Atropine Accord

Leaflet accompanying the packaging: patient information

Atropine Accord, 0.1 mg/ml, solution for injection in a pre-filled syringe

Atropine sulfate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Atropine Accord and what is it used for
• 2. Important information before using Atropine Accord
• 3. How to use Atropine Accord
• 4. Possible side effects
• 5. How to store Atropine Accord
• 6. Contents of the packaging and other information

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

Atropine belongs to a group of medicines called anticholinergics. An anticholinergic substance is one 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, for poisoning with organophosphorus insecticides, nerve-acting gases, and mushrooms. The medicine may be used as part of premedication before general anesthesia. It may also be used to prevent unwanted effects of other medicines used to reverse the action of muscle relaxants after surgery. Atropine Accord is indicated for use in adults and children from birth, but with a body weight above 3 kg.

2. Important information before using Atropine Accord

When not to use Atropine Accord:

• if the patient is allergic to atropine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has problems with urination;
• if the patient has increased eye pressure (glaucoma);
• if the patient has esophageal disease (achalasia of the esophagus), intestinal obstruction (paralytic ileus), or acute colonic dilation (toxic megacolon).

However, these contraindications do not apply in life-threatening situations.

Warnings and precautions

Before starting treatment with Atropine Accord, the patient should discuss it with their doctor if they have:

• hyperthyroidism,
• prostate disease,
• heart failure,
• liver or kidney disease,
• certain heart diseases,
• stomach diseases, such as pyloric stenosis,
• chronic bronchitis,
• fever,
• if the patient is a child or elderly,
• myasthenia (severe muscle weakness),
• gastroesophageal reflux disease (GERD).

Atropine Accord and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• tricyclic antidepressants,
• certain antihistamines,
• medicines for Parkinson's disease,
• phenothiazine, clozapine, neuroleptics (for mental illnesses),
• quinidine or disopyramide (used for heart diseases),
• antispasmodic medicines (for irritable bowel syndrome).

Pregnancy and breastfeeding

Pregnancy
Limited data on the use of atropine in pregnant women indicate no adverse effect of atropine on pregnancy or fetal health. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or childbirth may cause rapid heart rate in the fetus and mother. This medicine should only be used during pregnancy after careful consideration of the benefit-to-risk ratio.
Breastfeeding
Small amounts of atropine may pass into breast milk and may affect the baby. Atropine may inhibit milk production. The doctor will weigh the benefits of breastfeeding against the benefits of treatment. If the decision is made to continue treatment, breastfeeding should be discontinued. However, if the decision is made to continue breastfeeding during treatment, the doctor will perform additional tests on the baby.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Atropine may cause disorientation or blurred vision. Patients should not drive or operate machinery after receiving an injection.

Atropine Accord contains sodium

The medicine contains 17.7 mg of sodium (the main component of common salt) in each 5 ml pre-filled syringe, which corresponds to 0.885% of the maximum recommended daily intake of sodium in the diet for adults. A 10 ml syringe contains 35.4 mg of sodium, which corresponds to 1.77% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Atropine Accord

The doctor will decide what dose is suitable for the patient and how and when the injection will be administered. The usual doses are as follows:
Pre-medication before anesthesia
Intravenous administration directly before surgery; if necessary, intramuscular administration 30-60 minutes before surgery.
Adults: 0.3-0.6 mg intravenously.
Children and adolescents: 0.01-0.02 mg/kg; the dose should be adjusted according to the patient's response and tolerance (maximum 0.6 mg per dose).
Reversal of muscle relaxant effects
Adults: 0.6-1.2 mg intravenously in combination with neostigmine.
Children and adolescents: 0.02 mg/kg intravenously.
Slow heart rate, heart block, cardiac arrest
Adults:

• Sinus bradycardia (slow heart rate): 0.5 mg intravenously every 2-5 minutes until the desired heart rate is achieved.
• Atrioventricular block (blockage of conduction between the atria and ventricles): 0.5 mg intravenously every 3-5 minutes (maximum 3 mg).

