• The preparation is a drug for local anesthesia (local anesthetic of the ester type)
• It is used within the framework of neural therapeutic application principles.

• Always use this medicine exactly as directed. If you are not sure, ask your doctor or pharmacist.
• The medicine is usually administered by a doctor. Please ask your doctor if you are unsure about its use.
• In principle, only the smallest dose that achieves the desired, adequate nerve block may be administered. The dosage must be determined individually according to the specific characteristics of the individual case.
• Unless otherwise directed by your doctor:
  • Adults and adolescents aged 15 years and over with an average height:
• Skin hives:
  • per wheal up to 10 mg corresponding to 0.5 ml injection solution.
• The recommended maximum dose for a single injection in tissues from which drugs are rapidly absorbed is 500 mg procaine (equivalent to 25 ml of injection solution). For use in the head, neck and genital area, the recommended maximum dose for a single injection is 200 mg procaine (within 2 hours).
• In patients with certain pre-existing conditions (vascular occlusions, hardening and narrowing of the vessels (arteriosclerosis) or nerve damage due to diabetes), the dose should also be reduced by a third. In cases of impaired liver or kidney function, increased plasma levels may occur, particularly with repeated use. In these cases, a lower dose range is also recommended.
• Please talk to your doctor if you feel that the effect is too strong or too weak.

• Duration of application:
  • In principle, the duration of use is not limited, but please note the information under Areas of Application.

• If you have used more than you should,
  • the treating physician must be informed immediately.
    • a. Symptoms of overdose
      • The drug acts as a stimulant on the central nervous system in low, damaging doses, but has the opposite effect in high, damaging doses. Procaine hydrochloride poisoning occurs in 2 phases:
        • They become restless, complain of dizziness, acoustic and visual disturbances and tingling, especially in the tongue and lip area. Speech is slurred, chills and muscle twitches are the precursors of an impending seizure affecting the whole body. As the poisoning of the central nervous system progresses, there is increasing dysfunction of the brain stem with symptoms of respiratory restriction and coma, and even death.
    • b. Emergency measures and antidotes will be prescribed by the attending physician
      • of the symptoms of the disease should be initiated immediately.

• If you forget to use it:
  • Do not use a double dose to make up for a forgotten dose.

• If you cancel the application:
  • Treatment can be stopped at any time.

• The medicine is injected into the skin (intracutaneously).
• It should only be sprayed by persons with appropriate knowledge to successfully carry out the respective application.
• In principle, only low-concentration solutions of procaine should be used for continuous application.
• Repeated use of this medicine may result in reversible loss of efficacy due to tachyphylaxis (rapid development of tolerance to the medicine).
• The injection solution is intended for single use only. It must be used immediately after opening the container. Any unused portion must be discarded.

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The following categories are used to indicate the frequency of side effects:
• Possible side effects:
  • If you experience any of the side effects listed below, stop using the medicine and contact your doctor as soon as possible.
• Undesirable effects of procaine affecting the whole body mainly affect the central nervous system and the cardiovascular system.
• At plasma concentrations generally achieved with regular use, blood pressure is generally only slightly influenced by the cardiac strength and rate-stimulating effect.
• Procaine can induce changes in the propagation of excitation in the heart, which are seen in the ECG (as a flattened T wave or shortened ST segment).
• A drop in blood pressure can be the first sign of a relative overdose in the sense of a damaging effect on the heart. Central nervous system disorders can include discomfort around the mouth, restlessness, impaired consciousness or a seizure.
• Allergic reactions in the form of hives, swelling of the tissue due to water retention, spasms of the airways or shortness of breath as well as circulatory reactions have been described.
• Local allergies and allergy-like reactions in the form of skin inflammation with redness, itching and even blistering can occur upon contact with ester local anesthetics such as this one.
• In addition, local reactions such as swelling, redness of the skin and bruising may occur when used under the skin (subcutaneously) and in the muscle (intramuscularly).
• If you notice any side effects, talk to your doctor or pharmacist. This includes any side effects not listed.

