Lidodepomedrol: detailed information

Patient information leaflet

LIDODEPOMEDROL 40 mg/ml + 10 mg/ml injectable suspension

Metilprednisolone acetato + lidocaina cloridrato monoidrato
Please read this leaflet carefully before this medicine is administered to you and/or your child, as it contains important information for you and/or your child.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or the doctor treating your child or your pharmacist.
This medicine has been prescribed only for you and/or your child. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
If you and/or your child experience any side effects, including those not listed in this leaflet, consult your doctor or the doctor treating your child or your pharmacist. See section 4.

Contents of this leaflet:

What Lidodepomedrol is and what it is used for
What you need to know before Lidodepomedrol is administered
How Lidodepomedrol will be administered
Possible side effects
How to store Lidodepomedrol
Contents of the pack and other information

1. What Lidodepomedrol is and what it is used for

Lidodepomedrol contains two active substances: methylprednisolone and lidocaine.
Methylprednisolone belongs to a class of medicines called corticosteroids.
Corticosteroids are substances naturally produced by the body and are important for many bodily functions.
Lidocaine is a local anaesthetic used to reduce pain in the area where the injection is administered.
Lidodepomedrol is used to help treat symptoms caused by the following conditions:

Synovitis: inflammation of the membrane lining the joint;
Bursitis: inflammation of the fluid-filled sacs located around the shoulder, knee and/or elbow joints;
Osteoarthritis, rheumatoid arthritis and gouty arthritis: localized inflammation affecting the joints;
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Epicondylitis (tennis elbow);
Tendinitis and tenosynovitis: inflammation of a tendon or of the tendon sheath;
Cysts located in or near a tendon.

Lidodepomedrol may be prescribed to treat conditions other than those
listed above. Consult your doctor if you are unsure why this
medicine has been prescribed for you or your child.

2. What you should know before using Lidodepomedrol

Lidodepomedrol must not be administered to you and/or your child if:

you are allergic to methylprednisolone, lidocaine, or any of the other components of this medicine (listed in section 6);
you are allergic to other local anesthetics (medicines used to relieve pain in the treated area) similar to lidocaine;
you have a fungal infection that has spread to certain organs or throughout the body;
your child was born prematurely, is a newborn, or is a child under 3 years of age (see also sections “Newborns and children” and “Lidodepomedrol contains benzyl alcohol”).

Lidodepomedrol must not be administered to you/your child via injection into
a blood vessel (intravascular administration, e.g., intravenous administration),
into the back (intrathecal/epidural administration), or into a muscle
(intramuscular administration).
You or your child must not receive live or live attenuated vaccines during
treatment with Lidodepomedrol.

Warnings and precautions
Talk to your doctor or pharmacist BEFORE this medicine is administered to you or your child if:

you have or have previously had a severe infection or inflammation in the joint where Lidodepomedrol is to be injected;
you have or have previously had tuberculosis;
you are under particular conditions of stress. In such cases, your doctor may prescribe a higher dose of this medicine for you or your child;
you have Cushing's syndrome, a condition characterized by excessive production of natural corticosteroids in the body. Lidodepomedrol may worsen your or your child’s condition;
your thyroid gland is underactive ( hypothyroidism ). In this case, doses of Lidodepomedrol should be reduced;
you have diabetes;
you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue, or you are scheduled for surgery with general anesthesia involving the use of muscle-blocking drugs (e.g., pancuronium). In this case, the risk that Lidodepomedrol causes muscle problems is increased;
you suffer from seizures (epilepsy);
you have an eye infection caused by the Herpes simplex virus;
you have high blood pressure ( hypertension );
you have elevated levels of fats in the blood ( dyslipidemia );
you have cardiac conduction problems with altered heart rate or rhythm ( conduction disorders );
you have heart problems ( heart failure );
you have reduced blood volume with rapid heartbeat, weak pulse, confusion, and loss of consciousness ( hypovolemia );
you have a slow heart rate ( bradycardia );
you suffer from or are predisposed to developing blood clots in the veins;
you have a stomach ulcer or other serious stomach or intestinal problems;
you have kidney problems;
you have scleroderma (also known as systemic sclerosis, an autoimmune disease), as corticosteroid use may increase the risk of a serious complication called scleroderma renal crisis;
you have a brain injury due to trauma;
you are being treated with non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid) (see section “Other medicines and Lidodepomedrol”);
you have a type of tumor called pheochromocytoma;
you have liver cirrhosis, a liver disease;
you suffer from peritonitis or other gastrointestinal disorders, as glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis;
if you are debilitated, elderly, or if the patient is a child.

