ATROPINE Aguettant 0.1 mg/ml Injectable Solution in Pre-filled Syringe

Introduction

Leaflet: Information for the user

ATROPINE SULFATE AGUETTANT 0.1mg/ml, injectable solution in a pre-filled syringe

Atropine Sulfate

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The name of this medicine is Atropine Aguettant 0.1 mg/ml injectable solution in a pre-filled syringe, and it will be referred to as Atropine Aguettant throughout this leaflet.

Contents of the leaflet:

1. What is Atropine Sulfate Aguettant and what is it used for
2. What you need to know before using Atropine Aguettant
3. How to use Atropine Aguettant
4. Possible side effects
5. Storage of Atropine Aguettant
6. Package contents and additional information

1. What is Atropine Aguettant and what is it used for

Atropine belongs to a class 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 cases of poisoning by organophosphorus insecticides or nerve gas, for example, and for cases of mushroom poisoning.

It can be used as part of the pre-medication before general anesthesia. It can also be used to prevent the side effects of other medications used to counteract the effects of muscle relaxants after surgery.

Atropine 0.1 mg/ml injectable solution in a pre-filled syringe is used to treat adults and children from birth with a body weight over 3 kg.

2. What you need to know before using Atropine Aguettant

Do not use Atropine Aguettant:

• if you are allergic (hypersensitive) to atropine or any of the other components of this medicine (listed in section 6);
• if you have urinary problems;
• if you have high pressure in the eye (glaucoma);
• if you suffer from esophageal disease (esophageal achalasia), intestinal blockage (paralytic ileus), or a form of acute colonic distension (toxic megacolon).

These contraindications do not apply in cases of potentially life-threatening emergencies.

Warnings and precautions

Consult your doctor before starting to use Atropine Aguettant if you suffer from:

• hyperthyroidism;
• prostate disease;
• heart failure;
• liver or kidney disease;
• certain heart diseases;
• stomach disease, such as pyloric stenosis;
• chronic bronchitis;
• fever;
• if you are a child or an elderly person;
• severe myasthenia (severe muscle weakness);\li>
• heartburn (reflux).

Using Atropine Aguettant with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine:

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

Pregnancy and breastfeeding

Pregnancy

Limited data on the use of atropine in pregnant women indicate that there are no adverse effects on pregnancy or fetal health. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or at term may cause a faster heart rate in the fetus and mother. This medicine should only be administered during pregnancy after careful consideration of the benefits and risks of treatment.

Breastfeeding

Small amounts of atropine may pass into breast milk and have effects on the infant. Atropine may inhibit milk production. Your doctor will weigh the benefits of breastfeeding against the benefits of treatment. If treatment is to be continued, breastfeeding should be interrupted. However, if breastfeeding is to be continued during treatment, your doctor will perform additional tests on the infant.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The injection of atropine can cause confusion or blurred vision. You should not drive or operate machinery after receiving an injection.

Atropine Aguettant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to use Atropine Aguettant

Your doctor will decide the correct dose for you and how and when the injection will be administered. If in doubt, consult your doctor again.

The recommended dose is:

As pre-medication before anesthesia

Intravenous (IV) administration immediately before surgery; if necessary, intramuscular administration 30-60 minutes before the operation.

Adults: 0.3-0.6 mg IV

Children: 0.01-0.02 mg/kg, adjusting the dose according to the patient's response and tolerance (maximum 0.6 mg per dose).

To counteract the effects of muscle relaxants:

Adults: 0.6-1.2 mg IV with neostigmine.

Children: 0.02 mg/kg IV

In case of low heart rate, heart block, or cardiac arrest:

Adults:

• Sinus bradycardia (low pulse rate): 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
• AV block (blockage of the transmission of contraction between the atrium and ventricle): 0.5 mg IV, every 3-5 minutes (maximum 3 mg).

Children: 0.02 mg/kg IV in a single dose (maximum dose 0.6 mg).

As an antidote for organophosphate poisoning (insecticides or nerve gas), anticholinesterases, or muscarinic mushroom poisoning:

Adults: 0.5-2 mg IV, may be repeated after 5 minutes and then every 10-15 minutes as needed.

