LIDOCAINE/ADRENALINE NORMOGEN 20 mg/mL + 0.0125 mg/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Lidocaine/Adrenaline Normogen20 mg/ml + 0.0125 mg/ml injectable solution EFG

lidocaine hydrochloride/epinephrine

Read all of this leaflet carefully before you start using 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 dentist or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your dentist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Lidocaine/Adrenaline Normogen and what is it used for
2. What you need to know before you use Lidocaine/Adrenaline Normogen
3. How to use Lidocaine/Adrenaline Normogen
4. Possible side effects
5. Storage of Lidocaine/Adrenaline Normogen
6. Contents of the pack and further information

1. What is Lidocaine/Adrenaline Normogen and what is it used for

Lidocaine/Adrenaline Normogen is an injectable solution indicated for local dental anesthesia, by infiltration or perineural route.

All surgical and non-surgical interventions in dentistry. Lidocaine/Adrenaline Normogen 20 mg/ml + 0.0125 mg/ml injectable solution is indicated when it is necessary to prolong the duration of anesthesia or when a decrease in local blood flow is required.

2. What you need to know before you use Lidocaine/Adrenaline Normogen

Do not use Lidocaine/Adrenaline Normogen

• if you are allergic to lidocaine, adrenaline, local anesthetics of the amide type or any of the other components of this medicine (listed in section 6).
  • if you have uncontrolled epilepsy with treatment.
  • if you have severe heart disease, serious arterial disorders or hypertension, ischemia, serious cardiac rhythm disorders, migraine, hyperthyroidism, diabetes, benign prostatic hyperplasia, acute angle glaucoma or kidney disease, as this medicine contains a vasoconstrictor.

Warnings and precautions

Talk to your dentist or pharmacist before using lidocaine/adrenaline.

• if you have high blood pressure or heart problems.
• if you have liver or kidney problems.
• if you have diabetes.
• if you have thyroid problems.

In case of doubt about whether any of the above situations affect you, consult your dentist or nurse before administering lidocaine/adrenaline.

Other medicines and Lidocaine/Adrenaline Normogen

Tell your dentist or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or herbal medicines. This is because lidocaine/adrenaline can affect how some medicines work and, in turn, some medicines can affect lidocaine/adrenaline.

In particular, tell your dentist if you are taking or using any of the following medicines:

• Betablockers such as propranolol.
• Butyrophenones for vomiting, such as domperidone.
• Other butyrophenones for treating mental problems, such as haloperidol.
• Phenothiazines for treating mental problems, such as chlorpromazine.
• Medicines for depression, such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
• Cimetidine

Lidocaine/Adrenaline Normogen with food, drinks, and alcohol

After administering lidocaine/adrenaline, do not eat until sensitivity has returned.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your dentist or pharmacist before using this medicine.

Driving and using machines

Lidocaine may temporarily affect your ability to move, attention, and coordination. Your doctor will tell you if you can drive or use machines.

Use in athletes

This medicine contains adrenaline, which can produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

Lidocaine/Adrenaline Normogen contains sodium metabisulfite

It can rarely cause severe hypersensitivity reactions and bronchospasm.

Lidocaine/Adrenaline Normogen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per cartridge; it is essentially "sodium-free".

3. How to use Lidocaine/Adrenaline Normogen

Your dentist will administer lidocaine/adrenaline by injection. Your dentist knows the correct way to administer this medicine.

The dose your dentist administers will depend on the type of pain relief you need. It will also depend on your body size, age, and physical condition, as well as the part of the body where the medicine will be injected. You will be given the smallest possible dose that produces the necessary effect.

Lidocaine/adrenaline prevents nerves from transmitting pain messages to the brain. It prevents you from feeling pain. It will start working a few minutes after the medicine is injected and the effect will gradually disappear when the medical procedure is finished.

Use in children and special populations

In children, the dose will be reduced based on weight and age.

If you have been given too much Lidocaine/Adrenaline Normogen

Severe side effects from receiving too much lidocaine/adrenaline require special treatment. Your dentist is specialized to act in these situations. The first signs of having received too much lidocaine/adrenaline are usually the following:

• Dizziness or slight drowsiness.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Vision problems.

Your dentist will stop administering lidocaine/adrenaline as soon as these signs appear to reduce the risk of serious side effects. This means that if you experience any of them or think you have received too much lidocaine/adrenaline, you should inform your dentist immediately.

