Polstigminum

Package Leaflet: Information for the Patient

POLSTIGMINUM, 0.5 mg/ml, Solution for Injection

(Neostigmine Methylsulfate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Polstigminum and what is it used for
• 2. Important information before using Polstigminum
• 3. How to use Polstigminum
• 4. Possible side effects
• 5. How to store Polstigminum
• 6. Contents of the pack and other information

1. What is Polstigminum and what is it used for

Polstigminum, 0.5 mg/ml, solution for injection contains the active substance neostigmine methylsulfate, which increases the activity of the parasympathetic nervous system (a part of the autonomic nervous system that regulates involuntary body functions, mainly responsible for rest and improved digestion), causes smooth muscle contraction, increases intestinal peristalsis, constricts pupils, increases saliva secretion, and improves muscle tone and contractility.

Indications:

• Symptomatic treatment of muscle weakness (muscle weakness and fatigue of unknown cause) when the oral form of the medicine cannot be used;
• Prevention and treatment of postoperative intestinal obstruction and postoperative urinary retention, after excluding mechanical causes of these pathological conditions;
• Reversal of blocked neuromuscular transmission that has caused skeletal muscle weakness, after the use of so-called non-depolarizing muscle relaxants.

2. Important information before using Polstigminum

When not to use Polstigminum, 0.5 mg/ml, solution for injection:

• in combination with depolarizing muscle relaxants, such as succinylcholine, due to the possibility of exacerbating neuromuscular blockade and subsequent prolongation of apnea.

Warnings and precautions

Before starting treatment with Polstigminum, 0.5 mg/ml, solution for injection, the patient should discuss it with their doctor, pharmacist, or nurse.
Neostigmine should be used with caution in patients with bronchial asthma, epilepsy, parkinsonism, recent myocardial infarction, bradycardia (slow heart rate) or other heart rhythm disorders, hypotension, vagotonia (increased vagus nerve activity), hyperthyroidism, stomach or duodenal ulcers.
During treatment with neostigmine, the doctor will pay special attention to distinguishing between myasthenic crisis and cholinergic crisis, caused by neostigmine overdose. In both cases, significant muscle weakness occurs, but the treatment must be completely different.
Using Polstigminum, 0.5 mg/ml, solution for injection in children:
The dose of the medicine is determined by the doctor.
Using Polstigminum, 0.5 mg/ml, solution for injection in patients with kidney or liver dysfunction:
The medicine should be used with caution in patients with liver or kidney failure.
In kidney failure, the dose is reduced, and there is no need to change the dose in renal replacement therapy.
Using Polstigminum, 0.5 mg/ml, solution for injection in elderly patients:
No special dosage recommendations are required for elderly patients.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
The decision to administer neostigmine during pregnancy is made by the doctor. The medicine may be used during pregnancy only in cases where the doctor believes the benefit to the mother outweighs the potential risk to the fetus.
Medicines that inhibit acetylcholinesterase activity, given intravenously to pregnant women, may increase uterine contractions and cause premature labor.
Breastfeeding
There is no data on the penetration of neostigmine into breast milk. Due to the risk of side effects in infants, the medicine should not be used during breastfeeding, or breastfeeding should be discontinued during treatment with the medicine.

Driving and using machines

During treatment with neostigmine, the patient should not drive vehicles or operate mechanical devices in motion.

Polstigminum, 0.5 mg/ml, solution for injection and other medicines

Neostigmine acts antagonistically to agents that cause neuromuscular junction blockade.
The medicine does not counteract, and may even reverse, neuromuscular transmission caused by depolarizing muscle relaxants, such as succinylcholine.
Certain antibiotics from the aminoglycoside group (neomycin, streptomycin, kanamycin) may increase muscle relaxant activity. They can be used in patients with muscle weakness only if necessary, and the dosage must be adjusted accordingly.
Local anesthetics and some general anesthetics (e.g., halothane, cyclopropane, enflurane, isoflurane, desflurane, sevoflurane), antiarrhythmic drugs (e.g., procainamide, quinidine), and other medicines that affect neuromuscular conduction (e.g., ganglion blockers like hexamethonium or trimethaphan) may cause neuromuscular blockade as a side effect.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Polstigminum contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

3. How to use Polstigminum

The medicine is intended for intramuscular, intravenous, or subcutaneous administration.
The daily dose of neostigmine administered parenterally should not exceed 4-6 mg.
The dosage of the medicine is determined by the doctor.

• Symptomatic treatment of muscle weakness when the oral form of the medicine cannot be used:Adults:0.5 mg of neostigmine methylsulfate should be administered 3 times a day intramuscularly or intravenously. Subsequent doses are determined according to the individual patient's response. The therapeutic dose is usually between 1 mg and 5 mg, and up to 2.5 mg in children.

Children:
Transient myasthenia in newborns may be treated with 0.1 mg of neostigmine methylsulfate administered intramuscularly. Subsequent doses are determined according to the individual patient's response, but usually 0.05-0.25 mg intramuscularly, up to a maximum of 0.03 mg/kg intramuscularly every 2-4 hours.
Due to the spontaneous resolution of the disease in newborns, the daily dose should be reduced before completely discontinuing the medicine.
Children up to 12 years of age:
The usual dose is 0.2-0.5 mg.
Subsequent doses are determined according to the individual patient's response.

