Atropine sulfuricum wzf

Package leaflet: Information for the patient

Atropinum Sulfuricum WZF, 0.5 mg/ml, solution for injection
Atropinum Sulfuricum WZF, 1 mg/ml, solution for injection
Atropini sulfas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Atropinum Sulfuricum WZF is and what it is used for
2. What you need to know before using Atropinum Sulfuricum WZF
3. How to use Atropinum Sulfuricum WZF
4. Possible side effects
5. How to store Atropinum Sulfuricum WZF
6. Contents of the pack and other information

1. What Atropinum Sulfuricum WZF is and what it is used for

Atropinum Sulfuricum WZF contains atropine sulfate, which belongs to a group of medicines
called anticholinergics (cholinolytics). Atropine acts on receptors present in exocrine glands,
smooth muscles, cardiac muscle, and the central nervous system. Atropine increases heart rate,
reduces secretion of saliva and sweat, decreases bronchial, nasal, lacrimal, and gastric secretions,
reduces intestinal peristalsis, and inhibits urination.
Atropine accelerates sinus rhythm and increases conduction velocity between the atria and
ventricles of the heart muscle.
Atropinum Sulfuricum WZF is used:

• in sinus bradycardia (significant slowing of heart rate due to vagus nerve conduction disorders, which mediates between the brain and the sinoatrial node in controlling the heart), and in arrhythmias;
• as premedication prior to general anesthesia;
• in poisoning with organophosphorus insecticides or cholinomimetic drugs;
• in poisoning with mushrooms containing muscarine;
• to reverse neuromuscular blockade;
• as an adjunct in spastic conditions of smooth muscles in the abdominal cavity (hepatic colic, renal colic);
• in radiological diagnostics, when relaxation of smooth muscles and slowing of intestinal transit are desired.

2. Important information before using Atropinum Sulfuricum WZF

When not to use Atropinum Sulfuricum WZF:

• if the patient is allergic to atropine sulfate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has urinary bladder outlet obstruction, e.g. due to prostate enlargement (symptoms: difficulty passing urine);
• if the patient has reflux esophagitis (symptoms: heartburn, damage to the esophageal mucosa);
• if the patient has myasthenia gravis (muscle weakness);
• if the patient has paralytic ileus (symptoms: fever, severe abdominal pain, bloating);
• if the patient has severe ulcerative colitis (symptoms: presence of blood and mucus in stool);
• if the patient has diseases causing gastrointestinal obstruction;
• if the patient has narrow-angle glaucoma (increased intraocular pressure (in the eye(s))).

Warnings and precautions
Before starting treatment with Atropinum Sulfuricum WZF, discuss this with your doctor or
pharmacist.

• Exercise particular caution when using Atropinum Sulfuricum WZF in the following patients:
• over 40 years of age due to the risk of prostate enlargement and urinary tract disorders;
• with respiratory diseases, as atropine may worsen breathing difficulties;
• with hyperthyroidism, arterial hypertension, tachyarrhythmia (fast, irregular heart rhythm), congestive heart failure, angina pectoris, autonomic neuropathy, gastrointestinal disorders (e.g. peptic ulcer, gastroesophageal reflux);
• elderly patients;
• with impaired kidney and/or liver function.
• Caution should be exercised when administering atropine to children, and patients should be closely observed.
• Administration of the drug in susceptible individuals may trigger an acute attack of glaucoma or accelerate the onset of complete obstruction in cases of pyloric stenosis.
• Caution is advised when administering atropine to patients with elevated body temperature, as it may further increase body temperature. During atropine administration, the patient should avoid staying in environments with high ambient temperatures.
• Cases of severe bradycardia (slowed heart rate) induced by hyperkalemia (increased potassium levels in blood), unresponsive to atropine administration, have been reported.
• Paradoxical atrioventricular block or sinus arrest has been observed in several patients following heart transplantation after atropine administration.
• Atropine should be used with particular caution during therapeutic or diagnostic procedures in patients after heart transplantation. ECG monitoring is recommended during use, and resuscitation equipment should be readily available.
• Doses of atropine not exceeding 1 mg have a slight stimulating effect on the central nervous system. Higher doses may cause psychiatric disturbances and depression of central nervous system function. Children and elderly patients are especially sensitive.

