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ATROPINE SULPHATE INJECTION BP

Active substance: ATROPINE SULPHATE

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PATIENT INFORMATION LEAFLET
ATROPINE SULPHATE INJECTION 3MG IN 10ML IN APREFILLED SYRINGE
WHAT SHOULD YOU KNOW ABOUT ATROPINE SULPHATE INJECTION?
This leaflet contains important information· about Atropine Sulphate Injection 3mg in
10ml in a Prefilled Syringe. Please read' this leaflet before you are given this injection.
In some circumstances this may not be possible if you are given this injection in an
emergency.
If you have any other questions or are not sure about anything, ask your doctor or
pharmacist for more information
This leaflet will be kept in a safe place for you should you wish to read it again.
WHAT DOES ATROPINE SULPHATE INJECTION CONTAIN?
This injection contains the active ingredient atropine sulphate. Each 1ml
contains 300 micrograms in a sterile solution for injection.
This injection contains the following inactive ingredients: Sterile Water for
Injections.
The injection is supplied as a single 10ml Prefilled Syringe in a carton
PRODUCT LICENCE HOLDER
hamelnpharmaceuticals ltd
Gloucester
UK
MANUFACTURER
Federa S.C.
Avenue Jean Jaures 71
81030 Brussels
Belgium
WHAT IS ATROPINE SULPHATE INJECTION USED FOR?
Atropine Sulphate belongs to a group of medicines known as anticholinergics. lt can
be used as part of the premedication before general anaesthesia to reduce saliva
secretions, to restore normal heartbeat during a cardiac arrest, as an antidote to organophosphorus
insecticides and inmushroompoisoning, in combination with other drugs to reverse the effect of muscle
relaxants used during surgery.
WHO CAN TAKE THE INJECTION?
The injection can be administered by a doctor to adults and children over 12 years.
BEFORE THE INJECTION IS GIVEN TO YOU
Please tell your doctor or pharmacist before being given the injection if:
• You are pregnant or breast feeding
• You are taking medicine to treat depression e.g. Monoamine oxidase inhibitors or have taken this type
of medicine in the last two weeks
• You are taking any anti-flu drugs e.g. Amantadine
• You are taking nefopam
• You are sensitive or allergic to Atropine
• You are taking other drugs such as mexiletine and ketoconazole
• You have to dissolve any tablet under your tongue this may not be possible whilst taking Atropine
• You are suffering from diarrhoea, difficulty urinating, history of heart attacks, high blood pressure or
fever
• You have anything in the list below
• Loss of vision due to high pressure in the eye (glaucoma)?
• Enlargement of the prostate gland?
• Abnormal weakness or muscle tiredness?
• Paralytic Ileus or stenosis (Stomach Problems)?
• Inflammation and ulceration of the colon or rectum?
• If you suffer from Down's Syndrome?

• Abnormally high heart rate associated with over-active thyroid gland, poor heart function or heart
failure?
If you are going to have an operation, please tell the doctor at the hospital that you are receiving
Atropine. Please tell your doctor or pharmacist if you are taking any other medicines as these may
interfere with this injection.
HOW IS THE INJECTION ADMINISTERED?
The injection should only be administered to you by a member of the medical profession. The amount
of Atropine you will receive depends on your condition and other factors. You may be given another
injection depending on your response to the first injection
The usual doses are:CARDIOPULMONARY RESUSCITATION
Adults and Children over 12 years: 3mg I.V. once only
AS AN ANTIDOTE TO CHOLINESTERASE INHIBITORS
Adults and Children over 12 years:2mg I.M. orI.V. repeat dose every 3-10
minutes until signs of atropinisation appear
AS AN ANTIDOTE TO ORGANOPHOSHATE PESTICIDES AND IN
MUSHROOM POISONING
Adults and Children over 12 years: 2mg I.M. or I.V. repeat dose every 10 - 30
minutes until muscarinic signs and symptoms subside.
IN ARRHYTHMIAS
Adults and Children over 12 years
Bradycardia associated with acute myocardial infarction
0.3mg increasing to 1mg if necessary
Children-Not recommended
Elderly- As for Adults
WHAT SHOULD I DO IF SOMEONE TAKES MY INJECTION?
Contact your doctor or local hospital immediately.
WILL I HAVE ANY PROBLEMS?
Atropine Sulphate Injection may cause drowsiness or blurred vision. You should not
drive or operate machinery after having been given this injection.
Common side effects include dry mouth with difficulty swallowing, thirst, dilation of
the pupils, flushing, dryness of the skin, slow heart beat followed by a fast heart
beat, palpitations, difficulty in passing urine or constipation.
Rare side effects include being sick, rashes and confusion.
If you think this injection is causing you 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 at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
HOW WLI L MY INJECTION BE KEPT?
Your Injection will be kept for you by your pharmacist or doctor.
Maximum storage temperature 25oC.
Protect from light
A use by date can be found on the label, e.g. Do not use after August 2006
Date of Preparation
February 2015
Product Licence No.:
01502/0055

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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