Prospect: Information for the User

Atropina Accord 0.1 mg/ml Injectable Solution in Pre-filled Syringe

Atropine Sulfate

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Atropina belongs to a class of medications 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 for cases of organophosphate insecticide poisoning or neurotoxic gas, for example, and for cases of poisoning due to consumption of mushrooms.

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

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

No use Atropina Accord:

• if you are allergic (hypersensitive) to atropine or to any of the other components of this medication (listed in section 6);
• if you have urinary problems;
• if you have high eye pressure (glaucoma);
• if you suffer from 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 use Atropina Accord if you suffer from:

· hyperthyroidism;

· prostate 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).

Other Medications Atropina Accord

Inform your doctor or pharmacist if you are taking, have recently taken 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 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 Machines

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

Atropina Accord contains sodium

In each 5 ml syringe, this medication contains less than 23 mg of sodium (1 mmol) per preloaded syringe, which is essentially "sodium-free".

In each 10 ml syringe, this medication contains 35.4 mg of sodium (main component of table salt/for cooking) per preloaded syringe. This is equivalent to 1.77% of the recommended daily maximum sodium intake for an adult.

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

The usual 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: 0.3-0.6 mg IV

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

To counteract the effects of muscle relaxants:

Adults: 0.6-1.2 mg IV with neostigmine.

Children: 0.02 mg/kg IV

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

Adults:

• Bradycardia (low heart rate): 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
• AV block (blockage of transmission between the atrium and ventricle): 0.5 mg IV, every 3-5 minutes (maximum 3 mg).

Children:

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

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

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

Children: 0.02 mg/kg, which can be repeated several times until symptoms disappear.

Other forms of this medication may be more suitable if a dose greater than 0.5 mg is needed.

Use in children

Atropine is used to treat children from birth with a weight of over 3 kg.

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, and you feel your heart is racing, you are breathing 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 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.

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;
• Peak in blood pressure.

Unknown frequency (cannot be estimated from available data)

• Headache;
• Restlessness;
• Unstable gait and balance problems;
• Insomnia.

Reporting of 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 the Spanish 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. By doing so, you will help protect the environment.

Composition of Atropina Accord

The active ingredient is Atropine Sulfate: Each milliliter of injectable solution contains 0.1 mg of atropine sulfate monohydrate, which is equivalent to 0.083 mg of atropine.

Each 5 mL syringe contains 0.5 mg of atropine sulfate monohydrate, which is equivalent to 0.415 mg of atropine.

Each 10 mL syringe contains 1 mg of atropine sulfate monohydrate, which is equivalent to 0.83 mg of atropine.

The other components are: Sodium chloride, concentrated hydrochloric acid (for pH adjustment), water for injection.

Appearance of the product and contents of the package.

This medication is a transparent and colorless solution free of visible particles in a preloaded glass syringe.

Preloaded glass syringe (transparent type I glass) of 5 mL with stopper, stopper plug (bromobutyl rubber) and plunger rod (polypropylene). The syringe body has graduations of 0.5 mL, from 0 mL to 5 mL.

Preloaded glass syringe (transparent type I glass) of 10 mL with stopper, stopper plug (bromobutyl rubber) and plunger rod (polypropylene). The syringe body has graduations of 1 mL, from 0 mL to 10 mL.

The preloaded syringe is supplied without needle, packaged in an outer box.

Atropina Accord is supplied in boxes of 1 preloaded syringe.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor

08039 Barcelona.

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Pharmadox Healthcare Ltd.

KW20A

Kordin Industrial Park,

Paola, PLA3000, Malta

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Last review date of this leaflet: September 2020

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

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

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

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.