Other more serious side effects from receiving too much lidocaine/adrenaline include, among others, speech problems, irrational behavior, muscle spasms, convulsions, effects on the heart and blood vessels, loss of consciousness, coma, and interruption of breathing for a short period (apnea).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1000 people):

Low blood pressure, altered heart rhythm (arrhythmias), cardiac arrest, metallic taste, tinnitus (ringing in the ears), dizziness, anxiety, tremors, nystagmus (uncontrolled eye movements), headache, increased respiratory rate, paresthesia in lips and tongue (loss of sensitivity accompanied by a burning sensation). Loss of consciousness and convulsions, coma, and respiratory arrest (in case of overdose). Nausea, vomiting, and increased respiratory rate followed by a decrease in respiratory rate, which can cause respiratory arrest.

Due to the presence of adrenaline as a vasoconstrictor, the following adverse reactions can also occur rarely: high blood pressure, chest pain, altered heart rhythm (arrhythmias), cardiovascular arrest, sensation of heat, sweating, headaches, inflammation of the thyroid gland.

Very rare (may affect up to 1 in 10,000 people):

Skin rash, erythema (redness), pruritus (itching), edema (swelling) of the tongue, lips, or mouth, allergic reactions, or anaphylactic shock.

Due to the presence of sodium metabisulfite as an excipient, the following adverse reactions can also occur very rarely: in people with bronchial asthma, allergic reactions can occur with vomiting, diarrhea, wheezing, acute asthma attack, decreased level of consciousness, or anaphylactic shock.

Reporting of side effects

If you experience side effects, talk to your dentist, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine/Adrenaline Normogen

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

Do not use this medicine after the expiry date stated on the packaging and cartridge after CAD. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep in the original packaging to protect from light.

Do not use this medicine if you see any particles or if the solution is not transparent.

The cartridges are for single use. Use immediately after opening the cartridge. Discard unused solution.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lidocaine/Adrenaline Normogen

• The active substances are lidocaine hydrochloride and epinephrine (adrenaline) as bitartrate. Each ml of injectable solution contains lidocaine hydrochloride monohydrate, equivalent to 20 mg of anhydrous lidocaine hydrochloride (34 mg per 1.7 ml cartridge) and 12.5 micrograms of epinephrine (adrenaline) (as epinephrine bitartrate) (21.3 micrograms per 1.7 ml cartridge).

• The other components are sodium metabisulfite (E-223), sodium chloride, and water for injectable preparations.

Appearance of Lidocaine/Adrenaline Normogen and contents of the pack

Lidocaine/Adrenaline Normogen is a clear, colorless or slightly yellowish solution.

It is packaged in single-use glass cartridges, sealed at the base with a movable rubber piston and at the top with a rubber stopper held by an aluminum cap.

Packaging containing 50 cartridges of 1.7 ml.

Packaging containing 100 cartridges of 1.7 ml (clinical packaging).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Dilocain

France: Lidocaine Normon 20 mg/ml Adrenaline 0.0125 mg/ml, solution injectable

Iceland: Lident

Portugal Lidocaine + Adrenaline Normogen

Romania Lident 20 mg/ml + 0.0125 mg/ml solutie injectabila în cartus

Spain Lidocaine/Adrenaline Normogen 20 mg/ml + 0.0125 mg/ml injectable solution EFG

Date of last revision of this leaflet August 2024

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This information is intended only for healthcare professionals:

To avoid intravenous injection, aspiration should always be performed before injection. The use of the appropriate syringe for injection ensures perfect functioning and maximum safety against cartridge breakage. Only the contents of intact cartridges should be injected.

In order to avoid any risk of infection (e.g., prevention of hepatitis transmission), it is essential to use newly sterilized syringes and needles. The remaining contents of partially used cartridges should not be administered to other patients.

For the external disinfection of cartridges, 91% isopropyl alcohol or 70% ethanol without denaturants is recommended. Solutions containing heavy metals are not recommended, as they release ions (mercury, zinc, copper, etc.) that produce edema during the injection of local dental anesthetics.

When using any local anesthetic, oxygen, resuscitation equipment, and medications should be available.

Injection into an inflamed area should be avoided.

Before use, a visual inspection of the solution should be performed, and only particle-free, transparent solutions should be used.

The cartridges are for single use. If only part of the cartridge is used, the remaining contents should be discarded.

Use immediately after opening the cartridge.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.