PATIENT INFORMATION LEAFLET

Patient Information Leaflet:information for the patient

Lidbree 42 mg/ml intrauterine gel

lidocaine

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What is Lidbree and what it is used for

2.What you need to knowbeforestarting touse Lidbree

3.How to use Lidbree

4.Possible side effects

5Storage of Lidbree

6.Contents of the pack and additional information

Lidbree is a topical anesthetic gel used to prevent pain from gynecological procedures, such as the placement of contraceptive devices in the uterus and biopsy sampling for laboratory evaluation in gynecological exams, in adults and adolescents 15 years of age and older. It contains the active ingredient lidocaine, a local anesthetic of the amide type (which numbs the body parts to which it is applied).

How does Lidbree work?

After gel application, 2 to 5 minutes are required before the genital area (mucosa) is numbed. It has been shown that the gel reduces pain during gynecological procedures and for at least 30 minutes after the procedure. After 1 hour, the analgesic effect disappears.

No use Lidbree

If you are allergic to lidocaine or any of the other components of this medication (listed in section 6).

Warnings and precautions

For exclusive use via endocervical and intrauterine routes. After use of the gel for placement of an intrauterine contraceptive device (intrauterine device, IUD), in cases of difficult insertion, bleeding and/or exceptional pain may occur. In such cases, a physical examination and ultrasound should be performed immediately to rule out uterine or cervical perforation. The average is 1 perforation per 1,000 IUD insertion procedures.

Inform the professional administering Lidbree:

-if you have a heart rhythm disorder (partial or complete heart conduction block) as local anesthetics may affect it;

-if you are receiving treatment for a heart rhythm disorder (with so-called potassium channel blockers or class III antiarrhythmics, for example, amiodarone) because cardiac effects may increase;

-if you have a condition called acute porphyria (a condition found in the family, related to one of the proteins in the blood). Lidocaine may cause porphyria attacks and should only be prescribed in patients with acute porphyria in urgent or necessary cases;

-if you have poor overall health.

Children and adolescents

This medication should not be administered to children under 15 years of age due to the risk of side effects caused by high lidocaine concentrations in the blood.

Other medications and Lidbree

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication containing lidocaine, or medications to treat irregular heart rhythm (antiarrhythmics, such as mexiletine or class III antiarrhythmics like amiodarone), as their effects on the heart will add to the effects of lidocaine.

Pregnancy, breastfeeding, and fertility

Based on long-term experience, it is unknown whether lidocaine produces adverse effects in the newborn.

Lidocaine may be secreted in breast milk, but in such small quantities that there is generally no risk of this affecting the newborn. Therefore, breastfeeding may continue in the case of treatment with Lidbree.

The effect of lidocaine on fertility is unknown.

Driving and operating machines

Lidbree has a negligible or insignificant influence on the ability to drive and operate machines.

Lidbree contains ricinoleate of macrogolglycerol (castor oil polioxyl), and butylhydroxytoluene

Ricinoleate of macrogolglycerol may cause severe allergic reactions.

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).

Your doctor or nurse will apply the anesthetic gel step by step, starting from the uterine entrance.

Use inadolescents

Teenagers with a low weight, below 66 pounds of body weight, should receive a reduced dose.

If you use more Lidbree than you should

With the recommended doses, the following effects are not expected, however, inform your doctor or nurse immediately if you experience numbness of the lips or tongue, dizziness, ringing in the ear (tinnitus) or have difficulty speaking or seeing correctly (visual disturbances), as they could be the first symptoms of high lidocaine concentrations in the blood. In some cases, muscle spasms or tremors (tremors) or interruptions in breathing (apnea) may occur, in which case your doctor or nurse must ensure that you breathe correctly (airway support) and administer anticonvulsants.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used or ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The side effects experienced after the use of Lidbree in the insertion of contraceptives in the uterus (womb) are similar to those that occur in the same process without the application of Lidbree.

The possible adverse effects are:

• Very Frequent(more than 1 in 10 people): nausea (sensation of discomfort).
• Frequent(may affect up to 1 in 10 people): dizziness, headache, unpleasant sensations in the abdomen.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date (month-year) that appears onthe box and on the syringe.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofpackaging and medications that are no longerneeded.By doing so, you will help protect the environment.

