Pharmacotherapeutic group: 13.8.2 Local anaesthetics and antipruritics.

• Temporary relief of pain caused by minor burns and mild skin abrasion, such as sunburns, Herpes Zoster and oral Herpes, sore nipples and insect bites.
• Anaesthesia of the mucosae, such as in haemorrhoids and anal fissures.
• Pain relief during medical procedures such as proctoscopy, sigmoidoscopy, cystoscopy, endotracheal intubation.
• Stomatology: superficial anaesthesia of the gums before injection, tartar removal and fitting of dentures.

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

Do not take Lidonostrum:

• If you are hypersensitive to lidocaine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidonostrum.

The absorption through injured skin surfaces and mucosae is relatively high, particularly at bronchi level. This must be considered especially when the ointment is used in children for the treatment of large areas.

The oropharyngeal use of topical anaesthetic agents may interfere with swallowing and thus the danger of aspiration is justified. This is particularly important in children.

Avoid contact with the eyes.

Other medicines and Lidonostrum

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

Lidocaine must be used with caution in patients receiving antiarrhythmic drugs such as tocainide, since toxic effects are additive.

Lidonostrum with food, drink and alcohol

Not applicable.

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 using this medicine.

Lidocaine crosses the placenta and so its use is not recommended, particularly during the first 3 months of pregnancy.

Lidocaine reaches the mother’s milk but in such small amounts that, when used in therapeutic doses, there is no risk of affecting the baby.

Driving and using machines

Lidocaine may temporarily affect coordination and locomotion. Lidonostrum contains 250 mg of propylene glycol for each gram of ointment.

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

As with other local anaesthetic adverse reactions and complications may be easily avoided if the minimum effective dose is used.

In debilitated patients, elderly and children the doses must be adapted to age and physical condition.

The ointment must be applied in a thin layer for an adequate control of the symptoms.

For endotracheal intubation apply directly on the tube.

In stomatology apply in the oral mucosa previously dried. Let the ointment act for at least 3-5 minutes in order to obtain the effect.

In sore nipple apply with the help of a small gauze. The ointment must be removed prior to breast-feeding.

Do not apply more than 20 g of ointment within 24h.

If you use more Lidonostrum than you should

The treatment of a patient with toxicity signs must ensure adequate ventilation. If seizures occur, these can be treated with intravenous administration of diazepam or thiopental. If ventricular fibrillation or cardiac arrest occurs proceed to cardiovascular resuscitation. Adrenaline in repeated doses and sodium bicarbonate must be administered as soon as possible.

If you forget to use Lidonostrum

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

If you stop using Lidonostrum

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

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

In some rare cases, local anaesthetics have been associated to allergic reactions (including severe anaphylactic shock).

Systemic adverse reactions are extremely rare and may occur due to high serum levels that may have been caused by excessive dosing, fast absorption or hypersensitivity, idiosyncrasy or reduced tolerance from the patient. Such reactions are systemic and involve the central nervous system and/or the cardiovascular system.

Reactions at central nervous system level are excitatory and/or depressive and can be characterized by anxiety, dizziness, seizures, unconsciousness and possibility of respiratory arrest. Excitatory reactions can be very quick or may not even occur. In this case, the first manifestation of toxicity is characterized by drowsiness. Cardiovascular reactions are depressive and can be characterized by hypotension, myocardial depression, bradycardia and the possibility of cardiac arrest.

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.

INFARMED, I.P.
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 Line: 800222444 (free)
Fax: + 351 21 798 73 97
internet Website: http://www.infarmed.pt/web/infarmed/submissaoram
E-mail: farmacovigilancia@infarmed.pt

Store at room temperature.

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

Do not use this medicine after the expiry date which is stated on the carton after VAL:. 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 contains

The active substance is lidocaine. 1 gram of Lidonostrum ointment contains: lidocaine 50 mg.

The other ingredients are: Macrogol 3350, Macrogol 400, Macrogol 1500, propylene glycol (E1520) and purified water.

What Lidonostrum looks like and contents of the pack

Lidonostrum is a white to greyish white ointment for topical use. 35 g of ointment.

Marketing Authorisation Holder and Manufacturer:

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

Tel: 219426100
Fax: 219416205
E-mail: geral@sidefarma.pt

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

This leaflet was last revised in April 2018.