Atropine sulfate Laboratoire Aguettant

Package leaflet: Information for the user

ATROPINA SOLFATO LABORATOIRE AGUETTANT

0.2 mg/ml, solution for injection in pre-filled syringe
Atropine sulfate
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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

This medicine is called ATROPINA SOLFATO LABORATOIRE AGUETTANT 0.2 mg/ml
solution for injection in pre-filled syringe, but will be referred to as ATROPINA SOLFATO
LABORATOIRE AGUETTANT throughout this package leaflet.
Contents of this leaflet:

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

1. What ATROPINA SOLFATO LABORATOIRE 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 organophosphorus insecticides or in nerve gas poisoning and mushroom poisoning.
It may be used as part of premedication prior to 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.
Atropina Solfato Laboratoire Aguettant 0,2 mg/ml solution for injection in pre-filled syringe is
indicated only in adults.

2. What you need to know before using ATROPINE SULFATE LABORATOIRE AGUETTANT

Do not use ATROPINE SULFATE LABORATOIRE 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 an esophageal disease (esophageal achalasia), intestinal blockage (paralytic ileus), or acute distension of the colon (toxic megacolon).

These contraindications do not apply in life-threatening emergencies.
Warnings and precautions
Talk to your doctor before using ATROPINE SULFATE LABORATOIRE 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 elderly;
• myasthenia gravis (severe muscle weakness);
• heartburn (reflux).

Other medicines and ATROPINE SULFATE LABORATOIRE AGUETTANT
Inform 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 perform additional monitoring of the infant.
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 SULFATE LABORATOIRE AGUETTANT contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per syringe, i.e. it is practically "sodium-free".

3. How to use ATROPINE SULFATE LABORATOIRE AGUETTANT

Your doctor will decide the correct dose for you and how and when the injection will be administered.
The usual doses are:
As premedication before anesthesia
Adults: 0.3 – 0.6 mg i.v. immediately before induction of anesthesia or 0.3 – 0.6 mg i.m. 30 to 60
minutes before anesthesia.
To reverse the effects of muscle relaxants:
Adults: 0.6 – 1.2 mg i.v. with neostigmine.
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 (impaired conduction of the heartbeat between atria and ventricles): 0.5 mg i.v. every 3–5 minutes (maximum 3 mg).

As an antidote in organophosphate poisoning (insecticides or nerve gases), anticholinesterase agents,
and in poisoning by muscarinic mushrooms:
Adults: 0.5 – 2 mg according to patient characteristics and response; may be repeated
after 5 minutes and subsequently as needed.
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
a very fast heartbeat, rapid 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 everybody gets them.
Side effects depend on the administered dose 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), lump in the throat, breathing or swallowing difficulties, fever, dehydration, shock and fainting.
These are all very serious side effects. Inform your doctor immediately 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 (dilated pupils, 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;
• Urticaria;
• Skin rash.

Common side effects (may affect up to 1 in 10 people)

• Excitement (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);
• Flushing;
• 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ATROPINE SULFATE LABORATOIRE 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.
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 deterioration.
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 LABORATOIRE AGUETTANT contains

• The active substance is atropine sulfate: Each ml of injectable solution contains 0.2 mg of atropine sulfate monohydrate, equivalent to 0.17 mg of atropine. Each 5 ml syringe contains 1 mg of atropine sulfate monohydrate, equivalent to 0.83 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 LABORATOIRE AGUETTANT and
contents of the pack
This medicine is a clear, colourless injectable solution contained in a sterile 5 ml polypropylene pre-filled syringe.
Packs 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 pack are sterile and should 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 on the tip cap) is broken.
The outer surface of the syringe remains sterile until the blister pack is opened.

1. Remove the syringe from the sterile blister pack.

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 on 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 23 to 20 gauge are suitable for intravenous administration and 23 to 21 gauge for intramuscular administration.