Analgesic ointment for painful wounds, e.g. burns, ulcerous nipples in connection with breastfeeding, and insect bites.

Analgesic ointment for various anal conditions such as haemorrhoids and fissures. Following anorectal procedures or in connection with anorectal exploration.

Xylocaine ointment is intended for adults and children of all ages (for children under the age of 18 months, use only if prescribed by a doctor).

Wound care: Apply the ointment either directly to the irritated area in a thin layer or apply to a wound dressing.

For anal conditions: The ointment is to be applied rectally 1–3 times daily. In the case of painful bowel motions, the ointment should be applied 5–10 minutes prior to using the toilet.

Paediatric population

Children ≤ 12 years: No data on plasma concentration are available. From a safety perspective it should be assumed that bioavailability is 100% following application to mucous membranes and compromised skin. A single dose should not exceed 0.1 g ointment/kg body weight (equivalent to 5 mg lidocaine/kg body weight). The minimum dosage interval should be 8 hours.

Children > 12 years: Patients weighing less than 25 kg should be given doses in proportion to their weight and physical condition.

Should not be used on children under the age of 18 months unless prescribed by a doctor.

Caution should be observed in patients with partial or complete heart block if there is a risk of high plasma concentrations due to the method of administration or the dose administered. The elderly and patients with severe hepatic disease, severe renal impairment or poor general condition also require particular attention.

Patients treated with antiarrhythmic class III agents (e.g. amiodarone) should be monitored closely and ECG monitoring should be considered as the cardiac effects may be additive.

Excessive lidocaine doses or inadequate time intervals between doses can lead to high plasma concentrations and severe undesirable effects (see section 4.9, Overdose).

Patients should be urged to closely follow the recommended doses.

Xylocaine ointment should be used with caution in patients with compromised mucosal membranes and/or inflammation at the intended application site.

Xylocainee ointment contains propylene glycol, which can cause skin irritation.

Lidocaine should be used with caution in combination with dental anaesthesia administered by injection, other local anaesthetics or substances structurally related to amide-type local anaesthetics, such as class IB antiarrhythmics, as the toxic effects are additive.

No specific interaction studies with local anaesthetics and class III antiarrhytmics have been carried out, but caution is recommended (see section 4.4, Special warnings and precautions for use).

Medicinal products that inhibit the metabolism of lidocaine (e.g. cimetidine and beta blockers) can cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a prolonged period. Such interactions are not clinically relevant in short-term lidocaine therapy at recommended doses.

Pregnancy

There are no adequate data on the treatment of pregnant women with lidocaine.

Lidocaine crosses the placenta. It is reasonable to assume that lidocaine has been used in a large number of pregnant women and women of childbearing age. There is no evidence that lidocaine has a negative impact on reproductive processes, such as increased malformations or direct or indirect effects on the foetus. However, the risks for humans have not been fully investigated.

Animal studies are incomplete with regards to the effects on pregnancy, development of the embryo/foetus, childbirth and postnatal development (see section 5.3).

In the case of temporary use of Xylocaine ointment during pregnancy, the benefit is judged to outweigh potential risks.

Breastfeeding

Lidocaine is excreted in small quantities in human milk. It is unlikely that the infant would be affected when recommended doses are used. It is therefore possible to continue breastfeeding when being treated with Xylocaine ointment.

When Xylocaine ointment is used on ulcerous nipples in connection with breastfeeding, the ointment should be thoroughly wiped off or rinsed off with water prior to breastfeeding.

Xylocaine ointment has no or negligible influence on the ability to drive and use machines.

Adverse reactions to local anaesthetics in the strict sense occur in less than 1 per 1,000 treated patients.

To report any side effect(s):

· Saudi Arabia:

-Other GCC States:

Adverse reactions of the same type as those arising in cases of absolute overdose of parenterally administered lidocaine may occur in case of overdose of Xylocainee ointment. Systemic toxicity is, however, very unlikely at recommended doses. In case of toxicity, the symptoms are expected to be similar to those seen after other local anaesthetic treatment, i.e. excitatory CNS symptoms, and in rare cases CNS depression and myocardial depression.

Topical administration of 8.6–17.2 mg/kg lidocaine gave very severe toxicity in small children.

Treatment:

If signs of acute systemic toxicity appear, administration of the local anaesthetic must be immediately suspended. Treatment must be given to maintain good ventilation, oxygen supply and circulation. Oxygen is always administered; if required, controlled ventilation is to

be administered. If the convulsions have not ceased spontaneously within 15–20 seconds, administer thiopental sodium 1–3 mg/kg IV to permit adequate ventilation or diazepam

0.1 mg/kg IV (somewhat slower onset of effect). Convulsions of long duration are a risk to the patient’s breathing and oxygenation. The injection of a muscle relaxant (e.g. suxamethonium 1 mg/kg) creates more favourable conditions for ventilation and oxygenation of the patient, but requires experience of tracheal intubation and controlled ventilation. In the case of a drop in blood pressure or bradycardia, administer a vasopressor (e.g. ephedrine 5–10 mg IV, which can be repeated after 2–3 minutes).

In the case of circulatory arrest, cardiopulmonary resuscitation should be commenced immediately. It is important to maintain a good oxygen supply, breathing and circulation, and to treat acidosis.

Pharmacotherapeutic group: Local anaesthetics, ATC code: D04AB01

Xylocaine ointment contains 5% lidocaine dissolved in an ointment base which consists of a mixture of carbowaxes and propylene glycol. Xylocainee ointment has good penetration properties and a rapid anaesthetic effect. Xylocaine ointment is easily washed off with water and does not impede wound healing. The propylene glycol in the ointment base has an antibacterial effect on many pathogenic bacteria.

Paediatric population

Children ≤ 12 years: No data on plasma concentration are available. From a safety perspective it should be assumed that bioavailability is 100% following application to mucous membranes and damaged skin.

Reproduction toxicology

No teratogenic effects were observed in studies of embryo/foetal development in rats and rabbits involving administration during organogenesis. Embryotoxicity was seen in rabbits at a dose causing maternal toxicity. The offspring of rats treated with a dose causing maternal toxicity during late gestation and lactation showed decreased postnatal survival.

Genotoxicity and carcinogenicity

Genotoxicity studies of lidocaine were negative. The carcinogenicity of lidocaine has not been studied. The metabolite of lidocaine 2,6-xylidine has genotoxic potential in vitro. In a carcinogenicity study in rats exposed to 2,6-xylidine in utero, postnatally and over the entire lifespan, tumours in the nostrils, subcutaneous tissue and liver were seen. The clinical relevance of the tumour findings to short-term or intermittent use of lidocaine is unknown.

Macrogol, propylene glycol, purified water.

Not applicable.

Do not store above 25°C.

Aluminium tube with polypropylene screw cap

10 g tube

35 g tube

No special requirements.