Atropine sulfate Monico

Package leaflet: Information for the user

ATROPINA SOLFATO MONICO 0.5 mg/ml injection solution, 1 mg/ml injection solution

Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What ATROPINA SOLFATO MONICO is and what it is used for

ATROPINA SOLFATO MONICO contains the active substance atropine sulfate, which belongs to a group of medicines (Belladonna Alkaloids) that work by blocking the action of acetylcholine on the nervous system (anticholinergic drugs).
This medicine is used as a premedication before anaesthesia to reduce saliva production and fluid secretion in the bronchi.
It is also used in the treatment of slow heart rate (sinus bradycardia), especially when associated with low blood pressure (hypotension).
It is additionally used in emergency situations as an antidote in poisoning by insecticides (organophosphates), to counteract the reduction in heart rate.

2. What you need to know before using ATROPINE SULFATE MONICO

Do not use ATROPINE SULFATE MONICO

• if you are allergic to atropine sulfate or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure in the eyes (closed-angle glaucoma);
• if you have gastroesophageal reflux;
• if you have narrowing of the stomach or intestine (pyloric stenosis, gastrointestinal obstruction);
• if you have a chronic inflammatory bowel disease (ulcerative colitis);
• if you have an enlarged prostate (prostatic hypertrophy);
• if your intestine is not functioning properly (paralytic ileus, intestinal atony);
• if you suffer from a neuromuscular disease characterized by muscle weakness (myasthenia gravis) (except when you are simultaneously administered an anticholinesterase medicine).

In emergency situations where your life may be at risk (e.g. in case of severe heart problems such as bradyarrhythmia or poisoning), medical personnel may administer this medicine to you even if you have one of the conditions listed above.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ATROPINE SULFATE MONICO.
Inform your doctor and use this medicine with caution in the following cases:

• if you have Down's syndrome;
• if you have had intestinal surgery such as ileostomy or colostomy, or if you experience episodes of diarrhea which may indicate intestinal obstruction;
• if your thyroid gland produces high levels of hormones (hyperthyroidism);
• if you have severe kidney or liver problems (renal or hepatic insufficiency);
• if you have heart circulation problems (coronary disorders, acute myocardial ischemia, acute myocardial infarction); in case of ischemia or infarction, this medicine may worsen your condition;
• if you suffer from abnormal heart rate (tachycardia, tachyarrhythmia);
• if you have urinary tract problems (obstructive uropathies; urinary retention);
• if you suffer from a disease affecting the bronchi (chronic obstructive bronchopulmonary disease);
• if you have a fever or the ambient temperature is high;
• if you have undergone a heart transplant and need to take this medicine, your doctor must exercise extreme caution, as serious heart problems may occur;
• doses of atropine higher than 1 mg may cause mental disturbances and adverse effects on the central nervous system (depression), especially in children and elderly patients (see sections “Children” and “Elderly”).

Children
This medicine must be administered with caution in children. In children, a lower dosage than that recommended for adults is required.

Elderly
This medicine must be administered with caution in elderly patients. In elderly patients, dosage adjustment may be useful to reduce the risk of adverse effects on the heart and central nervous system.

Other medicines and ATROPINE SULFATE MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

In particular, ATROPINE SULFATE MONICO must not be administered if you are taking the following medicines:

• other anticholinergic medicines such as Belladonna alkaloids, because the activity of the medicine may be increased;
• halothane, a medicine used in anesthesia, because it may reduce the effect of the medicine on heart rate (bradycardia);
• procainamide, used to regulate heartbeats, because it may increase the effects of the medicine on the heart (atrioventricular conduction);
• methacholine, an acetylcholine analogue used in asthma diagnosis, because its effects are inhibited.

This medicine must be administered with caution if you are taking any of the following medicines, as they may increase the adverse effects of atropine (urinary retention, constipation, dry mouth):

• tricyclic antidepressants, medicines used for depression;
• anti-H1 antihistamines and mequitazine, medicines used for allergies;
• medicines for the treatment of Parkinson's disease;
• disopyramide and quinidine, medicines used for heart problems;
• phenothiazines, neuroleptic medicines, and clozapine, medicines used for mental disorders;
• atropine-like antispasmodics, medicines that relax smooth muscle.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine should not be administered during pregnancy. ATROPINE SULFATE MONICO may be used only in cases of absolute necessity during pregnancy.
If you are breastfeeding, your doctor may advise you to discontinue breastfeeding or treatment with this medicine. If you decide to continue breastfeeding during treatment with atropine, your doctor must monitor your baby.

Driving and use of machines
This medicine impairs your ability to drive or operate machinery.