Inform your doctor or the doctor treating your child if any of the following conditions appear or worsen DURING treatment with this medicine (see also section 4 “Possible side effects”):

depression of the skin surface at the injection site. This effect usually resolves within a few months after discontinuation of treatment;
infections. This medicine may reduce resistance to various infections, mask certain infection symptoms, worsen existing infections, or cause recurrence or worsening of hidden old infections. New infections may also occur during use of Lidodepomedrol. Therefore, certain infections may occur more easily during treatment, such as chickenpox and measles. These infections may be mild, severe, or sometimes fatal. Your doctor will closely monitor you for signs of infection and may consider, if necessary, stopping treatment or reducing the dose;
Kaposi's sarcoma, a type of skin tumor. In this case, treatment with Lidodepomedrol must be discontinued;
severe allergic reactions;
swelling in different parts of the body, especially in the legs and ankles, or changes in normal levels of electrolytes in the blood;
onset or worsening of psychiatric disorders (e.g., depression). Inform people living with you about the possible effects of this medicine;
eye problems;
severe inflammation of the pancreas;
osteoporosis (fragile bones);
fat accumulation compressing the spinal cord;
hepatobiliary disorders (reversible after discontinuation);
blurred vision or other visual disturbances.

Oral anticoagulants (medicines taken by mouth to prevent blood clotting) taken together with Lidodepomedrol may increase the risk of bleeding. In some cases, the effectiveness of oral anticoagulants may be reduced. Your doctor may need to frequently monitor your risk of bleeding by performing additional blood tests during treatment with Lidodepomedrol. Your doctor may also need to adjust the dose of Lidodepomedrol if necessary.

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Newborns and children
Long-term or high-dose treatment with Lidodepomedrol in newborns and children may cause growth retardation, increased intracranial pressure, and pancreatitis.
Benzyl alcohol, one of the components of this medicine, may cause serious, even fatal, adverse effects in children and newborns, such as a condition called “gasping syndrome,” characterized by severe metabolic acidosis, neurological deterioration, and respiratory distress. Due to the presence of benzyl alcohol, this medicine must not be administered to children under three years of age (see also section “Lidodepomedrol contains benzyl alcohol”).

Elderly
If you are elderly, long-term treatment with Lidodepomedrol may increase the risk of developing osteoporosis, excessive fluid retention, and high blood pressure. Your doctor will assess your condition and administer this medicine cautiously.

Other medicines and Lidodepomedrol
Inform your doctor or pharmacist if you and/or your child are taking, have recently taken, or might take any other medicines, including

medicines obtained without a prescription. Some medicines may enhance the effects of Lidodepomedrol, and your doctor may wish to monitor you closely if you are taking these medicines.
The following medicines may affect the activity of Lidodepomedrol, or Lidodepomedrol may affect the efficacy and/or toxicity of the following medicines:

