Prospecto: information for the user

Lidocaína/Adrenalina Normogen20 mg/ml + 0.0125 mg/ml injectable solution EFG

lidocaína hidrocloruro/epinefrina

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your dentist or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your dentist or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Lidocaína/Adrenalina Normogen and for what it is used

2.What you need to know before starting to use Lidocaína/ Adrenalina Normogen

3.How to use Lidocaína/ Adrenalina Normogen

4.Possible adverse effects

5.Storage of Lidocaína/ Adrenalina Normogen

6.Contents of the package and additional information

Lidocaína/Adrenalina Normogenis an injectable solution indicated for local dental anesthesia, by infiltration or perineural route.

All surgical and non-surgical interventions in dentistry. Lidocaína/Adrenalina 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 local decrease in blood flow is required.

No use Lidocaína/Adrenalina Normogen

-if you are allergic to lidocaína, adrenalina, local anesthetics of the amide type or any of the other ingredients of this medication (listed in section 6).

• if you have uncontrolled epilepsy with treatment.
• if you have a serious heart disease, severe arterial disorders or hypertension, ischemia, severe arrhythmias, migraine, hyperthyroidism, diabetes, benign prostatic hypertrophy, acute angle glaucoma or kidney disease, as this medication contains a vasoconstrictor.

Warnings and Precautions

Consult your dentist or pharmacist before starting to use lidocaína/adrenalina.

• 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 affects you, consult your dentist or nurse before lidocaína/adrenalina is administered to you.

Other Medications and Lidocaína/Adrenalina Normogen

Inform your dentist or pharmacist if you are using, have used recently or may need to use any other medication, including over-the-counter medications or herbal medications. This is becauselidocaína/adrenalinamay affect the way some medications work and, conversely, some medications may affect lidocaína/adrenalina.

Especially, inform your dentist if you are taking or using any of the following medications:

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

Lidocaína/Adrenalina Normogen with Food, Drinks and Alcohol

After administration of lidocaína/adrenalina, do not take food until you have recovered sensitivity.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your dentist or pharmacist before using this medication.

Driving and Operating Machines

Lidocaína may temporarily affect your ability to move, pay attention and coordinate. Your doctor will tell you if you can drive or operate machines.

Use in Athletes

This medication contains adrenalina, which may produce a positive result in doping control tests (see references in section 4.4 of the technical data sheet).

Lidocaína/Adrenalina Normogen contains Sodium Metabisulfite

Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

Lidocaína/Adrenalina Normogen contains Sodium

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

Your dentist will administerlidocaína/adrenalinavia injection. Your dentist knows the correct way to administer this medication.

The dose administered by your dentist will depend on the type of pain relief you need, as well as your body size, age, physical condition, and the area of the body where the medication will be injected. The lowest effective dose will be administered.

Lidocaína/adrenalinaprevents nerves from transmitting pain messages to the brain. It prevents you from feeling pain. It will start to take effect a few minutes after the medication is injected and the effect will gradually wear off when the medical procedure is completed.

Use in children and special populations

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

If you have been administered more Lidocaína/AdrenalinaNormogen than prescribed

Severe side effects from receiving too muchLidocaína/adrenalinarequire special treatment. Your dentist is trained to handle these situations. The first signs of having received too muchlidocaína/adrenalinausually include the following:

• Dizziness or mild drowsiness.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Problems with hearing.
• Problems with vision.

Your dentist will stop administeringlidocaína/adrenalinaas soon as these signs appear to reduce the risk of severe adverse effects. This means that if you experience any of these or think you have received too muchlidocaína/adrenalina,you must inform your dentist immediately.

Other severe side effects from receiving too muchlidocaína/adrenalinainclude, among others, speech problems, irrational behavior, muscle spasms, seizures, effects on the heart and blood vessels, loss of consciousness, coma, and temporary interruption of breathing (apnea).

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

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

Rare (may affect up to 1 in 1,000 people):

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

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

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 metabisulfiteasexcipient, the following adverse reactions may also occur:very rare:in people with bronchial asthma, may produce allergic reactions that may include vomiting, diarrhea, wheezing, acute asthma attack,decreased level of consciousnessoranaphylactic shock.

Reporting Adverse Effects

If you experience adverse effects, consult your dentist, pharmacist, or nurse, even if they do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and the cartridge after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not refrigerate or freeze.

Store in the original packaging to protect it from light.

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt,ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Lidocaine/EpinephrineNormogen

• The active principles are lidocaine hydrochloride and epinephrine (adrenaline) as bitartrate. Each ml of injectable solution contains lidocaine hydrochloride monohydrate, equivalent to 20mg of anhydrous lidocaine hydrochloride (34mg per 1.7ml cartridge)and12.5 micrograms of epinephrine (adrenaline) (as epinephrine bitartrate) (21.3 micrograms per 1.7 ml cartridge).

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

Appearance of Lidocaine/EpinephrineNormogen and packaging content

Lidocaine/EpinephrineNormogen is a transparent, colorless or slightly yellowish solution.

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

Package containing 50 cartridges of 1.7ml.

Package containing 100 cartridges of 1.7ml (clinical package).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

Spain

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

Bulgaria:Dilocain

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

Iceland:Lident

PortugalLidocaine + Adrenaline Normogen

RomaniaLident 20 mg/ml + 0.0125 mg/ml injectable solution in cartridges

SpainLidocaine/EpinephrineNormogen 20mg/ml + 0.0125mg/ml injectable solution EFG

Last review date of this leaflet August 2024

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This information is intended solely for healthcare professionals:

To avoid intravenous injection, a prior aspiration should always be performed before injection. The use of the appropriate syringe for injection for the infiltration of anesthesia ensures perfect functioning, as well as maximum safety against cartridge breakage. Only intact cartridges should be injected.

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

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

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

Injection in an inflamed area should be avoided.

Before use, a visual inspection of the solution should be performed, and only transparent solutions without particles should be used.

Cartridges are for single use. If only part of the cartridge is used, the remaining content should be discarded.

Use immediately after opening the cartridge.

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