SUMMARY CMI

LIDOCAINE NORIDEM

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Lidocaine Noridem?

Lidocaine Noridem contains the active ingredient lidocaine(lignocaine) hydrochloride. Lidocaine Noridem is used to prevent or relieve pain, but it will not put you to sleep.

For more information, see Section 1. Why am I using Lidocaine Noridem? in the full CMI.

2. What should I know before I use Lidocaine Noridem?

Do not use if you have ever had an allergic reaction to lidocaine (lignocaine) hydrochloride or any other local anaesthetics eg. Bupivacaine or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Lidocaine Noridem? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Lidocaine Noridem and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Lidocaine Noridem?

Lidocaine Noridem will be injected by your doctor into the skin, near a single nerve, or into an area which contains a large number of nerves. More information can be found in Section 4. How do I use Lidocaine Noridem? in the full CMI.

5. What should I know while using Lidocaine Noridem?

For more information, see Section 5. What should I know while using Lidocaine Noridem? in the full CMI.

6. Are there any side effects?

If Lidocaine Noridem is given wrongly, or you are very sensitive to it, it sometimes causes fits, unconsciousness, breathing problems, low blood pressure, slow heartbeat, collapse. Some mild side effects that may occur include tremors, nervousness, dizziness, blurred vision, numbness, nausea, vomiting.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

LIDOCAINE NORIDEM

Active ingredient(s): Lidocaine (Lignocaine) hydrochloride

Consumer Medicine Information (CMI)

This leaflet answers some of the common questions people ask about Lidocaine Noridem. It does not contain all the information that is known about Lidocaine Noridem.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Lidocaine Noridem against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Lidocaine Noridem.

Where to find information in this leaflet:

1. Why am I using Lidocaine Noridem?
2. What should I know before I use Lidocaine Noridem?
3. What if I am taking other medicines?
4. How do I use Lidocaine Noridem?
5. What should I know while using Lidocaine Noridem?
6. Are there any side effects?
7. Product details

1. Why am I using LIDOCAINE NORIDEM INJECTION?

Lidocaine Noridem contains the active lidocaine (lignocaine) hydrochloride. Lidocaine Noridem belongs to a group of medicines called local anaesthetics. It is injected into the body where it makes the nerves unable to pass messages to the brain.

Lidocaine Noridem is used to prevent or relieve pain, but it will not put you to sleep.

Lidocaine Noridem is also used after surgery to relieve pain. It can also be used to make childbirth less painful.

Depending on the amount used, Lidocaine Noridem will either totally stop pain or will cause a partial loss of feeling.

Lidocaine Noridem is sometimes combined with adrenaline (epinephrine) to make it last longer. Adrenaline (epinephrine) makes the blood vessels at the site of injection narrower, which keeps the Lidocaine Noridem where it is needed for a longer time.

Your doctor will have explained why you are being treated with Lidocaine Noridem and told you what dose you will be given.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Lidocaine Noridem is not addictive.

2. What should I know before I use LIDOCAINE NORIDEM INJECTION?

Warnings

Do not use Lidocaine Noridem if:

• you are allergic to Lidocaine (Lignocaine) hydrochloride or any of the ingredients listed at the end of this leaflet.
• If you have allergies to other local anesthetics eg bupivacaine
• Always check the ingredients to make sure you can use this medicine.
• If you are pregnant or breastfeeding do not use Lidocaine Noridem unless your doctor says so.
• Lidocaine Noridem will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.
• you have any of these medical conditions
  - problems with your blood pressure or circulation
  - blood poisoning
  - problems with the clotting of your blood
  - nerve problems, e.g. epilepsy
  - heart, liver or kidney problems
  - thyroid problems
  - malignant hyperthermia
  - diabetes
  - skin infections

It may not be safe for you to take Lidocaine Noridem if you have any of these conditions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

If you are pregnant or breastfeeding do not use Lidocaine Noridem unless your doctor says so. Ask your doctor about the risks and benefits of using this medicine while you are pregnant or breastfeeding.

Lidocaine Noridem has been widely used during pregnancy and there have been no reports of any ill effects on the baby. It can be used during childbirth.

Your baby can take in very small amounts of Lidocaine Noridem from breast milk if you are breastfeeding, but it is unlikely that the amount available to the baby will do any harm.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if you are taking any other medicines, including

• ones to control your heart beat
• ones for blood pressure (anti-hypertensives)
• ones for epilepsy or fits
• ones for depression
• cimetidine
• any medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Lidocaine Noridem works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Lidocaine Noridem

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Lidocaine Noridem.

4. How do I use LIDOCAINE NORIDEM INJECTION?

Lidocaine Noridem will be injected by your doctor into the skin, near a single nerve, or into an area which contains a large number of nerves.

This will result in an area of numbness at the site of injection, near the site of injection or in an area that may seem unrelated to the site of injection. The last will be the case if you are given an EPIDURAL injection (an injection around the spinal cord).

Lidocaine Noridem should not be injected directly into the blood.

The dosage you will be given will depend on your body size, age and the type of pain relief required. Your doctor will have had a lot of experience injecting Lidocaine Noridem or other local anaesthetics and will choose the best dose for you. They will be willing to discuss this decision with you.

