ATROPINE SULPHATE INJECTION BP 1MG/ML
Active substance(s): ATROPINE SULPHATE / ATROPINE SULPHATE / ATROPINE SULPHATE
Atropine Sulfate 1mg in 1ml Solution for injection
(Referred to as Atropine Solution for injection in this leaflet)
Read all of this leaflet carefully before you start using
this medicine because it contains important information
• Keep this leaflet. You may need to read it again
• If you have any further questions, please 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.
What is in this leaflet:
1. What Atropine Solution for injection is and what it is
2. What you need to know before you are given
Atropine Solution for injection
3. How Atropine Solution for injection is given
4. Possible side effects
5. How to store Atropine Solution for injection
6. Contents of the pack and other information
1. What Atropine Solution for injection is
and what it is used for
Warnings and precautions
Talk to your doctor, pharmacist or nurse before being
given Atropine Solution for injection if:
• you have urinary difficulties
• you have heart failure
• you have had heart attack
• you have a heart transplant
• you have chronic pulmonary obstructive disease (a
condition where the airflow to your lungs is restricted
and you may cough and feel breathless)
• you have an overactive thyroid
• you have high blood pressure
•you have a fever
• you are suffering from diarrhoea
•you have reflux oesophagitis (heartburn)
Other medicines and Atropine Solution for
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken, or might take any other medicines
including medicines obtained without prescription.
Other medicines which may interact with Atropine
Atropine Solution for injection belongs to a group of
medicines known as anticholinergics. These medicines Solution for injection are:
• medicines to treat psychosis or depression.
are often used:
• amantidine (a medicine for Parkinson’s disease)
• before general anaesthesia to reduce saliva
• antihistamines (medicines to treat hayfever and
• to restore normal heartbeat during a cardiac arrest
• as an antidote to some insecticides and in mushroom • medicines to regulate your heart (disopyramide and
In combination with other drugs to reverse the effect of • ketoconazole (a medicine to treat fungal infections).
muscle relaxants used during surgery.
Pregnancy, fertility and breast-feeding
If you are pregnant or breast-feeding, think you may be
2. What you need to know before you are given pregnant or planning to have a baby, ask your doctor
Atropine Solution for injection
or pharmacist for advice before you are given this
You should not be given Atropine Solution for
• you are allergic to Atropine Sulfate or to any of the
Driving and using machines
other ingredients of this medicine (listed in section 6). You should not drive or use machinery if affected by
• you suffer from closed-angle glaucoma (a condition
the administration of Atropine Solution for injection.
that affects your eyes).
• you are a man with an enlarged prostate.
3. How Atropine Solution for injection is
• you suffer from myasthenia gravis (weakness of
• you suffer from pyloric stenosis (narrowing of the
Your nurse or doctor will give you the injection.
opening that takes away food from your stomach).
• you suffer from paralytic ileus (your intestine stops
Your doctor will decide the correct dosage for you and
how and when the injection will be given.
• you suffer from ulcerative colitis – a disease of the
colon and rectum.
If you think you have been given too much Atropine
Solution for injection than you should be given:
Since the injection will be given to you by a doctor or
nurse, it is unlikely that you will given too much. If you
think you have been given too much or you begin to
your heart beating very fast, you are breathing quickly,
have high temperature, feel restless, confused, have
hallucinations, or lose co-ordination you must tell the
person giving you the injection immediately.
5. How to store Atropine Solution for
4. Possible side effects
Do not store above 25°C.
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side
effects have been reported.
Keep the ampoule in the outer carton in order to
protect from light.
Contact your doctor or nurse immediately if you get
any of the following:
• Sudden life – threatening allergic reaction such as rash,
itching or hives on the skin, swelling of the face, lips,
tongue or other parts of the body, shortness of breath,
wheezing or trouble breathing.
Other Side effects include:
• blurred vision
• dry mouth with difficulty swallowing
• dilation of the pupils
• dryness of the skin
• slow heart beat followed by fast heart beat
• palpitations (you are aware of your heart beating)
• difficulty in passing urine or constipation
• confusion especially in the elderly or severe
• coughing and bringing up phlegm ( bronchial
• changes in the way the heart beats (arrhythmias)
• heart condition ( atrioventricular block) after
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 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
6. Contents of the pack and other
What Atropine Solution for injection contains:
The active ingredient is Atropine Sulfate 0.1% w/v.
The other ingredients are sodium chloride and water
for injections. It may also include sodium hydroxide and
sulfuric acid to make a neutral solution.
What Atropine Solution for injection looks like and
contents of the pack:
Atropine Solution for 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
Macarthys Laboratories Ltd, T/A Martindale Pharma,
Bampton Road, Harold Hill,
Romford, RM3 8UG, UK
Product Licence Number: PL 01883/6172R
This leaflet was revised in: August 2016
If you would like any more information, or would
like the leaflet in a different format, please contact
Medical Information at the above address.
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. By reporting side effects
you can help provide more information on the safety of
100mm Measurement Verification Bar
PIL ATROPINE SULFATE 1MG/ML
170 x 296 mm
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.