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ATROPINE SULPHATE INJECTION BP 1MG/ML

Active substance(s): ATROPINE SULPHATE

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4. Possible side effects

Package leaflet: information for the user

Atropine Sulphate Injection BP 1mg in 1ml
Atropine Sulphate
(Referred to as Atropine Injection in this leaflet)
Read all of this leaflet carefully before you are given
Atropine Injection
• 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, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.
In this leaflet:
1. What Atropine Injection is and what it is used for
2. Before Atropine Injection is given
3. How Atropine Injection is given
4. Possible side effects
5. How to store Atropine Injection
6. Further 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 as a result of taking
beta-blocker drugs.
Atropine Injection is also given to reduce fluid in the lungs
during general anaesthesia.

2. Before Atropine Injection is given
You should not be given Atropine Injection if:
• you have problems with your prostate, often indicated by a
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 suffer from a muscle disorder known as myasthenia
gravis
Take special care with Atropine Injection
Tell your doctor if:
• you have a fever
• you have an inflamed gut with symptoms of blood and
mucus in the faeces
• you have a heart disorder
• you have acid reflux with heartburn (gastro-oesophageal
reflux)
• you suffer from Down’s syndrome
• you are suffering from diarrhoea
• you have had a heart attack or heart failure
• you have had heart surgery
• you are suffering from high blood pressure
• you are suffering from an overactive thyroid
If you are elderly or if this medicine is being given to your
child your doctor will take particular care.
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 (SSRIs and tricyclic
antidepressants) such as paroxetine
• medicines used to treat severe depression known as
monoamine oxidase inhibitors (MAOIs)
• medicines used to treat schizophrenia and other mental
disorders (buterophenones and phenothiazines) such as
haloperidol and clozapine
• medicines used in the treatment of Parkinson’s disease such
as amantidine and levodopa

• medicines used to stabilise the heartbeat e.g.

disopyramide, mexiletine and digoxin
• nefopam, a pain killer
• medicines used to treat fungal infections such as
itraconazole and ketoconazole
• medicines that are designed to be placed under the
tongue e.g. sublingual nitrates.
• medicines used to treat bacterial infections (antibiotics)
such as erythromycin and clarithromycin
• medicines used to treat HIV such as ritonavir and
atazanavir
• medicines used to treat high blood pressure (calcium
channel blockers) such as verapamil
• medicines used to treat feeling or being sick such as
domperidone and metoclopramide
• ciclosporin, a medicine used to prevent rejection after an
organ transplant and to treat certain skin conditions
• memantine, a medicine used to treat Alzheimer’s disease
• medicines used to treat the muscle disorder myasthenia
gravis and to reverse the effects of an anaesthetic such as
neostigmine, edrophonium chloride and pyridostigmine
bromide
• pilocarpine, a medicine used to treat raised pressure in the
eye (glaucoma)
• medicines used to treat difficulty passing urine such as
bethanechol chloride and distigmine bromide
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or trying to become
pregnant before you are given this medicine. You should not
be given this medicine if you are breast-feeding.
Driving and using machines
Atropine Injection may affect your vision or your mood (you
might become excited or delirious or become confused). If
you feel at all unwell you should not drive or use machinery.

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 under the skin, into a vein or into a muscle.
Adults (including the elderly)
As treatment to increase heart rate:
• 100 micrograms into the vein or under the skin.
For reducing fluid in the lungs during an operation:
• 300 - 600 micrograms under the skin or into a muscle 30
minutes before the anaesthetic
• Alternatively, 300-600 micrograms may be given into a vein
immediately before the anaesthetic.
Children
For drying fluids during an operation (given 30 minutes before
the anaesthetic):
Infants
• Premature
Up to 60 micrograms given under the skin
• Full term
Up to 100 micrograms given under the skin
• 6-12 months Up to 200 micrograms given under the skin.
Older Children
• Up to 20 micrograms per kg of body weight given into a
muscle.
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 receive 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.
Continued overleaf

Like all medicines Atropine Injection can cause side effects,
although not everybody gets them.
If any of the following symptoms occur tell your doctor or
nurse immediately. These are symptoms of a serious allergic
reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other possible side effects include:
• excitement or delirium
• dilated pupils and sensitivity to light
• blurred vision or difficulty focusing
• hot flush
• dry skin, dry mouth, thirst
• difficulty passing urine
• constipation
• an unusually fast, slow or irregular heartbeat
• a dry cough
• an increased need to pass urine
Rare side effects include:
• fever
• a feeling of confusion, particularly if you are elderly
• a rash
• feeling or being sick
• feeling giddy
• raised pressure in the eye (angle closure glaucoma).
If any of these side effects get serious, or you notice any
other side effects not listed in this leaflet, please tell your
doctor or nurse.

5. Storing Atropine Injection
Keep out of the reach and sight of children.
You should not be given this medicine if it has passed the
expiry date shown on the ampoule 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.

6. Further Information
What Atropine Injection contains:
The active ingredient is Atropine Sulphate 0.1% w/v.
The other ingredients are sodium chloride and water for
injections. It may also include sodium hydroxide and sulphuric
acid to make a neutral solution.
What Atropine Injection looks like and contents of the
pack:
Atropine Injection is a clear, colourless solution supplied in
glass ampoules each containing 1ml. The ampoules are
supplied to your pharmacist or doctor in packs of 10.
The Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals, Bampton Road, Harold Hill,
Romford, RM3 8UG, UK
Product Licence Number: PL 1883/6172R
Date of last revision:
March 2009
If you would like any more information, or would like the
leaflet in a different format, please contact Medical
Information at the above address.

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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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