3. How to use ATROPINE SULFATE MONICO

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
ATROPINE SULFATE MONICO will be administered by a doctor or other healthcare professional
into a vein (intravenous route), into the muscle (intramuscular route), or under the skin (subcutaneous route), depending on your needs.
Pre-anaesthetic medication:
The recommended dose is 0.3–0.6 mg by intravenous injection immediately before induction
of anaesthesia, or by subcutaneous or intramuscular injection 30–60 minutes before anaesthesia.
Treatment of sinus bradycardia:
The recommended dose is 0.3–1.0 mg administered intravenously.
Antidote in organophosphorus poisoning:
The recommended dose is 2 mg by intramuscular or intravenous route, repeated every 5–10 minutes depending on the severity of poisoning, until the skin becomes flushed and dry, the pupils dilate, and an increase in heart rate (tachycardia) occurs.
Use in children and adolescents
The recommended dose for pre-anaesthetic medication is 0.02 mg per kg of body weight
(maximum dose 0.6 mg).
The recommended dose for treatment of organophosphorus poisoning is 0.02 mg per kg
of body weight.
If you use more ATROPINE SULFATE MONICO than you should
This medicine will be administered by a doctor or nurse; therefore, it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much atropine and experience symptoms such as dryness of mucous membranes, pupil dilation, increased heart rate (tachycardia), fever, and skin irritations (rash), or if you feel restless, confused, disoriented, or have hallucinations (neurological symptoms) lasting more than 48 hours, inform your doctor or nurse immediately so that appropriate measures can be taken, or go to the nearest hospital emergency department.
In some cases, serious effects may occur such as respiratory depression, coma, severe drop in blood pressure (circulatory collapse), and death.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have occurred:
Not known (frequency cannot be determined from the available data)

• changes in growth hormone levels;
• porphyria, a rare blood disorder;
• increased or decreased body temperature (hyperthermia or hypothermia);
• drowsiness (sedation), disorientation, and dizziness;
• short-term memory disturbances;
• mental disorders (psychosis);
• hallucinations (especially at high doses);
• seizures;
• headache (cephalalgia);
• double vision (diplopia) and visual difficulties (accommodation disorders);
• dilation of the pupil (mydriasis);
• changes in intraocular pressure;
• heart circulation problems (angina, atrioventricular block);
• changes in heart rate (arrhythmias);
• decreased heart rate (bradycardia) followed by increased heart rate (tachycardia, palpitations, and arrhythmias);
• increased blood pressure (hypertension);
• hot flushes;
• reduced bronchial secretions;
• esophageal reflux, dry mouth with difficulty swallowing and speaking, nausea, vomiting, bloating sensation, stomach problems (inhibition of gastric secretion);
• skin redness and dryness, urticaria, skin rash;
• reduced sweating (in cases of intramuscular administration);
• bladder problems (inhibition of parasympathetic control of the urinary bladder) and urinary retention;
• allergic reactions, including severe (anaphylactic) reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via signal-a-suspected-adverse-reaction. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ATROPINA SOLFATO MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
No special storage conditions regarding temperature are required.
Store in the original packaging to protect the medicine from light.
The medicine should be used immediately after opening; any remaining solution must be discarded.
The solution must be clear, colourless, and free from visible particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ATROPINA SOLFATO MONICO contains
ATROPINA SOLFATO MONICO 0.5 mg/ml solution for injection

• The active substance is atropine sulfate monohydrate. 1 ml of solution contains 0.5 mg of atropine sulfate, equivalent to 0.21 mg of atropine base.
• The other component is: water for injections.

ATROPINA SOLFATO MONICO 1 mg/ml solution for injection

• The active substance is atropine sulfate monohydrate. 1 ml of solution contains 1 mg of atropine sulfate, equivalent to 0.42 mg of atropine base.
• The other component is: water for injections.

Description of the appearance of ATROPINA SOLFATO MONICO and contents of the pack
Pack containing 5 or 10 vials of 1 ml of solution for injection.
Marketing Authorization Holder and Manufacturer
MONICO SPA - Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy
The following information is intended exclusively for physicians and healthcare professionals:
OVERDOSE
At the first signs, in case of respiratory depression, administration of oxygen is recommended; if seizures persist and circulatory conditions allow, intravenous administration of short-acting barbiturates (e.g. thiopental) or benzodiazepines (e.g. diazepam) should be performed. Since atropine is eliminated via the kidneys, intravenous fluid administration is recommended. In cases of delirium and coma, intravenous infusion of physostigmine is recommended at a dose of 1 to 4 mg (0.5 – 1 mg in children), administered slowly.