Atropine sulfate Aguettant

Patient Information Leaflet: Information for the User

ATROPINA SOLFATO AGUETTANT 0.1 mg/ml, solution for injection in pre-filled syringe

Atropine sulfate
Please read all of this leaflet carefully before 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 pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

This medicine is called ATROPINA SOLFATO AGUETTANT 0.1 mg/ml solution for injection in pre-filled syringe, but will be referred to as ATROPINA SOLFATO AGUETTANT throughout this leaflet.
Contents of this leaflet:

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

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

Atropine belongs to a group of medicines called anticholinergics. An anticholinergic is a substance that blocks the neurotransmitter acetylcholine in the central and peripheral nervous system. It is used in emergency situations when the heart beats too slowly, as an antidote, for example, to organophosphate insecticides or in nerve gas poisoning and mushroom poisoning.
It may be used as part of premedication before general anaesthesia. It may also be used to prevent the undesirable effects of other medicines used to reverse the effects of muscle relaxants after surgical procedures.
Atropine 0.1 mg/ml solution for injection in pre-filled syringe is used to treat adults and children from birth with a body weight greater than 3 kg.

2. What you need to know before using ATROPINE SULPHATE AGUETTANT

Do not use ATROPINE SULPHATE AGUETTANT

• if you are allergic (hypersensitive) to atropine or to any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty urinating;
• if you have high intraocular pressure (glaucoma);
• if you have oesophageal disease (oesophageal achalasia), intestinal blockage (paralytic ileus), or an acute form of colon distension (toxic megacolon).

These contraindications do not apply in life-threatening emergencies.
Warnings and precautions
Talk to your doctor before using ATROPINE SULPHATE AGUETTANT if you suffer from:

• hyperthyroidism;
• prostate disease;
• heart failure;
• liver or kidney disease;
• certain heart conditions;
• stomach disorders, such as pyloric stenosis;
• chronic bronchitis;
• fever;
• if you are a child or elderly;
• myasthenia gravis (severe muscle weakness);
• heartburn (reflux).

Other medicines and ATROPINE SULPHATE AGUETTANT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

• tricyclic antidepressants;
• certain antihistamines;
• medicines for Parkinson's disease;
• phenothiazines, clozapine or neuroleptic drugs (for mental illnesses);
• quinidine or disopyramide (for heart conditions);
• antispasmodic drugs (for irritable bowel syndrome).

Pregnancy and breastfeeding
Pregnancy
Limited data on the use of atropine in pregnant women indicate no adverse effects on pregnancy or fetal health. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or at term may cause an increased heart rate in both the fetus and the mother. This medicine should be administered during pregnancy only after careful assessment of the benefits and risks of treatment.
Breastfeeding
Small amounts of atropine may pass into breast milk and may affect the infant. Atropine may inhibit breast milk production. Your doctor will evaluate the benefit of breastfeeding against the benefit of treatment. Breastfeeding should be discontinued if treatment is initiated. However, if breastfeeding is continued during treatment, your doctor will carry out additional examinations on the infant.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Atropine injection may cause confusion or blurred vision. After receiving an injection, you must not drive or operate machinery.
ATROPINE SULPHATE AGUETTANT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per syringe, i.e. it is essentially ‘sodium-free’.

3. How to use ATROPINE SULFATE AGUETTANT

Your doctor will decide the correct dose for you and how and when the injection will be administered.
Usual doses are:
As premedication before anesthesia
Intravenous (i.v.) administration immediately before surgery; if necessary,
intramuscular administration may be given 30-60 minutes before surgery.
Adults: 0.3-0.6 mg i.v.
Children: 0.01-0.02 mg/kg, dose adjusted according to patient response and tolerance (maximum
0.6 mg per dose).
To reverse the effects of muscle relaxants:
Adults: 0.6-1.2 mg i.v. with neostigmine.
Children: 0.02 mg/kg i.v.
In case of slow heart rate, heart block, or cardiac arrest:
Adults:

• Sinus bradycardia (slow heart rate): 0.5 mg i.v. every 2-5 minutes until the desired heart rate is achieved.
• Atrioventricular block (block in the transmission of contraction between atrium and ventricle): 0.5 mg i.v. every 3-5 minutes (maximum 3 mg). Children: 0.02 mg/kg i.v. as a single dose (maximum dose 0.6 mg).