• Use with other medicines:
  • Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
  • The following interactions of procaine with other medicines are known:
    • Prolongation of the effect by certain agents for relaxing the skeletal muscles (non-depolarizing muscle relaxants)
    • Enhancement of the effect by physostigmine (agent for stimulating part of the autonomic nervous system)
    • Reduction in the effectiveness of certain antibiotics (sulfonamides). Procaine should not be used together with certain agents that stimulate a part of the autonomic nervous system (cholinesterase inhibitors). The toxicity of procaine is increased, among other things, due to the influence on procaine degradation.
  • By adding small amounts of atropine, the analgesic effect can be prolonged.
  • Physostigmine in low doses may have a preventive effect against toxic procaine effects.
  • Most important chemical incompatibilities:
    • Procaine should not be mixed with other medicines, as a change in pH or electrolyte concentration may lead to precipitation of the active ingredient.
• Use with food and drink:
  • No mutual interference is to be expected since it is an injection solution, i.e. it is administered without passing through the gastrointestinal tract.

• This medicine must not be used:
  • if you are hypersensitive (allergic) to procaine, other ester-type local anesthetics or any of the other ingredients
  • in the case of a known deficiency of a certain endogenous substance (pseudocholinesterase) resulting in a significantly slowed breakdown of procaine
  • for injection into arteries, into the area surrounding the outer membrane of the central nervous system (epidural) or into the spinal canal (spinal).

• Pregnancy:
  • Do not use this medicine during pregnancy unless your doctor considers it absolutely necessary.
• Breastfeeding:
  • Procaine hydrochloride passes into breast milk. However, with short-term use, interruption of breastfeeding will not be necessary. If repeated treatment or treatment with higher doses is required, you should stop breastfeeding.

• Warnings and Precautions:
  • if you are interested in
    • certain form of muscle weakness (myasthenia gravis)
    • Disturbance of the cardiac conduction system
    • suffer from heart muscle weakness or
    • the injection should be given into an inflamed area.
  • Before use, the doctor administering the medication will always ensure that the circulatory system is well filled, carefully monitor the circulatory system and have all measures for ventilation, treatment of seizures and resuscitation available.
  • The doctor must also know whether you have had an allergic reaction to other drugs that are chemically related to procaine, as this can also lead to an allergic reaction to procaine (paragroup allergy). These can include sulfonamides (a certain group of antibiotics), oral antidiabetics (medicines for diabetes), certain dyes, X-ray film developers or other local anesthetics.
  • If you are able to break down procaine very slowly because a certain substance in your body is not as active (pseudocholinesterase deficiency), side effects from procaine are more likely to occur.
  • When used in the head and neck area, there is a higher degree of danger because the risk of poisoning in the central nervous system is increased.
  • To avoid side effects, the following points should be observed:
    • In certain cases, an additional drip may be required prior to use.
    • Choose dosage as low as possible.
    • As a rule, do not use any vasoconstrictor additives.
    • Before injection, carefully aspirate in two planes (rotation of the cannula).
    • Be careful when injecting into infected areas (due to increased absorption and reduced effectiveness).
    • Inject slowly.
    • Check blood pressure, pulse and pupil size.
  • It should be noted that when being treated with blood thinners (anticoagulants such as heparin), non-steroidal anti-rheumatics or plasma substitutes, not only can accidental vascular injury during pain treatment lead to serious bleeding, but that an increased tendency to bleed must be expected in general. Therefore, appropriate laboratory tests should be carried out before use. If necessary, the anticoagulant treatment should be stopped in good time.
  • Use in conjunction with preventive therapy to avoid thrombosis with low molecular weight heparin should only be carried out with particular caution.
  • Children:
    • There is no experience with use in children and adolescents under 15 years of age from which general dosage recommendations can be derived.
  • Older people:
    • In elderly people, a dosage adjustment is recommended according to the general condition.

• Ability to drive and use machines:
  • Let your doctor decide on a case-by-case basis whether you are allowed to actively participate in road traffic, operate machinery or carry out work without a secure footing.

Procaine hydrochloride, LOPHAKOMP Procaine 2 ml injection solution