isoniazid, troleandomycin, clarithromycin, and erythromycin (antibiotics);
rifampicin (antibiotic for tuberculosis);
phenobarbital, phenytoin, and carbamazepine (medicines for seizures);
aprepitant and fosaprepitant (anti-nausea medicines);
itraconazole, ketoconazole, and amphotericin B (antifungal medicines);
HIV treatments such as indinavir, ritonavir, and cobicistat (medicines against HIV virus);
aminoglutethimide (medicine for excessive production of natural corticosteroids);
diltiazem and propranolol (medicines used for heart problems or high blood pressure);
ethinylestradiol/norethindrone (hormones used in combination as oral contraceptives);
cyclosporine, cyclophosphamide, and tacrolimus, medicines used to prevent organ transplant rejection and treat autoimmune diseases;
oral anticoagulants (medicines taken by mouth to prevent blood clotting);
neuromuscular blockers and skeletal muscle relaxants (medicines causing muscle relaxation);
anticholinesterases (medicines for muscle diseases such as myasthenia gravis and Alzheimer's disease);
antidiabetics (medicines for diabetes);
aspirin (acetylsalicylic acid);
diuretics (medicines that increase urine production);
xanthines and beta-2 agonists (medicines for asthma);
procainamide (medicine used for heart rhythm disorders);
cimetidine (medicine used for stomach ulcers);
local anesthetics (medicines causing loss of sensation);
class Ib antiarrhythmics (medicines used for abnormal heart rate).

Lidodepomedrol and beverages
You or your child must not drink grapefruit juice during treatment with Lidodepomedrol, as the efficacy and toxicity of this medicine may increase.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you use this medicine during pregnancy, especially for a prolonged period, your baby may experience adverse effects at birth. Therefore, if you are pregnant, your doctor will prescribe Lidodepomedrol only if strictly necessary.
Lidodepomedrol contains benzyl alcohol (see “Lidodepomedrol contains benzyl alcohol”).

Breastfeeding
Lidodepomedrol passes into breast milk and may cause adverse effects in the infant. If you are breastfeeding, your doctor will prescribe Lidodepomedrol only if strictly necessary.
Lidodepomedrol contains benzyl alcohol (see “Lidodepomedrol contains benzyl alcohol”).

Fertility
Based on currently available information, this medicine may reduce fertility.

Driving and use of machinery
Do not drive or operate machinery if you experience dizziness, vertigo, visual disturbances, movement or coordination problems, fatigue, euphoria, or mood disturbances during treatment with Lidodepomedrol.

Lidodepomedrol contains benzyl alcohol
Lidodepomedrol contains 8.7 mg and 17.4 mg of benzyl alcohol in 1 ml and 2 ml of solution, respectively, equivalent to 8.7 mg/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with a risk of serious adverse effects, including respiratory problems (so-called "gasping syndrome") in young children. Do not use medicines containing benzyl alcohol in newborns (up to 4 weeks of age), and do not use these medicines for more than one week in young children (under 3 years of age), unless advised by a doctor. Consult your doctor or pharmacist if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects such as increased blood acid levels (called "metabolic acidosis") (see also section “Lidodepomedrol must not be administered to you and/or your child if”).

Lidodepomedrol contains sodium
Lidodepomedrol contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free.”

3. How Lidodepomedrol will be administered

Use this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose will be determined by the doctor based on your condition or that of your child and the type of disease. The doctor will decide how often the medicine will be administered and the duration of treatment with Lidodepomedrol.
Please note that treatment with Lidodepomedrol will improve the symptoms of the disease, but it is not a cure and does not affect the underlying cause of the disease in you and/or your child.
Lidodepomedrol will be administered by trained healthcare personnel via injection into the joint (intra-articular, periarticular, or intrabursal route) or via direct injection into the lesion (intralesional route), depending on the type of disease affecting you and/or your child.

If more Lidodepomedrol is administered to you and/or your child than should be
Inform your doctor immediately or go to the nearest hospital if you or your child has been given an excessive dose of Lidodepomedrol.
Symptoms may include: yawning, restlessness, nausea, vomiting, numbness around the mouth, tongue numbness, altered sensation in limbs or other body parts (e.g., tingling), hearing or vision disturbances, increased sensitivity to sound, perception of a continuous ringing in the ear even in the absence of external sounds, tremors, headache, dizziness, loss of ability to articulate words, difficulty coordinating voluntary movements, euphoria, agitation, confusion, disorientation, hallucinations, lethargy, muscle twitching, seizures, loss of consciousness and coma, breathing difficulties, respiratory depression, apnea, low blood pressure, slowed or irregular heartbeat, reduced cardiac contractility, circulatory collapse, and potentially life-threatening cardiac arrest.
Acidosis increases the toxic effects of local anaesthetics.
If a dose of this medicine greatly exceeds that prescribed, Cushing's syndrome (a disorder characterized by excessive production of natural corticosteroids) may occur.