As an antidote in organophosphate poisoning (insecticides or nerve gas), anticholinesterase poisoning,
and muscarinic mushroom poisoning:
Adults: 0.5-2 mg i.v., repeatable after 5 minutes and subsequently every 10-15 minutes as needed.
Children: 0.02 mg/kg, preferably repeated several times until signs and symptoms disappear.
Other formulations of the medicine may be more suitable if a dose higher than 0.5 mg is required.
Use in children
Atropine may be used to treat children from birth with a body weight above 3 kg.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
The injection will be administered by a doctor or nurse; therefore, it is unlikely that you will receive an excessive dose of atropine. If you think you have received too much atropine and experience symptoms such as very rapid heartbeat, fast breathing, high fever, restlessness, confusion, hallucinations, or loss of coordination, you must inform the person administering the injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects depend on the dose administered and usually disappear when treatment is discontinued.
Rarely, an allergic reaction may develop, which can cause skin rashes, severe itching, skin peeling, facial swelling (especially around the lips and eyes), tightness in the throat, and breathing or swallowing difficulties, fever, dehydration, shock, and fainting.
These are all very serious side effects. Immediately inform your doctor if you experience any of these side effects. You may require urgent medical attention.

Very common side effects (may affect more than 1 in 10 people)

• Visual disturbances (pupil dilation, difficulty focusing, blurred vision, inability to tolerate light);
• Reduced bronchial secretion;
• Dry mouth (difficulty swallowing and speaking, sensation of thirst);
• Constipation and heartburn (reflux);
• Reduced gastric acid secretion;
• Loss of taste;
• Nausea;
• Vomiting;
• Feeling of bloating;
• Lack of sweating;
• Dry skin;
• Hives;
• Skin rash.

Common side effects (may affect more than 1 in 10 people)

• Excitation (especially at higher doses);
• Loss of coordination (especially at higher doses);
• Confusion (especially at higher doses);
• Hallucinations (especially at higher doses);
• Overheating of the body;
• Certain heart conditions (fast heartbeat, irregular heartbeat, temporary further slowing of heartbeat);
• Hot flushes;
• Difficulty urinating.

Uncommon side effects (may affect up to 1 in 100 people)

• Psychotic reactions.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions;
• Seizures (epileptic fits);
• Drowsiness.

Very rare side effects (may affect up to 1 in 10,000 people)

• Severe hypersensitivity reaction;
• Irregular heartbeat, including ventricular fibrillation;
• Chest pain;
• Sudden increase in blood pressure.

Not known (frequency cannot be estimated from the available data)

• Headache;
• Restlessness;
• Unsteady gait and balance problems;
• Insomnia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ATROPINA SOLFATO AGUETTANT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, syringe, and blister pack.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of degradation.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What ATROPINA SOLFATO AGUETTANT contains

• The active substance is atropine sulfate: Each ml of injectable solution contains 0.1 mg of atropine sulfate monohydrate, equivalent to 0.083 mg of atropine. Each 5 ml pre-filled syringe contains 0.5 mg of atropine sulfate monohydrate, equivalent to 0.415 mg of atropine.
• The other components are: Sodium chloride, concentrated hydrochloric acid (to adjust pH), water for injectable preparations.

Description of the appearance of ATROPINA SOLFATO AGUETTANT and pack contents
This medicine is a clear, colourless injectable solution contained in a sterile 5 ml polypropylene pre-filled syringe.
Pack sizes: Boxes of 1, 5, 10, 12 and 20 syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LABORATOIRE AGUETTANT
1, RUE ALEXANDER FLEMING
69007 LYON
FRANCE
More detailed information on this medicine is available on the AIFA website.

The following information is intended exclusively for healthcare professionals:

The pre-filled syringe is for single use only. Dispose of the syringe after use. Do not reuse.
The contents of a closed and intact blister are sterile and must be opened only immediately before use.
The product should be inspected visually for the presence of particles and changes in color before administration. Use only a clear, colorless solution free from particles or precipitates.
The product must not be used if the tamper-evident seal on the syringe (the plastic cover over the tip cap) is broken.
The outer surface of the syringe is sterile until the blister is opened.

1. Remove the syringe from the sterile blister.

2. Push the plunger to dislodge the stopper.

3. Rotate the tip cap to break the seal.

4. Check that the syringe seal (the plastic cover over the tip cap and the seal beneath the tip cap) has been completely removed. If not, close the cap again and rotate it once more.

5. Expel air by gently pushing the plunger.
6. Attach the syringe to the vascular access device or needle. Push the plunger to inject the required volume.
   For use with the syringe, needles of gauge 23 to 20 are suitable for intravenous administration and needles of gauge 23 to 21 for intramuscular administration.