Composition of Lidbree

• The active principle is lidocaine. Each ml of intrauterine gel contains 42 mg of lidocaine.
• The other components are:
• Ricinoleate of macrogolglycerol (castor oil polioxil)
• Poloxamer (contains butylhydroxytoluene (E 321))
• Sodium ascorbate (E 301)
• Hydrochloric acid to adjust the pH
• Sodium hydroxide to adjust the pH
• Water for injectable preparations

Appearance of the product and contents of the package

The product is an intrauterine gel (inside the uterus) that is sterile, transparent or almost transparent, a slightly brown-yellowish viscous liquid at room temperature, containing 42 mg/ml of lidocaine. The formulation shows a reversible gelation dependent on temperature, it is a gel at body temperature (thermogelation).The intrauterine gel Lidbree 42 mg/ml is presented in a sterile preloaded syringe of 10 ml (cyclic olefin copolymer) with a bromobutyl rubber stopper and cap, conditioned in a blister with the plunger rod. The syringe is graduated in ml. A sterile applicator (polypropylene) with a Luer lock blocking accessory compatible with the preloaded syringe is provided in a separate bag inside the box. Up to 8.5 ml of gel can be extracted from the applicator..

Package size: 1 × 10 ml of intrauterine gel in preloaded syringe.

Label symbols of the Lidbree applicator

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Gedeon Richter Plc.

Gyömroi út 19-21.

Budapest H-1103

Hungary

Manufacturers:

Recipharm Karlskoga AB

Björkbornsvägen 5

SE691 33 Karlskoga

Sweden

Gedeon Richter Plc.

Gyömroi út 19-21.

Budapest H-1103Hungría

You can request more information about this medication by contacting the local representative of the marketing authorization holder:marketing authorization holder:

Gedeon Richter Ibérica, S.A.

Sabino Arana, 28 - 4º 2ª

08028 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Austria, Belgium,Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland,France, Croatia,Hungary, Ireland, Iceland, Italy, Luxembourg, Latvia, Lithuania, Malta, Norway, Poland, Portugal, United Kingdom, Romania, Sweden, Slovenia, Slovakia: Lidbree

Last review date of thisleaflet:June2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)}>

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This information is intended exclusively for healthcare professionals:

Exclusive use by endocervical and intrauterine route.

After using Lidbree, in cases of difficult insertion and/or exceptional pain or bleeding during or after insertion, a physical examination and ultrasound should be performed immediately to rule out a perforation of the body or cervix, as the patient may not react with pain in case of perforation, as with an effective topical anesthetic.

Thermogelating formulation:Lidbree is a local anesthetic, a thermogelating viscous liquid, without preservatives. The formulation forms a gel when the temperature increases to body temperature, adhering to the mucous tissue of the cervical canal and uterus (minimizing the losses that would occur with a liquid formulation).

Method of application and dosage

Lidbree should be administered in a liquid state. If a gel is formed, place in the refrigerator until it becomes liquid again. The visible air bubble in the syringe moves if the syringe is tilted.

Prepare the sterile applicator included in the package following the indicated steps and apply the medication:

1)Check the appearance of the syringe while tilting it. The air bubble will move when tilting the syringe when the product is in a liquid state ready to use. If the air bubble does not move, it is because a gel has formed, in which case you should place the syringe in the refrigerator until it becomes liquid again.

2)Connect the plunger rod and the applicator to the syringe, making sure they are well seated.

3)Remove the air bubble and fill the applicator with gel by carefully pushing the syringe plunger.

4)Use the centimeter scale on the applicator to measure the amount of Lidbree.

Once the applicator is placed, up to 8.5 ml of gel can be administered from the syringe. One ml contains 42 mg of lidocaine. Apply the gel step by step (1 to 3) as illustrated in the figure.

Cervical procedures

1. Using the sterile applicator, apply 2 to 3 ml of gel in a thick layer on theexocervix.
2. Using the applicator, administer 3 ml in the cervical canal 5 minutes before the start of the procedure.

Intrauterine procedures

1. Using the sterile applicator, apply 1 to 2 ml of gel on the anterior lip of theexocervix.
2. Using the applicator, administer 2 to 3 ml in the cervical canal. Wait 2 minutes for the effect to start in the internal canal.
3. Then, insert the applicator into the uterine cavity and introduce 3 to 5 ml of gel, 5 minutes before the procedure. The applicator is marked with a centimeter scale. A smaller volume can be administered, for example, in nulliparous patients, if the patient experiences discomfort before finishing administering the entire volume.

A single intrauterine dose should not exceed 10 ml. Discard any unused content.

Population from 15 years old.

In adolescents with low weight, body weight below 30 kg, the dose shouldbe reduced proportionally, the single dose should not exceed the maximum recommended parenteral dose (6 mg/kg of lidocaine hydrochloride, which corresponds to 5.2 mg/kg of lidocaine base in Lidbree, that is, 1.2 ml per 10 kg of body weight). In adolescents with a body weight of 30 kg, the maximum dose of Lidbree is 3.6 ml in total.

Duration of effect

It has been demonstrated that the gel reduces pain during gynecological procedures and for at least 30 minutes after the procedure. After 1 hour, the analgesic effect has disappeared.