If you forget to use Lidodepomedrol
Do not use a double dose to make up for the forgotten dose.

If you stop treatment with Lidodepomedrol

You or your child must not stop using Lidodepomedrol suddenly. Lidodepomedrol may cause reduced function of the adrenal glands, which produce natural corticosteroids, and abrupt discontinuation may lead to death.
Moreover, sudden interruption of treatment with Lidodepomedrol may lead you or your child to develop withdrawal symptoms such as: anorexia, nausea, vomiting, drowsiness, headache, fever, muscle and joint pain, skin peeling, weight loss, low blood pressure, and psychiatric disturbances.
When stopping treatment, doses should be gradually reduced. Your doctor will advise you on the correct way to do this.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
Contact your doctor if you experience any of the following side effects:

Common (may affect up to 1 in 10 people)

confusion, anxiety, euphoric mood
decrease in blood pressure (hypotension)
feeling cold or hot
increase in fluid in tissues (edema)

Frequency not known (frequency cannot be estimated from the available data):

infections, including infections occurring when the body's immune defenses are very low
round or moon-shaped face (Cushingoid appearance)
fluid and sodium retention in the body
diabetes or worsening of existing diabetes
increased blood pressure
muscle weakness
stomach ulcer with possible bleeding and perforation
acne
depression, euphoria, mood swings, abnormal behavior, insomnia
cataract
increased internal eye pressure (glaucoma)
poor wound healing
decreased potassium levels in the blood
bruising
temporary increase in pain at the injection site (pain flare after injection)
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bone fragility (osteoporosis)
irritability
swelling
nervousness, loss of consciousness
seizures
decreased response to a given stimulus
tremor
drowsiness
dizziness
double vision, blurred vision, or other visual disturbances
ringing in the ears (tinnitus)
reduced heart rate, abnormal heart rate (cardiac arrhythmias)
breathing blockage/reduction, breathing difficulty caused by narrowing of the airways (bronchospasm), labored or difficult breathing (dyspnea)
nausea, vomiting
muscle contraction
abdominal inflammation (peritonitis)
increased number of white blood cells (leukocytes) in the blood
hypersensitivity to the medicine
severe allergic reaction, e.g. swelling of the face, tongue, and throat with difficulty swallowing and breathing (angioedema)
reduced hormone secretion from the pituitary gland (a gland located at the base of the brain)
withdrawal syndrome (see section 3 “If you stop treatment with Lidodepomedrol”)
metabolic acidosis
loss of acidic substances from the body
high levels of fat in the blood
increased appetite and body weight
increased body fat
inability of the heart to pump sufficient blood to the rest of the body (congestive heart failure)
formation of blood clots in veins and lungs
cardiocirculatory collapse, cardiac arrest
warmth and redness of the skin (hot flushes)
hiccups
muscle and joint pain, muscle disorders and diseases
reduced muscle mass
bone tissue death and loss
fractures due to increased bone fragility
abdominal distension and pain
diarrhea
difficulty digesting
stomach bleeding and intestinal perforation
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inflammation of the esophagus with or without ulcers
inflammation of the pancreas
skin lesion
facial edema (swelling)
increased hair growth
excessive sweating
appearance of small red spots or thin purplish streaks on the skin
skin atrophy
skin patches of unusual color
itching, hives
skin rashes, skin redness
irregular menstruation
reaction at injection site
abscess
fatigue, malaise
difficulty remembering
vertigo
headache
increased pressure of fluid within the skull
fat accumulation compressing the spinal cord
psychiatric disorders such as: manic behavior, delirium, hallucinations, schizophrenia, emotional disturbances (e.g. dependency, affective lability, suicidal ideation), mental disorders, personality changes
disturbances in thought processes affecting awareness of reality
protruding eyes
reduced central vision
abnormal liver function tests
glucose metabolism disorder (impaired glucose tolerance)
increased calcium levels in urine
reduced response to skin tests
increased blood urea levels
vertebral fractures (traumatic or spontaneous), tendon rupture

