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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Atropina Accord 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Atropine belongs to a class of medicines known as anticholinergics. An anticholinergic is a substance 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 in cases of poisoning by organophosphorus insecticides or nerve gas, for example, and in cases of poisoning due to mushroom ingestion.

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

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

2. What you need to know before using Atropina Accord

Do not use Atropina Accord:

• if you are allergic (hypersensitive) to atropine or to any of the other ingredients 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 life-threatening emergencies.

Warnings and precautions

Consult your doctor before using Atropina Accord 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).

Other medicines and Atropina Accord

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 breast-feeding

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.

Breast-feeding

Small amounts of atropine may pass into breast milk and affect the infant. Atropine may inhibit breast milk production. Your doctor will assess the benefit of breast-feeding against the benefit of treatment. If treatment is maintained, breast-feeding should be discontinued. However, if breast-feeding is continued during treatment, your doctor will perform additional examinations on the infant.

If you are pregnant or breast-feeding, 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 Accord contains sodium

Each 5 ml pre-filled syringe of this medicine contains less than 23 mg of sodium (1 mmol) per pre-filled syringe, which is essentially "sodium-free".

Each 10 ml pre-filled syringe of this medicine contains 35.4 mg of sodium (main component of table/cooking salt) per pre-filled syringe. This corresponds to 1.77% of the maximum daily recommended sodium intake for an adult.

3. How to use Atropine Accord

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 usual dose is:

As premedication prior to anaesthesia

Intravenous (IV) administration immediately before surgery; if necessary, intramuscular administration may be used 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 patient 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 (block of contraction transmission between 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 dose 0.6 mg).

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

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

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 is 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. If you think you have been given too much atropine and experience symptoms such as very rapid heartbeat, fast 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 can cause adverse effects, although not everyone will experience them.

Adverse effects depend on the dose you receive and usually disappear when treatment is stopped.

A rare allergic reaction may occur. This can cause skin rashes, intense itching, skin peeling, swelling of the face (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 (dilation of the pupils, 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);
• increased body temperature;
• certain cardiac disorders (fast 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 Accord

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 there are 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 once they are no longer needed. This will help protect the environment.

6. Contents of the container and additional information

Composition of Atropine Accord

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 pre-filled syringe contains 0.5 mg of atropine sulfate monohydrate, equivalent to 0.415 mg of atropine.

Each 10 ml pre-filled syringe contains 1 mg of atropine sulfate monohydrate, equivalent to 0.83 mg of atropine.

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

Appearance of the medicinal product and contents of the container

This medicine is a clear, colourless solution free from visible particles in a glass pre-filled syringe.

Clear glass pre-filled syringe (clear type I glass) of 5 ml with closure, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). The syringe barrel has 0.5 mL graduations from 0 mL to 5 mL.

Clear glass pre-filled syringe (clear type I glass) of 10 ml with closure, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). The syringe barrel has 1 mL graduations from 0 mL to 10 mL.

The pre-filled syringe is supplied without a needle, packaged in an outer carton.

Atropine Accord is supplied in packs of 1 pre-filled syringe.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor

08039 Barcelona, Spain

Manufacturer

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

or

Accord Healthcare single member S.A.

64th Km National Road Athens, Lamia, Schimatari, 32009, Greece

Date of the most recent revision of this summary: September 2020

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

This information is intended for healthcare professionals only:

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

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

The needle size required for use with the syringe is gauge 23–20 for IV administration and gauge 23–21 for IM administration.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.