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What LIDBRI is and what it is used for
LIDBRI is an analgesic gel that is used to prevent pain during gynecological procedures, such as placing a contraceptive device in the uterus, taking a biopsy for laboratory tests during a gynecological examination, in women and girls aged 15 years and older. The gel contains the active substance lidocaine, which is a local anesthetic of the amide type (anesthetizes the parts of the body to which it is applied).
How LIDBRY works
After the application of the gel, the analgesia of the genital surface (mucosa) occurs after 2 to 5 minutes. The gel has been shown to reduce pain during gynecological procedures and for at least 30 minutes after the end of the procedure. After 1 hour, the anesthetic effect passes.
2. What you need to know before you use LIDBRI
Do not use LIDBRI 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 using the gel when inserting an intrauterine contraceptive device (IUD), in some cases bleeding and/or severe pain may occur if there were difficulties with insertion. In such cases, a physical examination and ultrasound examination should be performed to rule out perforation of the uterus or cervix (neck of the uterus). Uterine perforation has been reported in an average of 1 in 1,000 cases of IUD placement.
Tell the healthcare professional who gives you LIDBRI:
If you have a heart rhythm disorder (partial or complete heart conduction block), as the local anesthetic may affect it.
If you are taking treatment for an irregular heart rhythm (with so-called potassium channel blockers or class III antiarrhythmic drugs (eg amiodarone)), as the effect on the heart may be increased.
If you have a disease called acute porphyria (an inherited disease related to one of the proteins in the blood). Lidocaine can cause attacks of porphyria, and treatment with it should be prescribed to patients with acute porphyria only when there are definite indications or emergencies.
If your general health is not good.
Children and adolescents
Children under the age of 15 should not take this medicine due to the risk of side effects due to a high concentration of lidocaine in the blood.
Other medicines and LIDBRI
Tell your doctor or other healthcare professional if you have recently taken other medicines containing lidocaine, medicines to treat abnormal heart rhythms (antiarrhythmics such as mexiletine or class III antiarrhythmics such as amiodarone) as their effect on the heart will added to the action of lidocaine.
Pregnancy and breastfeeding
Based on long-term experience, the use of lidocaine during pregnancy is not known to cause adverse effects in the newborn.
Lidocaine can pass into breast milk, but in such small quantities that there is generally no risk of impact on the newborn. Breast-feeding can be continued during treatment with LIDBRI.
Lidocaine is not known to affect fertility.
Driving and using machines
LIDBRI has no or negligible influence on the ability to drive and use machines.
LIDBRI contains macrogolglycerol ricinoleate (castor oil, polyoxyl) and butylated hydroxytoluene (E 321)
Macrogolglycerol ricinoleate can cause severe allergic reactions, butylated hydroxytoluene (E 321) can cause mucous membrane irritation.
3. How to use LIDBRI
The numbing gel will be applied to you by your doctor or midwife (nurse) in a sequence, starting at the entrance to the uterus.
Use in adolescents
A reduced dose should be used in adolescents with a low body weight of less than 30 kg.
If you are given more than the required dose of LIDBRI
At the recommended dose, this is not expected. However, tell your doctor or nurse straight away if you experience numbness of the lips and tongue, dizziness, ringing in the ears (tinnitus) or trouble speaking or seeing (visual disturbances), as these may be early signs of high concentration of lidocaine in the blood. Sometimes muscle twitching or shaking (tremor) or breathing stops (apnoea) may occur, in which case your doctor or nurse will take steps quickly to ensure you are breathing properly (breathing support) and give you anticonvulsants .
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions that may occur after using LIDBRI with an intrauterine contraceptive are similar to those that occur with an intrauterine contraceptive without the use of LIDBRI.
Possible side effects are:
Very common side effects (may affect more than 1 in 10 people): nausea (feeling sick).
Common side effects (may affect up to 1 in 10 people): dizziness
5. How to store LIDBRI
Keep out of the reach of children.
Do not use this medicine after the expiry date (month-year) which is stated on the carton and syringe. The expiration date corresponds to the last day of the specified month.
This medicinal product does not require special storage conditions.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What LIDBRY contains
The active substance is lidocaine. Each ml of gel contains 42 mg of lidocaine.
The other ingredients are:
Macrogolglycerol ricinoleate (castor oil, polyoxyl)
Poloxamer (containing butylated hydroxytoluene (E 321))
Sodium ascorbate (E 301)
Hydrochloric acid for pH adjustment
Sodium hydroxide for pH adjustment
Water for injections
What LIDBRI looks like and contents of the pack
This product is an intrauterine gel (for intrauterine use). A sterile, clear to nearly clear, slightly yellowish-brown, viscous liquid at room temperature containing 42 mg/ml lidocaine. The product has a reversible gelation that depends on the temperature (thermogelation). LIDBRI 42 mg/ml intrauterine gel is available in a sterile 10 ml pre-filled syringe packed in a blister. A sterile applicator with a luer-lock tip compatible with the pre-filled syringe is packaged in a separate envelope placed inside the carton. 8.5 ml can be pushed (released) from the applicator. Packaging: 1x10 ml intrauterine gel in a pre-filled syringe.
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