Leaflet: Information for the user

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

Atropine Sulfate

Read this leaflet carefully before you start using this medicine because 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 for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

·If you experience any 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 0.1mg/ml pre-filled syringe injectable solution, which will be referred to as Atropine Aguettant throughout this leaflet.

1.What isAtropine Sulfate Aguettantand what is it used for

2.What you need to know before starting to useAtropine Aguettant

3.How to useAtropine Aguettant

4.Possible side effects

5.Storage ofAtropine Aguettant

6. Contents of the pack and additional information

Atropine belongs to a class of medications known as anticholinergics. An anticholinergic is a substance that blocks the neurotransmitter acetylcholine in the central and peripheral nervous systems. It is used in emergency situations, when the heart beats too slowly, as an antidote for cases of organophosphate insecticide poisoning or neurotoxic gas, for example, and for cases of poisoning due to mushroom consumption.

It may be used as part of pre-anesthetic medication.It can also be used to prevent the side effects of other medications used to counteract the effects of muscle relaxants after a surgical procedure.

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

No use Atropina Aguettant:

·if you are allergic (hypersensitive) to atropine or to any of the other ingredients of this medicine (listed in section 6);

·you have urinary problems;

·you have high eye pressure (glaucoma);

·you have esophageal disease (achalasia of the esophagus), 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 useAtropina Aguettantif you suffer from:

·hyperthyroidism;

·prostatic disease;

·heart failure;

·liver or kidney disease;

·some heart diseases;

·stomach disease, such as pyloric stenosis;

·chronic bronchitis;

·fever;

·if you are a child or an elderly person;

·myasthenia gravis (severe muscle weakness);

·heartburn (reflux).

Use of Atropina Aguettant with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medicine:

·tricyclic antidepressants;

·some antihistamines;

·medicines for Parkinson's disease;

·phenothiazine, clozapine or neuroleptic drugs (for mental illnesses);

·quinidine or disopyramide (for heart diseases);

·spasmolytics (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 the mother. This medicine should only be administered during pregnancy after carefully considering the benefits and risks of treatment.

Breastfeeding

Small amounts of atropine may pass into breast milk and affect the infant. Atropine may inhibit milk production. Your doctor will evaluate the benefit of breastfeeding against the benefit of treatment. If you decide to continue treatment, you should stop breastfeeding. However, if you decide to continue breastfeeding during treatment, your doctor will perform additional investigations on the infant.

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

Driving and operating machinery

The injection of atropine may cause confusion or blurred vision. Do not drive or operate machinery after receiving an injection.

Atropina Aguettant contains sodium

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

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

The recommended dose is:

As pre-anesthetic medication

Immediate intravenous (IV) administration before a surgical procedure; if necessary, intramuscular administration 30-60 minutes before the operation is possible.
Adults: 0.3-0.6mg IV

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

To counteract the effects of muscle relaxants:

Adults: 0.6-1.2mg IV with neostigmine.

Children: 0.02mg/kg IV

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

Adults:

- Sinus bradycardia (low heart rate): 0.5mg IV, every 2-5minutes until the desired heart rate is achieved.

- AV block (blockage of transmission between the atrium and ventricle): 0.5mg IV, every 3-5minutes (maximum 3mg).

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

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

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

Children: 0.02mg/kg, may be repeated several times until the disappearance of symptoms.

It is possible that other forms of this medication may be more suitable if a dose greater than 0.5mg is needed.

Use in children

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

If you have any other questions about the use of this medication, 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 believe you have received an excessive amount of atropine, feel that your heart is racing, breathe quickly, have a high fever, feel restless, confused, have hallucinations or lose coordination, inform the person who administered the injection.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects depend on the dose you receive and usually disappear with the interruption of treatment.

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 constriction, and difficulty breathing or swallowing, fever, dehydration, shock, and fainting. All of these are very serious side effects. Inform your doctor immediately if you experience any of these side effects. You may need urgent medical attention.

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

·visual disturbances (pupil dilation, difficulty focusing, blurry 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;

·skin dryness;

·hives;

·eruption.

Common side effects (that 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 problems (rapid heartbeat, irregular heartbeat, temporary slowing of the heartbeat);

·redness;

·difficulty urinating.

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

·psychotic reactions.

Rare side effects (that may affect up to 1 in 1000 people)

·allergic reactions;

·seizures (convulsions);

·drowsiness.

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

·severe allergic reaction;

·irregular heartbeat, including ventricular fibrillation;

·chest pain;

·spike in blood pressure.

Unknown frequency (cannot be estimated from available data)

·headache;

·restlessness;

·unstable gait and balance problems;

·insomnia.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.Also, you can report side effects through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, syringe, and blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Atropine Aguettant Composition

-The active ingredient is Atropine Sulfate:

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

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

-The other components are:

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

Appearance of the Atropine Aguettant product and contents of the packaging.

This medicine is a transparent and colorless injectable solution in a preloaded syringe of 5ml.

Boxes of 10, 12, and 20 syringes.

It is possible that not all sizes will be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder :

Laboratoire Aguettant

1, Rue Alexander Fleming

69007 Lyon

France

Responsible manufacturer:

Laboratoire Aguettant

1, rue Alexander Fleming

69007Lyon

France

Laboratoire Aguettant

Lieu-Dit “Chantecaille ”

07340 Champagne

France

Last review date of this leaflet: December 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS). http//www.aemps.gob.es

This information is intended solely for healthcare professionals:

The preloaded syringe is intended for a single patient. Dispose of the syringe after use. Do not reuse.

The unopened and intact blister pack contents are sterile and should not be opened until it is to be used.

The product should be visually inspected to detect particles and discoloration before administration. Only use the transparent, colorless, and particle-free solution.

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

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

1) Remove the preloaded syringe from the sterile blister.

2)Push the plunger to release the stopper.

3)Turn the tip cap to remove it and break the seal.

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

5)Remove the air by gently pushing the plunger.

6) Connect the syringe to the vascular access device or needle. Push the plunger to inject the required volume.

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