Lidonostrum Gele 2% is indicated in the superficial anaesthesia and lubrication:

• of the urethra;
• of the nasal and pharyngeal cavities;
• during procto-rectoscopy;
• during tracheal intubation;
• for the relief of pain in children after circumcision;
• in the symptomatic treatment of pain related to cystitis and urethritis.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

Do not use Lidonostrum Gele 2%:

• if you are allergic to lidocaine (active substance) or to any of the ingredients of Lidonostrum Gele 2% (listed in section 6).
  

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidonostrum Gele 2%

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

The recommended doses for different situations must be closely monitored. Toxic concentrations of lidocaine in blood may have been caused by excessive doses, repeated doses in short periods of time or increased absorption due to pre-existing injuries in the mucosa.

Generally, the absorption is higher in bronchi and less significant in pharynx and very reduced at urethral level.

When using Lidonostrum Gele 2% in the lubrication of endotracheal tubes the use of an excessive dose must be avoided. The gel must not get inside the tube since it may cause the obstruction of the same.

Other medicines and Lidonostrum Gele 2%

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

You must also tell any other doctor prescribing you new medication, that you are using Lidonostrum Gele 2%.

Several interactions with different drugs are described, such as beta-adrenergic blocking agents and cimetidine, which may increase lidocaine concentrations in the blood by decreasing its elimination.

The duration of apnoea induced by succinylcholine or curarizing drugs may be prolonged in patients to whom lidocaine has been administrated.

Enzyme activating drugs, such as phenytoin, benzodiazepine and barbiturates may increase the necessary doses of lidocaine.

Lidocaine has also shown to be porphyrinogenic in animals and so it cannot be used in patients with acute porphyria.

Bearing in mind that the normal use of Lidonostrum Gele 2% causes low concentrations of lidocaine in the blood, the above mentioned interactions do not have great clinical significance.

Pregnancy, breast-feeding and fertility

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, such as other local anaesthetics, crosses the placenta.

In pregnant women to whom lidocaine has been administered at any stage of the pregnancy no increase in the incidence of congenital malformations has been observed.

Lidocaine is present in the mother’s milk but in such small amounts that there is generally no risk of affecting the baby.

Driving and using machines

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

This medicine contains methyl and propyl parabens as preservatives which are slightly irritating for the mucosae and may increase the risk of jaundice in the newborn baby. May cause allergic reactions (possibly delayed).

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

Lidonostrum Gele 2% is used in the anaesthesia of mucosae having a duration of approximately 20 to 30 minutes and a very quick onset, usually up to 5 minutes.

The absorption from the mucosae is variable being particularly high in bronchi. Blood concentrations of lidocaine reached after applying the gel, in doses up to 800 mg in the undamaged urethra and bladder, are much lower than limits considered as toxic.

Lidocaine blood concentration is much higher after rectal administration rather than oral administration.

Elderly or debilitated patients, children aged 12 years old or more or patients with acute diseases or infections must receive doses adapted to their age, weight and physical condition.

Use in children

In children aged 12 years old or less, the dose must not exceed 6 mg/kg.

Do not use more than 4 doses within a 24 h interval.

Urethral anaesthesia:
For an adequate anaesthesia of the adult male urethra it is usually necessary about 20 ml of gel (corresponding to 400 mg of lidocaine hydrochloride). The gel is slowly instilled until the patient feels tension, which normally corresponds to about 10 ml. Wait a few moments for an adequate anaesthesia and then the remaining gel can be instilled. In case a more profound anaesthesia is needed, up to a maximum of 40 ml of gel can be administered, divided into 3-4 applications.

For superficial anaesthesia of the female urethra, 5 to 10 ml of gel must be instilled, in small amounts until filling the entire urethra, waiting a couple of minutes before starting the procedure.

Digestive endoscopy and bronchoscopy
The instillation of 10 to 20 ml is recommended. A small amount can be applied in the instrument as lubricant. When the gel is applied in combination with other products containing lidocaine the total amount of lidocaine must not exceed 400 mg.

Lubrication for endotracheal intubation:
Apply approximately 2 ml of gel on the surface of the tube immediately before intubation. Be careful not to let any of the product go inside the tube.

If you use more Lidonostrum Gele 2% than you should
If you use an excessive dose of Lidonostrum Gele 2%, please contact your doctor or pharmacist.

Toxic reactions to lidocaine usually begin in central nervous system and secondly in the cardiovascular system.

Toxicity at the level of the central nervous system presents signs and symptoms of growing severity. The first symptoms are perioral paraesthesia, numbness of the tongue, dizziness, hyperacusis and buzzing. Visual disturbances and muscular trembling are more serious symptoms that precede general seizures. Unconsciousness and grand mal type seizures may follow. These may last from a couple of seconds to several minutes. Associated to seizures hypoxia and hypercapnia may rapidly occur due to the increase of muscular activity and problems in the normal respiratory process. In more severe cases, apnoea may occur.

Acidosis increases the toxic effects of local anaesthetics.

Cardiovascular effects normally occur after the signs of central nervous system toxicity are observed and are characterized by severe hypotension, bradycardia, arrhythmia and cardiovascular collapse.

Treatment:
The goals of treatment are the maintenance of an adequate ventilation, the control of seizures and, if necessary, blood circulation support.

In case seizures occur, oxygen must be administered and, if necessary, mechanical ventilation. If seizures do not stop spontaneously in about 15-20 seconds an intravenous anticonvulsant must be administered: 100-150 mg of IV thiopental immediately stop seizures. Alternatively, 5-10 mg of IV diazepam can be administered, although this drug has a slower action. Suxamethonium stops muscular seizures rapidly but it requires tracheal intubation and mechanical ventilation and must only be used by personnel trained in these procedures.

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

In case circulatory arrest occurs cardiopulmonary resuscitation must start immediately as well as treatment of acidosis.

Adrenaline (0.1-0.2 mg in intravenous or intracardiac injection) must be administered as soon as possible and the administration repeated, if necessary.

If you stop using Lidonostrum Gele 2%

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

Like all medicines, Lidonostrum Gele 2% can cause side effects, although not everybody gets them.

Very rare cases of allergy to lidocaine are described. Allergic reactions related to other components of the gel, such as preservatives, may also occur.

It is not expectable to reach toxic concentrations in the proposed doses and indications. However, if an excessive dose is used and/or if the absorption of the gel is higher the signs of toxicity referred to in section 3 (If you use more Lidonostrum Gele 2% than you should) may occur.

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 national reporting system listed 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:

Direção de Gestão do Risco de Medicamentos

Parque da Saúde de Lisboa, Av. Brasil 531749-004 Lisboa

Tel: +351 21 798 73 73

Medicines hotline: 800222444 (free)

e-mail: farmacovigilancia@infarmed.pt

Do not store above 25º C.

After the first opening of the tube, the gel can be used for 12 months.

Keep this medicine out the sight and reach of children.

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

Do not use this medicine 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 Gele 2% contains

The active substance is lidocaine hydrochloride.

The other ingredients are: hydroxypropylmethylcellulose, methylparaben, propylparaben, sodium hydroxide solution (2M) and/or hydrochloric acid (2M) for pH 6.2-7.0 and purified water.

What Lidonostrum Gele 2% looks like and contents of the pack

Topical application gel for cutaneous use, packed in 30 g aluminium tubes.

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.

Medicinal product not subject to medical prescription.

Your doctor has more complete information on Lidonostrum Gele 2% and can assure you will use the medicine adequately.

This leaflet was last revised in June 2023.