LIDBREE Intrauterine gel Ref.[49920] Active ingredients: Lidocaine

For cervical and intrauterine use only. Acute symptoms of local anaesthetic toxicity and life-threatening embolic complications may occur if the viscous thermogelling liquid is unintentionally injected intravascularly (for treatment of systemic toxic reactions see section 4.9). Other unintentional parenteral routes of administration may result in local tissue toxicity.

In case of difficult insertion of intrauterine contraceptives and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation of the uterine corpus or cervix, as with effective topical anaesthesia the patient might not react with pain in case of a perforation.

Some patients require special attention:

• Patients with partial or complete heart conduction block – due to the fact that local anaesthetics may depress myocardial conduction.
• Patients treated with antiarrhythmics of class III (e g amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
• Patients with acute porphyria. Lidocaine is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients. - Patients in poor general condition.

Paediatric population

Lidbree should not be administered to mucous membranes of infants and children less than 15 years old as plasma concentrations of lidocaine may exceed the threshold for toxicity (see section 5.1).

Excipients

This medicinal product contains macrogolglycerol ricinoleate (castor oil polyoxyl) and butylated hydroxytoluene (E 321). Macrogolglycerol ricinoleate may cause severe allergic reactions. Butylated hydroxytoluene (E 321) may cause irritation to the mucous membranes.

In the case of concomitant use of Lidbree and other lidocaine-containing products, large doses of lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g. certain anti-arrhythmics, such as mexiletine, since the systemic toxic effects are additive. Specific interaction studies with lidocaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).

Pregnancy

No studies on reproductive and development toxicity have been conducted with Lidbree. Lidocaine crosses the placenta. It is reasonable to assume that lidocaine has been used in a great number of pregnant women and women of fertile age. There is no evidence that lidocaine causes disturbances in the reproductive process such as increased incidence of malformations. The risk to humans has, however, not been completely investigated. The reproduction toxicity of lidocaine has been investigated in non-clinical models that revealed no harm to the foetus.

Breast‑feeding

Lidocaine may enter the mother’s milk, but in such small amounts that there is generally no risk of this affecting the neonate.Breastfeeding may therefore continue in the case of treatment withLidbree.

Fertility

There are no adequate data on the effect of Lidbree on fertility. No effect on fertility or early embryonic development is known for lidocaine.

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

Summary of the safety profile

The adverse reactions reported in clinical studies were similar in type and frequency in women treated with Lidbree and women treated with placebo gel and were representative of transientundesirable effects seen in connection with placement of intrauterine contraceptive devices. No serious adverse events have been reported.

Tabulated list of adverse reactions

Adverse reactions are classified according to frequency and system organ class. Frequency categories are defined according to the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). The following undesirable effects have been reported at 2% or higher frequency following administration of Lidbree.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: HPRA Pharmacovigilance Website: www.hpra.ie.

Not applicable.