Skip to Content

ATROPINE SULPHATE INJECTION BP 400MCG/ML

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Atropine Sulfate 400 micrograms in 1ml Solution for injection
Atropine Sulphate

(Referred to as Atropine Solution for injection in this leaflet)

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

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
1. What Atropine Solution for injection is
Solution for injection are:
• medicines to treat psychosis or depression.
and what it is used for
• amantadine (a medicine for Parkinson’s disease)
• antihistamines (medicines used to treat hayfever
Atropine Solution for injection belongs to a group of
and allergies)
medicines known as anticholinergics.

medicines to regulate your heart (disopyramide and
These medicines are often used:
mexiletine)
• before general anaesthesia to reduce saliva
• ketoconazole (a medicine to treat fungal infections).
secretions
• medicines that you take by allowing them to dissolve
• to restore normal heartbeat during a cardiac arrest
slowly in your mouth – atropine may cause your
• as an antidote to some insecticides and in mushroom
mouth to become dry, making it more difficult for
poisoning.
these medicines to dissolve.
• In combination with other drugs to reverse the effect
of muscle relaxants used during surgery.
Pregnancy and breast-feeding
if you are pregnant or breast-feeding, think you may
2. What you need to know before you are
be pregnant or are planning to have a baby, ask your
given Atropine Solution for injection
doctor or pharmacist for advice before you are given
this medicine.
You should NOT be given Atropine Solution for
injection if:
Driving and using machines
• you are allergic to Atropine sulfate or to any of the
other ingredients of this medicine (listed in section 6). You should not drive or use machinery if you are
affected by the administration of Atropine Solution for
• you suffer from closed-angle glaucoma (a condition
injection.
that affects your eyes).
• you are a man with an enlarged prostate.
• you suffer from myasthenia gravis (weakness of
3. How Atropine Solution for injection is
breathing muscles).
given
• you suffer from pyloric stenosis (a narrowing of the
opening that takes away food from your stomach).
Your nurse or doctor will give you the injection.
• you suffer from paralytic ileus (your intestine stops
functioning properly).
Your doctor will decide the correct dosage for you and
• you suffer from ulcerative colitis – a disease of the
how and when the injection will be given.
colon and rectum.

D0333200000

D0333200000

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, 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.

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.

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

If you think this injection is causing you any problems,
or you are at all worried, talk to your doctor, nurse or
pharmacist.

5. Storing 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.
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 0.04% 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 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:
Macarthys Laboratories Ltd., T/A Martindale Pharma,
Bampton Road, Harold Hill,
Romford, RM3 8UG, UK
Product Licence Number:
Date of last revision:

01883/6122R
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
this medicine.

Continued overleaf

D0333200000

100mm Measurement Verification Bar

D0333200000

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03332
PIL ATROPINE 400MCG/ML

170 x 296mm

29/04/16

BM

16/08/16

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.

Hide