Additional side effects in children
Frequency not known (frequency cannot be estimated from the available data):

growth retardation

Reporting of side effects
If you/your child experience any side effect, including those not listed in this
leaflet, talk to your doctor or pharmacist. You can also report side effects
directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-

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avverse . By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store Lidodepomedrol

Keep this medicine out of sight and reach of children.
Do not freeze.
Do not use this medicine if you notice the presence of particles or any change in colour.
Do not use this medicine after the expiry date which is stated on the carton and vial after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lidodepomedrol contains

The active substances are: methylprednisolone acetate and lidocaine hydrochloride monohydrate. 1 ml of suspension contains 40 mg of methylprednisolone acetate (equivalent to 36 mg of methylprednisolone) and 10 mg of lidocaine hydrochloride monohydrate (equivalent to 8.11 mg of lidocaine).
The other components are: Macrogol 3350; sodium chloride; sodium hydroxide; benzyl alcohol (E1519) (see sections “Lidodepomedrol contains benzyl alcohol” and “Lidodepomedrol contains sodium”), hydrochloric acid, myristyl gamma pyridinium chloride; water for injections.

Description of the appearance of Lidodepomedrol and package contents
Lidodepomedrol is a white injectable suspension available in
1 ml or 2 ml glass vials sealed with a rubber stopper.
Lidodepomedrol is available in packages containing either 1 vial (1 ml or 2 ml) or 3
vials (1 ml each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

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The following information is intended exclusively for healthcare professionals

PRECAUTIONS FOR USE
Multi-dose use
Using a single vial of acetate metylprednisolone with lidocaine for multiple withdrawals requires special care to avoid contamination of the contents. Although the solution is originally sterile, repeated use of the same vial may lead to contamination if strict aseptic technique is not observed. Single-use syringes and needles must be employed. Benzalkonium chloride is an inadequate antiseptic for sterilizing multi-dose vials. Sterile techniques must be adopted to prevent infections or contamination. A povidone-iodine solution or similar products are recommended for cleaning the vial stopper before withdrawing the contents.

Special precautions regarding the use of lidocaine for local anesthesia
When administering local anesthetics such as lidocaine contained in injectable methylprednisolone with lidocaine solution, appropriate resuscitation equipment must be readily available. Some local anesthetic procedures may be associated with serious adverse reactions, generally resulting from elevated plasma concentrations due to accidental intravascular injection, excessive dosing, or rapid absorption from highly vascularized areas, or may arise from hypersensitivity, idiosyncrasy, or reduced patient tolerance. Systemic toxicity primarily affects the central nervous system and/or the cardiovascular system (see sections “Possible side effects” and “If you and/or the child are administered more Lidodepomedrol than intended”).

As with other local anesthetics, lidocaine must be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disorders, congestive heart failure, hypovolemia, and bradycardia. Pediatric, elderly, or debilitated patients require reduced doses adjusted according to age and physical condition.

SPECIAL WARNINGS
Lidodepomedrol is contraindicated for intrathecal, intravascular (e.g., intravenous), intramuscular, epidural, or any other non-approved route of administration.

The contents of the vial must be inspected visually before administration to ensure the absence of particulate matter or discoloration.

