Prospect: information for the user

ATROPINE AGUETTANT 0.2mg/ml, injectable solution in pre-filled syringe

Atropine, sulfate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

The name of this medication is Atropine Aguettant 0.2mg/ml injectable solution in pre-filled syringe, which will be referred to as Atropine Aguettant throughout this prospect.

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

2. What you need to know before starting to use Atropine Aguettant

3. How to use Atropine Aguettant

4. Possible adverse effects

5. Storage of Atropine Aguettant

6. Contents of the package 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.

Atropina Aguettant 0.2 mg/ml injectable solution in pre-filled syringe is used to treat only adults.

No use Atropina Aguettant:

• if you are allergic (hypersensitive) to atropine or to any of the other components of this medication (listed in section 6);
• have urinary problems;
• have high pressure in the eye (glaucoma);
• have esophageal disease (achalasia of the esophagus), intestinal blockage (paralytic ileus) or acute 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 have:

• hyperthyroidism;
• prostatic disease;
• heart failure;
• liver or kidney disease;
• some heart diseases;
• stomach disease, such as pyloric stenosis;
• chronic bronchitis;
• fever;
• if you are an elderly person;
• myasthenia gravis (severe muscle weakness);
• heartburn (reflux).

Use of Atropina Aguettant with other medications

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

• tricyclic antidepressants;
• some antihistamines;
• medications 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 medication 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 treatment is decided, breastfeeding should be interrupted. However, if treatment is decided to continue, your doctor will perform additional examinations on the infant.

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

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 medication contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

Your doctor will decide on the correct dose for you and how and when the injection will be administered.

The recommended dose is:

As pre-anesthetic medication

Adults: 0.3-0.6mg via intravenous injection immediately before anesthesia induction or 0.3-0.6 mg via intramuscular injection, 30-60 minutes before anesthesia.

To reverse the effects of muscle relaxants:

Adults: 0.6-1.2mg via intravenous injection with neostigmina.

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

Adults:

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

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

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

Adults: 0.5-2 mg depending on the patient's characteristics and response, may be repeated after 5 minutes and as needed.

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 beating very fast, breathe rapidly, have a high fever, feel restless, confused, have hallucinations, or lose coordination, inform the person who administered the injection.

Like all medicines, this medicine may 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.

Very 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, blurred vision, light intolerance);
• 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;
• Sensation of swelling;
• Lack of sweating;
• Dry skin;
• Rashes;
• Exanthema.

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 cardiac disorders (rapid heartbeat, irregular heartbeat, temporary slowing of heartbeat);
• Redness;
• Difficulty urinating.

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

• Psychotic reactions.

Rare side effects (that may affect up to 1 in 1,000 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;
• Sharp increase 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also 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 in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Atropine Aguettant

• The active principle is Atropine sulfate:

Each ml of injectable solution contains 0.2mg of atropine sulfate monohydrate, which is equivalent to 0.17mg of atropine.

Each syringe of 5ml contains 1mg of atropine sulfate monohydrate, which is equivalent to 0.83mg 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 sterile polypropylene syringe of 5ml.

Boxes of 1, 5, 10, 12, and 20 syringes.

Only some packaging sizes may be commercially 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 69007 LYON

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 pre-filled 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 use.

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 on the tip cap) is broken.

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

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