Atropine sulfate Accord

Package leaflet: Information for the patient

Atropina Solfato Accord 0.1 mg/ml, solution for injection in pre-filled syringe

atropine sulfate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Atropine belongs to a group of medicines called 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, for example, to organophosphate insecticides or in nerve gas poisoning and mushroom poisoning.
It may be used as part of premedication before general anaesthesia. It may also be used to prevent the undesirable effects of other medicines used to reverse the effects of muscle relaxants after surgical procedures.
Atropine Sulfate Accord 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 Atropine Sulphate Accord

Do not use Atropine Sulphate Accord if:

• you are allergic (hypersensitive) to atropine or to any of the other ingredients of this medicine (listed in section 6),
• you have difficulty urinating,
• you have high intraocular pressure (glaucoma),
• you have oesophageal disease (oesophageal achalasia), intestinal blockage (paralytic ileus), or acute distension of the colon (toxic megacolon).

These contraindications do not apply in life-threatening emergencies.
Warnings and precautions
Talk to your doctor before using Atropine Sulphate 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 elderly,
• myasthenia gravis (severe muscle weakness),
• heartburn (reflux).

Other medicines and Atropine Sulphate Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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),
• antispasmodic drugs (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 fetus and mother. This medicine should be administered during pregnancy only after careful assessment 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 evaluate the benefit of breastfeeding against the benefit of treatment. Breastfeeding should be discontinued if treatment is initiated. However, if breastfeeding is continued during treatment, your doctor will perform additional monitoring of the infant.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered.
Driving and using machines
Atropine injection may cause confusion or blurred vision. After receiving an injection, you must not drive or operate machinery.
Atropine Sulphate Accord contains sodium
This medicine contains 17.7 mg of sodium (a main component of table salt) in each 5 ml pre-filled syringe. This corresponds to 0.885% of the maximum daily dietary intake recommended for an adult. The 10 ml syringe contains 35.4 mg of sodium, equivalent to 1.77% of the maximum daily dietary intake recommended for an adult.

3. How to use Atropine Sulfate Accord

Your doctor will decide the correct dose for you and how and when the injection will be administered.
The usual doses are:
As premedication before 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 i.v.
Children: 0.01-0.02 mg/kg, dose adjusted 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 i.v. with neostigmine.
Children: 0.02 mg/kg i.v.
In case of slow heartbeat, heart block or cardiac arrest:
Adults:

• Sinus bradycardia (slow heartbeat): 0.5 mg i.v., every 2-5 minutes until the desired heart rate is achieved.
• Atrioventricular block (impaired conduction of electrical impulses between atria and ventricles): 0.5 mg i.v., every 3-5 minutes (maximum 3 mg).

Children: 0.02 mg/kg i.v. as a single dose (maximum dose 0.6 mg).
As an antidote in organophosphate poisoning (insecticides or nerve gases), anticholinesterase agents,
and in muscarinic mushroom poisoning:
Adults: 0.5-2 mg i.v., repeatable after 5 minutes and subsequently every 10-15 minutes as needed.
Children: 0.02 mg/kg, possibly repeated several times until signs and symptoms disappear.
Other formulations of the medicine may be more suitable if a dose higher than 1 mg is required.
Use in children
Atropine is used to treat children from birth with a body weight above 3 kg.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
The injection will be administered by a doctor or nurse; therefore, it is unlikely that you will receive
an excessive dose of atropine. If you think you have received too much atropine and experience a very
rapid heartbeat, rapid breathing, high fever, restlessness, confusion, hallucinations or loss of coordination,
inform the person administering the injection immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects depend on the dose administered and usually disappear when treatment is discontinued.
Rarely, an allergic reaction may develop, which can cause skin rashes, severe itching, skin peeling, facial swelling (especially around the lips and eyes), tightness in the throat, and breathing or swallowing difficulties, fever, dehydration, shock, and fainting.
All of these are very serious side effects. Contact your doctor immediately if you experience any of these side effects. You may require urgent medical attention.

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

• Visual disturbances (pupil dilation, difficulty focusing, blurred vision, inability to tolerate light),
• 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,
• Lack of sweating,
• Dry skin,
• Urticaria,
• Skin rash.

Common side effects (may affect more than 1 in 10 people)

• Excitement (especially at higher doses),
• Loss of coordination (especially at higher doses),
• Confusion (especially at higher doses),
• Hallucinations (especially at higher doses),
• Overheating of the body,
• Some heart conditions (fast heartbeat, irregular heartbeat, temporary further slowing of heartbeat),
• Hot flushes,
• Difficulty urinating.

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

• Psychotic reactions.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions,
• Seizures (epileptic fits),
• 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 increase in blood pressure.

Not known (frequency cannot be estimated from available data)

• Headache,
• Restlessness,
• Unsteady gait and balance problems,
• Insomnia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atropine Sulfate 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 that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atropina Solfato Accord contains
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.
Each 10 ml syringe contains 1 mg of atropine sulfate monohydrate, equivalent to 0.83 mg of atropine.
The other components are: Sodium chloride, sulfuric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Atropina Solfato Accord and contents of the pack
Atropina Solfato Accord is a clear, colourless solution free from visible particles, contained in a pre-filled clear glass syringe.
Pre-filled syringe of 5 ml made of clear glass (Type I clear glass) with a tip cap, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). Graduations of 0.5 ml are marked on the barrel of the syringe, from 0 ml to 5 ml.
Pre-filled syringe of 10 ml made of clear glass (Type I clear glass) with a tip cap, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). Graduations of 1 ml are marked on the barrel of the syringe, from 0 ml to 10 ml.
The pre-filled syringe is supplied without a needle, packaged in an outer carton.
Atropina Solfato Accord is available in packs containing 1 pre-filled syringe.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
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 B.V.
Winthontlaan 200, 3526KV Utrecht
The Netherlands

The following information is intended exclusively for healthcare professionals:

The pre-filled syringe is for single patient use only. Discard the syringe after use.
Do not reuse.
The product should be visually inspected for the presence of particles and changes in color before administration. Use only clear, colorless solution free from particles or precipitates.
For use with the syringe, needles from 23 to 20 gauge are suitable for intravenous administration and from 23 to 21 gauge for intramuscular administration.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.