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ATROPINE SULPHATE INJECTION BP 600MCG/ML

Active substance(s): ATROPINE SULPHATE / ATROPINE SULPHATE / ATROPINE SULPHATE

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Package leaflet: Information for the user

Atropine Sulfate 600 micrograms in 1ml Solution for injection
Atropine Sulfate
(Referred to as Atropine Solution for injection in this leaflet)

D03247

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, please ask your
doctor 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
used for
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
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 Solution for injection is
and what it is used for
Atropine Solution for injection belongs to a group of
medicines known as anticholinergics. These medicines
are often used:
• before general anaesthesia to reduce saliva
secretions
• to restore normal heartbeat during a cardiac arrest
• as an antidote to some insecticides and in
mushroom poisoning.
• In combination with other drugs to reverse the effect
of muscle relaxants used during surgery.

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

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 a heart attack
• you have had 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 have diarrhoea
• you have reflux oesophagitis (heartburn)
Other medicines and Atropine Solution for
injection:
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
Solution for injection are:
• medicines to treat psychosis or depression.
• amantadine (a medicine for Parkinson’s disease)
• antihistamines (medicines used to treat hayfever
and allergies)
• medicines to regulate your heart (disopyramide and
mexiletine)
• ketoconazole (a medicine to treat fungal infections).
• 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 you are given
this medicine.
Driving and using machines
You should not drive or use machinery if you are
affected by the administration of Atropine Solution for
injection.

3. How Atropine Solution for injection is
given
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 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 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.

5. How to store Atropine Solution for
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 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.
Do not store above 25°C.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side
effects have been reported.
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:
• drowsiness
• blurred vision
• dry mouth with difficulty swallowing
• thirst
• dilation of the pupils
• flushing
• 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
• vomiting
• confusion especially in the elderly or severe
confusion
• coughing and bringing up phlegm ( bronchial
plugs)
• restlessness
• hallucinations
• changes in the way the heart beats (arrhythmias)
• heart condition ( atrioventricular block) after
heart transplantation
• fever

Keep the ampoule in the outer carton in order to
protect from light.

6. Contents of the pack and other
information
What Atropine Solution for injection contains:
The active ingredient is Atropine Sulfate 0.06% w/v.
The other ingredients are sodium chloride and water
for injections. It may also include sodium hydroxide and
sulfuric acid.
What Atropine Solution for injection looks like and
contents of the pack:
Atropine Solution for injection is a clear, colourless
solution supplied in 1ml, (Type I) clear glass ampoules.
The ampoules are supplied to your pharmacist or
doctor in packs of 10.
The Marketing Authorisation Holder and
Manufacturer:
Mccarthy’s Laboratories Ltd, T/A Martindale
Pharmaceuticals. Bampton Road, Harold Hill, Romford,
RM3 8UG, UK.
Product Licence Number: PL 01883/6169R
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.

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. By reporting side effects
you can help provide more information on the safety of
this medicine.

Continued overleaf

D03247

3247-C

100mm Measurement Verification Bar

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03247
PIL ATROPINE SULFATE 600MCG/
ML
170 x 296 mm

11/03/16

BM

23/03/14

BM

17/08/16

BM

Expand Transcript

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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