• Prevention of postoperative intestinal obstruction and (or) postoperative urinary retention:Adults:0.25 mg of neostigmine methylsulfate is recommended to be administered subcutaneously or intramuscularly as soon as possible after surgery. The dose should be repeated every 4-6 hours for the next 2-3 days.
• Treatment of postoperative intestinal obstruction:0.5-2 mg of neostigmine methylsulfate should be administered slowly intravenously, subcutaneously, or intramuscularly. Continuous intravenous infusion of neostigmine methylsulfate at 0.4-0.8 mg/h for 24 hours.
• Treatment of postoperative urinary retention:0.5 mg of neostigmine methylsulfate should be administered subcutaneously or intramuscularly. If diuresis does not occur within an hour, a catheter should be inserted. If the patient has urinated or the bladder has been emptied, administration of 0.5 mg of neostigmine methylsulfate should be continued by injection every 3 hours, at least five times.
• Reversal of neuromuscular blockade caused by non-depolarizing muscle relaxants:Usually, a dose of 0.5-2 mg of neostigmine methylsulfate is administered slowly intravenously; if necessary, the dose can be repeated, up to a total dose of 5 mg of neostigmine methylsulfate.

Elderly patients:
There are no special dosage recommendations for elderly patients.
In case of using a higher dose of Polstigminum, 0.5 mg/ml, solution for injection than recommended:
than recommended:
Overdose of neostigmine may cause a cholinergic crisis, characterized by significant muscle weakness. The doctor will distinguish between the symptoms of cholinergic crisis and myasthenic crisis, which have similar clinical symptoms. In case of cholinergic crisis, neostigmine should be discontinued immediately and atropine administered.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of neostigmine are related to the enhancement of its pharmacological effects (stimulation of the parasympathetic nervous system) and most often include increased saliva secretion and muscle tremors. Less frequently, they may include abdominal cramps and diarrhea. In addition, during treatment with neostigmine, side effects with various frequencies may occur, affecting individual systems and organs:
The frequency of side effects in individual systems and organs is given below using the following convention: very common (>1/10); common (>1/100, <1>1/1000, <1>1/10 000, <1>Cardiac disorders:
Frequency not known: heart rhythm disorders (sinus bradycardia, tachycardia, atrioventricular block, nodal rhythm), non-specific changes in the ECG, cardiac arrest, fainting, and blood pressure drops.
Nervous system disorders:
Frequency not known: dizziness, ataxia, seizures, loss of consciousness, drowsiness, headaches, speech disorders.
Eye disorders:
Frequency not known: lacrimation, miosis, vision disturbances.
Respiratory, thoracic, and mediastinal disorders:
Frequency not known: increased secretion in the respiratory tract, dyspnea, bronchospasm, respiratory disorders, apnea.
Gastrointestinal disorders:
Frequency not known: nausea, vomiting, bloating, salivation, increased peristalsis, diarrhea.
Renal and urinary disorders:
Frequency not known: increased urination frequency.
Musculoskeletal and connective tissue disorders:
Frequency not known: muscle cramps and tremors, joint pain.
General disorders and administration site conditions:
Frequency not known: increased sweating, skin flushing, weakness.
Immune system disorders:
Frequency not known: allergic reactions (e.g., rash, urticaria) and anaphylactic reactions.
Psychiatric disorders:
Frequency not known: agitation, fear.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Polstigminum

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, protected from light.
Do not use Polstigminum, 0.5 mg/ml, solution for injection after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Polstigminum contains:

1 ampoule (1 ml) contains: 0.5 mg of neostigmine methylsulfate and the excipients: sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection.

What Polstigminum looks like and contents of the pack:

Ampoules made of colorless glass with a capacity of 1 ml, packed in cardboard boxes of 10.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Date of last revision of the leaflet:
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The following information is intended for healthcare professionals only:

Healthcare professionals:
Due to the possibility of unexpected hypersensitivity to neostigmine, the doctor should be prepared for the need to administer atropine and provide anti-shock treatment.
In case of administration of high doses of neostigmine, concurrent or prior injection of atropine sulfate is recommended. It is necessary to use separate syringes for neostigmine and atropine.
In case of intravenous administration of neostigmine, it is recommended to administer atropine sulfate (10 μg/kg iv every 3-10 minutes until the disappearance of muscarinic symptoms) intravenously in a separate syringe. It is recommended to administer the atropine injection a few minutes before administering neostigmine rather than administering both medicines simultaneously.
The patient should be ensured oxygen supply and maintenance of airway patency until normal breathing is fully restored.
The optimal time for administering the medicine is during hyperventilation, when the carbon dioxide concentration in the blood is low.
In patients with cardiovascular or other severe diseases, the required dose of neostigmine should be carefully determined according to the indications of a peripheral nerve stimulator.
In case of bradycardia, the heart rate should be increased to 80/minute by prior administration of atropine.
Before administering the medicine, it should always be checked whether the clarity or color of the solution has changed.