Children: 0.02 mg/kg, may be repeated several times until the signs and symptoms disappear.

Other forms of this medicine may be more suitable if a dose higher than 0.5 mg is needed.

Use in children

Atropine is used to treat children from birth with a weight over 3 kg.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

This injection will be administered by a doctor or nurse, so it is unlikely that you will receive an excessive amount of atropine. If you think you have been given too much atropine, feel that your heart is beating very fast, breathe rapidly, have a high fever, feel restless, confused, have hallucinations, or lose coordination, you should inform the person who administered 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 you receive and usually disappear when treatment is stopped.

Rarely, an allergic reaction may occur. This can cause skin rashes, intense itching, skin peeling, swelling of the face (especially around the lips and eyes), throat tightness, and difficulty breathing or swallowing, fever, dehydration, shock, and fainting. All these are very serious side effects. Tell your doctor immediately if you experience any of these side effects. You may need urgent medical attention.

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

• visual disturbances (pupil dilation, difficulty focusing, blurred vision, light intolerance);
• reduced bronchial secretion;
• dry mouth (difficulty swallowing and speaking, feeling of thirst);
• constipation and heartburn (reflux);
• reduced gastric acid secretion;
• loss of taste;
• nausea;
• vomiting;
• feeling of bloating;
• absence of sweating;
• dry skin;
• rash;
• eruption.

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

• excitement (especially with higher doses);
• loss of coordination (especially with higher doses);
• confusion (especially with higher doses);
• hallucinations (especially with higher doses),
• excessive temperature;
• certain heart disorders (fast heart rate, irregular heart rate, temporary slowing of the heart rate);
• 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 (convulsions);
• drowsiness.

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

• severe allergic reaction;
• irregular heart rate, including ventricular fibrillation;
• chest pain;
• peak in blood pressure.

Frequency not known (cannot be estimated from available data)

• headache;
• restlessness;
• unstable gait and balance problems;
• insomnia.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atropine Aguettant

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton, syringe, and blister. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Atropine Aguettant

• The active ingredient is Atropine Sulfate:

Each ml of injectable solution contains 0.1 mg of Atropine Sulfate monohydrate, which is equivalent to 0.083 mg of atropine.

Each 5 ml syringe contains 0.5 mg of Atropine Sulfate monohydrate, which is equivalent to 0.415 mg of atropine.

• The other ingredients are:

Sodium chloride, concentrated hydrochloric acid (for pH adjustment), water for injectable preparations.

Appearance of the product Atropine Aguettant and package contents.

This medicine is a clear, colorless injectable solution in a 5 ml pre-filled polypropylene syringe.

Packs of 10, 12, and 20 syringes.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATOIRE AGUETTANT

1, RUE ALEXANDER FLEMING

69007 LYON

FRANCE

Manufacturer:

LABORATOIRE AGUETTANT

1, rue Alexander Fleming

69007 LYON

France

LABORATOIRE AGUETTANT

Lieu-Dit “Chantecaille ”

07340 CHAMPAGNE

France

Date of last revision of this leaflet: December 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS). http//www.aemps.gob.es

This information is intended only for healthcare professionals:

The pre-filled syringe is intended for a single patient. Discard the syringe after use. Do not reuse.

The contents of the unopened and intact blister are sterile and should not be opened until use.

The product should be visually inspected for particles and discoloration before administration. Only the clear, colorless solution without particles or precipitates should be used.

The product should not be used if the security seal of the syringe (plastic cover up to the tip cap) is broken.

The outer surface of the syringe is sterile until the blister is opened.

1. Remove the pre-filled syringe from the sterile blister.

1. Push the plunger to release the stopper.

1. Twist the tip cap to remove it and break the seal.

1. Check that the syringe seal (plastic cover up to the tip cap and seal under the tip cap) has been completely removed. If not, replace the cap and twist it again.

1. Remove the air by gently pushing the plunger.

1. Connect the syringe to the vascular access device or needle. Push the plunger to inject the necessary volume.

The needle size required to use with the syringe is 23-20 gauge for IV administration and 23-21 gauge for IM administration.