Atropine Sulphate Injection Bp
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Atropine Sulphate
(Referred to as Atropine Injection in this leaflet)
Read all of this leaflet carefully before you are given Atropine Injection because it contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or nurse
• If any of the side effects get serious please tell your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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 Atropine Injection is given
4. Possible side effects
5. How to store Atropine Injection
6. Contents of the pack and other information
This leaflet contains a summary of the information available for this medicine. You should ask your doctor or nurse if you are unsure about any aspect of this medicine.
1. What Atropine Injection is and what it is used for
Atropine belongs to a group of medicines called antimuscarinics. These medicines are often used in anaesthesia to reduce the flow of saliva and other body fluids. Atropine may also act on the vagus nerve (a nerve that sends information from the brain to other parts of the body). This helps to make the heart beat faster.
Atropine Injection is used to raise the heart rate if it has become too slow after a heart attack or to restart the heart.
Atropine Injection is also used to treat pesticide and mushroom poisoning and can be used as an antidote for overdose of cholinesterase inhibitors (a type of medicine usually used to treat the symptoms of Alzheimer's disease).
2. What you need to know before you are given Atropine Injection
You should not be given Atropine Injection if:
• you are allergic (hypersensitive) to Atropine Sulphate or any of the other ingredients of the injection listed in Section 6 of this leaflet
• you have problems with your prostate, often indicated by difficulty passing urine, particularly in elderly men
• you have glaucoma (increased pressure in the eye)
• you have difficulty having bowel movements because you have paralysis of the bowel (paralytic ileus)
• you have a condition called pyloric stenosis which means that it is difficult for food to move from your stomach into the small intestine and which causes pain or vomiting
• you have a muscle weakening disease known as myasthenia gravis
• you have an inflamed gut with symptoms of blood and mucus in the faeces.
Warnings and precautions Tell your doctor if:
• you have a fever or the weather is hot
• you have diarrhoea
• you have problems passing urine
• you have thyroid problems
• you have a heart disorder or high blood pressure
• you have acid reflux with heartburn (gastro-oesophageal reflux)
• you have Down's Syndrome
• you have lung disease.
Special care should be taken in children and the elderly.
If any of the above applies to you, please tell your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines including medicines obtained without prescription.
Other medicines which may interact with Atropine Injection are:
• medicines used to treat allergies (antihistamines)
• medicines used to treat depression (tricyclic antidepressants)
• medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs)
• medicines used to treat schizophrenia and other mental disorders (phenothiazines)
• amantadine (a medicine used in the treatment of Parkinson's disease)
• metoclopramide (a medicine used to stop you being sick)
• medicines used to stabilise the heart beat e.g. disopyramide and mexiletine
• nefopam, a pain killer
• ketoconazole, a medicine used to treat fungal infections
• medicines that are designed to be placed under the tongue e.g. sublingual nitrates.
Pregnancy and breast-feeding
This medicine should not be used if you are pregnant, trying to become pregnant or breast-feeding, unless your doctor has recommended it.
Driving and using machines
Atropine Injection may affect your vision or your mood. If you feel at all unwell you should not drive or use machinery.
Continued overleaf
3. How Atropine Injection is given
This medicine is an injection which will be given to you by a doctor. Your doctor will determine the dose you require. It will be given into a muscle or a vein (if a suitable vein is not available then it could be administered using a tube which is inserted into the windpipe).
Adults, the elderly and children over 12 years of age:
As treatment to restart the heart:
3mg (in 10ml) into a vein
repeated if necessary up to a maximum dose of 6mg.
As an antidote to cholinesterase inhibitors:
2mg into a vein or muscle
Repeated every 5-10 minutes until symptoms are reversed.
As treatment for pesticide and mushroom poisoning:
2mg into a vein or muscle
Repeated every 10-30 minutes until symptoms are reversed.
As treatment to increase heart rate:
0.3mg into a vein or under the skin Increasing to 1mg if necessary.
Children under 12 years of age:
Not recommended.
If you think you have been given too much Atropine Injection
This medicine is given to you by your doctor so it is unlikely you will eceive too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment, please talk to your doctor.
4. Possible side effects
_ike all medicines Atropine Injection can cause side effects, although not everybody gets them.
Possible side effects include: dilated pupils and sensitivity to light hot flush dry skin
dry mouth, difficulty swallowing, thirst fast, slow or irregular heart beat (arrhythmias) difficulty passing water constipation.
Rare side effects include: fever
a feeling of confusion a rash
feeling sick and being sick giddiness or excitement.
Reporting of side effects
f you get any side effects, talk to your doctor 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
5. How to store Atropine Injection
Keep out of the sight and reach of children.
You should not be given this medicine if it has passed the expiry date shown on the label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.
store below 25°C. Protect from light.
6. Contents of the pack and other information
What Atropine Injection contains:
The active ingredient is Atropine Sulphate 0.03% w/v.
The other ingredients are water for injections, sulphuric acid and nitrogen.
What Atropine Injection looks like and contents of the pack:
Atropine Injection is a clear, colourless solution supplied in 10ml prefilled syringes.
The Marketing Authorisation Holder:
Aurum Pharmaceuticals, Bampton Road, Harold Hill, Romford,
RM3 8UG, United Kingdom.
Manufacturer:
Martindale Pharmaceuticals Ltd., Bampton Road, Romford,
RM3 8UG, United Kingdom.
Product Licence Number: PL 12064/0057
Date of revision:
November 2013
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom
Aurum
D02600-A