Atropinum Sulfuricum WZF and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Medicines that enhance the effects of atropine:

• tricyclic antidepressants,
• antispasmodic drugs (e.g. used in irritable bowel syndrome),
• drugs used in Parkinson's disease,
• some antihistamines (first-generation),
• phenothiazines (medicines used in psychiatric disorders),
• disopyramide, quinidine (drugs used in heart diseases).

Atropine, by delaying gastric emptying, may slow down or accelerate the absorption of certain orally administered drugs.
During anesthesia with propofol and concomitant use of atropine, the heart rate response to intravenous atropine may be reduced (and this effect cannot be effectively counteracted by administering high doses of atropine).
Particular caution is required during stress echocardiography using dobutamine and atropine, or during concomitant administration of catecholamines with atropine in patients who appear to be under strong stress or who have a condition called hyperadrenergic state (autonomic nervous system dysfunction, potentially leading to severe complications such as sudden drops in blood pressure, rapid heart rate, fainting, dehydration due to chronic diarrhea), due to the risk of Tako-tsubo syndrome. Symptoms of this syndrome include: chest pain, worsening shortness of breath, anxiety, pallor, cold sweat, decreased arterial blood pressure, disturbances of consciousness, ventricular fibrillation, cardiac arrest.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.
Intravenous administration of atropine to a pregnant woman or during labor may cause fetal tachycardia.
Small amounts of atropine pass into breast milk and may cause adverse effects in the infant. Use of atropine in breastfeeding women requires caution. It may also inhibit milk secretion.

Driving and operating machinery
This medicine impairs the ability to drive vehicles and operate machinery.

3. How to use Atropinum Sulfuricum WZF

This medicine should always be used as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
Atropinum Sulfuricum WZF is administered exclusively by medical personnel.
The medicine may be given subcutaneously, intramuscularly, or intravenously.
Detailed dosage information is provided in the section "Information intended exclusively
for healthcare professionals".
Administration of a higher than recommended dose of Atropinum Sulfuricum WZF
Symptoms of overdose: dryness of the mouth with a burning sensation, difficulty swallowing,
photophobia, redness and dryness of the skin, elevated body temperature, rash, nausea and vomiting,
increased heart rate, and elevated arterial pressure. Due to central nervous system stimulation,
symptoms such as restlessness, tremors, confusion, agitation, hallucinations, and delirium may occur.
These symptoms may progress to drowsiness, stupor (a state of near-unconsciousness), respiratory and circulatory failure, sometimes life-threatening.
Treatment of severe cases consists of intravenous, intramuscular, or subcutaneous administration of 1 mg to 4 mg of physostigmine; the dose may be repeated if necessary.
If required, the physician will administer oxygen to the patient, provide respiratory support, and ensure adequate fluid supply. In case of photophobia, the patient should be moved to a darkened room.
Missed dose of Atropinum Sulfuricum WZF
Do not use a double dose to make up for a missed dose.
Discontinuation of Atropinum Sulfuricum WZF
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions are related to the dose of atropine administered and usually resolve after
discontinuation of the medicine.
After administration of relatively small doses, atropine reduces the secretion of saliva, sweat, and bronchial mucus. Dry mouth and decreased or inhibited sweating may occur. Reduced bronchial mucus secretion may lead to thickening of retained secretions and formation of an obstructive mucus plug, difficult to remove from the airways. The above adverse reactions intensify with increasing doses of atropine.
After administration of large doses of atropine, dilated pupils, accommodation disorders, increased heart rate with possible occurrence of atrial flutter or fibrillation, atrioventricular dissociation, and additional ventricular contractions have been reported. Urinary retention and constipation may also occur. Increasing doses of atropine inhibit gastric secretion.
In some patients, anaphylaxis, urticaria, and rash, sometimes accompanied by skin desquamation, may occur.
Other adverse reactions: hallucinations, increased intraocular pressure, loss of taste, headache, nervousness, drowsiness, weakness, fatigue, dizziness, facial flushing, insomnia, nausea, vomiting, and abdominal distension. Disorientation and/or excitement may occur, especially in elderly patients.
Cases of severe bradycardia caused by hyperkalemia, unresponsive to atropine administration, have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Atropinum Sulfuricum WZF

Store below 25°C.
Keep ampoules in the outer packaging to protect from light. Do not freeze.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Atropinum Sulfuricum WZF contains

• The active substance is atropine sulfate. Each ml of solution contains 0.5 mg or 1 mg of atropine sulfate.
• Other components: dilute hydrochloric acid (for pH adjustment), water for injections.

