Atropinum sulfuricum delfarma

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Atropinum Sulfuricum Delfarma, 0.5 mg/ml, solution for injection
Atropini sulfas
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, 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.

Table of contents of the leaflet

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

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

Atropinum Sulfuricum Delfarma contains atropine sulfate, which belongs to a group of medicines
called anticholinergics. Atropine acts on receptors present in exocrine glands, smooth muscles,
the heart 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 the sinus rhythm and increases the conduction velocity between the atria and ventricles of the heart.

Atropinum Sulfuricum Delfarma is indicated for:

• 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), arrhythmia;
• premedication prior to general anesthesia;
• poisoning with organophosphorus insecticides or cholinomimetic drugs;
• poisoning with mushrooms containing muscarine;
• reversal of neuromuscular blockade;
• adjunctive treatment of spastic conditions of smooth muscles in the abdominal cavity (e.g. biliary or renal colic);
• in radiological diagnostics, when relaxation of smooth muscles and acceleration of intestinal transit are desired.

2. Important information before using the medicine Atropinum Sulfuricum Delfarma

When not to use the medicine Atropinum Sulfuricum Delfarma:

• 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 benign prostatic hyperplasia (symptoms: difficulty urinating);
• 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 Delfarma, discuss this with your doctor or pharmacist.

• Exercise particular caution when using Atropinum Sulfuricum Delfarma in patients:
• over 40 years of age due to the risk of benign prostatic hyperplasia and urinary tract disorders;
• with respiratory diseases, as atropine may worsen breathing difficulties;
• with hyperthyroidism, arterial hypertension, tachyarrhythmia (fast, irregular heartbeat), congestive heart failure, angina pectoris, autonomic neuropathy, gastrointestinal disorders (e.g. peptic ulcer disease, gastroesophageal reflux);
• in elderly patients;
• with impaired kidney and/or liver function.
• Exercise caution when administering atropine to children and monitor the patient closely.
• Administration of the medicine in susceptible individuals may trigger an acute attack of glaucoma or accelerate the onset of complete obstruction in cases of pyloric stenosis.
• Caution is required when administering atropine to patients with elevated body temperature, as it may further increase body temperature. Patients should avoid staying in environments with high ambient temperatures during atropine treatment.
• Cases of severe bradycardia (slowed heart rate) induced by hyperkalemia (elevated blood potassium levels) have been reported, which did not respond to atropine administration.
• 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 administration, 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 Delfarma and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Medicines that enhance the effects of atropine:

• tricyclic antidepressants,
• antispasmodic drugs (used e.g. in irritable bowel syndrome),
• drugs used in Parkinson's disease,
• some antihistamines (classified as first-generation),
• phenothiazines (medicines used in psychiatric disorders),
• disopyramide, quinidine (medicines 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 a high dose 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 significant stress or are in a hyperadrenergic state (autonomic nervous system dysfunction may lead to severe complications such as sudden drops in blood pressure, rapid heartbeat, fainting, dehydration due to chronic diarrhea), due to the risk of developing Tako-tsubo syndrome. Symptoms include: chest pain, worsening shortness of breath, anxiety, pallor, cold sweat, lowered 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 is planning 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 and 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. Suppression of milk secretion may occur.

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

3. How to use Atropinum Sulfuricum Delfarma

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Atropinum Sulfuricum Delfarma is administered exclusively by medical personnel.
This medicine may be given subcutaneously, intramuscularly, or intravenously.
Detailed dosage information is provided in the section "Information intended exclusively for
professional medical personnel".
Use of a higher than recommended dose of Atropinum Sulfuricum Delfarma
Symptoms of overdose: dryness of the mouth accompanied by a burning sensation, difficulty in
swallowing, photophobia, skin flushing and dryness, elevated body temperature, rash, nausea and
vomiting, increased heart rate, and elevated arterial blood pressure. Due to central nervous system
stimulation, the following may occur: restlessness, tremors, confusion, agitation, hallucinations, and
delirium. These symptoms may progress to drowsiness, stupor (a state of near-unconsciousness),
and 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 replacement. In case of photophobia, the patient should be moved to a darkened room.
Missed dose of Atropinum Sulfuricum Delfarma
Do not use a double dose to make up for a missed dose.
Discontinuation of Atropinum Sulfuricum Delfarma
If you have any further questions about 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 everyone experiences them.
Adverse reactions are dose-related to atropine and usually resolve after discontinuation of the medicine.
After administration of relatively low doses, atropine reduces salivary, sweat and bronchial secretions. Dry mouth and decreased or inhibited sweating may occur. Reduced bronchial secretion may lead to thickening of retained secretions and formation of a bronchial plug, difficult to remove from the airways. The above adverse reactions intensify with increasing doses of atropine.
After administration of high doses of atropine, dilated pupils, accommodation disturbances, increased heart rate with possible occurrence of flutter or atrial 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 with epidermal exfoliation, may occur.
Other adverse reactions: hallucinations, increased intraocular pressure, loss of taste, headache, nervousness, drowsiness, weakness, fatigue, dizziness, facial flushing, insomnia, nausea, vomiting and flatulence. Disorientation and/or excitement may occur, especially in elderly patients.
Cases of severe bradycardia caused by hyperkalemia, unresponsive to atropine, 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 of Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atropinum Sulfuricum Delfarma

Protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Atropinum Sulfuricum Delfarma Contains

• The active substance is atropine sulfate. Each ml of solution contains 0.5 mg of atropine sulfate.
• Other ingredients: sulfuric acid (for pH adjustment), water for injections.

What Atropinum Sulfuricum Delfarma Looks Like and Contents of the Package
Atropinum Sulfuricum Delfarma is a clear, transparent liquid.
The package contains 10 ampoules of 1 ml capacity in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Italy, Country of Export:
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351, 53014 Monteroni d’Arbia (SI), Italy

Manufacturer:
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351, 53014 Monteroni d’Arbia (SI), Italy

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Italian Marketing Authorisation Number, Country of Export: 029829052
Parallel Import Licence Number: 372/25

Information intended exclusively for medical professionals:
Atropinum Sulfuricum Delfarma, 0.5 mg/ml, solution for injection
Atropini sulfas

Instructions for Opening the Ampoule
Before opening the ampoule, ensure that the entire 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.
A white dot is marked on each ampoule (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically in both hands with the white dot facing towards you – see Figure 2. Grasp the upper part of the ampoule so that the thumb is positioned above the white 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 may 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 at 5-minute intervals 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 to 3 times higher than the intravenous dose.

Premedication for general anesthesia
Intramuscularly or subcutaneously: 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; repeat 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 0.5 mg to 2 mg (using separate syringes).

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

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

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

In life-threatening situations with 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 anesthesia
Intramuscularly or subcutaneously; 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 dosing 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.