Overdose

The doctor giving you Lidocaine Noridem will be experienced in the use of local anaesthetics, so it is unlikely that you will be given an overdose.

However, if you are particularly sensitive to Xylocaine Lidocaine Noridem, or the dose is accidentally injected directly into your blood, you may develop problems for a short time with your sight or hearing. You may get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles.

Whenever you are given Lidocaine Noridem, equipment will be available to care for you if an overdose happens.

5. What should I know while using LIDOCAINE NORIDEM INJECTION?

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Lidocaine Noridem affects you.

Lidocaine Noridem may cause drowsiness and your reflexes may be slow

Drinking alcohol

Do not drink alcohol while you are being given Lidocaine Noridem.

If you drink alcohol while you are being given Lidocaine Noridem your blood pressure may drop making you feel dizzy and faint.

Tell your doctor if you drink alcohol.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you. Looking after your medicine

Storage

Lidocaine Noridem will be stored by your doctor or pharmacist under the recommended conditions.

Lidocaine Noridem should be kept in a cool dry place where the temperature stays below 25°C and protected from light.

Getting rid of any unwanted medicine

Any Lidocaine Noridem from a single dose preparation which is not used, will be disposed of in a safe manner by your doctor or pharmacist.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Lidocaine Noridem.

Lidocaine Noridem will help relieve pain in most people, but it may have unwanted side-effects.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

These are all mild side effects of Lidocaine Noridem

After an epidural injection you may develop a headache or backache which is not related to the medicine used. These can, on rare occasions, last for some months after the injection is given.

Serious side effects

If Lidocaine Noridem is given wrongly, or you are very sensitive to it, it sometimes causes:

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

Lidocaine Noridem solutions are clear and colourless.

This medicine is only available with a doctor's prescription.

What Lidocaine Noridem solution contains

What LIDOCAINE NORIDEM looks like

LIDOCAINE NORIDEM 1%

contains lidocaine (lignocaine) hydrochloride 10 mg/mL

in 5 X 2 mL polypropylene ampoules

AUST R 375334

5 x 5 mL polypropylene ampoules

AUST R 375332

5 x 20 mL polypropylene ampoules

AUST R 375331

LIDOCAINE NORIDEM 2%

contains lidocaine (lignocaine) hydrochloride 20 mg/mL

in 5 x 2 mL polypropylene ampoules

AUST R 375333

5 x 5mL polypropylene ampoules

AUST R 375330

5 x 20 mL polypropylene ampoules

AUST R 375335

Who distributes Lidocaine Noridem

Interpharma Pty Ltd
Suite 103/39 East Esplanade,
Manly NSW 2095, Sydney,
Australia
Ph: 02 9976 6876
[email protected]

This leaflet was revised in July 2022

Published by MIMS December 2022

1 Name of Medicine

Lidocaine (lignocaine) hydrochloride (as monohydrate).

2 Qualitative and Quantitative Composition

Plain aqueous solutions are sterile, isotonic and contain lidocaine (lignocaine) hydrochloride monohydrate, sodium chloride, sodium hydroxide for pH adjustment and water for injections.

Lidocaine Noridem 1%.

Lidocaine Noridem 2%.

3 Pharmaceutical Form

Lidocaine Noridem is a clear, colourless solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Lidocaine Noridem solutions are indicated for the production of local or regional anaesthesia by the following techniques:
Infiltration;
Intravenous regional anaesthesia;
Peripheral nerve block;
Epidural block;
Subarachnoid block.

4.2 Dose and Method of Administration

Lidocaine Noridem is available in 1% and 2%. For patients requiring treatment with lidocaine hydrochloride 0.5%, other brands are available.
The lowest dosage and volume that results in effective anaesthesia should be used and should be based on the status of the patient and the type of regional anaesthesia intended. Lidocaine Noridem solutions contain no antimicrobial agent and should be used only once and any residue discarded.
Lidocaine (lignocaine) should be administered with great caution to patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs.

Adult.

1. Recommended doses.

2. Hypotension.

3. Test dose.

Use in children.

Use in elderly.

With impaired hepatic function.

With impaired renal function.

4.3 Contraindications

1. Allergy or hypersensitivity to amide type local anaesthetics or to any excipients. Detection of suspected hypersensitivity by skin testing is of limited value.
2. Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension or coagulation disorders or in patients receiving anti coagulation treatment.
3. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection and/or in the presence of septicaemia.
4. General contraindications related to epidural anaesthesia, regardless of the local anaesthetic used, should be taken into account.