What Atropinum Sulfuricum WZF looks like and contents of the pack
Atropinum Sulfuricum WZF is a clear, transparent liquid.
The package contains 10 ampoules of 1 ml capacity in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Information intended exclusively for healthcare professionals:
Atropinum Sulfuricum WZF, 0.5 mg/ml, solution for injection
Atropinum Sulfuricum WZF, 1 mg/ml, solution for injection
Atropini sulfas

Instructions for opening the ampoule
Before opening the ampoule, ensure that all the solution is in the lower part of the ampoule.
Gently shake the ampoule or tap it with your finger to help the solution flow down.
Each ampoule has a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically with both hands, with the coloured dot facing towards you – see Figure 2. The upper part of the ampoule should be gripped so that the thumb is positioned above the coloured dot.
• Press in the direction of the arrow shown in Figure 3. Ampoules are intended for single use only and should be opened immediately before use. Any unused portion of the product must be discarded in accordance with applicable regulations.

Figure 1.

Figure 2.

Figure 3.

The medicine can be administered subcutaneously, intramuscularly, or intravenously.

Dosage

Adults, adolescents over 12 years of age, and elderly patients
Sinus bradycardia, arrhythmia
Intramuscularly or intravenously: 0.3 to 0.6 mg every 4–6 hours up to a total dose of 2 mg.
In resuscitation: 0.5 mg; the dose may be repeated every 5 minutes until cardiac rhythm stabilizes.
In cardiac arrest, administer a single intravenous dose of 3 mg. If intravenous administration of atropine is not possible during resuscitation, administer via endotracheal tube a dose 2–3 times higher than the intravenous dose.

Premedication for general anaesthesia
Subcutaneously or intramuscularly: 0.3 to 0.6 mg administered 30–60 minutes before the procedure, or the same dose administered intravenously immediately before the procedure.

Poisoning with organophosphorus insecticides, poisoning with cholinomimetic drugs, poisoning with mushrooms containing muscarine
Intramuscularly or intravenously: 1 to 2 mg; the dose may be repeated every 5 to 60 minutes until symptoms of poisoning resolve; do not exceed a maximum dose of 100 mg within the first 24 hours.

Reversal of neuromuscular blockade
Intravenously: 0.6 mg to 1.2 mg administered several minutes before or simultaneously with neostigmine at a dose of 0.5 mg to 2 mg (using separate syringes).

Adjunctive treatment in smooth muscle spasm of the abdominal cavity (hepatic, renal colic)
Intramuscularly or intravenously: 0.5 mg to 1 mg.

In radiological diagnostics, when relaxation of smooth muscle and increased intestinal transit are desired
Intramuscularly: 1 mg.

Children under 12 years of age
The usual intramuscular, intravenous, or subcutaneous dose is 10 micrograms/kg body weight (0.01 mg/kg); do not exceed 0.4 mg. If necessary, the dose may be repeated every 4–6 hours.

In life-threatening situations involving severe cardiac disturbances
For life-saving purposes: intravenously 20 micrograms/kg (0.02 mg/kg); minimum dose: 0.01 mg, which may be repeated every 5 minutes up to a maximum dose of 0.1 mg.

Premedication for general anaesthesia
Subcutaneously or intramuscularly; administer 30–60 minutes before surgical procedure.
Children with body weight up to 3 kg: 100 micrograms (0.1 mg).
Children with body weight from 7 to 9 kg: 200 micrograms (0.2 mg).
Children with body weight from 12 to 16 kg: 300 micrograms (0.3 mg).
Children with body weight above 20 kg: adult dosage applies.

Reversal of neuromuscular blockade
Intravenously: neonates, infants, and children: 20 micrograms/kg (0.02 mg/kg).
Maximum dose: 0.6 mg.

Poisoning with organophosphorus insecticides, poisoning with cholinomimetic drugs, poisoning with mushrooms containing muscarine
Intramuscularly or intravenously: 50 micrograms/kg (0.05 mg/kg) every 10–30 minutes; administer until symptoms of poisoning resolve.