10 mg / ml and 20 mg / ml injection solution
of lidocaine hydrochloride
What Lidocaine Accord is and what it is used for
Lidocaine Accord is a local anesthetic. It provides anesthesia of a limited part of the body in connection with small surgical procedures. It prevents the nerves from transmitting pain signals to the brain so that you do not feel any pain. It starts to work a few minutes after injection and the effect slowly subsides when the operation is over.
Lidocaine hydrochloride contained in Lidocaine Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Lidocaine Accord
You must not be given this medicine:
- if you are allergic to lidocaine hydrochloride, amide-type local anesthetics or any of the other ingredients of this medicine (listed in section 6)
- if you have very low blood pressure , if you have lost too much blood or other body fluids or if your heart can not pump enough blood for other reasons, you should not receive Lidocaine Accord as an injection in the spine
If any of the above applies to you, talk to your doctor before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Lidocaine Accord
- if you are older or have a reduced general condition
- if you have heart problems such as slow or irregular heartbeat or heart failure
- if you have a lung disease or respiratory disease
- if you have liver disease or kidney problems
- if you have seizures ( epilepsy )
- if you have an inflammation or infection in the area where the injection is to be given
- if you have porphyria (an unusual hereditary disease that affects the skin and nervous system)
- if you have problems with blood coagulation
- if you are pregnant during the last three months of pregnancy
If you are not sure if any of the above applies to you, talk to your doctor first
you get Lidocaine Accord.
Other medicines and Lidocaine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
- other local anesthetics
- medicines used to treat stomach or duodenal ulcers (eg cimetidine)
- medicines used to treat irregular heartbeats (eg amiodarone )
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Depending on the dose and route of administration, Lidocaine Accord may have a temporary effect on your ability to drive or use machines.
Ask your doctor when it is safe to resume these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lidocaine Accord contains sodium
Each ml of solution for injection contains approximately 0.118 mmol sodium (if the 10 mg / ml strength is used) or 0.082 mmol sodium (if the 20 mg / ml strength is used). This should be considered by patients on a low-salt diet.
How to use Lidocaine Accord
Lidocaine Accord is given by a doctor. It will be given to you as an injection into a vein, a muscle, under the skin, or in the epidural space (part of the spine).
The dose given by your doctor depends on the type of pain relief you need. It also depends on your body size, age, state of health, and what part of the body the drug is injected into. You will receive the lowest possible dose that gives the desired effect.
Use for children and adolescents
Dose one should be reduced to children and patients with the impaired general condition.
Lidocaine Accord is usually given near the part of the body where the procedure is to be performed.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get a severe allergic reaction ( angioedema or anaphylactic shock ), contact your doctor or nurse immediately. Signs of this may be the sudden onset of the following symptoms:
- swelling of the face, lips, tongue or throat, which may make it difficult to swallow
- severe or sudden swelling of the hands, feet and ankles
- breathing difficulties
- severe skin itching (with raised lumps)
- fever
- drop in blood pressure.
These side effects are rare (may affect up to 1 in 1,000 people).
Other possible side effects:
Very common (may affect more than 1 user in 10)
- low blood pressure
- nausea.
Common (may affect up to 1 in 10 people)
- bogs
- dizziness
- slow heart rate
- high blood pressure
- vomiting.
Uncommon (may affect up to 1 in 100 people)
- cramps
- numbness of the tongue or tingling around the mouth
- ringing in the ears or sensitivity to sound
- visual disturbances
- loss of consciousness
- shaking
- drowsiness
- confusion
- tinnitus
- feeling drunk
- speech difficulties.
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity reaction such as hives ( urticaria ), skin rash, swelling of the skin ( angioedema ) and in more severe cases anaphylactic shock
- emotional changes or muscle weakness ( neuropathy )
- inflammation of a membrane surrounding the spinal cord (arachnoiditis) that can cause pain in the lower back, or pain, numbness or weakness in the legs
- double vision
- irregular heartbeat or cardiac arrest
- slow breathing or respiratory arrest.
How to store Lidocaine Accord
Keep this medicine out of sight – and sight of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the ampoule/vial and carton after EXP. The expiration date is the last day of the specified month.
For single use only. To be used immediately after the first opening. All remaining material is discarded.
Do not use this medicine if you notice discoloration. The solution for injection should not be used if it contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is lidocaine hydrochloride.
Lidocaine Accord 10 mg / ml solution for injection : 1 ml solution for injection contains 10 mg lidocaine hydrochloride.
Lidocaine Accord 20 mg / ml solution for injection : 1 ml solution for injection contains 20 mg lidocaine hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and contents of the pack
Lidocaine Accord is a clear, colorless, sterile solution for injection. It is available in two strengths: 10 mg / ml and 20 mg / ml.
Lidocaine Accord 10 mg / ml solution for injection provided in
| Glass ampoules: | 5 x 2 ml, 10 x 2 ml, 20 x 2 ml |
| 5 x 5 ml, 10 x 5 ml, 20 x 5 ml | |
| 10 x 10 ml, 20 x 10 ml | |
| Glass vials: | 1 x 20 ml |
Lidocaine Accord 20 mg / ml solution for injection provided in
| Glass ampoules: | 5 x 2 ml, 10 x 2 ml, 20 x 2 ml |
| 5 x 5 ml, 10 x 5 ml, 20 x 5 ml | |
| 5 x 10 ml, 10 x 10 ml, 20 x 10 ml | |
| Glass vials: | 1 x 20 ml |
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
UK
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland