LIDOCAINE NORMON 20 mg/ml INJECTABLE SOLUTION
Ask a doctor about a prescription for LIDOCAINE NORMON 20 mg/ml INJECTABLE SOLUTION
How to use LIDOCAINE NORMON 20 mg/ml INJECTABLE SOLUTION
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lidocaine NORMON 20 mg/ml injectable solution EFG
Lidocaine, monohydrate hydrochloride
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 doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Contents of the pack:
- What is Lidocaine NORMON and what is it used for
- What you need to know before you use Lidocaine NORMON
- How to use Lidocaine NORMON
- Possible side effects
- Storage of Lidocaine NORMON
- Contents of the pack and other information
1. What is Lidocaine Normon and what is it used for
Lidocaine NORMON contains lidocaine hydrochloride monohydrate and belongs to a group of medicines called local anesthetics. It is used to block pain by reducing the conduction of nerve impulses near its site of action.
Lidocaine NORMON is used to provide anesthesia by local injection around nerves or areas where surgical procedures will be performed.
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 Lidocaine NORMON is administered to you.
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 treating stomach and duodenal ulcers) and propranolol (an antihypertensive), 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, pay attention, and coordinate. Your doctor will tell you if you can drive or use machines.
Important information about some of the ingredients of Lidocaine NORMON
Athletes should be aware that lidocaine can produce a positive result in doping tests.
Lidocaine NORMON contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per ampoule; it is essentially "sodium-free".
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 normally be administered near the part of the body that is to be operated on.
The dose that your doctor will administer 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 where 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 more Lidocaine NORMON than you should
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) immediately, 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 trembling, nervous movements, and tremors initially in the muscles of the face and 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 pressure 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 you have any of the side effects that 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 stated.
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 other information
Composition of Lidocaine NORMON
- The active substance is lidocaine. Each ml of solution contains 20 mg of lidocaine hydrochloride monohydrate.
- The other ingredients are: sodium chloride and water for injectable preparations.
Appearance and packaging of the product
Lidocaine NORMON 20 mg/ml is presented as an injectable solution in glass ampoules containing 200 mg of lidocaine hydrochloride monohydrate in 10 ml or 100 mg of lidocaine hydrochloride monohydrate in 5 ml. Each pack contains 1 ampoule or 100 ampoules of 10 ml or 5 ml.
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 injectable solution EFG
Lidocaine NORMON 50 mg/ml injectable solution EFG
Date of last revision of this leaflet: March 2013
Detailed and updated 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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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