10 mg/ml and 5 micrograms/ml solution
for injection
lidocaine hydrochloride and adrenaline
What Xylocaine adrenaline is and what it is used for
Xylocaine adrenaline contains the active substance lidocaine, which is a local anesthetic, and the active substance adrenaline, which prolongs the effect of lidocaine . It temporarily blocks the nerve signals in the area where it is injected. Xylocaine adrenaline spreads out in tissue and prevents you from feeling pain.
Lidocaine hydrochloride contained in Xylocaine adrenaline may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
Xylocaine adrenaline can be used by adults and children over 1 year of age.
What you need to know before using Xylocaine adrenaline
Do not use Xylocaine adrenaline
- if you are allergic to lidocaine, other local anesthetics similar to lidocaine, adrenaline, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to the preservatives methyl or propyl parahydroxybenzoate (parabens) or para aminobenzoic acid (PABA).
- if you have the excessive formation of hormones in the thyroid gland ( hyperthyroidism ).
- if you are in severe shock.
- if you have heart rhythm disturbances (heart block; AV block ), severe heart disease, or high heart rate ( tachycardia ).
- if you are going to have a spinal anesthetic (epidural) and have a local infection at the injection site.
Warnings and precautions
Be careful with the use of Xylocaine adrenaline:
- to the elderly and people with the reduced general conditions.
- to children. Does one must be reduced.
- in case of severe liver or kidney disease.
- if you have untreated high blood pressure.
- if you have diabetes.
- if you have the poor blood supply to the brain.
- if you have blood deficiency (anemia), dilated blood vessels, or heart failure ( circulatory failure ).
- during simultaneous treatment with certain agents against rhythm disturbances in the heart ( antiarrhythmics ).
- during spinal anesthesia (epidural anesthesia), as the blocking of central nerves can cause serious side effects.
- in the eye, because in rare cases the medicine can cause temporary or permanent side effects.
- in the lips, tongue, and oral cavity, as there is a risk of injury/bite wounds. You should therefore wait to eat until your mouth is back to normal.
- if you have a disease called acute porphyria.
- in peripheral body parts, such as the fingers and toes, or other body parts with low blood supply.
Other medicines and Xylocaine adrenaline
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines, including non-prescription medicines.
Xylocaine can affect or be affected by other medicines, such as:
- other local anesthetics
- medicines against disturbed heart rhythm (so-called antiarrhythmics )
- cimetidine (medicine against stomach ulcers ) and beta blockers (medicine against, among other things, high blood pressure ).
There may be a risk of serious high blood pressure if you use adrenaline at the same time as Xylocaine
- drugs for depression ( tricyclic antidepressants )
- medicines of the type ergotamine or certain beta-blockers.
Medicines that depress the nerves (eg phenothiazines, butyrophenones) can inhibit the effect of adrenaline and cause low blood pressure and slow heart rate.
When using inhaled anesthetics (e.g. halothane and enflurane) together with Xylocaine adrenaline, there is a risk of serious disturbances of the heart rhythm.
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 using this medicine.
Adrenaline may reduce uterine blood flow and the ability to contract, especially after accidental injection into the mother’s blood vessels. If the drug is used at the cervix, the doctor must monitor the fetal heart rate closely. Despite this, it is unlikely that the correct use of Xylocaine adrenaline would affect the fetus.
Lidocaine passes into breast milk, but it is unlikely to have any effects on the breastfed baby. It is unknown whether adrenaline passes into breast milk. Adrenaline is inactivated and secreted quickly. It is therefore unlikely that children who are breastfed can be affected.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. Medicines can affect your ability to drive or perform work that requires increased attention. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Some of the medicine can be absorbed into the body and affect your coordination, mobility, and attention.
Xylocaine adrenaline contains methyl parahydroxybenzoate, sodium metabisulfite, and sodium
Xylocaine adrenaline in vials contains the preservative methyl parahydroxybenzoate, which in some cases can cause allergic reactions (possibly delayed) and exceptional spasm in the trachea.
Xylocaine adrenaline also contains sodium metabisulphite, which in rare cases can cause serious hypersensitivity reactions and spasms of the airways.
The medicine contains 0.11 mmol (or 2.5 mg) of sodium per milliliter.
This should be taken into account by patients prescribed a low-salt diet.
How to use Xylocaine adrenaline
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose of Xylocaine adrenaline is determined by the doctor and depends on the type of anesthesia you need, the area to be numbed, and how long the anesthesia should last.
If you have used too much Xylocaine adrenaline
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. For other questions about the medicine, contact a doctor or pharmacist.
In case of overdose, poisoning reactions can occur, usually within 15-60 minutes. If Xylocaine is accidentally injected into a blood vessel, poisoning reactions can occur immediately (within seconds or minutes). The reactions mainly affect the central nervous system and the cardiovascular system, and the first signs are usually numbness in the mouth and tongue, a feeling of intoxication, sensitivity to sound, tinnitus, and visual disturbances. After that, you may have more serious symptoms, such as difficulty speaking, muscle twitching or tremors, and eventually convulsions and unconsciousness. In addition, you may experience breathing difficulties. In severe cases, low blood pressure can occur, slow heartbeat, heart rhythm disturbances, and even cardiac arrest. Such reactions must be treated immediately.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 users)): Low blood pressure, nausea.
Common side effects (may affect up to 1 in 10 users): High blood pressure, dizziness, tingling sensation in the skin, slow heart rate, vomiting.
Uncommon side effects (may affect up to 1 in 100 users): Signs of poisoning reactions in the central nervous system, such as convulsions, tingling or numbness around the mouth, numbness of the tongue, increased sensitivity to sound, visual disturbances, tremors, tinnitus, difficulty speaking clearly, reduced level of consciousness.
Rare side effects (may affect up to 1 in 1,000 users): Cardiac arrest, heart rhythm disturbances, allergic reactions, anaphylactic shock, difficulty breathing, pathological changes or damage to the nerves, inflammation of the arachnoid (the middle meninges) and double vision.
How Xylocaine adrenaline should be stored
Keep this medicine out of the sight and reach of children.
Store in a refrigerator or cool (2 °C-15 °C). Do not freeze.
Store in the original packaging. Light sensitive.
The vial may be used for a maximum of three days after opening.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are lidocaine hydrochloride and adrenaline.
- Other ingredients are sodium chloride, sodium hydroxide and/or hydrochloric acid (for pH adjustment), sodium metabisulphite, methyl parahydroxybenzoate (E218), and water for injections.
Appearance and package sizes of the medicine
Xylocaine adrenaline is a clear, colorless solution.
One package contains 5 vials with 20 ml solution for injection.
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Phone: +46 856 642 572
Manufacturer: Recipharm Monts, France