Lidbree 42 mg/mL intrauterine gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIDOCAINE

Available from:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC code:

N01BB02

INN (International Name):

LIDOCAINE 42 mg/ml

Pharmaceutical form:

INTRAUTERINE LIQUID GEL

Composition:

LIDOCAINE 42 mg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-07-13

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

1
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 microgram
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 mL in total.
The safety and efficacy of Lidbree in infants and