Lidbree 42 mg/mL intrauterine gel

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Leaflet: information for the patient

Lidbree 42 mg/ml intrauterine gel

lidocaine

Read all of 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Lidbree is and what it is used for
2. What you need to know before using Lidbree
3. How to use Lidbree
4. Possible side effects

5 Storage of Lidbree

1. Contents of the pack and other information

1. What Lidbree is and what it is used for

Lidbree is an anesthetic gel used to prevent pain during gynecological procedures, such as the placement of intrauterine contraceptive devices and the collection of biopsy samples for laboratory evaluation during gynecological examinations, in adults and adolescents aged 15 years and older. It contains the active substance lidocaine, an amide-type local anesthetic (which numbs the parts of the body to which it is applied).

How does Lidbree work?

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

2. What you need to know before using Lidbree

Do not use Lidbree

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

Warnings and precautions

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

Inform the healthcare professional who will administer Lidbree:

• if you have a heart rhythm disorder (partial or complete cardiac 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 (e.g., amiodarone)), because cardiac effects may be enhanced;
• if you have a condition called acute porphyria (a hereditary condition related to one of the blood proteins). Lidocaine may trigger porphyria attacks and should only be prescribed in patients with acute porphyria in urgent or necessary cases;
• if you have a poor general health condition.

Children and adolescents

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

Other medicines and Lidbree

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

Pregnancy, breastfeeding and fertility

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

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

The effect of lidocaine on fertility is unknown.

Driving and using machines

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

Lidbree contains macrogolglycerol ricinoleate (polyoxyl castor oil) and butylated hydroxytoluene

Macrogolglycerol ricinoleate may cause severe allergic reactions.

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

3. How to use Lidbree

Your doctor or nurse will apply the anaesthetic gel step by step, starting at the entrance of the uterus.

Use in adolescents

Adolescents with low body weight, below 30 kg, should receive a reduced dose.

If you use more Lidbree than you should

With the recommended doses, the following effects are not expected to occur; 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 properly (visual disturbances), as these could be the first symptoms of high concentrations of lidocaine in the blood. Occasionally, muscle spasms or tremors (tremors) or interruptions in breathing (apnea) may occur; in such cases, your doctor or nurse must quickly ensure that you are breathing properly (airway support) and administer anticonvulsant treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The side effects observed after using Lidbree during intrauterine contraceptive device (uterus) insertion are similar to those occurring during the same procedure without the use of Lidbree.

Possible adverse effects are:

• Very common (affects more than 1 in 10 people): nausea (feeling of discomfort).
• Common (may affect up to 1 in 10 people): dizziness, headache, unpleasant abdominal sensations.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidbree

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (month-year) stated on the carton and on the syringe. The expiry date refers to the last day of the stated month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the package and other information

Composition of Lidbree

• The active substance is lidocaine. Each ml of intrauterine gel contains 42 mg of lidocaine.
• The other components are:
• Macrogol glycerol ricinoleate (polyoxylated castor oil)
• Poloxamer (contains butylhydroxytoluene (E 321))
• Sodium ascorbate (E 301)
• Hydrochloric acid for pH adjustment
• Sodium hydroxide for pH adjustment
• Water for injections

Appearance of the product and contents of the pack

The product is an intrauterine gel (within the uterus) that is sterile, clear or almost clear, slightly brownish-yellow viscous liquid at room temperature, containing 42 mg/ml of lidocaine. The formulation shows reversible temperature-dependent gelation, becoming a gel at body temperature (thermogelling). Lidbree 42 mg/ml intrauterine gel is supplied in a sterile 10 ml pre-filled syringe (cyclic olefin copolymer) with a bromobutyl rubber closure cap and cap, packed in a blister with the plunger rod. The syringe is graduated in ml. A sterile applicator (polypropylene) with a Luer-lock connector compatible with the pre-filled syringe is provided in a separate pouch within the carton. Up to 8.5 ml of gel can be dispensed from the applicator.

Pack size: 1 × 10 ml of intrauterine gel in a pre-filled syringe.

Lidbree applicator label symbols

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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-1103 Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Gedeon Richter Ibérica, S.A.

Sabino Arana, 28 - 4º 2ª

08028 Barcelona

Spain

This medicinal product is authorised in the Member States of the European Economic Area under 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

Date of latest review of this summary: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

For endocervical and intrauterine use only.

After the use of 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 perforation of the uterine body or cervix, as with effective topical anaesthesia, the patient may not experience pain in the event of perforation.

Thermogelling formulation: Lidbree is a preservative-free, viscous liquid thermogelling local anaesthetic. The formulation forms a gel when the temperature rises to body temperature, adhering to the mucosal tissue of the cervical canal and uterus (minimising losses that would occur with a liquid formulation).

Method of administration and dosage

Lidbree must be administered in its liquid state. If a gel has formed, place the syringe in the refrigerator until it becomes liquid again. The visible air bubble in the syringe will move when the syringe is tilted.

Prepare the sterile applicator provided in the package according to the steps indicated and administer the medicine:

1. Check the appearance of the syringe while tilting it. The air bubble will move when the syringe is tilted if the product is in its liquid state and ready for use. If the air bubble does not move, this indicates that a gel has formed; in this case, place the syringe in the refrigerator until it becomes liquid again.
2. Attach the plunger rod and applicator to the syringe, ensuring they are securely fitted.

1. Expel the air bubble and fill the applicator with gel by gently pushing the syringe plunger.
2. Use the centimetre scale on the applicator to measure the amount of Lidbree.

Once the applicator is assembled, 8.5 ml of gel can be administered from the syringe. One ml contains 42 mg of lidocaine. Administer 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 as a thick layer to the exocervix.
2. Using the applicator, administer 3 ml into 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 to the anterior lip of the exocervix.
2. Using the applicator, administer 2 to 3 ml into the cervical canal. Wait 2 minutes for the effect to begin in the internal canal.
3. Then insert the applicator into the uterine cavity and instil 3 to 5 ml of gel, 5 minutes before the procedure. The applicator is marked with a centimetre scale. A smaller volume may be administered, e.g. in nulliparous patients, if discomfort occurs before the full volume is administered.

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

Paediatric population from 15 years of age.

In adolescents with low body weight (below 30 kg), the dose should be reduced proportionally. The single dose must not exceed the recommended maximum parenteral dose (6 mg/kg of lidocaine hydrochloride, corresponding to 5.2 mg/kg of lidocaine base in Lidbree, i.e., 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

The gel has been shown to reduce pain during gynaecological procedures and for at least 30 minutes after the procedure. After 1 hour, the analgesic effect has disappeared.