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Atropine Sulfate 600 micrograms/ml solution for injection

Active Ingredient:
atropine sulfate
Company:  
hameln pharma ltd See contact details
ATC code: 
A03BA01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 19 Mar 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL01502/0016R.

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Atropine Sulfate 600 micrograms/ml solution for injection

Package leaflet: Information for the patient

Atropine Sulfate 600 micrograms/ml solution for injection

atropine sulfate

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 further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Atropine Sulfate 600 micrograms/ml solution for injection, which will be referred to as Atropine Injection throughout this leaflet.

What is in this leaflet

1. What Atropine Injection is and what it is used for
2. What you need to know before you are given Atropine Injection
3. How to use Atropine Injection
4. Possible side effects
5. How to store Atropine Injection
6. Contents of the pack and other information

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

Atropine Injection belongs to a group of medicines known as anticholinergics. It is used:

  • before general anaesthesia to reduce saliva secretions and prevent changes in your heart rate that may occur before or during an operation.
  • in emergency situations when the heart beats too slowly.
  • to increase an abnormally low heart rate during an operation
  • as an antidote to some insecticides and in mushroom poisoning.
  • in combination with neostigmine to reverse the effect of muscle relaxants used during an operation.

2. What you need to know before you are given Atropine Injection
You should NOT be given Atropine Injection if you:
  • are allergic to Atropine Sulfate or to any of the other ingredients (listed in section 6) in this injection.
  • suffer from angle closure glaucoma or narrow angle glaucoma (a condition that affects your eyes).
  • are a man with an enlarged prostate.
  • suffer from myasthenia gravis (weakness of breathing muscles).
  • suffer from pyloric stenosis (a narrowing of the opening that takes food away from your stomach).
  • suffer from paralytic ileus (your intestine stops functioning properly).
  • suffer from ulcerative colitis – a disease of the colon and rectum.
  • suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Atropine Injection if you:

  • have urinary difficulties
  • have heart failure
  • have had a heart attack
  • have rapid and irregular heartbeat
  • have a heart disease caused by narrowing or blockage of blood vessels supplying the heart muscle
  • have had a heart transplant
  • have chronic pulmonary obstructive disease (a condition where the airflow to your lungs is restricted and you may cough and feel breathless)
  • have an overactive thyroid
  • have high blood pressure
  • have fever
  • have diarrhoea
  • have reflux oesophagitis (heartburn)
  • have liver or kidney disease

Other medicines and Atropine Injection

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Atropine Injection:

  • medicines to treat psychosis (such as clozapine) or depression
  • amantadine (a medicine for Parkinson’s Disease)
  • anti-histamines (medicines used to treat hay fever and allergies)
  • medicines to regulate your heart (disopyramide and mexiletine)
  • ketoconazole (a medicine to treat fungal infections).
  • domperidone and metoclopramide (medicines used to prevent or treat sickness and vomiting)
  • phenylephrine (may be present in cough or cold medicine)
  • medicines that you take by allowing them to dissolve slowly in your mouth – atropine may cause your mouth to become dry, making it more difficult for these medicines to dissolve.

Pregnancy and breast feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.

Driving and using machines

You should not drive or use machinery if you are affected by the administration of Atropine Injection.

3. How to use Atropine Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

If you are given more Atropine Injection than you should

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, or you begin to feel your heart beating very fast, you are breathing quickly, have a high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection immediately.

4. Possible side effects

Like all medicines, Atropine Injection can cause side effects, although not everybody gets them. The following side effects have been reported with frequency not known (cannot be estimated from the available data):

  • Anaphylaxis
  • drowsiness
  • blurred vision, dilation of the pupils and sensitivity to light
  • dry mouth with difficulty swallowing
  • thirst
  • fever
  • flushing
  • dryness of the skin, rashes
  • slow heart beat followed by fast heart beat
  • palpitations (you are aware of your heart beating)
  • changes in the rhythm of your heart (arrhythmias)
  • difficulty in passing urine or constipation
  • nausea, vomiting
  • reduced stomach acid production, heartburn
  • confusion, especially in the elderly
  • restlessness and delirium with high doses
  • dizziness

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atropine Injection

Keep this medicine out of the sight and reach of children.

Your injection will be stored at less than 25°C and protected from light.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

6. Contents of the pack and other information
What Atropine Injection contains

The active ingredient is Atropine Sulfate. Each 1 ml of solution contains 600 micrograms of Atropine Sulfate in a sterile solution for injection. Each 1 ml ampoule contains 600 micrograms of Atropine Sulfate.

The other ingredients are sulfuric acid and water for injections.

What Atropine Injection looks like and contents of the pack

Atropine Injection is supplied in 1 ml clear glass ampoules. 10 ampoules are supplied in each carton.

Marketing Authorisation Holder
hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany

hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic

HBM Pharma s.r.o.
03680 Martin
Sklabinská
Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last revised in February 2025

xxxxxx/07/25

hameln pharma ltd
Company image
Address
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
WWW
https://www.hameln-pharma.com
Telephone
+44 (0)1452 621 661
Fax
+44 (0)1452 632 732
Medical Information e-mail
[email protected]