4.4 Special Warnings and Precautions for Use

1. When any local anaesthetic agent is used, resuscitative equipment and drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems. Because of the possibility of hypotension and bradycardia following major blocks, an IV cannula should be inserted before the local anaesthetic is injected. Delay in proper management of dose-related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and death.
2. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce cerebral symptoms even at low doses.
3. Although intra-articular continuous infusions of local anaesthetics following arthroscopic and other surgical procedures is an unapproved use, there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in paediatric and adult patients following intra-articular continuous infusions of local anaesthetics with and without adrenaline (epinephrine) acid tartrate for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Therefore, Lidocaine Noridem should not be used for post-operative intra-articular continuous infusion.
4. Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be accomplished after each local anaesthetic injection. It should be kept in mind that at such times restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of CNS toxicity.
5. Low molecular weight heparins and heparinoids (spinal/epidural haematomas) - When neuraxial anaesthesia (epidural/spinal anaesthesia) is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters, traumatic or repeated epidural/spinal puncture, and the concomitant use of drugs affecting haemostasis such as NSAID, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment.
6. The safety and effectiveness of Lidocaine Noridem depends on proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted regarding specific techniques and precautions for various regional anaesthetic procedures.
7. The lowest dosage that results in effective anaesthesia should be used (see Section 4.2 Dose and Method of Administration). Repeated injection of Lidocaine Noridem may cause accumulation of lidocaine (lignocaine) or its metabolites and result in toxic effects.
Tolerance to elevated blood levels varies with the status of the patient. Elderly, young or debilitated patients, including those with advanced liver disease or severe renal dysfunction, should be given reduced doses commensurate with their age and physical condition.
8. Lidocaine (lignocaine) should be given with great caution to patients with epilepsy, impaired cardiac conduction, bradycardia, severe shock or digitalis intoxication. Lidocaine (lignocaine) should also be administered with great caution to patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs. In patients with Stokes-Adams syndrome or Wolff-Parkinson-White syndrome extreme care should be taken to avoid accidental arterio-venous injection.
9. Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia. Epidural anaesthesia should be used with caution in patients with impaired cardiovascular function. Epidural anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a sympathomimetic intravenously and repeated as necessary. Local anaesthetics should be given with great caution (if at all) to patients with preexisting abnormal neurological pathology, e.g. myasthenia gravis. Use with extreme caution in epidural, caudal and spinal anaesthesia when there are serious diseases of the CNS or of the spinal cord, e.g. meningitis, spinal fluid block, cranial or spinal haemorrhage, tumours, poliomyelitis, syphilis, tuberculosis or metastatic lesions of the spinal cord.
10. Since lidocaine (lignocaine) is metabolised in the liver and excreted via the kidneys, the possibility of drug accumulation should be considered in patients with hepatic and/or renal impairment (see Section 4.2 Dose and Method of Administration).
11. Inadvertent intravascular or subarachnoid injection of small doses of local anaesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.
Clinicians who perform retrobulbar blocks should be aware that there have been reports of cardiovascular collapse and apnoea following the use of local anaesthetic injections for retrobulbar block. Prior to retrobulbar block, necessary equipment, drugs and personnel should be immediately available as with all other regional procedures. Retrobulbar injections may very occasionally reach the subarachnoid space, causing temporary blindness, cardiovascular collapse, apnoea, convulsions etc. These must be diagnosed and treated promptly.
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles or nerves. The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated.
12. Foetal bradycardia/tachycardia frequently follows paracervical block and may be associated with foetal acidosis and hypoxia. Occasional cases of perinatal morbidity and mortality have been reported. When the recommended dose is exceeded the risk of foetal bradycardia increases. Careful monitoring of the foetal heart rate is necessary.
13. Lidocaine (lignocaine) should be used with caution in patients with known drug sensitivities.
14. Patients being treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring since cardiac effects may be additive.
15. Lidocaine Noridem solution for injection is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

1. Creatinine.

2. Creatine kinase.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Anti-arrhythmic drugs.

2. Amiodarone.

3. Beta adrenoreceptor antagonists.

4. Cimetidine.

5. Anticonvulsive agents.

6. Inhalational anaesthetics.

7. Skeletal muscle relaxants.

8. Structurally related local anaesthetics.

9. Alkaline solutions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Depending on dosage, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

4.8 Adverse Effects (Undesirable Effects)

Adverse experiences following the administration of lidocaine (lignocaine) are similar in nature to those observed with other amide local anaesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

Central nervous system.

Cardiovascular.

Haemodynamic.

Allergic.

Neurologic.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Symptoms of acute toxicity.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, sodium hydroxide and water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

This medicinal product does not require any special storage conditions. Store below 25°C.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2 - 8°C for not more than 24 hours. After dilution, chemical and physical in use stability has been demonstrated for 24 hours both at 25°C and 2 to 8°C if diluted in sodium chloride 9 mg/mL (0.9%) solution or 50 mg/mL glucose (5%) solution. From a microbiological point of view, the solution should be diluted and used immediately. If not diluted and used immediately, do not store for longer than 24 hours at 2°C to 8°C.
Local anaesthetics react with certain metals and cause the release of their respective ions which, if injected, may cause severe local irritation. Adequate precautions should be taken to avoid prolonged contact between Lidocaine Noridem solutions and metal surfaces such as metal bowls, cannulae and syringes with metal parts.
Containers are for single use only.
Solutions showing discolouration and unused portions of solutions from ampoules should be discarded.

6.5 Nature and Contents of Container

Lidocaine Noridem 1%.

Lidocaine Noridem 2%.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).