PATIENT INFORMATION LEAFLET

Lidocaína NORMON 20 mg/ml injectable solution EFG

Lidocaína, hydrochloride monohydrate

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

Lidocaína NORMON contains lidocaine hydrochloride monohydrate and belongs to a group of medications called local anesthetics. It is used to block pain by reducing the conduction of nerve impulses near its site of action.

Lidocaína NORMON is used to provide anesthesia through local injection around nerves or areas where surgical procedures will be performed.

Do not use Lidocaína NORMON

• If you are allergic to lidocaine hydrochloride monohydrate, to anesthetics of this type (designated as amide-type anesthetics) or to any of the other components of this medication (listed in section 6).
• For epidural anesthesia in patients with pronounced hypotension (very low blood pressure) or cardiogenic shock (the heart pumps blood inadequately) or hypovolemic shock (severe loss of blood or body fluids).

Warnings and precautions

Be especially careful:

• If you have a history of epilepsy.
• If you have heart or lung diseases.
• If you have liver or kidney diseases.

Consult your doctor or pharmacist before Lidocaína NORMON is administered to you.

Lidocaína NORMON interactions with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

If you take cimetidine (medication for treating gastric and duodenal ulcers) and propranolol (anti-hypertensive) inform your doctor as it may affect your response to lidocaine injection.

If you use beta-blockers, antiarrhythmics (including mexiletine, disopyramide or procainamide) or phenytoin (antiepileptic) inform your doctor before the administration of Lidocaína NORMON.

Pregnancy and breastfeeding

If you are pregnant, or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Lidocaína NORMON should not be administered during the early stages of pregnancy unless your doctor considers the benefits to outweigh the risks. Similarly, consult your doctor if you are breastfeeding.

Driving and operating machinery

This medication may temporarily alter your ability to move, attention and coordination. Your doctor will indicate if you can drive or operate machinery.

Important information about one of the components of Lidocaína NORMON

Competitors should be aware that lidocaine may produce a positive result in doping tests.

Lidocaina NORMON contains sodium

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

Lidocaína Normon will be administered by a doctor. It will be administered as an injection into a vein, into a muscle, under the skin, around the nerves, or in the epidural space near the spinal cord.

Lidocaína Normon will be administered normally near the part of the body that is going to be operated on.

The dose administered by the doctor will depend on the type of pain relief needed. It will also depend on the patient's height, age, physical condition, and the part of the body where the medication is injected. The patient will receive the lowest dose possible to produce the desired effect. The lidocaína dose should be reduced in special populations and in patients with poor general health.

Use in children

The dose should be reduced in children. Lidocaína should be used with caution in children under four years old.

If more Lidocaína NORMON is administered than it should be

Treatment will consist of stopping the seizures and ensuring adequate ventilation with oxygen.

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicological Information Service (Tel. 915 620 420), indicating the medication and the amount used.

Like all medications, Lidocaína NORMON may produce adverse effects, although not everyone will experience them.

Like other local anesthetics, the adverse effects of Lidocaína NORMON are infrequent and usually result from excessively high concentrations in the blood, generally due to rapid absorption or allergic reactions.

Among the possible adverse effects, the following can be mentioned:

• Nervous system disorders: dizziness, tongue and lip numbness, hearing loss, tinnitus (ringing), dysarthria (speech disorder), disorientation, and occasionally drowsiness. In extreme cases, there may be muscle twitching, nervous movements, and tremors initially in the facial muscles and distal extremities.
• Cardiac disorders: such as a drop in blood pressure and bradycardia (slow pulse).
• General disorders and changes at the administration site: Allergic reactions are very rare. They may present as skin reactions, pallor, lip swelling, itching, weakness, dizziness, sensation of chest oppression, chest pain, rapid pulse, and difficulty breathing (anaphylactic reaction).
• Horner's Syndrome (associated with epidural anesthesia or applications in the head and neck region)

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

No special storage conditions are required. Store in the original packaging.

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

Productfor single use. Any remaining solution residue should be discarded. Visually inspect before use. Use only if the solution is clear and free of visible particles.

Medications should not be disposed of through drains or in the trash. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of Lidocaína NORMON

• The active ingredient is lidocaína. Each ml of solution contains 20 mg of lidocaína hydrochloride monohydrate.
• The other components are: sodium chloride and water for injection preparations.

Appearance of the product and contents of the packaging

Lidocaína NORMON 20 mg/ml is presented as an injectable solution in glass ampoules containing 200 mg of lidocaína hydrochloride monohydrate in 10 ml or 100 mg of lidocaína hydrochloride monohydrate in 5 ml. Each package contains 1 ampoule or 100 ampoules of 10 ml or 5 ml.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos –Madrid (SPAIN)

OTHER PRESENTATIONS

Lidocaína NORMON 10 mg/ml injectable solution EFG

Lidocaína NORMON 50 mg/ml injectable solution EFG

Last review date of this prospectus: March 2013

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

This information is intended solely for doctors or healthcare professionals:

To prepare a 1.5% lidocaína hydrochloride monohydrate solution, lidocaína hydrochloride monohydrate 2% must be diluted in a syringe with sodium chloride 0.9%: 3 units (ml) of lidocaína hydrochloride monohydrate 2% with 1 unit (ml) of sodium chloride 0.9%. The diluted solution must be prepared immediately before use.

To prepare a 0.5% lidocaína hydrochloride monohydrate solution, lidocaína hydrochloride monohydrate 1% must be diluted in a syringe with sodium chloride 0.9%: 1 unit (ml) of lidocaína hydrochloride monohydrate 1% with 1 unit (ml) of sodium chloride 0.9%. The diluted solution must be prepared immediately before use.