Package leaflet: Information for the patient

Atropine Accord, 0.1 mg/ml, solution for injection in pre-filled syringe
Atropini sulfas
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same as yours.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Atropine Accord is and what it is used for
Important information before using Atropine Accord
How to use Atropine Accord
Possible side effects
How to store Atropine Accord
Contents of the pack and other information

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

Atropine belongs to a group of medicines called anticholinergics. An anticholinergic agent 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 example, in poisoning with organophosphorus insecticides, nerve agents affecting the nervous system, or mushrooms. Atropine may also be used as part of premedication prior to general anesthesia. It may also be used to prevent adverse 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, provided their body weight is 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 passing urine;
if the patient has increased eye pressure (glaucoma);
if the patient has oesophageal disease (oesophageal achalasia), intestinal obstruction (paralytic ileus) or acute dilatation of the colon (toxic megacolon).

However, none of these contraindications apply in life-threatening situations.
Warnings and precautions
Before starting treatment with Atropine Accord, consult a doctor if the patient has:

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

Atropine Accord and other medicines
Tell the doctor about all medicines currently used or recently used by the patient,
as well as any medicines the patient plans to use:

tricyclic antidepressants,
certain antihistamines,
medicines for Parkinson's disease,
phenothiazines, clozapine, neuroleptic medicines (for mental disorders),
quinidine or disopyramide (used in heart diseases),
antispasmodic medicines (in irritable bowel syndrome).

Pregnancy and breastfeeding
Pregnancy
Limited data on the use of atropine in pregnant women indicate no adverse effects of atropine on pregnancy or fetal health. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or childbirth may cause increased heart rate in both fetus and mother. This medicine may be used during pregnancy only after careful consideration of the benefit-risk ratio.
Breastfeeding
Small amounts of atropine may pass into breast milk and may affect the infant. 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 monitoring of the infant.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
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 (main component of table salt) in each 5 ml pre-filled syringe, corresponding to 0.885% of the maximum recommended daily dietary sodium intake for adults.
The 10 ml syringe contains 35.4 mg of sodium, corresponding to 1.77% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Atropine Accord

The doctor will decide the appropriate dose for the patient and when and how the injection should be administered.
Typical doses are as follows:
Premedication prior to anaesthesia
Intravenous administration ( i.v. ) immediately before surgery; if necessary, intramuscular administration may be given 30–60 minutes before surgery.
Adults: 0.3–0.6 mg intravenously.
Children and adolescents: 0.01–0.02 mg/kg; dosage should be adjusted according to patient 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 (impaired conduction of impulses from the atria to the ventricles): 0.5 mg intravenously every 3–5 minutes (maximum 3 mg).
Children and adolescents: 0.02 mg/kg as a single intravenous dose (maximum dose 0.6 mg).
As an antidote in cases of poisoning with organophosphorus compounds (pesticides, nerve agents), cholinesterase inhibitors, and muscarine-containing mushrooms
Adults: 0.5–2 mg intravenously; may be repeated after 5 minutes, then if necessary every 10–15 minutes.
Children and adolescents: 0.02 mg/kg; may be repeated several times until subjective and objective symptoms resolve.
In cases where doses above 5 mg are required, other pharmaceutical forms may be more appropriate.
Children and adolescents
Atropine may be used in the treatment of children from birth onwards, provided body weight is above 3 kg.
If you have any further questions regarding the use of this medicine, please 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 high a dose of atropine. However, if the patient is concerned that they have received too high a dose of atropine and experiences very rapid heartbeat, fast breathing, high body temperature, restlessness, disorientation, hallucinations, or loss of coordination, they should inform the person who administered the injection immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects are dose-dependent and usually resolve after discontinuation of treatment.
Rarely, an allergic reaction may occur, which can cause skin rash, severe itching,
peeling of the skin, swelling of the face (especially around the mouth and eyes), tightness in the throat, and difficulty
breathing or swallowing, fever, dehydration, shock, and fainting. These are very serious
side effects. If any of these side effects occur, a doctor should be informed immediately.
The patient may require urgent medical attention.

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

visual disturbances (dilated pupils, difficulty focusing, blurred vision, photophobia),
reduced bronchial secretions,
dry mouth (difficulty swallowing and speaking, sensation of thirst),
constipation and heartburn (reflux),
reduced gastric acid secretion,
loss of taste,
nausea,
vomiting,
bloating,
absence of sweating,
dry skin,
urticaria,
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 (particularly at higher doses),
overheating of the body,
certain heart conditions (fast heartbeat, irregular heartbeat, transient further slowing of heartbeat),
flushing,
difficulty in urination.

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 heartbeat, including ventricular fibrillation,
chest pain,
sudden change in blood pressure.

Unknown frequency (cannot be estimated from the available data):

headache,
anxiety,
unsteady gait and balance problems,
insomnia.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor or nurse.
Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Atropine Accord

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, syringe,
and blister pack. The expiry date refers to the last day of the stated 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. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Atropine Accord contains
The active substance is atropine sulfate: Each ml of injection solution contains 0.1 mg of monohydrate atropine sulfate, equivalent to 0.083 mg of atropine.
Each 5 ml pre-filled syringe contains 0.5 mg of monohydrate atropine sulfate, equivalent to 0.415 mg of atropine.
Each 10 ml pre-filled syringe contains 1 mg of monohydrate atropine sulfate, equivalent to 0.83 mg of atropine.
The other ingredients are sodium chloride, sulfuric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Atropine Accord looks like and contents of the pack
Atropine Accord is a clear, colourless solution free from visible particles, contained in a transparent Type I glass pre-filled syringe.
The 5 ml pre-filled syringe made of colourless Type I glass with a tip cap, equipped with a plunger stopper made of bromobutyl rubber and a plunger rod made of polypropylene, graduated every 0.5 ml from 0 ml to 5 ml.
The 10 ml pre-filled syringe made of colourless Type I glass with a tip cap, equipped with a plunger stopper made of bromobutyl rubber and a plunger rod made of polypropylene, graduated every 1 ml from 0 ml to 10 ml.
The pre-filled syringe is supplied without a needle and packaged in an outer carton.
Atropine Accord is available in packs containing 1 pre-filled syringe.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
ul. 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

The following information is intended exclusively for healthcare professionals:
The pre-filled syringe is intended for single patient use only. After use, the syringe must be discarded. DO NOT RE-USE.
Before administration, inspect the solution for particulate matter and discoloration. Only use clear, colourless solutions free from particles or precipitates.
Suitable needle sizes for use with the syringe are 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.