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DOSAGE

Rheumatoid arthritis and osteoarthritis
The dose of methylprednisolone for intra-articular administration depends on the size of the joint and varies according to the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from 1 to 5 weeks or longer, depending on the degree of improvement achieved after the first administration. The following methylprednisolone doses are provided as a general guide:

Table 1: Methylprednisolone dosage
_______________________________________________________________
Joint size Examples Methylprednisolone dosage
_________________________________________________________________
Large knees, ankles, shoulders 20–80 mg
Medium elbows, wrists 10–40 mg
Small metacarpophalangeal, interphalangeal 4–10 mg
sternoclavicular, acromioclavicular
_________________________________________________________________

Administration method: An anatomical review of the joint to be treated is recommended before proceeding with intra-articular injection. To achieve full anti-inflammatory activity, it is essential that the injection is administered into the synovial space.

Using the same sterile technique as for lumbar puncture, rapidly insert a sterile 20–24 gauge needle attached to a dry syringe into the synovial cavity.

If local anesthetic administration is considered necessary (see section “Precautions for use”), aspiration of a few drops of synovial fluid ensures complete entry of the needle into the joint space.

The injection site for each joint is determined by the location of the most superficial synovial cavity and the area least likely to contain large vessels and nerves.

While leaving the needle in place, replace the syringe containing the aspirated fluid drops with another syringe containing the desired amount of Lidodepomedrol. Further confirm correct needle placement by aspiration.

After injection, gently move the joint to promote dispersion of the suspension within the synovial fluid.

Cover the injection site with sterile gauze.

Suitable sites for intra-articular injection include the knee, ankle, wrist, elbow, shoulder, finger joints, and hip.

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Occasionally, difficulties may be encountered when attempting to access the hip joint; therefore, precautions must be taken to avoid large vessels in the area.

Joints unsuitable for injection are those that are anatomically inaccessible, such as spinal and sacroiliac joints lacking a synovial space.

2. Bursitis

Sterilize the area surrounding the site to be infiltrated and administer a local anesthetic if deemed necessary (see section “Precautions for use”).
Insert a sterile 20-24 gauge needle into the bursal cavity, attached to a dry syringe, and aspirate the fluid. Leaving the needle in place, replace the syringe containing the aspirated fluid with a smaller syringe containing the desired dose of Lidodepomedrol.
After injection, remove the needle and apply a sterile gauze.

3. Tendon cysts, tendinitis, epicondylitis

Adequately sterilize the overlying skin before infiltration.
In the treatment of tendinitis and tenosynovitis, inject the suspension into the tendon sheath rather than into the tendon substance itself.
The tendon can be easily palpated when it is stretched.
For treating epicondylitis, it is advisable to accurately identify the area of maximum tenderness prior to infiltration.
Ganglion cysts (tendon cysts) should be infiltrated directly.
The dose to be administered in the treatment of these conditions ranges from 4 to 30 mg.
In chronic or recurrent conditions, multiple infiltrations may be necessary.
Using a single vial for multiple withdrawals requires particular care to avoid contamination of the contents (see section “Precautions for use”).
Standard sterile precautions must be observed for each infiltration.

INCOMPATIBILITIES
It is advisable not to dilute or mix Lidodepomedrol with other solutions.

Adverse reactions reported with contraindicated routes of administration (intrathecal/epidural): arachnoiditis, gastrointestinal/bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures, sensory disturbances.
When administered via routes other than those indicated, visual disturbances including blindness, ocular and periocular inflammations, as well as tissue residues or eschars at the injection site have also been reported.

Adverse reactions related to lidocaine are generally due to elevated plasma concentrations resulting from accidental intravascular injection, excessive dosing, or rapid absorption from highly vascularized areas. Alternatively, they may arise from hypersensitivity, idiosyncrasy, or reduced patient tolerance. Systemic toxicity primarily affects the central nervous system and/or the cardiovascular system. Neurological symptoms of systemic toxicity include dizziness or lightheadedness, nervousness, tremor, perioral paresthesia, tongue numbness, drowsiness, seizures, coma. Cardiovascular reactions are of a depressive nature and may present as hypotension, bradycardia, myocardial depression, cardiac arrhythmias, and potentially cardiac arrest or circulatory collapse. Blurred vision, diplopia, and transient amaurosis may also be signs of lidocaine toxicity.

For further information, please refer to the SmPC (Summary of Product Characteristics).