Atropine Aguettant 0.1 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ATROPINE SULFATE AGUETTANT 0.1 mg/ml, solution for injection in pre-filled syringe

Atropine Sulfate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

The name of this medicine is Atropina Aguettant 0.1 mg/ml solution for injection in pre-filled syringe; it will be referred to as Atropina Aguettant throughout this leaflet.

Leaflet contents:

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

1. What Atropina Aguettant is and what it is 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 systems. It is used in emergency situations when the heart beats too slowly, as an antidote in cases of poisoning by organophosphorus insecticides or neurotoxic gases, for example, and in mushroom poisoning.

It may be used as part of premedication prior to general anesthesia. It may also be used to prevent the side effects of other drugs used to reverse the effects of muscle relaxants after surgery.

Atropine 0.1 mg/ml solution for injection in a pre-filled syringe is used to treat adults and children from birth onwards who have a body weight above 3 kg.

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

Do not use Atropina Aguettant:

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

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

Warnings and precautions

Consult your doctor before using Atropina Aguettant if you have:

• 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 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 recently taken, or might need to 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);
• spasmolytics (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 increased heart rate in both the fetus and the 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 may affect the infant. Atropine may inhibit breast milk production. Your doctor will weigh the benefits of breastfeeding against the benefits of treatment. If treatment is continued, breastfeeding should be discontinued. However, if breastfeeding is maintained during treatment, your doctor will perform additional monitoring of 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 use of machines

Atropine injection may cause confusion or blurred vision. You should 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, i.e., essentially "sodium-free".

3. How to use Atropina 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-anesthetic medication

Intravenous (IV) administration immediately before a surgical procedure; 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 reverse 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, cardiac 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 (impaired conduction of the heartbeat from atria to ventricles): 0.5 mg IV, every 3–5 minutes (maximum 3 mg).

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

As an antidote in organophosphate poisoning (insecticides or nerve gas), anticholinesterase poisoning, or muscarinic mushroom poisoning:

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

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

Other formulations of this 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 onwards, provided they weigh more than 3 kg.

If you have any further 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. However, if you think you have been given too much atropine and experience a very fast heartbeat, rapid breathing, high fever, restlessness, confusion, hallucinations, or loss of coordination, inform the person who administered the injection immediately.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects depend on the dose received and usually disappear when treatment is discontinued.

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

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

• visual disturbances (pupil dilation, difficulty focusing, blurred vision, light sensitivity);
• 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;
• bloating sensation;
• absence of sweating;
• dry skin;
• hives;
• rash.

Common adverse 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);
• elevated body temperature;
• certain cardiac disorders (rapid heartbeat, irregular heartbeat, temporary slowing of heartbeat);
• flushing;
• difficulty urinating.

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

• psychotic reactions.

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

• allergic reactions;
• epileptic seizures (convulsions);
• drowsiness.

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

• severe allergic reaction;
• irregular heartbeat, including ventricular fibrillation;
• chest pain;
• spike in blood pressure.

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report side effects via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the carton, syringe, and blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atropina Aguettant

• 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 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 (for pH adjustment), water for injections.

Appearance of the medicinal product Atropina Aguettant and contents of the pack

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

Cartons containing 10, 12 or 20 syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: December 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es

This information is intended for healthcare professionals only:

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

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

The product should be visually inspected for particles and discoloration prior to administration. Only clear, colourless solutions free from particles or precipitates should be used.

The product must not be used if the syringe's security seal (plastic covering up to the tip cap) is broken.

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

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

1. Push the plunger to release the stopper.

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

3. Check that the syringe seal (plastic covering up to the tip stopper and seal under the tip cap) has been completely removed. If not, reattach the cap and twist again.

4. Expel air by gently pushing the plunger.

5. Attach the syringe to a vascular access device or needle. Push the plunger to inject the required volume.

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