10 mg / ml solution for injection. 20 mg / ml solution for injection.
lidocaine hydrochloride
What Lidocaine Mylan is and what it is used for
Lidocaine Mylan is a local anesthetic. It provides anesthesia of a limited part of the body.
It works by temporarily blocking the nerve signals in the area where it is injected and used to numb fingers, toes, ears, nose or penis. The drug can also be used for other local anesthetics in patients where adrenaline can not be used.
Lidocaine Mylan can be used in adults and children over 1 year of age.
Lidocaine hydrochloride contained in Lidocaine Mylan 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 you receive Lidocaine Mylan
Do not use Lidocaine Mylan
- If you are allergic (hypersensitive) to lidocaine hydrochloride or other local anesthetics similar to lidocaine or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to the preservatives methyl and / or propyl parahydroxybenzoate, or paraaminobenzoic acid (PABA).
- If you are in severe shock
- If you have heart rhythm disorders (heart block).
- If you have an infection at the injection site
Warnings and cautions
Talk to your doctor or nurse before taking Lidocaine Mylan :
- if you are older and have a reduced general condition.
- if you are going to give Lidocaine Mylan to your child. Dose one must be reduced.
- if you have severe liver or kidney disease.
- if you are taking other antiarrhythmic medicines ( antiarrhythmics ).
- if you have a disease called acute porphyria .
The use of local anesthetics can cause serious side effects , you may be at greater risk if:
- you suffer from heart disease
- Lidocaine Mylan is used in your eyes, head and neck region or in the back ( epidural )
Other medicines and Lidocaine Mylan
Talk to your doctor, nurse or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important with the following medicines as they may interact with Lidocaine Mylan:
- Antiarrhythmics – drugs used to regulate heart rhythm
- Beta blockers , e.g. propranolol – used for angina, high blood pressure and other heart problems
- Cimetidine – used for stomach ulcers or heartburn
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Lidocaine Mylan is unlikely to affect the fetus. If the medicine is used in the cervix, the doctor must closely monitor the fetal pulse.
Lidocaine Mylan is excreted in breast milk, but it is unlikely to have any effects on the breast-fed baby.
Driving and using machines
Some of the medicine can be absorbed into the body and affect your ability to coordinate, move and pay attention. Depending on where and how lidocaine hydrochloride is used, it may affect your ability to drive or use machines. Ask your doctor when it would be safe to drive or use machines. You should not drive or use machines if you have been influenced by administration .
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.
Important information about some of the ingredients of Lidocaine Mylan
Lidocaine Mylan contains sodium methyl parahydroxybenzoate, which in some cases may cause an allergic reaction .
This medicine contains 2.49 mg sodium per ml. This should be considered by patients on a low-salt diet.
How to get Lidocaine Mylan
Your nurse or doctor will give you an injection .
Your doctor will decide which dose is right for you and how and when an injection should be given. This depends on the type of anesthesia you need, the area to be anesthetized and the duration of the anesthesia.
If you take more Lidocaine Mylan than you should
In case of overdose, poisoning reactions may occur (see section 4. Possible side effects ), usually within 15-60 minutes. If Lidocaine Mylan is injected into a vein, a poisoning reaction may occur immediately (within seconds or minutes). The reactions mainly affect the central nervous system and the cardiovascular system.
Such reactions must be treated immediately by a physician.
Poisoning reactions can occur with overdose or if Lidocaine Mylan is accidentally injected into a vein. The reactions mainly affect the central nervous system and the cardiovascular system, and the first signs are usually numbness in the mouth and tongue, dizziness, sensitivity to sound, tinnitus and visual disturbances. Subsequently, more severe symptoms may occur, such as difficulty speaking clearly, muscle twitching or tremors, and eventually convulsions and unconsciousness. In addition, you may have difficulty breathing. In severe cases, you can get low blood pressure , slow heart rate, heart rhythm disorders and even cardiac arrest.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, talk to your doctor straight away:
Allergic reactions and / or symptoms that indicate the onset of a severe allergic reaction (anaphylactic shock ), such as itchy skin, rash ( hives ), redness , swelling of the lips, throat, tongue, hands and feet, wheezing, hoarseness, nausea, vomiting, abdominal cramps and / or inhibition of breathing. In rare cases, abnormal heart rate or rhythm ( cardiac arrhythmia ) and cardiac arrest may occur.
Common side effects (may affect up to 1 in 10 people)
- High or low blood pressure, dizziness, tremors, slow heartbeat, nausea, a stinging and burning sensation in the skin and numbness ( paresthesia ) and vomiting.
Uncommon side effects (may affect up to 1 in 100 people)
Signs of poisoning reactions such as cramps, tingling or numbness around the mouth, numbness in the tongue, increased sensitivity to sound, visual disturbances, tremors, tinnitus , speech disorders, a feeling of numbness or tingling in the region around the mouth (circumoral paresthesia ) and impaired nerve function.
Rare side effects (may affect up to 1 in 1,000 people)
Cardiac arrest, cardiac arrhythmias, allergic reactions, anaphylactic shock , respiratory arrest, pathological changes or damage to the nerves, inflammation of the spinal cord (central meninges) and double vision.
How to store Lidocaine Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton after “EXP” and on the vial after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice visible signs of deterioration.
From a microbiological point of view, the product can be stored for a maximum of 7 days at 25 ° C after opening. Storage times and storage conditions after dilution are the responsibility of the user.
Medicines should not be disposed of via wastewater. 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
1 ml contains 10 mg or 20 mg lidocaine hydrochloride (as monohydrate).
Other ingredients are:
Sodium chloride
Sodium hydroxide / hydrochloric acid
Sodium methyl parahydroxybenzoate (E219)
Water for injections
What the medicine looks like and contents of the pack
Lidocaine Mylan solution for injection is supplied in clear glass vials with rubber stoppers.
Pack sizes: 5 x 20 ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate, Dublin 13
Ireland
Manufacturer
SALF SpA Laboratory Pharmacologico
Via Marconi, 2
24069 Cenate Sotto, Bergamo – Italy