Lidbree 42 mg/mL intrauterine gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

Gedeon Richter Plc

ATC code:

N01BB02

INN (International Name):

Lidocaine

Dosage:

42 milligram(s)/millilitre

Pharmaceutical form:

Intrauterine gel

Therapeutic area:

lidocaine

Authorization status:

Not marketed

Authorization date:

2020-11-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIDBREE 42 MG/ML INTRAUTERINE GEL
lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lidbree is and what it is used for
2.
What you need to know before you use Lidbree
3.
How to use Lidbree
4.
Possible side effects
5.
How to store Lidbree
6.
Contents of the pack and other information
1.
WHAT LIDBREE IS AND WHAT IT IS USED FOR
Lidbree is a numbing gel used to prevent pain from gynaecological
procedures, such as placement of
contraceptive devices into the womb (uterus) and sampling biopsies for
laboratory evaluation at
gynaecological examinations, in adults and adolescents from 15 years
of age. It contains the active
substance lidocaine, an amide type local anaesthetic (that numbs the
parts of the body it is applied to).
HOW LIDBREE WORKS
After application of gel it takes 2 to 5 minutes before the genital
area (the mucosa) is numb. The gel
has been shown to reduce the pain during gynaecological procedures and
up to at least 30 minutes
after the procedure. After 1 hour the pain relieving effect has worn
off.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LIDBREE
_ _
DO NOT USE LIDBREE if you are allergic to lidocaine or any of the
other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
For cervical and intrauterine use only. After use of the gel for the
placement of intrauterine
contraceptives (intrauterine contraceptive devices, IUDs), in some
cases bleeding and/or exceptional
pain may occur after difficult insert

Summary of Product characteristics

Health Products Regulatory Authority
13 July 2021
CRN00CCQJ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidbree 42 mg/mL intrauterine gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 42 mg/mL
Excipients with known effect:
Each mL of gel contains 284 mg of macrogolglycerol ricinoleate (castor
oil polyoxyl) and up to 28 micrograms of butylated
hydroxytoluene (E 321).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Intrauterine gel. Sterile, clear to almost clear, slightly
brown-yellow viscous liquid that is a gel at body temperature.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidbree is indicated for topical anaesthesia for moderate acute pain
during cervical and intrauterine procedures, in adults and
adolescents from 15 years of age. See section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Cervical procedures_
Apply 2 to 3 mL in a thick layer to the portio, and 3 mL into the
cervical canal using the sterile applicator 5 minutes before start
of procedure.
_Intrauterine procedures_
Using the sterile applicator, apply 1 to 2 mL to the anterior lip of
the portio, and 2 to 3 mL into the cervical canal. Wait
2 minutes for the onset of effect at the inner meatus. Thereafter
insert the applicator into the uterine cavity and introduce
3 to 5 mL, 5 minutes before the procedure. The applicator is marked
with a centimetre scale. A smaller volume can be
administered, e.g. in nulliparous patients, if the patient experiences
discomfort before the whole volume has been given. A
single intrauterine dose should not exceed a total of 10 mL.
_Paediatric population from 15 years of age_
In low-weight adolescents below 30 kg body weight the dose should be
proportionally reduced, and a single dose should not
exceed the maximum recommended parenteral dose (6 mg/kg lidocaine
hydrochloride, corresponding to 5.2 mg/kg lidocaine
base in Lidbree, i.e. 1.2 mL per 10 kg body weight). In adolescents
with a body weight of 30 kg the maximum dose of Lidbree is
3.6