LIDOCAINE NORMON 50 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Lidocaine Normon

Do not use Lidocaine NORMON

• If you are allergic to lidocaine hydrochloride monohydrate, to anesthetics of this type (called amide-type anesthetics) or to any of the other components of this medicine (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 blood or fluid loss).

Warnings and precautions

Be especially careful:

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

Consult your doctor or pharmacist before you are given Lidocaine NORMON.

Interaction of Lidocaine NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If you are taking cimetidine (a medicine for stomach and duodenal ulcers) and propranolol (a medicine for high blood pressure), tell your doctor, as it may affect your response to the lidocaine injection.

If you are using beta-blockers, anti-arrhythmics (such as mexiletine, disopyramide, or procainamide) or phenytoin (an antiepileptic), you should inform your doctor before administration of Lidocaine NORMON.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

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

Important information about some of the components of Lidocaine NORMON

Athletes should be aware that lidocaine can produce a positive result in doping tests.

3. How to use Lidocaine Normon

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

Lidocaine Normon will usually be administered near the part of the body that is to be operated on.

The dose that your doctor administers will depend on the type of pain relief you need. It will also depend on your height, age, and physical condition, as well as the part of the body into which the medicine is injected. You will receive the lowest possible dose to produce the desired effect. The dose of lidocaine should be reduced in special populations and in patients in poor general condition.

Use in children

The dose should be reduced in children. Lidocaine should be used with caution in children under four years of age.

If you are given too much Lidocaine NORMON

Treatment will consist of stopping the convulsions and achieving adequate ventilation with oxygen.

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

4. Possible side effects

Like all medicines, Lidocaine NORMON can cause side effects, although not everybody gets them.

As with other local anesthetics, the side effects of Lidocaine NORMON are rare and are usually the result of excessively high concentrations in the blood, generally due to rapid absorption or allergic reactions.

Among the possible side effects are:

• Nervous system disorders: dizziness, numbness of the tongue and lips, hearing failure, tinnitus (ringing in the ears), dysarthria (speech disorder), disorientation, and occasionally somnolence. In extreme cases, there is twitching, nervous movements, and tremors initially in the muscles of the face and the distal parts of the limbs.
• Cardiac disorders: such as a drop in blood pressure and bradycardia (slow pulse).
• General disorders and administration site conditions: Allergic reactions are very rare. They can occur as skin reactions, paleness, swelling of the lips, itching, weakness, dizziness, feeling of oppression in the chest, 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 think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Lidocaine Normon

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

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

For single use only. Any remaining solution should be discarded. Inspect visually before use. Use only if the solution is clear and free of visible particles.

Medicines should not be disposed of via wastewater or household waste. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Contents of the pack and further information

Composition of Lidocaine NORMON

• The active substance is lidocaine. Each ml of solution contains 50 mg of lidocaine hydrochloride monohydrate.
• The other ingredients are: water for injections.

Appearance and packaging of the product

Lidocaine NORMON 50 mg/ml is presented as a solution for injection in glass ampoules containing 500 mg of lidocaine hydrochloride monohydrate in 10 ml. Each pack contains 1 ampoule or 100 ampoules.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Lidocaine NORMON 10 mg/ml solution for injection EFG

Lidocaine NORMON 20 mg/ml solution for injection EFG

Date of last revision of this leaflet: March 2013

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

This information is intended only for healthcare professionals:

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

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