are given Lidonostrum Bomba-Spray 10% to take home, you must use the dose recommended by your doctor.

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.

Each spray releases 10 mg of lidocaine. Anaesthesia begins 1-3 minutes after application. The duration of the anaesthesia is of 10 to 15 minutes depending on the area where the medicine is applied. It is not necessary to dry the area where the medicine is going to be used before applying it.

Use in children

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 and babies, the use of less concentrated solutions of lidocaine is recommended.

Lidonostrum Bomba-Spray 10% is given using the nozzle supplied in the pack. This nozzle may be re-used. To clean it you can submerge the nozzle in boiling water for 5 minutes. In health facilities it can be placed in the autoclave (sterilization equipment) for 20 minutes at 120º C for proper cleaning.

Applying Lidonostrum Bomba-Spray 10%

Do not use more than 20 sprays or the number of sprays recommended by the healthcare professional.

Use as few sprays as possible.

Do not get the spray in your eyes.

The spray nozzle is slightly bent so that it works properly. Do not try to change its shape or it might break.

Applying Lidonostrum Bomba-Spray 10% in the mouth and throat

When Lidonostrum Bomba-Spray 10% is used in the mouth and throat it causes a loss of feeling. This makes it more likely that food or liquid may go down the wrong way. Also, this may make it difficult to swallow or cause some people to accidentally bite their tongue or cheek.

Lidonostrum Bomba-Spray 10% should be used with care in older people, in people who are in poor general health and in children.

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

If you think you have used more Lidonostrum Bomba-Spray 10% than you should, talk to your doctor or pharmacist immediately.

Stay alert to the following symptoms and signs of overdose (find the help of a doctor immediately):

The symptoms and signs show a growing severity, the first symptoms being tingling of the tongue or tingling around your mouth (perioral paraesthesia), mild dizziness, changes in hearing (increased sensitive hearing; abnormal hearing sensation, tinnitus).

The following symptoms and signs are more severe, and you must urgently go to a doctor or hospital:

– changes in sight

– muscle tremors

– loss of consciousness

– seizures

– decrease in blood oxygen (hypoxia)

– increase of carbonic gas / carbon dioxide in arterial blood (hypercapnia)

– temporary respiratory arrest (apnoea)

– severe low blood pressure (hypotension)

– slow heart beat (bradycardia)

– irregular heart beat (arrhythmia)

– cardiovascular collapse

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

– Severe allergic reactions (rare)

Although they are rare, if you have a severe allergic reaction tell your doctor immediately.

Stay alert for these signs:

– swelling of your face, lips, tongue or throat. This may make it difficult to swallow.

– severe or sudden swelling of your hands, feet or ankles.

– difficulty breathing.

– severe itching of the skin, with raised lumps.

Other possible side effects:

– irritation where Lidonostrum Bomba-Spray 10% has been used

– sore throat.

– hoarse voice.

– loss of voice.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the contacts below. By reporting side effects you can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram

(preferably) or through the following contacts:

Direção de Gestão do Risco de Medicamentos

Parque da Saúde de Lisboa, Av. Brasil 53

1749-004 Lisboa

Tel: +351 21 798 73 73

Medicine hotline: 800222444 (free of charge)

E-mail: farmacovigilancia@infarmed.pt

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

Store below 25° C.

At temperatures below 8° C the spray solution may start to go solid. This will dissolve when the spray solution is warmed up gently to room temperature. Keep the medicine in the outer carton.

Do not use this medicine after the expiry date which is stated on the label and carton after VAL:. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of deterioration.

Keep the medicine in the outer carton.

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, and it comes in bottles of 50 g and 80 g.

Not all pack sizes may be marketed.

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.

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

This leaflet was last revised in December 2024.