Children and adolescents: 0.02 mg/kg intravenously in a single dose (maximum dose 0.6 mg).
As an antidote in case of poisoning with organophosphorus compounds (pesticides, nerve-acting gases), cholinesterase inhibitors, and mushrooms containing muscarine
Adults: 0.5-2 mg intravenously; may be repeated after 5 minutes and then every 10-15 minutes if necessary.
Children and adolescents: 0.02 mg/kg; may be repeated several times until symptoms subside.
In cases where a dose above 5 mg is required, other pharmaceutical forms may be more suitable.
Children and adolescents
Atropine is used to treat children from birth with a body weight above 3 kg.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
This injection will be administered by a doctor or nurse, so it is unlikely that the patient will receive too much atropine. If the patient is concerned that they have received too much atropine, feels a very rapid heart rate, rapid breathing, high temperature, anxiety, disorientation, hallucinations, or loss of coordination, they should inform the person who administered the injection.

4. Possible side effects

Like all medicines, Atropine Accord can cause side effects, although not everybody gets them. Side effects are dose-dependent and usually disappear after treatment is discontinued. Rarely, an allergic reaction may occur, which can cause skin rash, severe itching, skin peeling, facial swelling (especially around the mouth and eyes), throat constriction, and difficulty breathing or swallowing, fever, dehydration, shock, and fainting. These are very serious side effects. If any of these side effects occur, the patient should immediately inform their doctor. The patient may need urgent medical attention.
Very common side effects (may affect more than 1 in 10 people)

• vision disturbances (pupil dilation, difficulty focusing, blurred vision, photophobia),
• decreased bronchial secretions,
• dry mouth (difficulty swallowing and speaking, feeling of thirst),
• constipation and gastroesophageal reflux disease (GERD),
• decreased gastric acid secretion,
• loss of taste,
• nausea,
• vomiting,
• feeling of bloating,
• lack of sweating,
• dry skin,
• hives,
• rash.

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

• excitement (especially at higher doses),
• loss of coordination (especially at higher doses),
• disorientation (especially at higher doses),
• hallucinations (especially at higher doses),
• hyperthermia,
• certain heart diseases (rapid heart rate, irregular heart rate, transient further slowing of 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 1000 people)

• allergic reactions,
• seizures,
• drowsiness.

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

• severe hypersensitivity reaction,
• irregular heart rate, including atrial fibrillation,
• chest pain,
• blood pressure spike.

Unknown frequency (cannot be estimated from the available data)

• headache,
• anxiety,
• unstable gait and balance problems,
• insomnia.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Atropine Accord

The medicine should be stored out of 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.
This medicinal product does not require any special storage conditions.
Do not use this medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atropine Accord contains

The active substance of the medicine is atropine sulfate: Each 1 ml solution for injection contains 0.1 mg of atropine sulfate monohydrate, which corresponds to 0.083 mg of atropine. Each 5 ml syringe contains 0.5 mg of atropine sulfate monohydrate, which corresponds to 0.415 mg of atropine. Each 10 ml syringe contains 1 mg of atropine sulfate monohydrate, which corresponds to 0.83 mg of atropine. The other ingredients are sodium chloride, sulfuric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Atropine Accord looks like and contents of the pack

Atropine Accord is a clear, colorless solution without visible particles in a transparent glass pre-filled syringe. The 5 ml syringe is made of colorless glass type I with a tip cap, a plug (acting as a piston) made of bromobutyl rubber, and a piston rod made of polypropylene, graduated every 0.5 ml from 0 ml to 5 ml. The 10 ml syringe is made of colorless glass type I with a tip cap, a plug (acting as a piston) made of bromobutyl rubber, and a piston rod made of polypropylene, graduated every 1 ml from 0 ml to 10 ml. The pre-filled syringe is provided without a needle, packaged in an outer carton. Atropine Accord is available in packs containing 1 pre-filled syringe.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain

Date of last revision of the leaflet: December 2023

The following information is intended for healthcare professionals only:
The pre-filled syringe is for single-patient use only. After use, the syringe should be discarded. DO NOT REUSE.
Before administration, the product should be inspected for the presence of particles and discoloration. Only a clear, colorless solution without particles or precipitates should be used.
The recommended needle size for use with the syringe is 23 to 20 G for intravenous administration and 23 to 21 G for intramuscular administration.
Any unused product or waste material should be disposed of in accordance with local requirements.