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Lidonostrum ® Gel Bucal 20mg/ml - Oromucosal gel

Lidocaine Hydrochloride

lidonostrum gel 

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

  1. What LIDONOSTRUM is and what it is used for
  2. What you need to know before you use LIDONOSTRUM
  3. How to use LIDONOSTRUM
  4. Possible side effects
  5. How to store LIDONOSTRUM
  6. Other information

 

1. What LIDONOSTRUM is and what it is used for

LIDONOSTRUM is indicated for local anaesthesia of:

  • Irritated or inflamed mucous membranes such as those of the mouth and pharynx, as for instance after tonsillectomy.
  • Introduction of instruments and catheters in digestive and respiratory tract as in, for instance, bronchoscopy, oesophagoscopy.
  • Painful diseases of the gastrointestinal tract, such as, for instance oesophagitis.

 

2. What you need to know before you use LIDONOSTRUM

Do not use LIDONOSTRUM

  • if you have known hypersensitivity to local anaesthetics of the amide type or to any of the other components of the gel, such as methyl parahydroxybenzoate.

 

Take special care with LIDONOSTRUM

Excessive doses or small intervals between doses may cause increased plasma levels and serious adverse effects. Patients must carefully use the recommended dose. This is particularly important in children where the dose varies with weight.

Absorption from wounds and mucous membranes is relatively high. Lidocaine in the form of oromucosal gel must be used with caution in patients with damaged mucous membranes and/or infections in the area where the gel is to be applied.

Avoid ingesting any food while under the anaesthetic effect of LIDONOSTRUM.

Special attention is required: In patients with partial or total cardiac block Elderly patients and in debilitated health conditions Patients with advanced hepatic disease or severe renal impairment

 

Other medicines and LIDONOSTRUM

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

Lidocaine must be used with caution in patients receiving substances that are structurally related to local anaesthetics, such as tocainide, since toxic effects are additive.

 

LIDONOSTRUM with food and drink

Not described.

 

Pregnancy and breast-feeding

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

Until now, no specific disturbances in the reproductive process have been recorded, such as for instance an increase in the incidence of malformations.

As it happens with other local anaesthetics, lidocaine may reach 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 have a very mild effect on brain functions but they can, however, temporarily change locomotion and coordination.

Important information on some components of LIDONOSTRUM This medicine contains parabens. These may cause allergic reactions (possibly delayed).

 

3. How to use LIDONOSTRUM

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

LIDONOSTRUM produces topical anaesthesia in the upper digestive tract. It also provides symptomatic pain relief when applied in mucous membranes of the mouth and pharynx.

As with other local anaesthetics the safety and efficacy of lidocaine depend on a specific dose, on the use of a correct technique and on the adequate precautions for solving emergencies.

The following recommended doses must be taken as guidance. Clinical experience and the overall knowledge of the physical condition of the patient are important to determine the necessary dose.

Adults: For the treatment of pain from irritated or inflamed mucous membranes of the mouth and trachea, 5-10 ml (100-200 mg of lidocaine) of LIDONOSTRUM are recommended. The gel must be spread around the mouth and slowly swallowed. Do not exceed 6 doses within 24h. For topical anaesthesia before the introduction of instruments and catheters in upper respiratory or digestive tracts 10-15 ml (200-300 mg of lidocaine) of LIDONOSTRUM are recommended.

For the use in the pharynx gargling is recommended and the gel can be diluted. When combined with other products containing lidocaine (for instance for bronchoscopy) the total dose of lidocaine must not exceed 400 mg. For diseases of the upper gastrointestinal tract 5-15 ml of LIDONOSTRUM (100-300 mg of lidocaine) must be ingested in a single gulp. Do not exceed 6 doses within 24h.

Children: In children aged 12 years old or less, for the treatment of irritated or inflamed mucous membranes of the mouth or trachea, the dose must not exceed 4 mg/kg. Removing the excess of gel is recommended.

In children aged 3 years old or less the dose must be rigorously measured and applied in the affected area with an adequate instrument. The same procedure is recommended for older children with problems in expectorating. Do not exceed 4 doses within 12-24h.

 

If you use more LIDONOSTRUM than you should

Toxic reactions originate in the central nervous system and in the cardiovascular system.

The toxicity of the nervous system has a graded response with symptoms and signs of growing seriousness. The first symptoms are circumoral paresthesia, numbness of the tongue, drowsiness, hyperacusis and tinnitus (ringing). Visual disturbances and muscle tremors are more serious symptoms and precede generalized seizures. Unconsciousness and seizures with duration from a few seconds to a couple of minutes may follow. Hypoxia and hypercapnia rapidly occur after seizures due to an increase of muscular activity, together with the interference in normal breathing. In more severe cases apnoea may occur. Acidosis increases the toxic effects of local anaesthetics. Recovery is due to the re-distribution and to the metabolism of local anaesthetics from the central nervous system. Recovery can be quick despite the administration of large amounts of the drug.

The cardiovascular effects are only observed in cases where high systemic concentrations are reached. Severe hypotension, bradycardia, arrhythmia and cardiovascular collapse may result in those cases.

Cardiovascular toxic effects are generally preceded by signs of toxicity from the central nervous system unless the patient receives general anaesthetics or has received sedatives such as benzodiazepines or barbiturates.

Drugs and the equipment needed for the treatment of acute toxicity must be available. The objectives of the treatment are to maintain oxygenation, stop seizures and support circulation. Oxygen must be provided and, if necessary, assisted ventilation too. If seizures do not stop spontaneously within 15-20 seconds an IV anticonvulsant can be administered, such as thiopental or diazepam.

If visible cardiovascular depression occurs (hypotension, bradycardia), ephedrine can be administered. If circulatory arrest occurs cardiopulmonary resuscitation must start immediately. Oxygenation, ventilation and circulatory support, as well as acidosis treatment, are vital since hypoxia and acidosis increase the systemic toxicity of local anaesthetics.

 

If you forget to use LIDONOSTRUM

Do not take a double dose to make up for a forgotten dose.

 

If you stop using LIDONOSTRUM

Not applicable.

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

 

4. Possible side effects

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

Allergic reactions: allergic reactions to local anaesthetics of the amide type are rare (in most severe cases anaphylactic shock). Other components of the gel, such as propyl parahydroxybenzoate and methyl parahydroxybenzoate may also cause this type of reaction.

Acute systemic toxicity: if increased systemic levels occur lidocaine may cause acute toxic effects due to fast absorption or due to overdose.

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

 

5. How to store LIDONOSTRUM

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

Do not store above 25º C.

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

Store in the original package.

Do not use LIDONOSTRUM if you notice 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.

 

6. Other information

What LIDONOSTRUM contains

The active substance is: Lidocaine hydrochloride.

The other ingredients are: sodium carboxymethyl cellulose, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, sodium saccharin, cherry essence, purified water.

 

What LIDONOSTRUM looks like and contents of the pack

LIDONOSTRUM is presented as an oromucosal gel for topical use, in a 125 ml bottle.

 

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and manufacturer

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

Manufacturer

Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
Felgueira
3450-336 Sobral Mortágua

 

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

 

This leaflet was last revised in 2017.